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On March 4th, Public Citizen’s Health Research Group formally petitioned the FDA to ban the new cholesterol-lowering drug, rosuvastatin (CRESTOR). (See March 2004 issue of Worst Pills, Best Pills News). By the time of our petition, the total number of patients who had suffered the life-threatening muscle breakdown known as rhabdomyolysis was seven, including a 39-year-old American woman now dead because of this adverse effect. In addition, a total of nine patients have suffered either kidney...
On March 4th, Public Citizen’s Health Research Group formally petitioned the FDA to ban the new cholesterol-lowering drug, rosuvastatin (CRESTOR). (See March 2004 issue of Worst Pills, Best Pills News). By the time of our petition, the total number of patients who had suffered the life-threatening muscle breakdown known as rhabdomyolysis was seven, including a 39-year-old American woman now dead because of this adverse effect. In addition, a total of nine patients have suffered either kidney failure or other serious kidney damage while using the drug. Both of these serious problems were identified prior to the approval of the drug, whose approval we opposed and, unlike all other statin drugs, rosuvastatin is unique in its ability to cause primary kidney damage including failure.
As we have previously mentioned, one of the major U.S. health insurers, WellPoint/Blue Cross, representing 15 million people, had decided not to allow the drug on their formulary. Now, there is news of additional insurers and employers balking at using this uniquely dangerous drug with no unique benefits over other such cholesterol-lowering drugs.
According to the Delaware News Journal, in the home state where Crestor-pusher AstraZeneca is based, Medco Health Solutions, one of the largest prescription drug benefits managers, has decided not to put rosuvastatin on its preferred drugs list. As a result, General Motors, the nation’s largest self-insured company and a client of Medco, decided not to reimburse for the drug. Another Medco client, United Health Care, the nation’s largest insurer with 21 million people insured, will reimburse for the drug but is, in essence, discouraging patients from using it by placing it in the highest of three out-of-pocket payment categories.
As we have said before, this drug is a loser and will eventually be banned. Protect yourself and those you know by not using it (see article on p. 25 in this issue on overuse of statins in people with no heart disease).
Nefazodone (SERZONE)
On March 12th, Public Citizen’s Health Research Group filed a lawsuit in the Federal District Court to force the FDA to make a decision on our petition to the agency, now more than one year ago, to ban this antidepressant with unique liver toxicity. When we originally asked the FDA to ban the drug, it had just been taken off the market in Europe because of liver toxicity. When we amended our petition last fall, in the face of a rapidly-rising number of cases of liver toxicity, the Canadian government had ordered the drug off the market there. Now, both Australia and New Zealand have announced they are going to take the drug off the market because of its liver toxicity.
As of the time of our amended petition, there were already 94 liver injuries associated with the use of nefazodone. This included 55 cases of liver failure (with 12 liver transplants) and 20 deaths from liver toxicity. These data were only through May of 2003 because the FDA has not provided more recent data.
Needless to say, we continue to advise you to stay away from this drug. It is only a matter of time before the United States joins the rest of the world in getting rid of this dangerous product (see earlier article in December 2003 Worst Pills, Best Pills News about nefazodone).
What You Can Do
There is no medical reason that you or a family member should be taking either rosuvastatin or nefazodone. There are safer and at least equally effective alternatives available.
