Chinese language - Diabetes drug side effect reports triple

WORLD / Health

Diabetes drug side effect reports triple

(AP)
Updated: 2007-07-14 01:23

In the month after a surprising analysis revealed possible heart risks
from the blockbuster diabetes drug Avandia, reports of side effects to
federal regulators tripled.

The sudden spike is a sign that doctors probably were unaware of the
drug's possible role in their patients' heart problems and therefore may
not have reported many such cases in the past, several experts said.

It also shows the flaws of the safety tracking system and suggests that a
better one might have detected a potential problem before the drug had
been on the market for eight years.

Avandia is used to control blood sugar, helping more than 6 million
people worldwide manage Type 2 diabetes, the kind that is linked to
obesity. These people already are at higher risk for heart attacks, so
news that the drug might raise this risk by 43 percent was especially
disturbing.

In the 35 days after May 21, when the New England Journal of Medicine
published the analysis on the Internet, reports of heart attacks, deaths
and hospitalizations leaped. The sharp rise in reports of heart problems
appears in data obtained by The Associated Press through a Freedom of
Information Act request to the federal Food and Drug Administration.

Only five heart attacks were reported in the 35 days before the study,
compared with 90 in the same period afterward. Heart-related
hospitalizations went from 11 to 126. The reports involve rosiglitazone,
sold as Avandia and Avandamet.

Reporting a drug's side effects is voluntary, and only a crude indication
rather than a scientific measure of how many problems patients are
actually having. The FDA relies on this unenforced system once a drug is
on the market. Critics say it leads to haphazard oversight in which
problems can be missed because doctors don't connect the dots between a
drug and symptoms they see in an individual patient.

With Avandia, the published analysis likely led to more cases being
reported, said Vanderbilt University diabetes specialist Dr. Alvin C.
Powers.

"Now, patients and their doctors are much more aware of the possible link
between Avandia and cardiovascular disease. This is good �� this is going
to help us going forward to determine whether or not this drug is safe,"
he said.

The drug's manufacturer, British-based GlaxoSmithKline PLC, insists that
the drug is safe and effective.

"This is a very well-known phenomenon," where news reports lead to
increased reporting, said company spokeswoman Mary Anne Rhyne. "It's good
that there's awareness of the reporting system, but drawing conclusions
on such data is inappropriate."

The FDA plans hearings on safety concerns about the drug on July 30. In
the meantime, diabetes experts have advised users of the medication to
talk to their doctors and not to immediately discontinue it.

The side effects reported range from as minor as a blister to as serious
as sudden cardiac death. Most of the reports the AP reviewed seemed to
involve serious side effects, and rosiglitazone was listed by the FDA as
the "primary suspect" rather than other medicines the patient may have
been taking.

There was a total of only 50 adverse event reports in January and 73 in
February. From April 16 to May 21, when the study was published, 121
events were reported, including 11 deaths. In the 35 days after the
study, 357 events were reported, including 38 deaths.

"You really can't infer anything about incidence rates from that,"
because the spike in reports is likely due to the "publicity effect" of
the study, said Dr. David Graham, an FDA drug safety expert.

Dr. David Nathan, chief of diabetes care at Massachusetts General
Hospital, agreed, saying it was "not conceivable" that only five people
among the 1 million Americans taking Avandia had heart attacks in the
month preceding the May 21 study, as the FDA reports suggest.

"It just heightens the concern about the poor reporting we have," said
Nathan, who has received speaker fees from Glaxo and other drug
companies. Powers and Graham have no financial ties to any diabetes drug
makers.

The issue has roiled the medical community and sparked congressional
probes into whether the FDA is properly investigating safety issues. The
FDA issued a "safety alert" about the drug only after the May 21 study
came out, even though Glaxo had informed the agency of its own analysis
of heart risks nearly a year beforehand and possibly as early as 2005.

Avandia's label warns about possible heart failure and other heart
problems when taken with insulin. The drug also raises LDL, or bad
cholesterol, and can cause fluid retention and weight gain.

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