SALES OF CHEST-PAIN DRUG HALTED BECAUSE OF RISKY SIDE EFFECTS

WASHINGTON -- A drug company is withdrawing a popular medicine for
chronic chest pain and high blood pressure because it could cause
death if taken with certain other drugs, officials announced Monday.

Hoffmann-La Roche and the Food and Drug Administration, however,
warned that patients should not stop taking the drug, Posicor, without
first consulting a physician about switching to another medication.

Posicor, which is taken by nearly 200,000 Americans and 400,000 people
worldwide, has side effects that made it unacceptably risky, said
Murray Lumpkin of the FDA's Center for Drug Evaluation and Research.

``You could theoretically argue it would be perfectly safe to use,''
Lumpkin said, ``but the reality is . . . in the population for whom
this is intended -- primarily the elderly -- there are not going to be
people taking only Posicor.'' The FDA asked the company to withdraw
the drug, and the manufacturer complied voluntarily.

``Patient well-being is really our highest priority,'' said
Hoffmann-La Roche spokeswoman Valerie Suga.

The FDA has received 400 reports of health problems in Posicor
patients, including 24 deaths. Lumpkin noted that those reports do not
conclusively link the problems to the drug, but indicate a problem may
exist.

Posicor, which goes by the generic name mibefradil, blocks the normal
function of the liver. It keeps that crucial organ from breaking down
some medications, and those medications can then build up to hazardous
levels. Other substances, including grapefruit juice, can have a
similar effect -- but Posicor's was especially pronounced, Lumpkin
said.

When the FDA approved the drug last June, it required Hoffmann-La
Roche to warn patients not to take the medication with certain drugs,
including the antihistamine Hismanal.

Over time, the list of dangerous drug interactions lengthened to 25,
and in December the FDA warned against taking Posicor with
cholesterol-lowering ``statin'' drugs such as Pravachol and Zocor.

The potential for dangerous interactions, along with another troubling
tendency of the drug to slow heart rates to potentially dangerous
levels, made Posicor an unacceptable risk -- especially in light of
the fact that testing had proved the drug no more effective than other
medications for the same conditions, Lumpkin said.

A patient advocacy group denounced the FDA on Monday, saying that the
agency's recent attempts to speed drug approvals because of harsh
criticism from industry and lawmakers had compromised public health.

Posicor ``is an example of the risks that the American public will
face in the future because of the flood of new drugs that the FDA has
rushed to approve in the last several years,'' said Larry D. Sasich
and Sidney Wolfe of Public Citizen's Health Research Group.

FDA spokeswoman Lorrie McHugh said the Public Citizen allegations had
no merit.

``Posicor met all federal standards for approval'' and included all
pertinent warnings from the start, McHugh said.

Checked-by: (trikydik)