“Millions” In US Concerned About Effects Of Statins

ABC World News (6/9, story 8, 1:40, Sawyer) reported, “Tonight, the millions and millions of Americans who take a high dose, 80 milligrams of certain cholesterol lowering drugs, in particular Zocor [simvastatin] and Vytorin [ezetimibe and simvastatin], are on alert that these statins in high doses can cause muscle tissue to break down. The cells can actually die.” On the air, ABC interviewed Stephen Nissen, MD, of the Cleveland Clinic to discuss “the dangers with the higher dose.” Nissen discussed muscle deterioration or “pain or muscle weakness” and advised patients to “discuss it with their doctor,” noting that is “particularly important if you are taking this higher dose in the form of Zocor or Vytorin or the generic.”

Blogger: “Scary Thing” About Simvastatin Is Length Since Approval. In “The Medicine Show” blog at the Forbes (6/9) website, Matthew Herper wrote about “The Scary thing About the FDA’s Simvastatin Decision.” He argued that the decision to tell physicians not to prescribe the 80-milligram dose is “scary” because “simvastatin was approved in 1991. This drug has been on the market for 20 years” and underwent heavy scrutiny when it was approved. Herper added, “And, despite the tone of much of the coverage, this is not a medicine only taken by a few people,” but instead by some two million who the FDA said “had been prescribed the 80 milligram dose, either by itself or in a combination pill like Vytorin or Simcor, last year.”

Blogger: Some Answers To “What Took So Long?” The NPR (6/9, Knox) “Shots” blog reported that “the fact that 80 daily milligrams of simvastatin (brand name Zocor) can cause serious muscle damage has been known for years. So why did it take the Food and Drug Administration so long to tell doctors and patients they should avoid that dose?” He said “the answer reveals a lot about the FDA’s reluctance to restrict use of a popular drug — much less move to take it off the market — even when there are safer alternatives.” Knox explained his conclusion and quoted “Dr. Amy Egan, the FDA’s deputy director for safety in the division that deals with statin drugs,” who said “basically we had to go back to the statin sponsors and have them submit additional data from their large clinical trials.” The post also examined the role of the cost and popularity of the medicine.