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Health Canada issues Crestor advisory

Health Canada issues Crestor advisory

July 14, 2005

Health Canada advised patients with underlying health conditions that they could be at risk of serious Crestor side effects, as well as from other statin drugs.

Earlier this year, Health Canada requested statin makers, including AstraZeneca's Crestor, outline the potential for muscle damage in higher-risk patients, and now patient safety information sheets for the drugs contain warnings about the potential effects.

Late last year, Dr. David Graham, the associate director of the FDA's Office of Drug Safety, testified before the Senate Finance Committee about the FDA's failure to protect the public from unsafe drugs. Graham named Crestor as one of five drugs currently on the market whose safety must be "looked at quite seriously".

In March 2004, the watchdog group Public Citizen first petitioned the FDA to remove Crestor from the market, saying it had caused muscle breakdown leading to kidney failure in some patients. The group renewed its call for Crestor to be removed from the market in October 2004.

Although the FDA kept Crestor on the market, in March the agency ordered stronger warning labels for the drug stating Crestor may increase the risk of life-threatening muscle damage, especially among Asians. The agency's denial of Public Citizen's petition to ban Crestor was, according to the consumer group, the FDA's choice to side with AstraZeneca instead of the public.

Click here for a list of Crestor Side Effects.

 

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