safety concerns

Without admitting that there is a problem with generic drugs, the  U.S. Food and Drug Administration has just announced that it is initiating a $20 million testing program. The FDA’s new Office of Pharmaceutical Quality will scrutinize generic drugs, over-the-counter medications and brand name products in an effort to improve quality.

This is an incredible about-face by the FDA and a huge victory for patients. It is also a testimony to the thousands of stories people have shared on this and other web sites about their problems with generic drugs. In particular, the FDA admits that the new testing program evolved in part from the discovery that a generic version of Wellbutrin XL 300 (Budeprion XL 300 from Teva) was not bioequivalent to the brand name. That was a direct result of hundreds of patient reports on this website.

The FDA still states on its website that:

“All generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs, and the generic products must meet the same exacting specifications as any brand name product.”

That may seem reassuring, but it is quite clear that the FDA has not had the resources to regularly monitor manufacturing abroad. Serious flaws in foreign pharmaceutical plants have come to light in recent years. India now supplies 40% of over-the-counter and generic medications sold in the U.S. The FDA inspected 160 Indian drug plants in 2013 out of the 500 that are registered to export medicines to the U.S. That might not seem like many, but it is three times more than were inspected in 2009.

FDA Commissioner Margaret Hamburg, MD, is just back from a trip to India where she was presumably trying to improve quality standards. Improvement is essential. The FDA recently banned all exports from Ranbaxy, the largest drug company in India, because of concerns about faulty data and flaws in manufacturing. Another large Indian company, Wockhardt, also came under fire in recent months because of serious violations. It too has had drugs banned from the U.S. market.

Sadly, the top drug regulator in India seems to have undermined Commissioner Hamburg’s trip. Even before the ink was dry on a statement of cooperation between India and the U.S., the top Indian drug regulator was quoted:

“If I have to follow US standards in inspecting facilities supplying to the Indian market, we will have to shut almost all of those. We are not the US, the infrastructure and resources available there are much different from those in our country. Our priority is to make medicines available and affordable to all.” He also went on to say, “We don’t recognize and are not bound by what the US is doing and is inspecting…the FDA may regulate its country, but it can’t regulate India on how India has to behave or how to deliver.”

Things may be even worse in China. Only 78 inspections were carried out there last year. An effort to increase the number of inspectors on the ground in China has been blocked by Chinese authorities. Even though the FDA has new staffers ready to start inspections, visas for these people have been denied. There is also a problem with surprise inspections, which are not feasible in China. If manufacturers have to be informed in advance that FDA inspectors will be coming, the value of the inspections is questionable.

That is why we are so excited about the FDA’s new Office of Pharmaceutical Quality and the new testing program. Initially, about a dozen academic centers, including Duke University, University of North Carolina, University of Michigan, University of Maryland, Johns Hopkins University and Brigham & Women’s Hospital in Boston, will be involved in generic drug testing. These institutions will be examining the very medications that visitors to this website have been complaining about, including ADHD drugs, anti-seizure medicines, heart drugs, immunosuppressants and antidepressants.

If independent generic drug quality assessments are carried out by academic researchers, it will go a long way towards improving the current honor system that the FDA has relied upon for decades. Once generic manufacturers realize that their products will actually be tested they may clean up their act. Ultimately, this new program could go a long way toward reestablishing trust in generic medications.

To see why we are in desperate need of a verification system, here are some reports from visitors to this website.

“I am a recently retired family doctor of 35 years. This problem goes back at least 20 years. It was and still is most noticeable in psychiatric drugs which I used a lot in my clinic.

“Patients often found that when the pharmacy would change generic manufacturers they would lose control and as soon as they went back to the original drug maker they felt better within days. One person was on buproprion (Wellbutrin) and 3 different generics didn’t work and within 3 days she could tell a MAJOR improvement back on the brand.

“In the last few years prices of very inexpensive generics that have been available for many years have suddenly gone up 3-10 times the previous price, often over a few months. Many prices are only slightly less than the brand name.” Dr. E.W.L.

“I suffer from Obsessive Compulsive Disorder and had taken Zoloft for 5 years with excellent symptom relief. Within a week of switching to the generic sertraline, my symptoms returned full force.

“At first I had no idea what was happening, but then I started thinking that maybe it was the switch to the generic. I returned to brand name Zoloft and my symptoms stopped within a few days.

“My insurance company refused to pay for the brand name Zoloft even after my doctor told them it was medically necessary. I tried the generic several more times with the same results each time.

“I now must pay over $200 a month for my brand name Zoloft because insurance won’t cover it. If I want a normal life, I have no choice.” C.K.

“I was using Cardizem HCI 300mg. The prescription for name brand is no longer paid for. After trying a generic from a major discount store, it failed to control blood pressure, and I ended up in the hospital with A-fib.

“After checking around I found the generic version was in fact made in India. I did research and found a generic called Cartia XT by Watson produced in California; it actually works better than Cardizem. Do you homework when looking for generics.” R.J.W.

“Several years ago my husband was prescribed Norvasc for slightly elevated systolic blood pressure. The pharmacy filled the prescription with a generic form (amlodipine). Nothing happened. It did not work.

“One month later I had the doctor send a new prescription calling for the original Norvasc. It works. It is quite expensive, though.” P.L.S.

“I have used brand name Valium for decades on an as needed basis. No problems.

“Last year I was sent a generic and decided to try it. Within 20 minutes a friend looked at me over the card table and asked if I was all right. I felt totally out of it and could hardly focus. I have destroyed the bottle, and don’t know the manufacturer.

“6 or 8 years ago I was on Toprol XL for A-fib. I could use 25mg, which I did once or twice every 2 weeks, and that seemed to work fine. But when I was sent the generic metoprolol for Toprol XL I went into A-fib 7 or 8 times in a 2 week period. That was the end of that!” S.D.

“My Wellbutrin XL 300mg was changed to bupropion and within 3 months my family was concerned. I was showing traits of when I first broke down. I called my doctor, went in, took the bottle with me. She cancelled that immediately and put me back on Wellbutrin and told me to always make sure every doctor put “DAW” (dispense as written) on further prescriptions.

“Within a few weeks I was doing fine. Since then I question every generic as there is not enough info as to where it is made, what country made it, what was in it, etc. Why should we depend on foreign countries to take care of our basic medical needs when they are not as developed as this country is. That is turning our lives over to questionable facilities.” Carol

“I have tried to go generic for Keppra (levetiracetam), an epilepsy drug. I have been on Keppra without a problem for eight years . But I am jobless and Keppra costs thousands a year. To save money I have tried two generics. Neither works. Both cause itching, burning, and lethargy.” L.C.

“My daughter started having grand mal seizures at 10 years old in her sleep. Despite many tests, they could never find the cause of her condition. At first she was only having a few seizures in her sleep lasting between 20-60 seconds. When she was around 13 the seizures were happening more frequently, about once a month instead of a few times a year.

“At this time I decided to put her on meds. They started her on Keppra 500 mg twice a day. No seizures for 25 mos., not one. We thought we were in the clear. Then the generic came out and the insurance company will only pay for the generic because of course it all comes down to money.

“The pharmacy informed me there is no difference between the generic and the brand and just switched her without even notifying or asking the doctor. Since then she has been having relapse seizures. Every month the pills are different shapes, sizes, and colors. My neurologist informed me there are 28 different companies that manufacture this drug and none of them can be 100% identical. The doctor is very adamant about the generics being responsible and he is outraged by this. He has many patients experiencing the exact same thing with the generic form of Keppra.

“He wrote a letter to my insurance company demanding she be on the brand. I don’t know how they approve drugs that don’t work with something like this.

“I have switched my daughter back to the brand and I am paying for it. I will never put her back on the generic.” E.P.

Share your own experience with generic medications below. Let us know what you think about the FDA’s new generic testing program. We will let the FDA know what you think of their new program.

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  1. Rhonda

    I’ve found it doesn’t matter what any one of us do. Insurance companies can tell our physicians what is/ is not medically necessary. They can also tell our physicians every patient responds exactly the same to a generic drug versus a brand name.

    I’ve taken Adderall XR 20mg for ten years to combat my Multiple Sclerosis fatigue. Mind you, I’ve NEVER had a dosage increase!! Therefore I am not a drug abuser. I simply cannot function physically nor cognitively without it.

    That being said, my insurance company has removed this brand name from coverage, and I cannot take the generics. I have horrific side effects, and it doesn’t work. My doctor filed for an exception and was denied. Then she filed the appropriate appeal and was denied.

    Why would one think an insurance company who doesn’t know me from Adam’s house cat knows better than my neurologist of fifteen years!! UGH!! No one cares, and honestly this should be illegal!! I’ve already filed complaints with the FDA. I’m fairly certain that went nowhere!

  2. Sher

    What can people do about the substandard generic prescriptions? So many of them come from India or 3rd. world countries where quality controls are very questionable.

    A recent open heart patient, I’ve had several BP meds. (Metoprolol succinate, for one) and Statins (several versions) that I simply cannot tolerate due the side effects from inert ingredients and, as a result, have been forced to stop taking all. Many generics for sleeping medication (Ambien & Restoral) are equally offensive.

    Complaining to pharmacies is essentially useless, since the primary goal is their bottom line… not positive patient outcomes. 90-day Rx. refills obviously compound the problem. How can patients voices be effectively be heard? Other than your site, I haven’t been able to find any way to publicly complain. Kind of amazing in today’s online world.

  3. Linda
    Rogers, Arkansas

    I have also had “bad” experiences with certain generic. I found it interesting that some of the generic manufactures listed worked well for me ie TEVA, for Estradiol, Sandoz for Alprazolam (DAVA for Alprazolam was worthless). Also I was switched from brand name Intuniv to Actavis generic version of Intuniv and couldn’t tell the difference. Then my ins forced me to take MYLAN and I became zombie headed and yet had poor impulse control and more fidgets (Intuniv helps people with ADHD like me be stiller) I now have to pay for non time release “Guanfacine” ins co states it isn’t for adults (this is what I took before long acting Intuniv was available). It works well and thank thank God the the generic “AMNEA” is only $32.00/mo.

    I too experienced a generic that did harm to me. I take Duloxetine for severe depression and pain. CITRON was the latest generic switch but worked OK. Then the pharmacy said I had to take a dif generic. It was the Actavis form Duloxetine I thought it would be fine as Actavis Intuniv did fine for me. (I was on 90mg/night CITRON generic.) I took the Actavis for about 1 week and began having involuntary muscle spasms gradual at first then so bad my spouse told me that he clung to his side of the bed at night as I was kicking and flailing my arms all night. Also I was awake hourly. As soon as I dropped the dose to 60mg , I was better, tho I was so stove up that it was hard to move. I had been in touch with my DR who chgd the dose but even at 60mg I was “flying” mentally and physically, pupils dilated talking none stop. My Dr said try to get CITRON from pharmacy and they were able to do that. I resumed the CITRON Duloxatine at 60 mg for a few days and then back to 90mgdoing fine and even better sleep as before. So my thinking is that some people do well with a generic that is horrible for other. That is not uniform formulation.

    Now my spouse has had severe depression and anxiety for several years. The only thing that helps the anxiety is Tranxene. (without it he has been hospitalized for High B/P and chest pain. He has 2 aneurysms Thoracic aorta and aortic valve so this can be life threatening. Long story short his Dr. keeps him on the generic Tranxene. About 6 months ago the only generic for Clorazepate became MYLAN which was much weaker than other-Dr had to increase dose from 7.5mg 5x/day to 15mg TID. Then the cost went sky high and the supply became scarce. He paid $250.00 the first month. We used at Walgreens for the next fill cost $75.00. Next mo it was $100.00. At end of Dec cost $75.00 but had to give partial fill and were unable to order filled till maybe Feb 17th. Walgreens filled the bal with 7.5 mg. I am trying to get him to consider trying Clonazepam (he has tried Xanax/Ativan/Valium and they just do not manage the anxiety.

    Your site has been very helpful to me learning the dif generics making Clonazepam and dif peoples opinion of them. I want to let the FDA know that Generics are not the same. Even Drs have told me there can be up to 20% difference. I want to let congress know too since I think Ins will try to make all people use the cheapest generic. I plan on getting that done. I am slow because I get sick a lot from an immune globulin deficiency. By the way 2 reps from my RX ins told me that if my Dr. writes on the rx fill with “name of the generic brand you think best” that the pharmacy will fill it and ins will pay (even without special documentation) I have yet to test this statement.Thanks for your time.

  4. Brian

    I hope all these people are filling out complaints on the fdma wweb site. Maybe if enough are filed asome real action will be triggered.

  5. Carrie
    Carlsbad, CA

    Well , I won’t even get started on how emotionally upset I am and how negatively not having the equivalent medication to help me with my condition had impacted my life. I would rather focus on getting and sticking with the one company that actually makes the best and equivalent to the brand name of adder all which is the Sandoz tablets made by Eon Laboratories. Most the other generics made by other companies are sugar pills or rather headache pills and simply just do not work I would expect this kind of thing from the drug trade on the streets for many addicts who use and end up selling to afford their own habits usually cheat buyers buy selling them fake stuff and or significantly lesser quality in order to afford the good stuff.
    I don’t expect this to happen with drug companies regulated by the FDA but it’s happening folks. These drug companies are cutting drugs , using cutting agents and some of them have no substance hardly at all. And it’s wrong.

  6. Marion M.

    I suspect that the Warfarin it take has changed in the last year is not up to the same quality and strength that Coumadin is. This is based on the problems i have had keeping my PT/Inr up to therapeutic levels.

    Any chance you could do a follow-up on this FDA Agreement?

  7. Rod

    A number of years ago I had taken Lamictal with decent results when added with Neurontin. I felt a decrease in anxiety the next day. Years later I was going through a tough time, and my doctor put me back on the combo except this time NOTHING happened! The next day I didn’t notice any decrease in anything. I had a terrible careless doctor, and he would keep me on meds despite no improvement.

    I figured I should give the combo more time, and after 6 weeks of nothing I should’ve stopped the meds but I didn’t. A year later I was still on the same combo with no results, and even had to take time off work yet my dr just kept me on the same pills!!!! I suffered severe side effects from the generics and probably almost died. It turned out that the generics were making me much much worse, and I didn’t realize that generic drugs are garbage.

    I have no idea why I was so stupid to keep taking a med that not only wasn’t helping but making me worse. This same doctor eventually prescribed a very dangerous combo of meds, and I should’ve NEVER taken it. Two days after taking it I started feeling very sick and told my fiance that I wanted to stop taking it. She demanded that I keep taking it because of her own psychological issues. Since we were on vacation, and I had already dealt with a whole day of silent treatment from her, I did NOT want to experience anymore silent treatment so I kept taking it against my wishes. Two weeks later I was rushed to the hospital and suffered brain, nerve, muscle and kidney damage.

    This has ruined my life so badly you would not believe it. Never in my life have I been so sick, and the damage looks irreversible. All I can say is anyone taking medication be absolutely sure you need it. In other words, if you don’t take it will you die? If the answer is no I would be reluctant to ever take it. As for myself? My life is completely ruined, and I don’t even care anymore about anything or have any interest in anything that I used to. I’m beyond sad that I got involved with such a person that my fiancé was, and if I had broken up with her after the first sight of red flags I would be fine right now, but I am not.

  8. Ninaz
    Fremont, Ohio

    I have taken brand name Protonix for 12 years. It has been the only thing that has helped my gerd and other stomach problems. I have tried everything out there that was and is available. Nothing worked and I suffered because of it . Burning, stomach pain , nausea, acid up in my throat burning like a blow torch. Went to the E. R. Once for terrible symptoms. They thought I might be haveing a heart attack. A few years ago my insurance co. would no longer cover my brand name med. That is when I had to try other products before they would even consider covering it with prior authorization. The generic was absolutely worthless for me. After a long suffering road I now every year have to have this fight with the insurance co. about taking the brand name Protonix.I even had a rep I was talking to suggest that it was “all in my head” that even the generic didn’t work! Who are these companies that can tell you and your doctor what is best for each individual? I take all generic drugs with no problems yet except I do need the brand name Protonix in my case. Generics are NOT the same,I don’t care what anyone else says and I know I’m not alone!

  9. Vicky

    I have used the named brand Klonopin for over 20 years for severe anxiety, OCD, post traumatic disorder, and extreme panic attacks. Back in 2009 my insurance would no longer cover named brand so the pharmacy dispensed generic. I thought at the time it was a good idea because it would save money. I took just 1 and it caused my mouth, throat, and stomach to burn for 3 days! It seem to take effect quicker but didn’t work as well. The ingredients used to bind the tablet together had something that caused this reaction.

    I even contacted MEDWATCH and filled a complaint due to adverare reaction. The pharma company is purpac /Ativartis. The pill was hard as a rock. Named brand isn’t hard. I immediately went to the named brand and haven’t had any problems. There are several pharmas who make the generic clonazepam but I don’t know WHICH one makes it that isn’t hard and is more dissolvable like the named brand and one that will actually work. I know my body and I know named brand is far superior than generic. Needless to say I have to pay “out of pocket” over $235.00 monthly on a fixed income to live a life without debilitating issues. It’s the difference between life and no life at all for me I hope someone will do something.

  10. Ann

    I was changed from name brand cymbalta to generic , my depression started coming back. My dr said name brand medically necessary they still denied it, I appealed, they still denied it. My neurologist told me to order from Canada as I could continue to get name brand, he faxed a script to reputable pharmacy in Canada and I now get 90 days name brand from there for less than my co pay was in the USA.
    It is sad that we have to get our name brand meds from another country because our insurance won’t pay for it and then the USA charges ridicules high prices for name brand if we want to keep it. The USA is the only country that charges these high prices for name brand meds. It is shameful that we are forced to take generics that do not work and are not equivalent.

    • TL

      What is the name of the Canada pharmacy your doctor faxed the prescription to?

  11. Catharine

    This site is so helpful and informative. It’s unthinkable that our pharmaceutical companies would be causing harm rather than healing and health. Profit above lives creates a twisted and inhumane system. There must be avenues to correct this or atleast let voices be heard. Loudly! I ,too, have recently had a similar experience of withdrawal and anxiety with a new generic change for klonopin . I am into the third day of feelings of withdrawal, have moved to a new city not medical connections, and am also a neurological pain patient. Not sure where to turn, but am leaning towards complete withdrawal. All of the my choices for meds seem to be poor ones and the medication that was acceptable is no longer available to me. The writer is right…it’s just wrong. But no seems to be listening unless it’s personal for them.

  12. JJ

    Over three months ago in July 2015 my AFIB returned after a two year vacation (two years ago, my AFIB suddenly disappeared after my thyroid dose was corrected, and after a few weeks of generic Cardizem (sorry had no reason to ask who the manufacturer was back then ).

    Beginning in July 2015, after 90 days of successfully taking the dilitiazem/Cardizem Cartia XT, that was made by Par Farma, I changed to a different pharmacy who was using Cartia XT, generic cardizem manufactured by Actavis. Within a few days I noticed that my heart was racing for no apparent reason (i.e., no new stress, or heavy exercise) shortly after taking my daily dose. I was worried that things were getting worse for my heart. My doctor was on vacation and since they always leave patients in the care of a nurse practitioner, for such dangerous matters as out of control Atrial Fibrillation, the nurse practitioner told me to wait until he returned from vacation and make an appointment when he returns in two weeks. Even the on-call doctor did not ask any questions and told me to see my doctor in two weeks. They could have asked “Has anything new happened; did you change or add medications? etc., Why don’t doctors need to ask questions anymore?

    I decided to investigate whether the change in pills made the difference because the color was different and these bad reactions began right after I began taking the new orange pills from the new pharmacy. The pharmacist told me that the manufacturer was different and that the formulations are supposed to be identical except for additional additives.

    I felt convinced that the change in pills was causing my increased heart rate, and asked the pharmacies to change me back to the Cardizem made by Par Farma, and the very next day when I took the first pill, (the same formulation made by Par Farma taken the first 90 days) everything was fine. There was no racing of the heart up to 140 beats per minute as had happened the previous day on the dose made by ACTAVIS.

    This terrifying experience ( it is terrifying to know that AFIB, when it is too high can damage the atrium, as it did mine two years ago) Potentially too long a time with excessive AFIB can make one more vulnerable to heart attack. So it is absolutely critical that all generic manufacturers be required to make the medicines exactly the same as the Brand, which had passed the original testing due to its content and ingredients.

  13. Eric

    I too have been taking clonazepam for several years for panic disorder, generalized anxiety, and bipolar mood swings. I’ve never had brand name Klonopin to compare, but I when I started clonazepam, it was TEVA generic. The pharmacy I went to always dispensed the TEVA generic for the whole 2 years I went there. Then, I switched pharmacies due to a change in my insurance plan. The new pharmacy gives me a different generic almost every month. They had TEVA at first, then I got Mylan. Next was Qualitest. The latest one I got is EON Labs. The TEVA is the only clonazepam I had ever experienced, so I compare the others to it. The Mylan was not too bad, maybe even a quicker onset. The qualitest seemed to eventually get me to where I needed to be but took longer. This new one from EON Labs seems less potent to me. My anxiety is worse and it does not give me the same longer lasting sense of calmness as the others. It is important to note that although generics have to have the exact same active ingredient and the exact same amount in their products, they are not guaranteed to be absorbed to the same extent or at the same rate. These are measures of bioavailability. It is my understanding that a generic, with the same active ingredient and same amount in the product, is allowed a 20% difference from the referenced brand in terms of bioavailability. So, if one generic is 20% less bioavailable and another is 20% more bioavailable, you could end up getting 2 generics that differ by 40% from each other in bioavailability (referenced to the brand). For some drugs this can be a major issue – like seizure drugs for example. Many of them have to be kept in a very narrow range for safety and/or effectiveness. I hope the FDA makes the standards for generics more rigorous so that they are truly the same as the brand name.

  14. Eric

    I myself was prescribed xanax for quite sometime and found that the only generic that even compared to the name brand 2mg bars was Greenstone. The reason why is because Greenstone is a division of Pfizer who manufactures the name brand xanax. And I’ve tried A LOT of the generic alprazolam bars.

    The yellow Actavis seemed to hit fast and hard, but didn’t last long at all (alprazolam doesn’t last long in the first place). Mylan made the “pies” that were circular wafers that had break lines on the back that you can break into four .5mg pieces, similar to the bars. Those had terrible side effects and made me drowsy as hell. The Sandoz bars came on strong, lasts a good amount of time, but felt kind of “dirty” if that makes sense. The green bars made by Dava were probably my second favorite generic next to Greenstone, which I SWEAR is just as good as the name brand. They even have the same pill press with the ridge in the middle break line on the back of the pill.

    The only difference was the markings. The name brand had xanax written on the front, and a 2 on the back of the pill, whereas the Greenstone had G 372 2 on the front and no imprint on the back. But I swear they’re identical in quality to the name brand.

    Recently I was switched to clonazepam. Two 2mg pills in the morning and one or two 1mg pills before bed. I got Teva generics for the 2mg, and Mylan for the 1mg. This is my first month on them and I never had the pleasure of trying the name brand for comparison, but I will say the Teva’s are okay while the Mylans are inconsistent with pretty bad side effects. They make me drowsy, when they even work. That’s how inconsistent they are.

    My next refills I’m trying 2mg Qualitest, and 1mg Actavis as I hear those are good as far as generics go. But someone REALY needs to look into Mylan for their poor quality clonazepam. I’ve searched the web and apparently I’m not the only one who has a problem with their clonazepam.

    I have social anxiety disorder and panic attacks by the way. Xanax seems better at treating them and clonazepam seems better at preventing them. It’s a travesty that these drugs which are not only habit forming, but are used to treat serious conditions are so poorly regulated. America’s health care system and capitalism/greed are the root causes of these problems. Good luck and God bless.

  15. bill
    south amboy nj

    I have been suffering with seizure activity for most of my life. I thought I would die from it. I went to school to learn a trade, started a business as well. then I was put on keppra my seizures stopped. But then the generics came in to play. I began having worse seizures then before. They put me on levecetam or something like that. I lost my business cause they interfered with my work. Now I’m back on keppra the seizures have stopped but at the same time cause of the strain of having them again I cannot work anymore. And I’m still fighting the insurance cause they will not supply it. My future is in the hands of the government.

  16. Roberta

    This is about making sick people sicker & lying about it for years while they suffer & again more white collar crime! These company’s should be convicted for torturing people. And to add insult to injury.. We pay good money for bad & unsafe drugs that are poisoning us.
    Put generic Keppra XR by Teva on the inspectors list because it is making me sick & brand is unaffordable. I took brand & Teva doesn’t come close. Side effects are horrible & break through seizures are an everyday occurrence. These drugs have ruined the quality of my life & everybody else who is forced into this inhumane experience of how big pharma is getting paid to make us sick. This is so wrong & hard to believe .
    I’m hoping there will be class action suits galore against these criminal & those that supported them all these years.

  17. Scribe

    Generic drugs that are not effective and/or cause unwanted side effects are a punishment for anyone who is ill. We can usually tell the difference when we don’t know we’ve been switched to a generic.
    Twice now within the space of a few months those who cannot afford the brand name anti-depressants Wellbutrin and Cymbalta (the latter also used for anxiety, as well as pain relief from fibromyalgia) have been compelled to experience a return of symptoms and intolerable side effects as the generics fail to deliver. The downward spiral is heartbreaking.
    In February the patent for Cymbalta ran out. The generic substitute Duloxetine looks exactly like the brand capsules; same colors, same size. Only the writing on them is different. Symptoms while taking the generic were a fuzzy feeling in the head, insomnia for periods lasting more than 48 hours, pain, feeling flat and remote as positive emotions disappeared, and the resurgence of purely depressing and anxiety provoking thoughts. Theorizing that a different delivery system might require a change in time of administration, experiments ensued. But the drug simply didn’t work and the Brand had to be purchased to feel normal again. This is not acceptable. What to do with 168 useless, though not inexpensive generic capsules? Into the closet they go with all the other containers of unusable generics.
    Who, specifically, is making a lot of money on products that are not what they claim to be?
    The problem isn’t limited to brand vs. generic.
    It’s generic vs. generic, too, as in the case of Bupropion 300 XL, brand name Wellbutrin. After several years of heated debate in which there were hints that the contentions of complainants might be attributable to their ‘conditions’, the FDA finally asked the drug companies to retest their products. It was determined that some of the generics lacked bioequivalence. Consumers, who had known immediately, were again forced to jump from one generic to the other in search of relief, just as they had in 1999 when the original patent expired.
    Watson decided to pull their effective 150 XL at the same time they voluntarily pulled the 300 XL that lacked bioequivalence. Having merged with Actavis, Watson probably decided it was cost effective to continue producing the Actavis generic and cut their losses with the Watson formula.
    Watson or Actavis, whatever you call yourselves now, how could you do this? The 300 XL had never been proved effective; its acceptance was based on the “proven” efficacy of the 150 XL. (What’s going on with the FDA?) The Par generic that has been substituted for the Watson 150 XL generic isn’t working. In warehouses somewhere thousands of effective bupropion 150 XL tablets will probably be sold off to the global market along with the ‘inferior’ 300 XLs.
    Must they always capitalize on the misery of their customers for the sake of the bottom line? What exactly do pharmaceutical companies do to “give back” here in the United States?

    • Wendy
      United States

      Thank you for your comments regarding generic duloxotine (Cymbalta). I have been on Cymbalta for nine years with excellent results for generalized anxiety disorder. In effect, I credit it with making my life worth living. Approximately 6 months ago I started to experience insomnia, fatigue and increased anxiety. It took me several months to connect it with the change from brand to generic. As an RN I was skeptical to believe that it could make that much of a difference in how I felt. Like many others I am battling my insurer for coverage of the brand medication. I appreciate the People’s Pharmacy for providing a forum for discussing these issues and for advocating for consumers.

    • Chris

      I’ve experienced the same problem with the generic Cymbalta. It just doesn’t work! It also made me feel weird, kind of ill.

      It’s so wrong that insurance companies aren’t covering the brand name and make us jump through hoops to get the medication that we need. I have to get a prior authorization from my doctor, and he has to write “brand only” on script. LUCKILY my insurance has been paying for it, but it’s a pain every month because the pharmacy doesn’t normally have it so they have to order it.

      Now I’m stuck, though. I just found out that the prior authorization EXPIRED 3 wks ago! It would’ve been nice if Walgreens noticed /told me a month ago when I picked up my meds. So I can’t get my refill because insurance needs new prior authorization. But my doctor is out of town til 28th! Nice. So I have 5 days left of meds. You all know you CAN’T stop an SSRI and be without. Am I forced to take the generic? What if I have a reaction? Do I go to an urgent care and spend $$$ unnecessarily to see if they can prescribe me my brand Cymbalta?? This is added stress I do not need now. ?

  18. Helen M

    I would suggest stocking up on all the brand name you can find; that will give you time to try a generic here and there, just purchasing a few pills out of pocket. You will be able to question the pharmacist/s as to who makes the generic and where it comes from. A small pharmacy might be better for this than a chain pharmacy. It might be possible to find a well made generic by an American company.
    My husband uses fentanyl patches and insists on the Teva made ones, for various reasons. Teva is an Israeli company, and I would place far more trust in them than in an Indian or Chinese company. I remember when packages of medications bought over the net could be seized by customs and destroyed because we were told we could not trust any medication that did not originate in this country. Unfortunately it is all about greed and corruption reaching high into the FDA and the chain drugstores.

    • Chris

      Stock up on BRAND name medications?? What dream land do you live on? Lol. I don’t know what insurance you have, but I’m only allowed a certain quantity of pills/month. Basically just a 30 day supply is all I can get. It’s a BIG pain in butt. One of my meds is Cymbalta. Insurance companies don’t want people to “stock” up on certain meds, especially controlled substances. They’re afraid people could take too much and OD, or sell the extra pills.

  19. Lida R.

    I am a geriatric woman who has been taking the brand-name drug Klonopin for 28 years, since I contracted motor and sensory Peripheral Neuropathy in 1986. I take 3/4 mg. to 1 mg. daily, (0.5 mg. tablets which I cut in half), to stop body spasm, calf and foot spasm, esophageal spasms and nerve pain in all those areas.
    Recently, Roche-Genentech has stopped making brand-name Klonopin due, I am told, to the number of generic Clonzepam products on the market, which makes it not cost effective for them to keep producing the brand-name Klonopin, which sells for close to $260.00 per hundred, while the generic versions are much cheaper. I have called Roche-Genentech and their reps state that Klonopin may go back into production by October 2014, but they completely stopped production of their brand-name Valium last year too, so it seems unlikely.
    The problem if they stop making it, is that this drug is a habit forming, addictive drug, which has a very difficult, uncomfortable and long, drawn-out withdrawal period. I was told this when I first started taking Klonopin, but my Neurologist stated I’d have to be on the drug for the rest of my life, due to my neurological illness, and there was no generic version of course, at that time.
    I’ve tried many of the “generic” Clonzepam products and none of them work as effectively as the brand-name Klonopin, i.e., I go into severe withdrawal. I’ve searched the internet and find sites where many other brand-name Klonopin users are experiencing the same problem in attempting to switch over to a generic version of Clonazepam, i.e., horrendous, slow, withdrawal.
    One would think companies like Roche-Genentech would show some compassion for users of their brand-name drug, because of the terrible withdrawal symptoms they will almost certainly experience when switching to the generic equivalents, which many who have tried them state don’t work as well. As always, it’s only the bottom line in dollars these large companies seem to care about, and screw the patient!
    Frankly, I don’t know what I’m to do if this drug is withdrawn from the market?! Guess I’ll have to do myself in, as I don’t wish to live in a perpetual state of withdrawal…Sad state of affairs, and I know I’m not the only one…

  20. MM

    It is more than about time! A decade or more ago, there was an investigative report in the paper (remember those) where the reporter went to various pharmacies throughout the US to get a generic version of a drug, and had them analyzed at an independent lab. What was found was that the actual active ingredient varied widely from not only different manufacturers, but from region to region. This was of course way before medicare part D, but seems like nothing has changed.
    I too have noticed differences in generic vs brand drugs. There are some generics that work better than others, but if I were a heart patient, I would not mess around with generics, and I know cardiologists who only will dispense brand name, because they don’t trust generics either, which of course is a problem because these stupid insurance plans do not like to pay for brand if they can get away with it, and they will! They don’t care if the doctor says the patient must have brand name! As usual, it’s all about the bottom line for them, screw the patient, get the money! I really do wish I lived in Canada, because this sort of thing just doesn’t happen there, from what I can gather.
    In my own case, I have to be on a few drugs for various problems, and the only drug I have to insist for brand name is percocet (a couple of my other drugs are compounded, and those I have to pay for, and that’s expensive). When the insurance company switched me to generic, it just doesn’t work like brand name; it takes two of the generic to even start to get an effect, while only one of the brand name took care of everything!
    The doctor (who is certified as a doctor who just treats pain patients) insisted I get the brand name, but the insurance company refused, so I’m stuck with generic. I cannot afford to pay for brand name, and I don’t know what to do exactly, and recently, the pharmacy switched the generic, and this generic really does not work well at all, worse than the other one!
    This pharmacy I found had the best generic percocet, and I traveled one hour one way to get it, and now they switched it. I have to find out why, I really like this pharmacy, they will give me the details, and then I have to find out the manufacturer of the previous generic. People who are sick should not have to work so hard at getting decent medications!

  21. KR

    As odd as it sounds, I think a little more capitalism needs to be injected into the pharmaceutical market. The consumers are too far removed from the transactions. For example, I take drugs for ADHD, and I can tell the effects of various generics are quite different. Since my insurance company pays for my meds, and my insurance company considers them equivalent, my pharmacy stocks only the cheapest (ie worst) generic brand. I have to find small, independent pharmacies to request a specific manufacturer.
    The chains tell me a “distributor” determines which generics they can stock, and they can’t even order another brand. I keep thinking- if the consumers had a little more choice in this, regulation would be a bit easier. If we as consumers had some choice amongst generics, we’d stop buying the ones that don’t work, and the market would force better quality control. I am not suggesting this as a replacement for what the FDA is doing, but as a supplement. I find it so odd that in our capitalist economy, that this industry is exempt from consumer-driven demand. Forcing patients to purchase shoddy medications just reinforces poor quality control standards.

  22. Deb

    Update to my March 6 comment when I first called local store of big chain that will stop selling tobacco products asking for USA source of generic drug instead of India, China, etc was told not available. Then I called big chain customer service and registered complaint about their lack of options other than cheapest generics from India given recent FDA actions against these companies. Didn’t receive any call back from higher up the chain but called local store two days later and suddenly pharmacy found generic version from Mylan.
    Doesn’t solve issue of ineffective generic drugs but at least better than being forced to accept drugs from countries to far away to be effectively monitored.
    So as consumers, it might help to be vocal about our concerns about generic drugs and suppliers.

  23. Deb

    What are consumers supposed to do about the large chains now solely getting their generics from India. Given the recent FDA actions against several Indian countries, if a consumer is forced by insurance to accept a generic, shouldn’t they at least have a choice to get it from a US company who, due to proximity might be more easily monitored? These chains are getting the cheapest generics they can find and no one will be able to measure the harm done to the most vulnerable taking them. To the big chain that will stop selling tobacco products, please look into your policies on what you offer the helpless consumer in the way of generic drugs.

  24. Mike

    Last week my doctor ordered benazepril from Prime Pharmaceuticals, which is owned by 14 BCBS orgs. They filled it with product from Ranbaxy.
    I talked with a pharmacist there yesterday. She told me Ranbaxy is now outsourcing to US sources, mentioning one in North Brunswick, NJ, but I asked her to confirm the source of what they’d sent me. They called back today to assure me that all is well because it came not from India but from a Ranbaxy factory in China!
    I said that if I were a pharmacist, I wouldn’t want to give anyone anything from Ranbaxy and maybe not China and asked for another source. Today’s pharmacist gave me 3-4 names, one of which was Teva. I know I’ve taken Teva’s products (and probably others on her list), so they sent a fax to my doctor for a new Rx to special order Teva. Fortunately, as a generic, it won’t cost me extra.
    For further information, just google “ranbaxy fda”.

  25. BZ

    I have been a pharmacy tech for over 20 years and have seen many drugs come and go off the market. I have heard numerous complaints from our customers about this issue and a lack of credibility for their concerns from the pharmacists. I believe because the statement from the FDA is shoved down their throats as an absolute. It is both validating and frustrating to hear this NOW. How could we as Americans EVER allow this!!!!!!
    Really…. send something as critical and life changing and the ability to do whatever to the drugs we must take to treat our health needs, and not allow inspections or inspectors to get Visas, really? How big of a RED FLAG do you need FDA!!!! China, as we all know was putting lead in exports, like children’s toys and you let these people make our drugs?????
    This is so beyond comprehension that this was EVER allowed under these circumstances. WOW. This is HUGE.

    • SM

      Bz – my husband and I TOTALLY AGREE WITH YOU! A dear friend of ours has been an internist for over 20 years. He said pharmacist are now receiving “bonuses” for each brand name they convert to generic for pharmacy customers! That is so wrong.

      One drug store pharmacist said her company is not doing the bonuses but she knew of others that are. I too was one of those who had wonderful results with Toprol 25 XL. Now the generic is being forced on us. It doesn’t work as well and we have no idea where it is made.

      Another family prescription, Calan SR 120 or 180 mg has now been removed because “AmericSource” says they don’t have enough demand for it any longer. Oh, yes they do — they just tripled the prices for the brand name our doctor prescribed and force the generic verapamil om us. Those don’t work as well for our family.

      We have many friends who have been taken to the hospitals and suffering many side effects from sorry generic drugs. What do we do? Pfizer was called and they had Brand name our family needed. The Calan SR 120. The upper management said tell the pharmacy drug rep to call us, place an order and we will get the Calan to you asap! No so. The AmeriSource for Walgreens refuses to order the Calan.

      One of our family doctors is so angered by this. He said and I quote, “I am the doctor, I went to school many years for my education.” Now pharmacies are refusing to honor his “dispense as written” on his prescription? One lady who commented earlier is correct; some generics are so weak that patient must take two or three. That is just so wrong. My pharmacist told me he can’t even locate some of the generic drug info any longer that tells him the names of the filers in there or where they were made. I have taken Z pack off and on for several years for infections. The Zpack made in USA – PA and the ones made in Israel were fine. Now Z Pack is being made in Croatia. Take those and many get days of upset tummy and other! “Something has been put in the Croatian Z Pack that is not healthy for our bodies in my opinion.

      My husband and I have been to China. As part of his assignment, we had to visit several Chinese factories. Trust me; you don’t want their factories making your prescriptions. You don’t want China raising your shrimp in their poop filled ponds. When asked how they pass inspections with the filthy shrimp, the workers told us “anti-biotics.” Then smiled. God help; us all.

      We must demand we get safe prescriptions again in our country. Also, people should not be forced to pay $300-400 per month for prescriptions.
      Thank you for writing BZ. Keep us updated. SM

  26. kst

    I KNEW IT!!! like so many others I had to suffer through what I knew was happening to me when FORCED to switch to generic Welbutrin but insurance companies, one physician and pharmacists would tell me otherwise.
    I am STILL struggling and United HealthCare is STILL refusing to pay for brand Welbutrin while also trying to take brand name asthma medication (XOpenex anyone?) as well as brand name migraine medicine (if you ever had to go through the trial and error of find one that will finally work). The fight over this issue is exhausting.

  27. RBH

    In the past month I was put on the generic drug Mirtazapine (30Mg.) for Remeron to control my clinical depression; why the drug I had been taking stopped working I don’t know; altho that was a generic substitution as well. I have almost felt as if I have gone “crazy” since taking Mirtazapine. I just can’t tell you how I have reacted to this drug!! I just want to be by myself as I am awful to my friends, if I can any longer call them “friends”. My behavior has been bizarre.
    Today, I finally called my therapist to tell her I no longer wanted to take any drugs, I just wanted to “check out”. This evening I stopped taking the drug and just hope my behavior will revert back to normal. If not, I don’t know what is next for me. After reading several articles about various Pharmaceuticals in India, I wonder if my behavior as well as my depression has anything to do with these generics?

  28. JThorpe

    So glad to see this information on the FDA testing the generics. I, too, had problems with the generic Wellbutrin 300XL that had worked so well. We changed insurance last month because of Obamacare, and now BCBS won’t cover the brand name anymore. Surprise! My prescription would be $430. I didn’t want to go back on the generic, since I’d tried it three times before.
    On Wellbutrin’s website, I found a program that lets me get BRAND NAME Wellbutrin for $50 a month. This applies to everyone, insurance or no insurance. Another problem- I’ve been taking Adderall XR generic for a couple of months with no problem. For the last two nights I have had difficulty sleeping (up past 2 a.m.!) I noticed today around 5 that I felt jittery.
    Tonight I am still jittery and can feel my heartbeat like when I had Graves’ disease. I took the generic amphetamine salts, 30 mg at 7:30 this morning. No way they should still be active, but I can feel the effects. I am going to check to see if the manufacturer changed.
    I switched from Vyvanse to save money using a generic. At least I’ve figured out why I can’t get to sleep. I’ll skip the med tomorrow for sure. It’s great the med is lasting longer and keeping my appetite down all day, but I have to sleep- I’m getting cranky.

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