The other cases of rhabdomyolysis and drug-induced kidney disease occurred in the UK or Canada, where the drug had been on the market for a longer time. We have now obtained new information from the FDA about many additional post-marketing cases of rhabdomyolysis and kidney toxicity in reports updated to April 13th. In the relatively short interval since our first petition, 11 additional cases of rhabdomyolysis in patients using rosuvastatin, including at least 10 in the United States, have been reported to the FDA, as have three additional cases of renal failure or renal insufficiency in the United States, all in people using 10 milligrams.
Of the 10 new U. Five of the eight U. Despite the fact that the majority of U. AstraZeneca have written [on May 14th] to healthcare professionals to warn prescribers to initiate Crestor rosuvastatin at a dose of 10mg.
The manufacturer recommends that those patients who have already been started on doses greater than 10 mg should be reviewed at their next appointment, and appropriate down-titration of dose should be considered. Patients should be asked to report muscle pain, weakness or cramps immediately, and if symptoms are severe or if the CPK is greater than 5 times the upper limit of normal, treatment should be stopped.
Dear Healthcare Professional issued 14 May Rosuvastatin is a doomed drug. It should never have been approved, given the clear evidence of renal toxicity and the seven cases of rhabdomyolysis prior to approval. None of the other statins, including the ultimately doomed cerivastatin Baycol had any cases of rhabdomyolysis prior to approval and the primary renal toxicity separate from the secondary renal damage done as a consequence of rhabdomyolysis is unique to rosuvastatin.
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.
We renew our effort to get the FDA to ban this uniquely dangerous drug before it does any further damage. A top US lawmaker launched an investigation into pharmaceutical industry pricing practices on Monday, less than a week after he and fellow Democrats introduced legislation aimed at lowering medicine prices.
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