May 25, 2007
Calm Urged For Avandia Patients
Some Experts Say There's No Urgent Need to Stop Taking Diabetes Medicine; More Study Needed
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(CBS/AP)
Experts — including the doctor who sounded the Avandia alarm — tell WebMD there's no need for patients to panic.
The concern comes from the early release of a report in The New England Journal of Medicine (NEJM) suggesting that Avandia increases a diabetes patient's already-high risk of heart attack by 43%.
Researcher Steven Nissen, M.D., is chairman of Cleveland Clinic's cardiovascular medicine department. Nissen, past president of the American College of Cardiology, was one of the first doctors to raise the alarm about the heart risks posed by Vioxx. Nissen says his findings are valid, but he warns that the data are not definitive and must be confirmed by further studies.
"What patients need to know is there is some evidence of cardiovascular harm from Avandia — but there is not any reason to panic," Nissen tells WebMD.
Since news of the Nissen study broke on Monday, frightened diabetes patients have flooded their doctors' phone lines, says Luigi F. Meneghini, M.D., MBA, director of the diabetes treatment center at the University of Miami. "The way this has been presented has been completely out of proportion. It has created a lot of hysteria," Meneghini tells WebMD. "Patients have stopped taking their medications. They don't want to be on this medication any more."
Andrew Drexler, M.D., director of UCLA's Gonda Diabetes Center, is seeing the same reaction.
"We're definitely getting flooded with calls. Everybody wants to know what to do," Drexler tells WebMD.
So here's what these experts say you should do:
At least since 2005, the FDA has been aware of the possible heart attack risk of Avandia. But there's conflicting evidence, including a study of more than 30,000 diabetes patients in a large health maintenance organization (HMO) that found no extra heart attacks among Avandia patients.
For this reason, the FDA has decided not to pull Avandia from the market. Instead, the FDA is working as fast as it can to pull together an expert advisory panel to weigh all the available data.
The FDA warns patients not to stop taking Avandia on their own. Drexler agrees.
"When people read these stories about heart attack risk, they often stop taking their diabetes drugs," he says. "The resulting deterioration of their care can be very detrimental. Everyone says, 'Consult your doctor before stopping any prescribed medication,' but we really must stress this point more strongly."
An editorial released on Wednesday by the editors of the British medical journal The Lancet takes the unusual step of criticizing the NEJM for the "urgency" in the tone of the Nissen paper and an accompanying editorial.
"To avoid unnecessary panic among patients, a calmer and more considered approach to the safety of [Avandia] is needed," the Lancet's editors write. "Alarmist headlines and confident declarations help nobody."
Drexler notes that an ongoing study, the RECORD clinical trial, is studying whether Avandia truly causes heart problems. But the study will not be finished until the end of 2008 or 2009, depending on how many patients develop heart disease.
Another study, the ACCORD trial, which is studying outcomes in 10,000 patients with type 2 diabetes, should also reveal the true risks and benefit of Avandia. That trial, too, is years from completion.
GlaxoSmithKline, the company that makes Avandia, says these trials are being monitored by independent safety boards. Patients should be reassured by the fact that these safety boards have seen no reason to stop the studies, says GSK Chief Medical Officer Ronald Krall, M.D.
"The data safety monitoring boards have done an interim analysis very recently and have reassured us there is nothing in that analysis that should affect the conduct of the study or be of concern," Krall tells WebMD. "They have looked at the specific issues raised by Dr. Nissen. Because cardiovascular events are the RECORD study endpoints, they have looked at them in great detail."
Drexler says these safety boards should go one step farther and do a separate and specific analysis to ensure that no signal of heart risk has been missed for any group of patients.
"We are interested not just in whether the drug helps some patients, but in whether the drug is riskier for some patients," he says. "If the Nissen paper is valid, you should be able to see these differences by now."
By Daniel DeNoon
Reviewed by Louise Chang
© 2007 WebMD, Inc. All rights reserved.
Add a Comment
- Don't forget the mantra that you hear endlessly on television commercials today.
"Ask your doctor if Avandia is right for you."
or in this case,
"Ask your doctor if a heart attack is right for you." - Reply to this comment
- "Avandia increases a diabetes patient's already-high risk of heart attack by 43%."
Oh, right, remain calm! Who wrote this tripe?
Diabetes alone presents a greater danger, this medication multiplied that danger greatly.
What an outrage to suggest we remain calm. As we said as kids, "drop dead twice", we shouldn't stop taking Avandia? - Reply to this comment
- i would say if at all anybody wants to sue they should consider FDA.For any drug to come into the market it has to be approved by the FDA.The responsibility goes to the FDA.Terrapin78 beleive me your doctor had the best intentions in his mind when he prescribed you AVANDIA.This group of drug had the potential to halt the progression of the disease.my question is if Avandia is causing problems then why ACTOS is not included in the warning?It also works the same way as Avandia and it has proved to lower the risk of heart disease in diabetics.We need to be calm and wait till FDA constitutes an independent commitee to evaluate the data GSk has.If Avandia and Actos (Both are Thiazolidinedione Group of medicines)are implicated in causing cardiovascular complications then it is a real bad news for diabetics.I also confirm i am not a fan of big pharma companies.
- Reply to this comment
- It is your life, do not trust this article, the publisher of this article is paid by the GlaxoSmithKlien and BU$H FDA. There are so many medication in the market you can take the one is which is safe. (Terrapin78, I like the way you call BU$H). Once again, it is your life, take care. Sue the Doctor, FDA and GSK.
- Reply to this comment
- "When people read these stories about heart attack risk, they often stop taking their diabetes drugs. ... Everyone says, 'Consult your doctor before stopping any prescribed medication,' but we really must stress this point more strongly."
If the media wouldn't sensationalize these studies there wouldn't be the ensuing panic from the public. - Reply to this comment
- It makes no sense to sue your doctor. Did he cram it down your throat? You are responsible as well. If you have a problem GSK is who to sue. Your doctor only has the latest information.
But seriously take some responsibility for yourself. - Reply to this comment
- I resisted taking Avandia when my doctor suggested it. My reasoniong was that I don't TRUST EITHER THE BIG PHARMA OR THE BU$H FDA to provide the true results of studies.
I told him that I don't want to end up like Fen-Fen, Vioxx, Celebrex etc patients and be HARMED permanently.
My doctor continued to push me on it and I relented. NOW I AM PISSED!
I may have to look at suing my doctor. - Reply to this comment
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