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.
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 & Intrigue 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.”
“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.”
“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.”
“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.”
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.