WHO Carolyn Reece, 69,
Hamilton, Ohio
WHAT HAPPENED Less than two months after her doctor increased the dosage of the cholesterol-lowering drug Crestor to the maximum amount, Reece fell unconscious in her home. Her son rushed her to a hospital, where rhabdomyolysis, or muscle breakdown, and kidney failure were diagnosed. Reece must now undergo dialysis for four hours a day, three times a week. She’s suing the drug’s maker, AstraZeneca, charging among other things that the company failed to sufficiently “convey the true risks associated with the use of Crestor.” In court documents, the drugmaker denied the charges.
Some positive signs
The FDA has recently taken stronger action in some areas. In addition to issuing more warning letters about misleading ads,
it has begun releasing information on its Web site (www.fda.gov/cder/drug /drugsafety
/drugindex.htm) about possible adverse drug effects even before the information has been fully vetted, according to postings on the site.
And it promises to expand those early warnings on a new Drug Watch Web page. At press time, it had issued 12 public-health
advisories on major drug side effects in 2005, which is more than in the past four years combined. And since October 2004,
it has persuaded companies to add black-box drug warnings to all antidepressants, which are on our high-risk list, and all
nonsteroidal anti-inflammatory drugs.
Cruzan, the FDA spokeswoman, e-mailed a list of “the positive actions FDA has taken to address drug safety,” including the
appointment of a permanent director of the Office of Drug Safety (a position that has been vacant since October 2003) and
the formation of a new Drug Safety Oversight Board to monitor its own actions. However, that supposedly independent board
is composed mostly of top FDA officials. (For additional steps that Consumers Union believes are needed, see see our January 2006 Viewpoint.)
WHAT YOU CAN DO
Until the nation’s drug-safety system is adequately reformed, the following guidelines can help you protect yourself:
• In general, if you’re taking any of the 12 high-risk types, don’t just stop, but ask your doctor whether the risks outweigh
the benefits in your case and whether other options may be right for you.
• Don’t pressure your doctor to prescribe a drug, particularly a new one, unless other options haven’t helped and there’s
strong evidence that you need it.
• Ask your doctor whether nondrug treatments can achieve adequate results. If not, might a lower dosage suffice, particularly
combined with nondrug therapy?
• For a new drug, ask whether studies show that it’s more effective and apparently safer than older options. If not, older
ones with longer track records may be a better bet. Older drugs also tend to cost less.
• Ask your doctor or pharmacist for a list of the drug’s known adverse effects. Supplement that information by consulting
unbiased sources such as Consumer Reports’ Consumer Drug Reference, Consumers Union’s Web site (www.CRBestBuyDrugs.org), this site and www.ConsumerReportsMedicalGuide.org), or the National Library of Medicine’s Web site (www.nlm.nih.gov/medlineplus/druginformation.html). For the latest updates on drugs’ adverse effects, go to the FDA’s Web site (www.fda.gov/medwatch/safety.htm).
• Report any serious drug reactions to your doctor, or download the form from the FDA’s Web site, www.fda.gov/medwatch/report/consumer
/consumer.htm and bring it to the doctor or file it yourself.
• See our vital information to help you weigh medical treatments--both benefits and risks.
