Crestor Found to Have Life-Threatening Health Risks
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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`2
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
Nota Bene: Rhabdomyolysis is a muscle wasting disease caused by Co Enzyme
Q 10 depletion. Muscle wasting results in heart failure. There are other drugs
besides statins that deplete the body of Co Enzyme Q 10 including Beta Blockers
[Metoprolo; Betaloc; Durules; Nu-pMetop ], Vasodilators [Hydralazine], Thiazide
diuretics [Apo-Hydro; Diuchlor; Neo-codema; Novo-Hydrazide; Urozide]and ] anti
the diabetic drug Metformin [Glucophage]. Doctors are prescribing these
combinations for their patients without any knowledge about the potential
synergistic effects of such combinations.
