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"False, incomplete or out-of-date safety information is leading to needless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