With the whirlwind of criticism the Food and Drug Administration
(FDA) received after not moving fast enough in communicating potential
problems associated with COX-2 inhibitors, such as Merck's
Vioxx, officials have come up with a new plan to provide more preliminary
information than before.
Kicking the plan into gear, the FDA issued an advisory on Crestor,
a popular cholesterol-lowering statin drug, as part of its ongoing
effort to inform the public of potentially significant emerging
safety data so patients can make more educated medical care choices.
The issue with Crestor? It seems that AstraZeneca's Crestor
may be responsible for an increased risk of potentially life-threatening
muscle damage, known as rhabdomyolysis, which can lead to kidney
failure. The risk is especially prominent in people of Asian ancestry.
FDA Formal Crestor Advisory
In the Crestor advisory, the FDA indicated that the increased risk
for muscle damage, though small, was largely identified and understood
when Crestor was first approved in 2003. Yet due to new post-market
studies that underscored the concerns of this risk, the FDA concluded:
- The public should be informed
- Product label warnings should be strengthened
Additionally, Crestor's label revisions, which were proposed
by the company and approved by the FDA, give physicians instructions
on how to best use Crestor with their patients. Therefore, the formal
advisory, as well as the new instructions to physicians, reflect
a policy shift in how and when the FDA releases potentially troublesome
information regarding a specific product.
Criticism Thrown Crestor's Way
Not everyone was pleased with the FDA's new "safe-face"
Crestor advisory. In fact, it was severely criticized by a member
of the Public Citizen's Health Research Group, a consumer advocacy
organization, who argued the attention being thrown Crestor's
way is yet another example of how the FDA's dangerous cowardice
is not providing people with the protection they need from dangerous
prescription drugs.
It was further explained that since Crestor hit the market in September
2003, there have been 117 cases of rhabdomyolysis and 41 cases of
kidney failure. However, AstraZeneca is confident the drug is safe
and effective when used according to the prescribing information -- which
changed from the highest approved dose of 40 milligrams to half
that, or 20 milligrams.
Washington
Post March 3, 2005
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