Posted on 03/03/2005 12:48:37 AM PST by neverdem
FDA Issues Warning on Use of Cholesterol Drug, Especially by Asians
The popular new cholesterol-lowering drug Crestor may cause an increased risk of potentially life-threatening muscle damage, especially in people of Asian ancestry, the Food and Drug Administration said yesterday.
In a formal advisory, the agency said the risk is small and was largely identified and understood when the drug was approved in 2003. But because of new post-market studies that underscored the concerns, the agency concluded that the public should be informed and that warnings on the product label should be strengthened.
The advisory, and accompanying new instructions to physicians, reflect a recent policy shift in how and when the FDA releases potentially troublesome information about a product. In the wake of criticism that the agency did not move fast enough in communicating potential problems with COX-2 painkillers, including Merck's Vioxx, FDA officials said they plan to give out more preliminary information than in the past.
"Today's FDA advisory on Crestor is part of an ongoing effort to notify the public of potentially significant emerging safety data so that they can make more informed choices about their medical care," said Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research.
The manufacturers of Crestor, AstraZeneca, said the label revisions proposed by the company, and approved by the FDA, "provide physicians with further clarification on how best to use Crestor with their patients." The company added: "We continue to believe Crestor is safe and effective when used according to the prescribing information."
Crestor, an especially powerful statin that can lower high cholesterol levels faster than many others, has been linked to some fatal cases of muscle damage known as rhabdomyolysis, which can lead to kidney failure.
(Excerpt) Read more at washingtonpost.com ...
That's rare. The U.S. is usually the last to approve of new drugs. The politically incorrect results of ancestry are also addressed, but not in a very useful way. There are at least a few kinds of Asians. The main symptoms of this adverse effect are unexplained muscle pain and weakness.
FReepmail me if you want on or off my health and science ping list.
I wonder whether blood type and RH factors have anything to do with reaction to statins. (And perhaps to other drugs as well.) An AB-negative, I know I have very different reactions to drugs than most people, perhaps because of my blood type. Therefore, I try to avoid all drugs at all times.
From: http://www.madsci.org/posts/archives/mar2001/985200157.Ge.r.html
"we can use population genetics make some predictions about the incidence of Rh negative blood types in various populations. In Europeans, we expect that about 16% of the population will have Rh negative blood types. In the other populations of the world, the frequency of Rh negative types will be much lower; in Africans, only 9 people in 10,000 will be Rh negative, and in the non-African, non-European portion of the world (Asia, etc) , only 1 person in 10,000 will be Rh negative. "
For my money, I would look at cytochrome P450.
Genetic polymorphisms in cytochrome P450 enzymes: effect on efficacy and tolerability of HMG-CoA reductase inhibitors, i.e. statins.
Interesting. A home test for CYP2D6 would be handy. I took Lipitor for three months and my choles dropped 100 points. Doc said I was a "high responder," true not only for statins but for everything else. I'd love to find one way to know ahead of time whether a drug will work for me or have the opposite effect. Those opposite effects could be lethal.
FDA Panel Nixes OTC Cholesterol Drug Sales.
The NY Times' title was " F.D.A. Panel Votes Against Sale of Statins Over Counter". Could you let me know how the Alfalfa Powder extract works out for you?
When you read on Crestor at lower doses than the (I believe) 10mg minimum tablet size, it is still highly effective. At high doses it is incredibly powerful.
"A fourth would be to force drug companies to publish all their clinical data, not just the data that show their product in the best light. Editors at several prominent research journals are calling for measures that would do just that."
IIRC, Congress passed a law that required the drug companies to disclose all of their research, but it had no effective penalties for non-compliance. The drug companies argument was that it could force them to disclose proprietary research. I believe Congress is working on it.
Well, I'm on Crestor now, and if it lowers my cholesterol back to normal, I might see if I can keep it down with just exercise.
The bent one's doc had him on a statin. He stopped taking them sometime after he left the White House and had a coronary artery bypass graft last summer, so he couldn't campaign for the traitor last fall.
Even the disclosed research is suspect. Remember the parallel studies into the Cox2s? The government study showed a large increase in heart attacks while the industry funded study showed none. The numbers were too disparate for me anyway. (And as I said from the beginning, I think the Cox2's should be on the market with proper prescribing guidelines. The people made the decision to hide the data from doctors and patients need to be jailed for murder.)
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