Q. My wife has been taking Coreg for 10 years and doing well. Last week she was advised that a generic version of the drug (carvedilol) was available. At the advice of the pharmacist (who insisted that the ingredients were the same because the FDA approved it…Yada, Yada Yada), she went for the generic. Within 5 days, her blood pressure went from a 10-year average of 135/80 to 155/96; she had sore throat; pains in extremities; tiredness; and feelings of irritation (several of the side effects for carvedilol, which she had never had before). We went back to the pharmacy and insisted on Coreg. Within 24 hours of taking name brand Coreg, symptoms began to subside with a major improvement in the first day.
I have had personal experience working with Chinese manufacturers in the electronics industry. I am quite sure that the lack of quality control, need to drive costs down, and lack of regard for how the product affects the customer is true of the pharmaceutical industry as it is in the electronics industry. I hate to sound prejudiced, but it is a given fact that countries the likes of India, China, Vietnam, Mexico, etc. have a completely different perspective of product quality and regard for the impact on the end consumer. In these countries, warrantees do not exist. You buy it, you own it. As a result, many native consumers in these countries only buy open box, knowing that they have no recourse once they walk out the door. Knowing that this is the reality of day-to-day foreign environments, it is reasonable to see how this difference of quality and care for the consumer perspectives can easily invade the word of prescription drugs.
Joe and Terry, as a single person, I feel my voice cannot be heard, and quite frankly I’ve grown tired of all the stories of tainted imported food, toys, etc. In these products, effects are usually more evident and definable. In the prescription drug markets, as evidenced by this site alone, adverse symptoms or lack of effect of imported generic drugs are not as well defined or understood even by the medical professionals whom we trust, leading people to believe they are just imagining or having psychosomatic responses to the generics. As a group we have strength.
I beseech Joe and Terry to help us band together to shed light on this matter such that we can have a voice with our elected official and have their focus shifted from the unimportant issues of who did what to whom to gain political posture to that of addressing the issues of imports that can be killing Americans.

DAS
A. For decades we too discounted reports of generic drug failures. Just as you describe above, we chalked them up to psychosomatic reactions, prejudice against less expensive generic products or just plain imagination. Over the last decade, however, we have changed our tune. That’s because we have received so many complaints from people just like you. We have also learned that the FDA’s rules for generic drug approval could stand reexamination and also because of lack of adequate oversight of manufacturing, especially in foreign chemical/pharmaceutical plants.
On July 10, 2007 China took a drastic step, executing Zheng Xiaoyu, the former head of the Chinese drug regulatory agency [the equivalent of our FDA], for taking bribes to approve untested and substandard medicine. Zheng started running the Chinese Food and Drug Administration in 1998, around the time we started hearing complaints from consumers.
Zheng’s execution didn’t end the problem, though. In March, 2008 the FDA recalled large quantities of the blood thinner heparin. It turned out that tainted Chinese heparin made from pig intestines was directly linked to over 80 deaths in the U.S. Chondroitin sulfate had been added to the heparin to stretch supplies and boost income. Despite all the headlines and handwringing over the heparin disaster, Chinese regulatory authorities never cooperated fully with the FDA to investigate the problem or reveal what went wrong.
Chinese drug manufacturers aren’t the only ones suspected of taking short cuts. Ranbaxy was one of India’s largest drug companies and one of the top 10 generic drug manufacturers in the world. It supplied large numbers of generics to the U.S. market. In 2005 a whistle blower inside the company warned about altered test data and raw materials obtained from unapproved sources.
In 2008 investigators accused Ranbaxy of falsifying statements and fabricating information about its drugs. U.S. prosecutors alleged the company forged documents regarding drug quality and covered up violations of manufacturing practices. There were also accusations that the company failed to report patient complaints about certain drugs such as fluoxetine (the generic form of Prozac) in a timely manner. In September of 2008 the FDA finally issued an import alert that effectively banned Ranbaxy from selling 30 different drugs in the U.S. market.
Eventually the ban was lifted, but that was not the end of Ranbaxy’s problems. Just a few months ago Ranbaxy made headlines again when it had to pull 41 lots of the cholesterol-lowering drug atorvastatin from pharmacy shelves because of contamination with glass particles.
More About Coreg (Carvedilol)
This beta blocker is a valuable medication for dealing with a number of heart problems. It is especially important in the treatment of congestive heart failure. Unlike older beta blockers, such as atenolol, metoprolol and propranolol, it may be less likely to aggravate signs and symptoms of heart failure. Many cardiologists favor carvedilol over such old-fashioned beta blockers and we think their experience is worth noting. This drug is also prescribed to assist with “left ventricular dysfunction” following a heart attack. And it can help lower high blood pressure.
Coreg (Carvedilol) Side Effects
• Fatigue, exhaustion, dizziness, low blood pressure
• Digestive upset, diarrhea, nausea
• Headache, arthritis
• High blood sugar, diabetes, weight gain
• Visual problems, blurred vision
• Cough, asthma, difficulty catching breath, fluid in lungs
• Kidney problems, liver enzyme elevation
• Chest pain, slow heart rate, [do NOT stop taking carvedilol suddenly!]
• Skin reactions, rash [notify physician IMMEDIATELY!]
• Blood disorders [rare but serious]
• Sexual side effects

Other Stories of Woe & Intrique with Generic Coreg (Carvedilol)
“I am not sure what is going on–for 2 years I took carvedilol generic from Canada twice a day. In theory it was made in the UK. On 11/15/07 I switched over to carvedilol from a big-box discount drugstore. There were blue pills and white pills in the same container, supposedly all 3.125 mg. Turns out they were both 3.125 mg AND 6.2 mg in the same bottle.
“I am very sensitive to betas and the overdose brought on symptoms of heart failure–fluid in lungs, problems climbing stairs, heaviness in chest. After about 2 weeks I called the drugstore and asked about the colors, since I couldn’t think of any other factor. I found out about their mistake, and they supplied more. The pills were supposed to be the 3.125 mg but I still am symptomatic, though slightly less so.
“I am now wondering if others have had problems with the generics from discount drugstores. I am thinking maybe I have to go back to Canada to get the generic there. The discount price is great, but the symptoms suck.”

Jane
++++++++++++++++++++++++++++
“I have been taking 25 mg of Coreg twice daily for nearly 4 years (for congestive heart failure and high blood pressure) which developed after being given a contraindicated drug). It has proven to be effective.
“Recently, my Pharmacy Mail Service substituted the generic form, carvedilol, in lieu of the brand-name medication. While initially pleased at the lower cost, after four or five days of feeling fatigued and having an elevated blood pressure (an increase of 25-35/15-25 mmHg) it dawned on me that perhaps the change was a consequence of using the generic version. I had a few of the brand name Coreg left and began taking those; after a day or two, my symptoms improved and the blood pressure returned to its usual level. A week later, I tried the generic again, and as before, the results were the same (an elevated BP and fatigue).
“The generic was manufactured by TEVA, and given the reported lack of bioequivalence for its generic version of Wellbutrin, the reliability of the company’s generic version of Coreg would seem to be suspect. If others report this, and my experience was not due to one defective lot of the drug, then TEVA’s Coreg would be a good candidate for testing.”

DDH
++++++++++++++++++++++++++++
“I have successfully been on Coreg for cardiac arrhythmia for 2 yrs. In Dec. I was given a generic (Carvedilol) for it. It acted as a pro-arrhythmic for me, as my heart rate skyrocketed, my heart beat irregularly plus I felt generally unwell. I ended up paying $75 for the non generic, as I could not tolerate the way it made me feel. My appeals have been in vain so far. They should heed those who are made worse by their generics.”
ER
++++++++++++++++++++++++++++
“My Medicare Plan D company insisted they would only fill a brand name drug with a generic. The drug I have taken for over 6 years is Coreg, for blood pressure. The generic they substituted in May this year was carvedilol, made by Dr. Reddy’s LA. After 7 days of taking this drug I did not feel well and during a routine exam my GP commented on my blood pressure being elevated very high, and upon further examination found I also had heart arrhythmia.
“He did a quick EKG and put me on a heart monitor for 24 hours. I also got an emergency prescription for the brand drug and started taking it that day. By the next day my blood pressure was back to almost normal and the arrhythmia was gone…and to this day, almost 2 weeks later, the insurance company, is still fighting to not pay for this drug. I paid 100% cost of this drug and since I cannot change Plan D companies until the end of the year, I am stuck with a very expensive drug.”

Ira. K.
++++++++++++++++++++++++++++
If you would like to learn more about generic drug disasters, you may find the chapter in our book, Top Screwups Doctors Make and How to Avoid Them of great interest. We document some of the problems described above and provide practical tips on how to use generic drugs in a safer manner. Here is a link to the paperback edition of Top Screwups.
We wish we knew how to help DAS and everyone else mobilize to encourage the FDA to toughen its standards for approving generic drugs and improve its monitoring and oversight of drug manufacturing. Anyone who cares about generic drug quality should contact a Senator or Representative and encourage improved scrutiny. Perhaps the first thing our elected officials should do is put country of origin (for raw materials AND finished pills) on the label. We do not understand why our clothing and fruits and veggies have such labels but our medicines do not! Get busy folks.
What has been your experience with Coreg (carvedilol)? Have you had problems with the generic version or has it worked well for you.
We would like to know if you have experienced any side effects on beta blockers. Please comment below so others can benefit from your experience.

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  1. S. T.
    Reply

    Two years ago I had a “massive” heart failure with much heart damage, and a single bypass. The surgeon told me I would be on correg for the rest of my life. The side effects (dizzy, weak, etc.) were so severe I had to stop taking it. The heart internist won’t listen to me and insists I continue taking it. I’m sitting up typing this at one PM because of trouble breathing.
    My car is in the shop being repaired from a woman running a red light and wont be ready for a week, so I can’t drive to the hospital for a checkup that I can’t afford anyway due to the changes the affordable care act made to my insurance. I appreciate all the info on correg and knowing it’s not just all in my head. Thanks, all.

  2. R Vaughan
    Reply

    I had two stent implants last year (03/20/13) and one last month (April 2014). Ever since, of course, the first question doctors ask is “How are you feeling?” I am so tired of talking to these arrogant men that I now tell them the truth: “I have NO idea how I ‘feel’ since I have yet to go one day without being on your damned drugs.” You were so correct when you wrote “I have not once had a doctor that would admit that any drug he/she prescribed could cause the side effects that I’ve said I was having.” Their solution is always(!) the same–either a new pill or more of the old. I really do not want to believe this is all about “big pharmaceuticals” and profits and kickbacks for the doctors. But I have no good reason to believe anything else.

  3. Anonymous
    Reply

    When I’m treated like that I fire’em!

  4. nan
    Reply

    I only took the generic carvedilol, but after about one day I had irregular heart rhythms. It seems like this is a side effect for many BP drugs, but the beta blockers are supposed to control this.

  5. Nancy
    Reply

    Some people can tolerate most drugs, while others are very sensitive to certain medications. I am one of those unfortunate people. I was switched from Norvasc to Amlodipine and found that the Amlodipine caused pins and needles in my feet. 2 cardiologists told me that it was “all in my head.”
    Now Atenolol has been added and in addition to the pins and needles I also have severe itching that the doctor dismisses as the “winter itchies” I am an older adult and am so tired of the way doctors are dismissive of my concerns.

  6. Chris D.
    Reply

    I was on Coreg (the real stuff) for 6 years until my insurance plan insisted that I use a generic. I have been on the generic several years. (Teva is the company)
    I have Graves disease which gives me the feeling of a rapid heart beat. The Coreg stops that feeling.
    I have never had high blood pressure or heart issues, but with the generic I sometimes feel as though my head will explode. Recently, I have just felt not quite myself to the point where I was checking to make sure that the generic was still coming from Teva… which it is.
    I would love to find out if they have changed manufacturing facilities, and importantly just exactly where is it produced? I have made an appointment for a physical to get myself checked. It is extremely frustrating and indeed scary that we really have no recourse in issues with big drug companies and insurance companies that dictate what we can and cannot have.

  7. Ida
    Reply

    My Experience With Carvedilol
    Beta blockers play a role in the treatment and prevention of heart disease. However, as with other drugs, there are some things that you should know before simply going along with any treatment plan. Some medications are not right for every patient. For me, when I was given the drug Carvedilol, the generic of Coreg, it caused an allergic reaction and damaged my thyroid.
    Although I discarded the drug facts sheet that was given to me when I purchased my first prescription of Carvedilol, my husband retrieved them from the trash long enough to go over them on his own. This proved to be very beneficial later.
    Looking back, I can tell you with confidence that this drug immediately affected my thyroid because I started losing weight without really trying. Over a six month period, I lost more than twenty pounds, but that was not all. My lips developed a red rash and no matter how much lip balm I put on them they just got worse. Due to this problem, I went back to my doctor and he did some blood work that included a thyroid panel because of the rapid weight loss.
    When the results came back on the blood test, I was told that I was hyperthyroid. This got my husband’s attention and he immediately said it was the Carvedilol. This was one of the side effects reported by the makers of this product that appeared on the insert he dug out of the garbage.
    I got a copy of the same insert from my pharmacist and found that the red, rashy lips and extremely swollen legs I had been experiencing were also listed there. Because of the allergic type symptoms, I asked my doctor to set up an appointment with an allergy specialist to see if there was anything else I should know.
    After visiting with my allergist about my experiences with Carvedilol, he had a warning for me and others about this drug. He related what a colleague and friend of his had found during research.
    His friend conducted research on the correlation between Coreg and the deaths of numerous individuals with allergies to bee stings. Overwhelming evidence pointed to the fact that this drug may indeed help patients with heart disease live longer, more productive lives, but it also enhances the allergic reaction and inhibits the uptake of epinephrine. What that means is that it makes the allergic reaction worse while at the same time prevents the best remedy available for anaphylactic shock from working. Thus, many people die needlessly because of this potentially dangerous drug.
    As a result of the short time I was on this drug, I spent a year trying to repair the damage it had wrought on my thyroid. This was not effective and I continue to have dry lips that I attribute to the entire episode. I underwent radioactive iodine treatment to kill my thyroid and will be on thyroid hormone treatment for the rest of my life.
    The reason I feel responsible for telling my story is that I believe this drug is being prescribed far too often for people who simply do not need it. It should never be the drug of choice to control hypertension. There are other, less dangerous options.
    Even though my doctor refused to believe that Carvedilol caused any of my symptoms at first, with a little research I believe he is now convinced. My greatest hope is that he and other doctors like him will never automatically prescribe this drug to anyone again. I believe it should be reserved for those with no other options.

  8. jJudy
    Reply

    I take Carvidilol. Although I felt a bit tired at first (I naturally have blood pressure on the low side, I was prescribed this for rhythm issues) after two weeks I felt fine and continue to do so. No side effects. I buy from a big discount department store chain, they print the manufacturer on the label, Mylan Inc.
    My insurance company will pay for a name brand if it is medically necessary, my PAC is doing regular liver function tests to determine this since I have Hepatitis C. So far the numbers are fine, and will stay on Carvidilol for now since I am doing well on it.

  9. Mike
    Reply

    Amazed to see my experience echoed. I’m sitting here with arrhythmia and anxiety after taking the Carvedilol, again, after my doctor’s insistence. My blood pressure has NEVER been in the 150s before and this only started with this new drug. This is the second round – the doctor told me to stop for three day and then try again – same result!
    I’m posting this here to hopefully add my voice and convince other people to stop taking this drug and go to something else or at least the brand name equivalent. This is NOT just some psychosomatic reaction!

  10. Nancy L.
    Reply

    I was on Metroprolol for arrhythmia and was changed to Carvedilol 12.5 2x day. Always took it with food. Now I have severe diarrhea, burning eyes, blurred vision and very dry sore throat that has lasted for more than a week. I am cancelling lunch dates and theater due to the severity of the problem.
    Saw my regular internist and he said I must stick to the Crvedilol to prevent the rapid heart-rate. I also take a low dose of amlodipine (2.5) that has never given me any problems.
    I will see another cardiologist in 2 weeks and wonder if he will just ignore the problem. I am wondering if I need to see any allergist.
    Thank you for your input.

  11. Sam G.
    Reply

    I have been using Coreg and later generic Carvedilol for 20 years for heart failure with no problems or known side effects. I did have a heart rhythm problem at the beginning
    while the dose was being adjusted upward but believe that was due to concurrently taking a Calcium channel blocker. No problem since it was stopped.

  12. RJZ
    Reply

    I had been using Retin-A Micro for several years for adult acne and other lesions. It kept my forehead lesions invisible. The last refill I got (and this drug is considered cosmetic and is not covered by my insurance), I was switched to the generic, tretinoin cream, 0.1%. About a week ago, I discovered the lesions were starting to be visible again. And, it takes months to affect them, so I am behind the eight ball. So now I’m out half of the $40 some dollars of the cost of the generic, plus I have to pay for a new brand name, which runs about $100. Not right, FDA!

  13. JimP
    Reply

    I find that our chain pharmacy sometimes changes manufacturers of the generic drugs that it stocks. A generic drug that seems to work just like the brand name may not work the same after a refill. That happened to my wife with the generic Mirapex she takes for Restless Leg Syndrome.
    After a refill, her RLS symptoms were no longer well-controlled. We found that the pharmacy had changed manufacturers because the original manufacturer stopped making the drug. The pharmacy went to some trouble to order from a different generic manufacturer, and her RLS is back under control. I think everyone needs to not only keep track of what drugs they take, but also the manufacturer of any generic drugs so they will be aware if the manufacturer has changed.

  14. MAOM7
    Reply

    I have been on Carvedilol for four years. Yes, the generic. I have had NO trouble with it and it does what I need it to do. I get mine at Target, and the pills come from Teva. Perhaps it depends on the pharma company as to whether the product is just like the name-brand.

  15. Linnie
    Reply

    I had been on Keppra for 7 years before I tried three different companys generic Levetiracetam. All caused burning and itching. During a trial of the third generic I came down with medically induced peripheral neuropathy.I may never recover more than 80% of my pre-generic feelings.
    L.C.

  16. WI
    Reply

    I have been taking generic coreg for several years. 6.25 twice a day. Have never had a problem.

  17. RA
    Reply

    I was first given a Beta Blocker [BB] in 1987 for a new onset of HBP [high blood pressure]. Within months I developed an irritation (burning, itching, stinging, aching) in my arms that became so intense I was unable to sleep. I also experienced extreme fatigue and was switched to an ACE Inhibitor in 1990 which caused an extreme cough.
    In 1996 I was switched to a Calcium Channel Blocker and had some side effects and then a new doctor changed me back to a BB in 2010 and I began experiencing very cold hands and feet that developed into full blown Raynauds of the hands as well as HBP, fast & irregular pulse.
    In 2011 my next doctor tried me on several different hbp medicines but their side effects weren’t tolerable and the fast and irregular pulse persisted so in early 2012 she put me on Carvedilol. The side effects from this drug were worse than any I had experienced before . . . nausea, gas, dizziness, fatigue, increased Raynauds effect, insomnia, joint pain, night sweats and my legs and feet were aching, tingling, cold, going to sleep and it felt like electrical currents running up from my feet into the legs. I had several instances of my pulse and blood pressure going so high that I had to go to the emergency room and, of course, they insisted I spend the night for observation and numerous tests.
    After a negative catherization, ultrasounds, and several other tests, in August of 2012 my new cardiologist decided to take me off everything and see how it went. This morning my blood pressure was 118/80 with a pulse of 76. I do still have an instance of the blood pressure and pulse spiking for about 15 minutes periodically, but then it comes right back down. I no longer am experiencing the fatigue and dizziness and nausea that was always present when on the beta blockers.
    Unfortunately, the Raynauds in the hands and peripheral neuropathy in the legs and feet persist although they seem to be a little better. Hopefully, time will allow them to get back to normal. These are dangerous drugs that should be prescribed with great care. . . and I have not once had a doctor that would admit that any drug he/she prescribed could cause the side effects that I’ve said I was having.

  18. Ladyliza
    Reply

    There are some generics that are substandard as you claim, but there are others that are fine. And what the public needs to know is that there are often different manufacturers for the same generic drug. Trial and error is the only way to go.
    What people seem to miss is that the pharmaceutical companies often buy there raw materials off shore too, so it’s hard to generally say that all generic drugs are inferior.
    PEOPLE’S PHARMACY RESPONSE:
    We would NEVER say that all generic drugs are problematical. We believe that most are fine…but the trouble is we have no way of knowing which are fine and which are inferior except by patient reports. Trial and error is a terrible way to discover problems when it comes to the health of the public.

  19. Helen
    Reply

    When generic Plavix (Clopidigrel) came on the market the first available brand was by Dr. Reddy’s company. I had some urninary tract side effects which I could only attribute to the change in that particular med.
    I deal with a small pharmacy and after a couple weeks I called to see if he would be able to get the drug made by any other company. He had already had so many complaints that he had made arrangements to get another brand, and invited me to come in and exchange the remainder of my Rx. This is the advantage of dealing with a small neighborhood pharmacist face to face.
    I believe Plavix tends to cause some urinary tract problems, and something in the generic exacerbated it. I notified the FDA, which I think everybody should take the time to do.

  20. JFR
    Reply

    It seems that, these days, the only way to get through to our Senators or Representatives is through a joint message signed by hundreds of people, if then. I have, individually, contacted my Senator and Representative many times. Their response is a form letter that shows no acknowledgement of the issue I presented. Their action in Washington also shows no response. I am elderly, and technically challenged, to say the least. We are all depending on you younger people to make such a formal and group complaint about the inconsistency and many times life-threating effects of generic drugs possible. I, and my friends, will gratefully sign it.

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