Given the widespread (and increased) use of statins for the lowering of so-called “bad” LDL cholesterol, it’s time for a blast from the past - to the point where Crestor was being considered for the market by the US Food and Drug Administration (FDA).
Dr. Sidney M. Wolfe MD of Public Citizen was there, facing the FDA, urging the FDA not to approve Crestor.
“In opposing the drug’s approval at a July 9, 2003 FDA advisory committee meeting, we pointed to two cases of kidney failure and one case of kidney insufficiency in clinical trials prior to approval in which patients had also experienced both protein and blood in the urine,” wrote Dr. Wolfe, in a letter from late winter 2004 and posted to the official website of Public Citizen. “There were also a large number of patients who had blood and/or protein in their urine but had not suffered from kidney failure. In addition to this kidney toxicity, unique among all of the statin drugs, rosuvastatin is the only one of these drugs in which any cases of the life-threatening muscle destruction known as rhabdomyolysis was found to occur prior to approval.”
Wolfe’s appearance before the FDA was on July 9, 2003. Crestor was ultimately approved, but Public Citizen had more to say. In a letter to then-Commissioner Mark B. McClellan MD, PhD, of the FDA, dated March 4, 2004, Public Citizen was back demanding an outright ban of a drug that it opposed approval of in the first place, and that had been on the market for just five months.
“In the United States, where the drug has only been on the market for a little more than 5 months,” Wolfe writes, in 2004, “a 39-year-old woman, taking only 20 milligrams a day, died of Crestor rhabdomyolysis and renal insufficiency. In addition, a 63-year-old man in the US developed acute renal failure using a dose of only 10 milligrams a day and another patient in the US developed renal insufficiency and renal tubular necrosis after using rosuvastatin at a dose of 10 milligrams a day for only 2 weeks. The total number of new cases of adverse reactions after approval in the US, Canada and the UK combined include:
• 7 patients with Crestor rhabdomyolysis (patients using doses of 10, 20, 20, 20-40, 40, 40 and 80 milligrams per day)
• 4 patients with acute kidney failure (patients using 10, 10, 10 and 40 milligrams per day)
• 5 additional patients with kidney damage (patients using 10, 10, 10, 20 and 40 milligrams per day)
• 6 patients with bleeding or abnormal bleeding tests who were also using blood-thinning drugs such as Coumadin, known to have an abnormal interaction with rosuvastatin (patients using 10, 10, 10, 10, 20 and unknown milligrams per day).”
There was no mention of Crestor diabetes; however, various Crestor side effects lawsuits allege that Crestor patients, with no family history of diabetes and without known diabetes triggers such as poor diet and lack of exercise, are suddenly struck with diabetes.
Wolfe was back a year later, in March 2005, with concerns over the risks for Crestor rhabdomyolysis, which he cited as being 6.2 times higher for Crestor than all other statins, combined.
READ MORE CRESTOR LEGAL NEWS
According to a CBS/Associated Press report dated December 7, 2004, Dr. David Graham named Crestor as a “worrisome” drug that demanded expedited action. “The government should evaluate the occurrence of renal failure and other serious side effects among people taking Crestor,” Graham said. “Two of three other statin competitors prevent heart attack and stroke and do not cause renal failure.”
Almost 12 years later, it seems, little has changed.