Roche's Posicor May Pose Danger After Withdrawal
Bloomberg News
June 18, 1998, 6:22 p.m. ET
Roche's Posicor May Pose Danger After Withdrawal (Update1)
Chicago, June 18 (Bloomberg) -- Roche Holding AG's blood
pressure treatment Posicor, taken off the market earlier this
month because of worries over drug interactions, may linger in
patients' systems and cause problems when patients are put on new
medications, according to a report in a leading medical journal.
The Journal of the American Medical Association put out a
statement in advance of its publication of four case studies in
which patients stopped taking Posicor and went into shock after
they quickly began new medications in Posicor's drug class, known
as calcium channel blockers. One of the patients died.
''The journal editors deemed it important to get this
information out as quickly as possible,'' said Jeff Molter,
director of science news at the American Medical Association.
''There are 200,000 people out there coming off this
medication.''
Researchers who submitted the case reports, which will be
published in the July 8 issue of JAMA, said former Posicor
patients should have a ''wash-out'' period in which they take no
blood pressure drugs before moving onto calcium channel blockers
or another class of drugs known as beta blockers. Pfizer Inc.,
Zeneca Plc, and Bayer AG are the leading makers of calcium
channel blockers, while companies including Novartis AG and
SmithKline Beecham Plc sell beta blockers.
Patients who took Posicor should immediately consult with
their doctors on the issue, and doctors should monitor their
patients carefully. Roche said patients and doctors can call 1-
800-205-4611 with questions.
Other Conditions
The four cases identified by researchers at the Oregon
Poison Center at Oregon Health Sciences University occurred
before the drug was taken off the market when doctors decided
that Posicor wasn't working well enough to control blood pressure
in their patients and switched their medications.
''These patients had other medical conditions and other
medications,'' which may have added to the problem of dangerously
low blood pressure, researchers said. Still, the timing of the
problem within one day of taking Posicor, also known as
mibefradil, ''suggests that this combination should be avoided,''
they said.
Two of the cases occurred in Oregon and researchers heard of
two others as they compiled their case reports, said B. Zane
Horowitz, medical director of the Oregon Poison Center. Horowitz
said he didn't know of any other cases. Still, ''As patients and
physicians read this, they may think back to a case where
something similar had happened,'' he said.
For patients and doctors, ''the main thing is they need to
safely work out a plan to stop mibefradil and to control their
blood pressure,'' Horowitz said. If patients were only taking
Posicor, they should be able to immediately go onto a drug in a
class that works differently -- including drugs such as ACE
inhibitors -- as long as they are still monitored carefully, he
said. ACE inhibitors are sold by Zeneca, Merck & Co., Bristol-
Myers Squibb Co. and others.
After learning of the cases, Roche sent a letter to doctors
on June 12 advising them that a washout period should be used
before switching patients to certain other blood pressure drugs.
The length of the washout depends on which drugs the doctor plans
to prescribe.
''After the withdrawal took place, we got response from
physicians that a small number of patients experienced drug
interactions when they substituted'' Posicor for another drug,
said Martin Hirsch, a U.S.-based Roche spokesman. ''It was at
that point that we learned everything we could.''
In addition to the ''Dear Doctor'' letter, the company
launched an information campaign for doctors, instructed its
sales force to contact doctors directly and sent a letter to
companies that manufacture products that might be involved in
drug interactions, Hirsch said.
''We have tried to cover every base with every group,'' he
said. While declining to comment on whether additional reports
have been received by the company, he said, ''We are monitoring
the situation very very closely.''
Switzerland-based Roche, the world's sixth biggest
drugmaker, announced on June 8 that it would pull Posicor from
the $24 billion global market for hypertension treatments.
The drug, first sold last year, was expected to have up to
800 million Swiss francs ($544 million) in annual sales within
five years, analysts said, which would have made it one of
Roche's best-selling drugs behind antibiotic Rocephin. The
decision came after the U.S. Food and Drug Administration
recommended the drug be removed from sale.
The removal followed the addition of a warning to Posicor's
label late last year that said the drug might cause dangerously
low heart rates in some patients and might increase the risk of
muscle injury when taken with certain cholesterol lowering drugs.
JAMA's release of this information is reminiscent of last
year's move by the New England Journal of Medicine to warn
patients about heart valve problems seen in people taking a diet
drug combination known as fen-phen before the official
publication of research. The ''fen'' part of the combination,
known as fenfluramine, was later pulled from the market by its
manufacturer, American Home Products Corp.
''Journals are trying to be quicker in the release of
information,'' Molter said.
--Kristin Jensen in the Washington newsroom (202) 624-1843 with |
