corner
Healthy Skepticism
Join us to help reduce harm from misleading health information.
Increase font size   Decrease font size   Print-friendly view   Print
Register Log in

Healthy Skepticism Library item: 244

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Richwine , L .
Consumer Group Says Ban Cholesterol Drug
Reuters 2004 Mar 4


Full text:

A consumer group on Thursday asked the U.S. government to ban an AstraZeneca cholesterol drug approved only months ago, citing reports of dangerous reactions and one death.

The prescription drug, Crestor, was introduced in Canada in February 2003 and in Europe in March 2003. The drug hit the U.S. market last September.

Since the drug’s launch, seven patients who took it developed life-threatening muscle deterioration, and nine experienced kidney failure or damage, consumer group Public Citizen said.

One 39-year-old U.S. woman died from kidney damage and muscle breakdown, a known side effect of drugs such as Crestor called statins, the group said.

The information, detailed in a petition to the Food and Drug Administration, was based on reports submitted to regulators in the United States, Canada and Britain, Public Citizen said.

“For there to have been that many of those problems in basically in less than a year is very worrisome,” Dr. Sidney Wolfe, head of Public Citizen’s Health Research Group, said in an interview.

Cases of muscle breakdown, known as rhabdomyolysis, led to the 2001 withdrawal of Bayer AG’s Baycol, which was linked to more than 100 deaths.

AstraZeneca is relying on Crestor, known generically as rosuvastatin, to drive future profits. Millions of people take statins to lower high cholesterol, a major risk factor for heart disease.

More than 1 million patients have taken Crestor, AstraZeneca spokesman Gary Bruell said. Side effects so far “totally mirror the experience” in the company’s clinical trials that supported Crestor’s approval, he said.

The drug’s risks “are comparable to other statins,” he said.

While both the muscle and kidney problems were seen in premarketing trials of Crestor, the FDA concluded the drug’s benefits outweighed its risks at doses of five to 40 milligrams. Safety concerns had led AstraZeneca to drop plans to market an 80-milligram dose.

Public Citizen, which had urged the FDA not to approve Crestor in the first place, said the post-marketing information showed serious side effects occurred even in patients taking the lower doses.

 

  Healthy Skepticism on RSS   Healthy Skepticism on Facebook   Healthy Skepticism on Twitter

Please
Click to Register

(read more)

then
Click to Log in
for free access to more features of this website.

Forgot your username or password?

You are invited to
apply for membership
of Healthy Skepticism,
if you support our aims.

Pay a subscription

Support our work with a donation

Buy Healthy Skepticism T Shirts


If there is something you don't like, please tell us. If you like our work, please tell others.

Email a Friend








Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909