Cholesterol Drug Pulled From Market

[Guest guest]

Wednesday August 08 06:39 PM EDT

Cholesterol Drug Pulled From Market

By a Pozniak ABCNEWS.com

Bayer has pulled its cholesterol-lowering drug, Baycol, off

the market after 31 people who had been taking the drug

died.

Drug maker Bayer pulled its popular cholesterol-lowering

medication off the market today amid reports of a deadly

side effect.

According to the Food and Drug Administration (news - web

sites)., Bayer Pharmaceuticals voluntarily withdrew Baycol,

known generically as cerivastatin, as a result of the 31

patients deaths associated with the drug over the last four

years.

The drug's rare side effect, rhabdomyolysis, destroys muscle

cells then releases them into the bloodstream and can cause

severe muscle pain, frequently in the calves or lower back.

In rare instances the effects are so severe, patients

develop potentially fatal kidney or other organ failure.

Symptoms of the condition include muscle pain, weakness,

tenderness, fever, dark urine, nausea and vomiting.

Particular Risks

Approved in 1997, Baycol is part of a class of

cholesterol-lowering drugs called statins. Experts say

rhabdomyolysis is a known side-effect of all statins.

According to Doering of the University of Florida's

College of Pharmacy, the drugs have remained on the market

because " the positive benefits of the drug outweigh the rare

frequency of occurrence. "

But Baycol stands out because it has caused a significantly

higher number of reported deaths, especially when used in

high doses, in elderly patients, and particularly when

combined with another cholesterol-lowering drug called

gemfibrozil, also known as LOPID.

Doering blames the FDA's approval process for today's

recall: " This recall highlights a broader problem, and that

is the inability of the drug approval process to predict

what the true nature of any drug is, based solely on the

data required for an NDA [new drug application].

" It has taken this long for enough data to accumulate for

the FDA to finally drop the ax. This begs the question: What

is the threshold after which the benefits no longer outweigh

the risks? The answer, of course, would depend on the drug

and the disease which it treats. "

Other Drugs Called Safer

According to Stump, associate director of pharmacy

services at Yale-New Haven Hospital, " rhabdomyolysis was not

reported in clinical trials with Baycol, but case reports

appeared in the literature after the drug was marketed. "

Doering predicts " other companies making competing products

are shaking in their collective boots right now. "

But Merck spokeswoman Donna Kary disagrees. She says no

deaths have been associated with the company's popular

statin drug Zocor.

However, warning labels about the condition are " in the

literature, it's known, and we carry information about it in

our label. But we haven't seen any problems associated with

this. "

Statins Called Generally Safe

Experts warn patients not to overreact to the recall.

" My primary concern is that patients will stop taking all

statins because of fears about the safety of statins. The

other statins such as Zocor and Pravachol have been shown to

be safe and efficacious in excellent large outcome studies, "

says Dr. Colleen Conroy, vice chair of Colorado Health

Sciences University.

The FDA advises patients who are taking Baycol to contact

their doctors about switching to a different drug.

Experts were not immediately clear on why Baycol would

differ in danger from other statins, but conjectured that it

may combine differently with other drugs.

[Guest guest]

thanks!!!! guess i'd better ask for another drug now too!!!