Public Citizen, a consumer advocate group, has renewed its call for the Food and Drug Administration to ban the anti-cholesterol drug Crestor, citing new cases of patients with life-threatening side effects.
Crestor is the newest drug approved for the treatment of high cholesterol. It is made by the drug maker AstraZeneca and belongs to a group of cholesterol-lowering drugs called statins.
FDA records obtained by Public Citizen show that 10 new cases of rhadomyolysis, a side effect involving muscle breakdown, and kidney toxicity have been reported to the agency since February, on top of the 14 previously known.
Of the 10 new U.S. cases of rhabdomyolysis, seven of them were at the very low dose of 10 milligrams and three were at the next higher dose of 20 milligrams, said Public Citizen in a prepared statement issued Tuesday. Five of the eight U.S. patients whose ages are known were under the age of 50 and nine of the 10 U.S. patients had to be hospitalized because of the severity of the rhabdomyolysis.
Despite the fact that the majority of U.S. cases of rhabdomyolysis were in people using the 10 milligram dose, AstraZeneca has just sent a warning out to physicians that patients should start at that dose, blaming the four cases of rhabdomyolysis they report on higher doses but failing to mention the seven patients who suffered from rhabdomyolysis at the 10 milligram dose, the group said.
AstraZeneca Wednesday reaffirmed that Crestor is a safe and effective treatment for elevated cholesterol, in a prepared statement posted on its web site.
Crestor “is a doomed drug,” wrote Dr. Sidney Wolf, Directory of Public Citizen’s Heath Research Group, in a letter to the FDA. “It should never have been approved, given the clear evidence of renal toxicity and the seven cases of rhabdomyolysis prior to approval,” Wolf wrote.
Wolf added, “None of the other statins, including the ultimately doomed” Baycol “had any cases of rhabdomyolysis prior to approval and the primary renal toxicity is unique to” Crestor. “When the first months of marketing predictably brought additional cases of renal failure and rhabdomyolysis, the FDA should have responded by removing the drug from the market as we had urged in our March 4th petition.”
But AstraZeneca said: “To date, there have been no fatal rhabdomyolysis cases caused by CRESTOR in both the Clinical Development Program and post-marketing reporting.”.
(via Public Citizen)
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