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Tuesday, June 25, 2013
The Food and Drug Administration is charged with protecting the public health, but some of its recent actions raise serious questions about drug safety. One puzzle is its shifting stance on the diabetes drug rosiglitazone (Avandia).
Several years ago, Avandia was aggressively marketed and widely prescribed. In its heyday, it earned more than $3 billion a year, making it the most successful diabetes drug of all time.
Then cardiologist Steve Nissen, M.D., published an article in the New England Journal of Medicine (June 14, 2007) revealing a 43 percent increased risk of heart attack among patients taking Avandia.
Avandia immediately became a highly controversial medication. According to Dr. Nissen, the company and the FDA were aware of potential cardiovascular problems associated with Avandia even before he published his critical article. The FDA eventually restricted use of the drug, which was banned outright in Europe.
That might have been the end of the story, but the agency and the manufacturer, GSK, requested a reanalysis of a European study of Avandia. The researchers concluded that there was no increased risk of heart attacks after all. The FDA convened an advisory committee to hear this report, and this panel suggested that the restrictions on Avandia be loosened.
Has the FDA lost sight of the reported suffering that has been associated with this drug? One reader wrote:
“I have been a type 2 diabetic since 2001 and have been on metformin since 2002. Along with diet and daily exercise, it has managed my condition very nicely.
“In 2005, my 44-year-old son was also diagnosed with type 2 diabetes. His health needs were met by his company’s health plan. For some reason he was put on Avandia.
“He had a massive heart attack and died on Oct. 13, 2006, at age 45. I asked his wife what his medications were, and she said he was taking Avandia. Why he was put on that drug immediately upon being diagnosed I will never understand. A good physician usually tries the trusted drugs that have been on the market for a while. I believe that my son was one of the first guinea pigs to die because of Avandia.
“I also hold the FDA responsible in that (1) they approved a drug before the long-term effects were known, and (2) they failed to even listen to the drug manufacturer when warned of a serious side effect.
“I continue to tell everyone I know about Avandia. I will also refuse to take any new drug until I know what the long-term side effects are. I no longer trust the FDA.”
It can take years or even decades for the FDA to discover serious side effects of commonly prescribed medications. The pain reliever propoxyphene (Darvon, Darvocet), the weight-loss medicine sibutramine (Meridia) and the arthritis drug rofecoxib (Vioxx) were taken by millions of people before it was discovered that each increased the risk of heart attacks or strokes. They eventually were pulled off the market.
European drug regulators do not appear to be reconsidering the ban on Avandia. It remains to be seen whether the FDA will ease restrictions on this controversial drug. If the FDA wants to keep the confidence of the American people, it must put the public health uppermost in its Avandia deliberations.
Q: I took lisinopril for many years to control hypertension. Every time I complained to the doctor who prescribed it about my constant nagging cough, he just prescribed cough medicine. He never told me it was due to the lisinopril. When the coughing got so bad that I wet myself, he prescribed a pill for incontinence!
After eight years, I changed doctors. The new doctor took me off lisinopril immediately and explained the connection with the cough. He put me on losartan; the cough went away in less than a week.
No more cough meant no more losing control of my bladder, so he told me to toss the incontinence med along with the cough med. This new doctor encourages me to eat right for my health instead of taking a handful of pills.
If you are having seemingly unrelated health problems, be sure to check out the meds you take with your doctor or pharmacist to see if there is a connection. I wish I had done so way sooner!
A: Great advice! A cough caused by drugs like enalapril, lisinopril and ramipril is a common side effect of ACE inhibitors. Such a cough can be unbearable; prescribing another drug to counteract the complication of incontinence is incomprehensible.
We document such common mistakes in our book “Top Screwups Doctors Make and How to Avoid Them.” Anyone who would like to learn about common pitfalls and practical steps to protect oneself can find this book in libraries or online at www.PeoplesPharmacy.com.
Q: My nurse practitioner suggested that I start taking Coenzyme Q10 because I also am on simvastatin to control cholesterol. She said it would be beneficial for my muscles and my heart. When I asked my cardiologist, though, he didn’t have a clue what I was talking about. What can you tell me about this nutrient?
A: Coenzyme Q10, also known as ubiquinol, is a natural compound made by the body. It is essential for mitochondria, the energy factories of our cells.
Statin-type drugs deplete this crucial nutrient, and many doctors now recommend it for patients on such medications (Nutrition Reviews, March 2013). A new study presented at the European Society of Cardiology in May showed that Coenzyme Q10 reduced heart-failure mortality by about half. The lead author encouraged his cardiology colleagues to add Coenzyme Q10 to standard heart-failure therapy.
Q: My 3-year-old son has suffered with eczema on his legs and feet for two years. We treated it successfully with Elidel, but cancer concerns about its safety in children alarmed us. With consent from his doctor, we suspended its use.
I tried many creams to try to soothe his skin, but he cried about all of them, saying they hurt. I started using Noxzema moisturizer after reading about it on your website. Thankfully, there were no tears from him.
To my great surprise, his skin responded almost immediately. Almost all traces of eczema are gone. We have been using this product for about three weeks, in the morning and evening, without washing it off. It has truly changed my young son’s life.
A: Many other readers also have reported that Noxzema can ease their skin irritation. This nonsoap facial cleanser was developed in 1914. It was originally intended as a sunburn remedy, but early reports that it was helpful for “knocking eczema” allegedly led to the name “no eczema” or Noxzema.
“The People’s Pharmacy with Joe and Terry Graedon” airs Saturday at 7 a.m. on WVTF (89.1 FM) and at 4 p.m. Saturdays and Sundays on RADIO IQ (89.7 FM). Joe and Teresa Graedon’s column runs in Tuesday’s Extra.
Weather JournalIcy mix moves in this Sunday AM