Concerns about Rosuvatstin (Crestor™)

It might be useful to read this article in the context of our Taking Statins series.

A letter in a recent issue of The Lancet (v 363 p2189, 2004) raises questions about the safety of Rosuvastatin (Crestor™). Unlike systematic studies, letters express the opinion of an individual, and this should be factored in when considering the information and opinions presented. Dr. Wolfe is the Director of the "Public Citizen Health Research Group". In this capacity, he petitioned (March 4, 2004) the FDA "to immediately remove from the market rosuvastatin (Crestor-AstraZeneca) before additional cases of life-threatening rhabdomyolysis and kidney failure/kidney damage occur." You can Click Here to read the petition.

In the letter to The Lancet, Dr. Wolfe summarizes data from the FDA preapproval meeting (July 9, 2003), and from the FDA adverse event reporting system through April 13, 2004. The data shows that use of 80 mg doses caused problems, including cases of renal insufficiency (reduced capacity of the kidney to perform its functions). Dr. Wolfe also notes that there were 18 additional cases of rhabdomyolysis since marketing began. Several of these cases used doses lower than 80 mg; 20 cases of rhabdomyolysis and renal insufficiency or renal failure occured in patients taking 10 mg. Given the number of other statins available without these problems, coupled with the lack of unique benefit of Rosuvastatin, he requests removal before other patients are injured or killed.

Although the absolute risks are low, one should question why one should take a possibly lesser-than-safe medication, when other, safer versions abound. We should wait to see the response of the FDA, and also note that some health insurers are refusing to provide Rosuvastatin to their customers.

Next