Recalled Drugs Disproportionately Affect Women
by Sophia Cariati

(Washington DC, 11/15/01): According to a report from the US government, eight of the ten drugs recently removed from the market pose greater health risks to women than to men. The majority of these medications appear to put women at increased risk of rare but potentially fatal irregular heartbeats or arrhythmias.

The General Accounting Office (GAO), the investigative arm of the U.S. Congress, examined FDA documents and research studies to evaluate prescription drugs pulled from the market since 1997. The office concluded that eight of the ten drugs caused more harm in women than in men. Four may have caused a greater number of adverse events because women were the primary users. The remaining four products, however, caused health problems predominantly in women even though the drugs were prescribed equally among the sexes. For example, a study published in the Journal of the American Medical Association in 1993 revealed that 15 of 25 patients who developed torsades de pointes (a type of irregular heartbeat) in association with the drug terfenadine (Seldane) were women.

The four drugs withdrawn from the market that caused significantly more adverse events in women than men were as follows:

• Seldane (terfenadine) - an antihistamine
• Hismanal (astemizole) - an antihistamine
• Propulsid (cisapride monohydrate) - a gastrointestinal drug
• Posicor (mibefradil dihydrochloride) - a cardiovascular drug

Although the GAO did not analyze nonprescription drugs, some of these medications may also be particularly dangerous for women. For example, the FDA recently recommended that phenylpropanolamine (PPA) - a chemical commonly found in nonprescription drugs - be removed from all products because it increases the risk of hemorrhagic stroke (bleeding in the brain) in women but not men.

Experts warn that there are other drugs still on the market that have been shown to increase the risk of torsades de pointes in women. Studies have demonstrated that antibiotics such as erythromycin, anti-malarials like halofantrine, and the anti-arrhythmics quinidine and sotalol all are associated with an increased incidence of heartbeat irregularities among women. Go to www.torsades.org for more information on this condition.

Researchers have known for almost a decade that women are particularly susceptible to a type of drug-induced arrhythmia known as torsades de pointes. Yet there have been no consequent changes in drug labeling, nor government-sponsored awareness campaigns designed to caution physicians and patients of this potential complication.

According to Raymond Woosley, MD, PhD, "the information was in the literature, but there was nothing in the labeling indicating that these drugs are more harmful to women." Dr. Woosley is a former Director of the Georgetown University Center for Education and Research in Therapeutics (CERT) and Professor at Georgetown University School of Medicine in Washington, DC. He is currently the Dean of the College of Medicine at the University of Arizona.

Why the labeling omissions? One of the reasons is that the Food and Drug Administration (FDA) and the pharmaceutical industry, the groups responsible for changing drug labeling, do not regularly analyze safety data by gender. Despite an increasing number of studies showing clear differences between men and women in the incidence, manifestation, and mechanism of a number of diseases, gender-based data analysis is still a rare practice, according to Phyllis Greenberger, MSW, President of the Society for Women's Health Research in Washington, DC. This shortcoming sometimes keeps gender-specific risks as well as benefits buried beneath heaps of data. As a result, both men and women may be harmed needlessly by some drugs and unaware of the optimal use of others.

"We have been enrolling women in clinical trials for some time now," Dr. Woosley continued, "but researchers still don't analyze data to see if a drug's efficacy or safety profile is significantly different in men and women." He speculated that once scientists routinely adapt this practice, numerous classes of drugs might emerge as particularly hazardous or beneficial to men and women.

What can you do to protect yourself from potentially harmful side effects? Women must demand that their physicians and pharmacists fully inform them about the medicines they are prescribed. Before leaving the doctor's office or pharmacy, make sure you have answers to the following questions:

• What are the benefits of this drug?
• What are the common, rare, and serious side effects of this medication?
• Are there any safer alternatives to this drug?
• Can a small overdose, such as one extra pill, be dangerous?
• Can this prescription interfere with other medications or supplements I am taking, or vice versa?
• Does the drug have any serious interactions with other drugs or with a large number of other medications?
• Does the drug require laboratory monitoring to ensure that I am not having side effects?

With any medicine, the most important thing to know is that if you experience any side effects, you should report them to your doctor immediately.

The Society for Women's Health Research is the nation's only not-for-profit organization whose sole mission is to improve the health of women through research. Founded in 1990, the Society brought to national attention the need for the appropriate inclusion of women in major medical research studies and the resulting need for more information about conditions affecting women. The Society advocates increased funding for research on women's health, encourages the study of sex differences that may affect the prevention, diagnosis and treatment of disease, and promotes the inclusion of women in medical research studies. Dr. Donnica Moore has been a member of the Society since 1990 and is a past member of its Board of Directors.

For more information on clinical trials, click here.

Created: 11/15/2001  -  Sophia Cariati