The Food and Drug Administration isabout the cholesterol-lowering drug Crestor, the newest in a class of drugs known as statins.
The consumer group Public Citizen has long been calling for Crestor's recall, citing a higher risk for a serious muscle disorder called rhaddomyolysis.
The Early Show medical correspondent Dr. Emily Senay notes that Crestor's statin cousins include Lipitor and Zocor.
Crestor lowers a person's bad cholesterol, the "LDL," and raises good cholesterol, the "HDL."
The difference between Crestor and the other statins, Senay points out, is that this one has been touted as being able to lower cholesterol more aggressively.
Senay says certain experts and consumer advocacy groups believe that Crestor is associated with a higher risk of rhabdomyolysis, a potentially life-threatening muscle disorder.
Crestor is available in doses of 5mg to 40mg. The higher the dose you're on, the higher the potential for problems, Senay explains. The company originally wanted to market an 80mg pill, but changed its mind when it discovered a much higher risk for this muscle disorder among people taking that high a dose in clinical trials. And actually, frequency of this muscle disorder was a problem for a statin that was pulled from the market in 2001, Baycol.
The maker of Crestor, AstraZeneca, swears up and down that the drug is safe. The company says reports of adverse reactions to the drug are in line with those for other cholesterol drugs. But Public Citizen is petitioning the FDA to pull the drug from the market, and has been since Crestor was unveiled in August 2003. What's changed now is that the FDA has begun to comment. In fact, just last week, the agency demanded that a print ad for Crestor be pulled due to what the FDA said were misleading safety claims.
Senay speculates that the reason the FDA is getting more into the Crestor mix now is that we've had so many issues with other drugs, such as Vioxx and Aleve. The FDA may just be airing the dirty laundry now because it doesn't want to be caught looking the other direction in this climate.
Crestor, Senay continues, is a much newer drug than Lipitor and Zocor, having only been on the market a little over a year. The first statin hit the market in 1987, and Lipitor, the most popular statin, was introduced in 1997. We have a lot more data on the other statins, and they've proven to have very low risk of dangerous side effects. All statins have risks of side effects. Some of the common ones are muscle tenderness, abdominal pain, dizziness, and liver problems -- but the issues with crestor reportedly can be much more serious.
What should people who use Crestor? Should they keep taking it, or perhaps switch to another statin?
If you need to lower your cholesterol, and diet and exercise aren't lowering it enough, statins are an excellent way to do it, Senay points out. Your first choice should be one of the statins that's been on the market longer, such as Lipitor, Zocor, Prevachol or the generic Lovastatin. These drugs have a very good track record, and have been widely prescribed for years. We have very good data on these drugs. If these don't lower your cholesterol enough or you have an allergic reaction, then you might want to try Crestor and see if it works for you. It's supposed to be more aggressive and in some cases, you might need it to really attack that cholesterol level.