[Roche] Heart Drug Pulled From Market
JUNE 08, 09:51 EDT
By LAURAN NEERGAARD
AP Medical Writer
WASHINGTON (AP) - Roche Laboratories pulled its
new heart drug Posicor off the market worldwide today
because it causes potentially dangerous interactions
with more than 25 other medications, from
antihistamines to antibiotics.
The hundreds of thousands of patients now taking
Posicor for high blood pressure or chronic angina, a
type of chest pain, should not just stop taking the pills
on their own, the Food and Drug Administration
warned.
Stopping medications can be risky, so the FDA urged
patients to promptly call their doctors about getting an
alternative therapy - and until they get a new
treatment, they should not begin taking any additional
drug without a doctor's specific OK.
Switching to a new medicine should be easy, because
Posicor does not offer any unique protection against
hypertension or angina, FDA officials stressed. ''There
are plenty of other choices available,'' said drug chief
Dr. Murray Lumpkin.
About 400,000 people worldwide take Posicor, including
almost 200,000 Americans, Roche estimated. The drug
had been sold in about 38 countries.
The FDA approved Posicor last June, and it began
selling in August. The FDA knew at the time that it
could interact with three other drugs - many medicines
do cause such interactions - and followed the
standard procedure of placing a warning on Posicor's
label so doctors wouldn't prescribe it to patients taking
those other drugs.
But by December, the FDA was warning doctors not to
prescribe Posicor to patients taking an entire class of
cholesterol-lowering drugs, or to patients with low
heart rates, after receiving about 20 reports of serious
side effects.
The list of potentially dangerous interactions continued
to grow, as the FDA accumulated several dozen reports
of serious side effects, including some fatalities,
possibly linked to Posicor interacting with other
medications.
The FDA said Posicor doesn't offer patients any
advantage over similar blood pressure medicines known
as calcium-channel blockers. And Posicor is mostly
taken by older people who require many medicines for
diverse health problems, so simply warning doctors not
to allow such interactions was fast becoming
unfeasible, Lumpkin said.
The final straw came a few weeks ago, when a study
that Roche was hoping would show Posicor helped
patients with congestive heart failure instead failed.
Roche agreed to pull Posicor off the market.
Posicor, known chemically as mibefradil, is a chemically
unique calcium-channel blocker that significantly
interferes with the liver's metabolism of medicines.
While many medicines do inhibit liver function, Posicor
proved to be an extremely powerful liver inhibitor,
allowing other medicines to accumulate in the body to
dangerous levels, said FDA's Dr. Robert Temple.
Roche established a hot line - 1-800-205-4611, from 8
a.m. to 8 p.m. EDT - to answer physician and patient
questions. The company also will reimburse U.S.
patients for any Posicor they already have bought but
do not consume, and those patients should call the hot
line to get reimbursement information, said company
spokeswoman Valerie Suga.
The company also is writing thousands of doctors,
pharmacists and other health care workers today to
explain the problem. |
