4/16/2000 – More from Boston Globe on Drug Safety Issues

This story ran on page A10 of the Boston Globe on 5/15/2000.
© Copyright 2000 Globe Newspaper Company.


Better drug reporting deal with a wide range of conditions, from depression
to osteoporosis, doctors are reaching increasingly for their prescription
pads. Patients who consume these drugs have faith that any side effects other
patients have had are carefully reported by physicians and monitored by
officials so that, if need be, warnings can be issued.

That faith is misplaced.

While the drug companies and the US Food and Drug Administration have a
system for maintaining an adverse-event database, doctors are not required to
report the serious problems patients have with a drug. As a result, there are
distinct limitations in the system to track bad reactions and then add new
warnings on the drug’s label or withdraw it altogether. Public Citizen, a
watchdog group in Washington, D.C., reports that actual surveys of medical
records turn up 10 times as many drug reactions as are reported voluntarily
by doctors.

Under current practices, drug companies are required to alert the FDA within
15 days of any severe reactions to drugs and within a year of less serious
reactions, but without more mandatory reporting by practitioners (hospitals
and nursing homes are required to make such reports), companies’ own
awareness of problems will be stalled.

If reporting by doctors of bad reactions were mandatory, both the FDA and Eli
Lilly and Co. would know more than they do about some of the problems
connected with Lilly’s popular antidepressant, Prozac. While Prozac and
similarly acting drugs have been hailed by both doctors and patients for
relieving symptoms that can often presage suicide, there have long been
reports of extreme agitation and anxiety among a small percentage of users.

One argument against mandated reporting of adverse reactions from doctors is
the extra paperwork this would entail. But, for the past several years, the
FDA has maintained a Web site that permits doctors – and patients – to make
online reports with little fuss. Closer monitoring could give both health
professionals and the public a greater awareness of what to be alert for as
they make use of the drugs that are changing American medicine.

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