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FDA Fails to Catch Generic Drug Disasters

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For more than 10 years we have been worried about the FDA's ability to oversee the quality of generic drugs. That concern arose because of letters, email messages and comments posted to this website from patients who reported all manner of problems with a vast array of generic drugs.

Although we have shared our fears with executives at the FDA, hospital administrators, physicians and pharmacists, we have not been able to generate much alarm. Most health professionals seem to think that the FDA knows what it is doing and is taking care of business.

 Today that complacency has been shattered once and for all. Katherine Eban is an award-winning investigative reporter. Her most recent article was released today by Fortune Magazine. It is called "Dirty Medicine: The epic inside story of long-term criminal fraud at Ranbaxy, the Indian drug company that makes generic Lipitor for millions of Americans."

Ranbaxy is one of the largest generic drug companies in the world, with over 14,000 employees. It supplies dozens of different products to U.S. patients, including the hugely popular atorvastatin (the generic version of Lipitor). This Indian company (now owned by a Japanese multinational drug firm) makes more than $1 billion annually from its U.S. sales. Earlier this week Ranbaxy pleaded guilty to seven felony counts involving the manufacturing and selling of its pharmaceuticals. The company agreed to pay $500 million, the largest amount ever paid in fines, penalties and civil settlements by a generic drug company. Here is a list of the drugs implicated.

That is only the tip of the iceberg. The actual story of Ranbaxy's skullduggery is one of woe and intrigue. Katherine Eban spoke with a former employee, Dinesh Thakur, who started working for Ranbaxy in June of 2003. This whistleblower was a U.S. trained engineer who had worked at Bristol-Myers Squibb in New Jersey for a decade before moving to India to work for Ranbaxy. He was hired as director of research information and project management.

Starting in 2004, he discovered evidence that Ranbaxy researchers were "cooking the books" to make their generic drugs look better than they were. He filed the whistleblower complaint in 2007, after trying unsuccessfully to get the leadership of the company to address the problems he uncovered.

What makes this story so astonishing is that the FDA did NOT discover the problems at Ranbaxy on its own. Had it not been for Thakur, it is entirely possible that the FDA would be unaware of the fraud to this day. The FDA was apparently incapable of detecting forged data. Crucial tests had never been performed and the FDA didn't discover that its house of cards was teetering dangerously. In fact, agency inspectors gave Ranbaxy a clean bill of health during an inspection in December, 2004. That was after key Ranbaxy executives had concluded "that crucial testing data for many of the company's drugs did not actually exist and submissions to regulators had been forged."

Not an Isolated Event

This is not the first time that the FDA has completely missed serious problems in testing and manufacturing. This problem is not limited to foreign countries. Several weeks ago, a ProPublica investigation revealed that a Houston testing laboratory called Cetero Research had also been cooking the books. Cetero performed laboratory analyses and ran clinical trials for both generic and brand name pharmaceutical companies around the world.

Although the FDA had inspected the lab on numerous occasions, it had not discovered anything really serious. But when a former employee blew the whistle on the company in 2009, claiming that some of the chemists were manipulating and falsifying data, agency inspectors realized they should take a closer look. By 2011, two different investigative teams from FDA had confirmed the allegations and determined that drug tests conducted at Cetero between April 2005 and June 2010 were unreliable. When confronted, the company admitted its wrongdoing, but without the whistleblower's alert, it is unlikely FDA would have discovered what was going on.

When another generic firm, Teva, brought out a generic version of bupropion (Wellbutrin) under the name Budeprion, hundreds of patients complained that it did not work the same as the brand name medication. In this case, there is no allegation of fraud, and there was no whistleblower. But if it had not been for the persistence of The People's Pharmacy forwarding these complaints to FDA officials over five years, it is doubtful that the agency would have acted to investigate whether Budeprion was truly bioequivalent to Wellbutrin. The study FDA conducted demonstrated that the drugs were not in fact bioequivalent, and Budeprion was taken off the market in October, 2012.

Nor are the problems restricted to generic manufacturers. Drug giant GlaxoSmithKline was found guilty in 2010 of making contaminated drugs at its manufacturing facility in Cidra, Puerto Rico. How was this problem discovered? A whistleblower notified the FDA of manufacturing irregularities. The firm ended up paying $750 million in civil and criminal penalties.

In each of these cases, the FDA investigated serious issues in bioequivalence, testing procedures, manufacturing practices or quality control only after someone outside the agency uncovered them. Keep in mind that the cases we describe above involved huge pharmaceutical manufacturers like Ranbaxy, GSK and Teva. What about small chemical firms and drug companies in countries like China, India, Thailand, Indonesia and Slovakia? The FDA frequently has to notify these companies weeks if not months in advance that it is coming to inspect. Does anyone really think these inspections reflect what happens when an inspection is not imminent?

Let's face it, the system is terribly flawed. Despite reassurances by the FDA, pharmacy chains and insurance companies that generic drugs are fine, the Ranbaxy story by Katherine Eban should send shivers down your spine. To learn more about the generic drug fiasco, you may want to check out our book, Top Screwups Doctors Make and How to Avoid Them. In it, we detail our evolution from total believers in generic drug quality to determined advocates for change to the system.

It is time for Congress to act.

Here are our recommendations. Please pass them on to your representative.

1)       Country of origin labeling. You should know where your medicine comes from!

2)       The name of the manufacturer of your medicine should be on the label.

3)       The FDA should release its bioequivalence curves for all generic drugs. These data should not be kept secret, as they currently are.

4)       We must demand unannounced inspections in all countries that wish to export pharmaceuticals to the U.S. market.

5)       Every foreign drug manufacturing company must be inspected every two years, just as U.S. manufacturers are inspected.

6)       Doctors should be allowed to write "dispense as written" and not have insurance companies second-guess the doctor's decision and force patients to pay exorbitant prices.
 

If FDA is truly to protect the public health, it needs to increase its investigative capacity. This has an impact on every one of us, so it is up to us to lobby Congress to increase the agency's authority and resources so that it can do the job it should. And the FDA must become more transparent. Instead of protecting generic drug companies and allowing them to use the honor system, we need the agency to verify that the data are accurate and then make it available so that we can all see for ourselves.

 

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I completely agree with your recommendations. While many generic drugs that my family and I have used have worked fine, there are several instances dating back a dozen years when I can tell you with certainty that a generic drug was not in fact the equivalent of the brand name product. Your point #6 speaks directly to my current frustration with our pharmaceutical benefits manager, one of the country's largest. First, it forced me off brand name Lipitor to the Rambaxy generic. When the atorvastatin recall hit, customers they had supplied with the recalled medicine were told, "you're probably OK" and the company (which reported a billion dollar profit last year) refused to replace the pills.

It's all about the dollars, patient health is a distant second. Please continue to speak out.

Thank you so much, P'sP, for continuing to delve into the irregularities in the pharmaceutical industry. I have to cite your articles frequently when I receive a different generic drug for Paxil than the one I prefer, and have been on for many years. When I request the same generic (which is my right) I get a condescending sigh of disapproval from the pharmacist and a lame explanation of how "all generics are bio-equivalent." My experience obviously differs but, apparently, matters little in the world of for-profit pharmacy chains. I appreciate your diligence.

This is just one more of the many, many, many reasons I don't have a doctor and don't want to go to a doctor. Health care in this country has gone down the toilet and the toilet drains into the bank accounts of all those that continue to profit.

The real issue is that people can be so easily brainwashed into believing if they go to the doctor and they undergo that test and they take that pill, it will make it all OK. The supply will continue to meet the unrealistic demands. No thanks, I don't want any.

Thank you for this report. Though I'm fortunate to be on few medications, those I'm on are generic as required by Medicare and this has had me concerned for some time. In addition to our Congressmen, I would suggest also sending the recommendations to head officials of Medicare as well as to Secretary Kathleen Sebelius. The more officials who are involved in the decision-making process and/or administer guidelines in the use of generics, the better.

I have complained for years!!!! I have told my doctors that generics don't work the same for me and have been told that it is the same. I have had to pay 300% over what it would normally cost to get name brand. Finally the pharmacy and my doctors have put name brand only for me. I knew I was not mistaken about this. It is a good thing I am a fighter and know my body.

First of all read, " Bad Pharma." All of this is an outrage but the whole American health care system is an outrage. The United States is in the grip of devious, cheating, and dangerous corporations of all kinds that determine how we live, what we do, and basically there is no worthwhile regulation of any kind because politicians have emasculated regulation in the service of the plutocracy that governs this country, especially the small government clowns who want even less regulation in the interest of making obscene profits while endangering the people.

If there ever was a "1984" we're in the grip of it and other than taking to the streets the American public is screwed.

I wonder if Singulair may be the next drug for which generics are found not to be equivalent. Once it went off patent, my prescription was filled with a generic, and within days it was clear that it was ineffective. My allergist has switched me back to the brand version, and says that her practice has several patients where she has had to do this.

When in Florida for the winter 3 years ago, I took generic (required by Florida law) for Mirapex, a drug I needed for tingling I get during the night. This is also used for people with Parkinson's disease.

After a week, it stopped doing it's job, and I spent a miserable night. I contacted my insurance company, Independent Health out of Buffalo, New York, and they paid for a new prescription for Mirapex, not the generic of it.

Generic drugs are not sufficient, and I am concerned for people that have the Parkinson's disease that take this generic form.

My eye doctor prescribed drops to treat my glaucoma; Xalantan. By law in WV, if there is a generic available the pharmacist must substitute it unless the doctor says no. At my next visit, I mentioned this to the doctor and he said absolutely no substitutes!!!

He stated that "we don't have any knowledge of what is actually in the generic medication". Because of this, I gladly pay the difference in cost! Isn't it ironic that individuals can't buy drugs made in a foreign country and yet the majority of the prescription drugs are produced overseas!

I have tried to follow the debate about generic meds for some time. Interestingly, two brand name drugs used by my husband and me recently have been deemed "on back order" or "unavailable." They are Xopenex for nebulizer and Levoxyl for thyroid. As a protective measure, my primary care physician ordered DAW for generic company for ALL my drugs and my husband's. We thought that was our only recourse. Now I am concerned about one company mentioned in your article... TEVA, which manufactures 3 of my meds.

My next step will be to bring all your information to my primary and perhaps we can figure out a strategy.

Thank you for keeping us abreast of the most recent concerns!

Thanks Terry and Joe!!! Over and over you've rung the alarm bell. How frustrated you've been. Now, at last, you are experiencing some satisfaction for your efforts. I hope everyone will write their representative and senator about this current outrageous and dangerous predicament the American consumer can experience.

This is very revealing and disturbing. I have been managing patients taking Coumadin for several years. It is not unusual to have difficulty managing INR's, only to have the pt announce that their medication is "different". Variances in generic medications occur between manufacturers but absolutely should not be tolerated. Hopefully, the investigative information will awaken the FDA to all generic medications and tighten standards across the industry.

There seemed to be a big flap, in the past, about U.S. citizens going to Cananda to buy cheaper drugs. Yet Congress has no problem with drugs being made all over the world and purchased for distribution here. I have some Rx eye drops which I was surprised to find were made in Belgium. To find that out I had to peel the pharmacy label off the box because the info was underneath.

These prescription management companies, who are third parties making millions, have monopolized the drug business, driving the small pharmacies out of business. There is no reason to have that middle man raking in millions. They switch from generic to generic for price, with no interest in quality. The drug industry has no more scruples than the clothing manufacturing industry. We are currently seeing what those clothing factories are like. I try to support my local small pharmacy, so I can talk face to face in case I have a problem, and pay a few more dollars to do so.

There must be thousands of seniors who have no idea what they are taking, and are taking the wrong medication, or in many cases, not receiving the correct pills in the mail. They don't know the difference. Many generics are similar in color and size and a magnifying glass is needed to see the code on the tablet. I hope your readers know there is a website to go (if they have and can use a computer) to identify pills by shape and color, and see a picture of it, so you can make sure you received the correct medication. I never take anything new without checking it out. You certainly can't depend on the FDA for oversight.

In this era of cut,cut, cut by our congressmen you get an FDA that is spread TOO thin.

Then you blame the FDA. You realize the FDA has NO control over vitamins and natural remedies. The vitamins and herbals do NOT even have to have the ingredients labeled on the containers. Have you done a show or written comments on mislabeled or misbranded vitamin and herbals??

This is scary. I take a lot of prescription drugs, some that are on the list. I'm on Medicare and have limited means to buy non-insured medicine. I think that #6 should be highlighted and enforced. If a doctor cares enough to investigate a drug that he/she prescribes, then the insurance company should cover the drug.

I've had insurance companies "suggest" that I switch to another drug because the prescribed drug was too expensive. Case in point, last year I was taking Lyrica. They refused to re-fill my prescription and changed me to gabapentin. I have no idea where my gabapentin comes from but it's not better than Lyrica.

When I go to the trouble to find a doctor who knows what she/he is doing, then I want the prescription to be filled as written, not filled on the basis of cost. President Obama wants to bring jobs back to the US. I say lets start with prescription drugs. If we don't have enough qualified people, then start a training program immediately if not sooner.

Thanks again Terry & Joe for some valuable information brought to our attention. We appreciate your Newsletters more than you will ever know!

Thank you for this article. I am sending it to everyone I know. Hopefully they will read it. How can I find out who makes the generics I use?

All this failure to inspect officially accepted off-shore drugs makes the efforts of prevent US citizens from privately sourcing their drugs through off-shore pharmacies look even more preposterous. Yes, there are dangers, but in the light of the news you report, wouldn't one feel safer with a nice legit Canadian pharmacy than with the generics the pharmacy linked to one's health care provider dished out?

That said, I should note that my mail order drugs through my health insurance do come marked with country of origin, manufacturer, and description of what the pills should like, so that the end-users could detect an error.

I have not trusted the FDA for years. I think, one of their generics eye drops ruined my right eye. It felt like pure sulfuric acid and I was told to continue, and stupid enough, to put in another drop. Opthal. MD prescribed it, weeks after retinal surgery. That is my worst case, 82 yrs old. Blind right eye, but still sane, Some BP meds have skyrocketed my BP. It seems, they work in cahoots with the NIH, also the CDC. 90% of my problems have come from wrong meds. I am a very skeptic patient and changed Drs. I tear up many scripts. CAT scans were over-prescribed, instead of reg. xray, maybe still are. I tore up Fosomax & Cat scan scripts several years ago. C? test done, instead of Sed. rate. Very costly.

FDAs failures may be deliberate and inexcusable and should be investigated by Congress but of equal concern in Congress' defunding of so many government operations so that manufacturers won't be caught, environmental regulations won't be enforced and our countries borders won't be secure.

I think we are looking at a split responsibility for these disasters in health products which should have Americans incensed except for one thing. With so much money buying elections it is obvious that the average citizen has very little impact on the course of events.

As a senior, I appreciate your turning over the rock to expose the roaches.

This is one of the reasons I refuse almost all my doctor's suggestions to take prescription drugs. I prefer to find a homeopathic solution to problems.

This is also the reason I subscribe to your newsletter. It's almost a given that we'll not see this information in the media. Keep the pressure up on these people.

HOORAY! I wrote recently that I thought the generic Arimidex made by Teva was possibly not up to the standards that AstraZeneca had. Nobody will ever be able to convince me otherwise. Keep up the good work and for keeping us informed.

Yes, write your senators and congressmen; but also copy the letter to the appropriate committees.

In the Senate, it is the Senate Committee on Health, Education, labor and Pensions. The chairman is Senator Tom Harkin, (D-IA) and the ranking minority member is Senator Lamar Alexander, (R-TN) Their website is www.help.senate.gov.

In the House it is a subcommittee of the House Appropriations Committee: the subcommittee on Agriculture, Rural Development, FDA and related agencies. The chairman is Rep. Robert Aderholt of Alabama.
http://appropriations.house.gov/subcommittees/subcommittee/?IssueID=43419

If you go to the website of the US House and put in your zip code, it will bring up the name and address of your congressman/woman.

It also helps to write the House Speaker, and the party whips.
I've found that when you write a snail mail business letter to the committee leaders you do get more of a response. (They've got more staff to answer mail!)

Remember there are 3 issues: 1. failures, lack of oversight, foxes guarding the chicken coop, etc.
2. Lack of funds to do proper checks.
3. Lack of personnel spaces to staff this activity: Congress not only limits the funds, but the numbers of personnel spaces in each agency.

Tell them you want to see hearings on these issues, AND more importantly to fund and staff the FDA so that it can do its job properly, sequester or no! The failure of Congress in these last 2 areas has contributed to the problems.

Am I surprised? No. Shocked? Moderately. Angry? That would be a gross understatement.One must ask why these destructive practices are allowed to continue. I am sure all of us have some kinds of explanations; I would like to contribute mine. In my opinion, we are living in a declining, decaying society.

There are of course many reasons for societies to decline and for the accompanying signs and symptoms, but in the present context I would briefly like to address two, with special emphasis on democracies and capitalism: In order for both of these institutions to function properly and constructively, they require the presence of two particular characteristics: RESPONSIBILITY AND ACCOUNTABILITY. When "businesses" in general, and large "corporations" in particular, engage in fraud, deception, etc., to what extent are they held accountable? I put those two words in quotes for a reason.

For years we have treated corporations as though they are people, even though it is people who make decisions, use judgment, and take actions; not corporations (the follies of the Supreme Court notwithstanding). So what happens when "corporate" fraud and irresponsibility is discovered? The "companies" get fined, sometimes substantially, but those who committed the fraud (dare I say "people"?) are not touched at all. Thus, for those psychopathically inclined, there is no disincentive for their anti-social actions. They even may have benefited in some ways.
Basically, that is my belief. I shall stop at this point, since I am already too verbose.

It's a good thing that congresspeople don't have to use generics, or they would fund more FDA inspectors for Indian and China.

Thanks for sharing your experience. You stated that there was a website that allows us to ensure the accuracy of generic medications but did not list the address. I would appreciate knowing how to find this website. Thank you again.

PEOPLE'S PHARMACY RESPONSE: We don't have a website that tells about which generic drugs are good, but there is a list of the ones produced in the bad Ranbaxy facilities: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/ucm118441.htm

When I fell down a spiral staircase and crushed my elbow and arm, I was put one a generic at the hospital even though my doctor told them I could not tolerate generic pain pills. Found this out due to several surgeries. Well I knew the moment I started to hallucinate and think the nursers were planning to kill me what I had been given. I refused to take anymore medication and the hospital called my doctor to tell him. He set them straight.

Thank you for all you do. I learn so much from you.

Once again, I thank you for the information you make available. To be duped by the drug companies at such a high cost, both financially and physically, is outrageous.
I'm going to pass this information along to all in my mailbox. I hope they read it.

I would like to hear more about this subject.

News reports like this are frightening but how do you balance caution with the needs to buy drugs on a shrinking budget? My primary has declined to write a prescription for warfarin instead of Coumadin which costs $85 in copay instead of $5.

Since I rarely speak directly to the MD I have not been given his reason but he may have learned of too many of these generic drug disasters. But it is easy for an MD to refuse to allow generic dispensing to keep his patients safer and hard for them to pay for the name brand. Is there any research on the percentage of lower income folks who will just cut down or eliminate taking an expensive drug because of the cost?

Dear Peoples Pharmacy, Previously I had written to you about the serious problems I had with generic Wellbutrin, and to avoid having to deal with the side effects, I went back to name brand and have been paying hundreds of dollars regularly for the name brand. It's worth the money to not be on generic Wellbutrin.

Now that Ranbaxy is discovered, I want to add another Ranbaxy med that I have discontinued in favor of the name brand. Ranbaxy's Lorazepam (generic Ativan) savings in money was not worth the side effects. Having taken name brand Ativan for many years when I was in control of the med, once I started Ranbaxy's Lorazepam it was downhill to the point where the Lorazepam was in control of me. What I need this med for, the relief was not achieved. I steadily developed a serious dependency on Ranbaxy Lorazepam. Just before the end of 2012, I had the courage to admit to myself that I was addicted. I asked for and got back on name brand Ativan. The cost is out of this world, over $400 if I were to take the full amount that I am prescribed. But the good thing about Ativan is that I am in control. "Take as necessary" can be achieved because Ativan does not have the addicting effect like Ranbaxy's Lorazepam. I also want to add that during the period I was taking Ranbaxy's Lorazepam, I was getting deeper and deeper into my depression, needing to up the dosage of Wellbutrin. Even that did not work enough. But I did not suspect that it was Lorazepam along with causing an addition, what was causing the deepening depression. I thought and pointed fingers at the Bisoprolol Fumarate and even told my doctor my feelings about it and told her I wanted to get off of the bisoprolol. She was not happy because me not taking bisoprolol, a med that affords the protection that I need due to a history of heart attacks. But I was so depressed and the tone of my voice on the voicemail I left told the story. I was changed to a different beta blocker, which started up my irregular beats again. To make a long story shorter, I am now happily on name brand Ativan and name brand Wellbutrin. But the prices of the name brands are so restrictive that I have to take what I can afford and that means not the full and correct dosage sometimes. I know I should not be doing this, but the I am not rich and cannot pay hundreds for 2 meds.

Please if you can start an investigation into Ranbaxy Lorazepam. What ingredient is the culprit? How many other readers have experienced addictionand depression from it? It needs to be on a Ranbaxy poisonous drug list. By the way, when pharmacies were dispensing Milam lorazepam, I did not have any of the problems like Ranbaxy.

One last thing. There is not other person who knows me like I do. The person, the patient, knows best. Doctors need to listen to and believe their patients when they are complaining about generic brand problems. My doctor is more understanding than most, plus the fact that I have been her patient almost 20 years and she knows I am well aware of my body.

Thank you, Peoples Pharmacy. You are the only wide reaching source for the people about the serious problems with generics. I appreciate what you do. No other authority takes the action like you do.

Additional problems with generic medications surfaces when there is more that one generic manufacturer for a particular drug. Pharmacies often change the source of the generic when prescriptions are renewed.

Often that results in a pill that looks different in color or shape for a second time and introduces an additional unnecessary source of confusion and medication errors.
In addition, it has been my experience that just as there seem to be differences between brand name and generic meds there are differences among generic manufacturers of the supposedly same generic drug.

If we are forced to switch to a generic at a minimum the insurance company and pharmacy should be required to stay with one generic manufacturer in order to provide the patient with visual safety, medical consistency and an stable placebo or other psychological effect.

I found that one of the generics for Singulair made me dream a lot more or at least I was much more aware of dreaming.

Thank you for this article. I have asthma and recently was switched from Singulair to generic Montelukast. All of my asthma symptoms returned (wheezing, shortness of breath, using my rescue inhaler 3-4 times per day). I saw my physician last week and was given a short burst of Prednisone (40mg x 2 days, 20mg x 4 days) and placed on Symbicort full time. At the time of seeing him I did not mention the change to the generic version of Singulair. After looking on the internet I found many just like me were having the exact same problem.

Luckily my pharmacist was able to get an override on my prescription from my insurance company and within days of being back on Singulair my problems have disappeared. I don't know how many other patients are out there suffering with their asthma right now who don't realize it is their generic.

I have taken generics for Lipitor, L-thyroxine and Atenolol with no problems but this was a very scary problem to have. I plan on calling my doctor tomorrow to report this as well so that my prescription can be written as brand only. What scares me is when the brand is no longer available.

My husband also has had a reaction to generic Ciproflaxin. But when he tries to get brand Cipro it is not carried any longer.

Thank you so much, Peoples Pharmacy, for forwarding reports of negative Rx drug reactions to the proper authorities. And still, the response is glacial! Simply amazing. Or not...

Just this afternoon I took one of my husband's medications back to the pharmacy and made the pharmacist trade the blood pressure pills he was given the last time the prescription was filled to the kind he received previously.

The orange and white pills were passing through his body undissolved! He had been complaining of extraordinary tiredness so hopefully getting the green capsule version of his meds will help him feel better. The orange and white pills that do not dissolve were manufactured in India!

You know, when you're in the hospital, you get your pills served to you in a little white container, you have no idea what country they're from, who the manufacturer is and if they are generic or not.

Thank you for including references to Bad Pharma and 1984 in your comment. I believe knowledge these books/movies should be included on high school graduation exams! Too many I meet today lack appreciation for what lessons history share. And, more shocking, most have no understanding of how propaganda keep the American public distracted and fear driven.

I was using lipitor (Brand) since 2004 after my heart attack. I never had any problem until the end of 2012. In 2012, November I had to take generic atrovastatin and then all the problem started. I complained to lipitor, because I thought it is because of Lipitor. Severe muscle pain and back pain in the muscle, tiredness and fatigue. Then I stopped taking generic in the month of January 2013. I still hold the bottles of atrovastatin made by Ranbaxy. I can provide it for further tests, but the damage is already incurred and I have to suffer with that for the whole life. Please stop these counterfeited generic drugs for ever.

I was recently switched to generic Rizatriptan 10mg from Maxalt. The generic drug was way stronger than the brand. I had hallucinations and severe chest pain when I switched to the new drug. Even when I took half a tablet the side effects were terrible.

Having experienced the generic problems with sertraline, I am not too surprised by the article, but I am disgusted. I finally had to go back on name brand Zoloft and it was costing fortune. Fortunately, Pfizer issued a discount card, but one of its restrictions if I understood them properly was that you couldn't be on Medicare to get use the card. I'm five years away from Medicare and very nervous that Zoloft will not be affordable. Even when it was a tier 3 drug, the cost was excessive. Thank you very much for the article. Please continue to alert the FDA about this terrible problem.

Recently my pharmacy notified me that they were using a different supplier for my Sotalol (generic) for atrial fibrillation. This drug had worked well for me. Within 12 hours of taking the new supplier's drug, I developed a-fib and for the next 7 days, had 5 more episodes. The pharmacy was notified and they promised to order the previous drug for me. How can such a thing happen? Should I report this, or the pharmacy?

I have this; http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm344476.htm

FDA warning letter to Apotex where you can read that the FDA can't really take action against this polluted factory where the plant should have to be closed immediately due to imminent shortage of the drug supply to the U.S. if they do so. The FDA is i.m.o. completely powerless to take any action. These factories are more powerful then governments are. Scary.

Thanks. I listened to People's Pharmacy this morning, and was trying to track down more information on generic lipitor (atorvastin) which I have taken for some years...and stumbled on the report on Ranbaxy Pharmaceuticals (India). I don't know whether anything has happened with the FDA to reduce these risks, but I have been suspicious of Asian-produced drugs for years; and even more so since the sequester has reduced the oversight and regulation of so many safety measures affecting our health and our lives. Please someone let me know if there is an update on this! Thanks, Anne

Anne N; As you can read in the warning letter, you don it's not a Asian problem, and due to dangers of shortages the FDA can't shut down a factory, like in the food sector for instance, for whatever the reason, they will. You can find any information on google by whatever product you want. I've found a lot, but it doesn't help much. I hear people complaining, I'm reading for years now, starting because of the problems I'm having with generics, and want a make a wake up call. Am sending this link to lots of health practitioners Most of them are not interested at all. Here's a list of avorvastatin recalls concerning ranbaxy. http://google2.fda.gov/search?q=atorvastatin&spell=1&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&ie=UTF-8&access=p Greetings Robert. And a Happy X-Mas too.

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