 |
 |
The risks that accompany the benefits of prescription drugs. WASHINGTON (June 10, 1998 09:32 a.m. EDT http://www.nando.net) -- A flurry of reports from the government and private advocacy groups underscores the risks that accompany the benefits of prescription drugs. A report issued Tuesday by the Alliance for Aging Research found that health problems brought on by improper use or adverse reactions to medicines cost some $85 billion a year, nearly 10 percent of the nation's total health tab. And people over age 65 are particularly vulnerable. And a report issued by the watchdog group Public Citizen found widespread flaws in the drug information leaflets that pharmacists distribute to millions of Americans. The group cited the 1996 death of a 7-year-old Houston boy, Cory Christen, who was taking three times the recommended dose of an anti-depressant called imipramine for attention deficit disorder. His parents were never warned, either by their doctor or through a drugstore leaflet distributed with the drug, that it could cause potentially fatal heart rhythm problems. "If the leaflet had told us about ... potentially harmful effects of imipramine, we would never have given it to Cory, and he would be alive today," said the boy's mother, Patricia. "False, incomplete or out-of-date safety information is leading to needless drug-induced deaths,"said Dr. Sidney Wolfe, who directs the Health Watch program at Public Citizen. The organization has filed a petition with the Food and Drug Administration to more tightly police the leaflets. FDA officials say legislation that reorganized the agency two years ago precludes regulation of the materials unless they're found to involve serious side effects. Both reports came a day after the FDA announced that Roche Laboratories was removing the heart drug Posicor from the market due to a growing list of other drugs that caused severe, even fatal, adverse reactions when taken together. With 400 reports of health problems among patients taking the drugs, including at least 24 deaths, connected to interactions with more than 25 other prescription drugs, the FDA and Roche concluded that safe delivery of the drug would be too complicated to guarantee for the some 200,000 Americans taking the drug, given that it offered no special advantage over other heart and blood pressure drugs. There is growing concern that neither patients nor doctors are fully aware of all the potential pitfalls of many prescription drugs. FDA research indicates up to a third of doctors don't properly warn patients of the risks of drugs they're prescribing. The report from the Alliance for Aging notes that people over age 65 are particularly vulnerable to medication-related problems due to the number of drugs they take and the physical changes brought about by aging and disease. "This is a complex but solvable problem," said Daniel Perry, executive director of the group. "It can stem from patients not taking medications properly, lack of information about medication effects in the elderly, insufficient knowledge of how strong medications affect the frail elderly, and inadequate training of health care professionals in geriatric pharmacology." According to a recent report published in The Journal of the American Medical Association, adverse reactions to drugs severe enough to cause death or disability are frequent. It estimated the toll at some 106,000 fatal adverse drug reactions annually among Americans of all ages. Yet except for about 40 "high-risk" drugs for which the FDA requires drugmakers to provide consumer warnings of side effects in layman's language approved by the agency, there is no government oversight of the content of prescription information for patients. Although the government is pushing drugstores and other prescription distributors to voluntarily provide consumer advisories, the FDA has no authority to make the warnings or the information in them mandatory until 2001, agency officials said. Wolfe's group argues the FDA's general authority to ensure safe medications allows scrutiny of the leaflets now. As an example of the information gaps, Public Citizen studied 59 consumer bulletins for non-steroidal anti-inflammatory drugs, a class of painkillers that can often cause stomach bleeding to the extent that they hospitalize an estimated 41,000 Americans each year. The group found that only a quarter of the leaflets advised patients to stop taking the drugs if they suffered abdominal pain. A report from the Inspector General at the Department of Health and Human Services last fall found that one in five older patients are regularly given drugs considered by medical experts to be unsuitable for older people because of the high risk of unintended harm. The alliance report, "When Medicine Hurts," recommends, among other things, that government agencies distribute lists of drugs that are especially risky for older patients; that specific warning labels for older patients be required for over-the-counter medicines and that studies on the safety and effectiveness of drugs done both before and after medications are approved for sale include more frail, elderly people. by Lee Bowman for Scripps Howard News Service. Copyright 1998 Nando.net Copyright 1998 Scripps Howard janet paterson aka calendar control supervisor 51/10 - sinemet/selegiline/prozac - [log in to unmask] quotations: http://newww.com/cgi-bin/do_cal?c:newvoice pwp event calendar: http://newww.com/cgi-bin/do_cal?c:pwpc