Norvir Advisory
Abbott Announces Difficulty Manufacturing
Norvir (Ritonavir) Capsules
Company Plans to Substitute With Liquid Formulation
Abbott Park, Illinois, July 27, 1998 Abbott Laboratories announced
that it is experiencing manufacturing difficulties with
the capsule formulation of its HIV protease inhibitor, Norvir
(ritonavir).
"We have encountered an undesired formation of a Norvir crystalline
structure that affects how the capsule form of Norvir
dissolves," said Arthur Higgins, senior vice president, pharmaceutical
operations, Abbott Laboratories. "Although maximum
efforts are underway, to date we do not have a solution to the capsule
problem."
The manufacturing difficulties with Norvir capsules will result in
shortages and interruption in supply capsules. Abbott is
planning to supply Norvir oral solution (liquid formulation) to provide
continued Norvir therapy for patients.
Norvir capsules currently in distribution are not affected by this
issue. When used in accordance with the prescribing
information, product on the market is safe and effective.
"We deeply regret this inconvenience," said Higgins. "Abbott is
committed to doing everything it can to enable patients to
continue Norvir therapy without interruption, and to resuming timely
delivery of Norvir capsules."
The active ingredients in Norvir liquid and Norvir capsules are
identical, as is their activity against HIV.
Pharmacists and physicians are being informed of dosing instructions to
address the capsule-to-liquid conversion.
Abbott has contacted and is working with the U.S. Food and Drug
Administration (FDA), the European Agency for the
Evaluation of Medicinal Products (EMEA) and other international
regulatory agencies to address the problem. Abbott will
be communicating with health care providers, consumers and the AIDS
community through letters.
In addition, the company has set up a toll-free number for inquiries and
has placed information on its website. For health
care provider and patient questions regarding Norvir liquid in the
United States, call 1-800-637-2400 or visit
www.norvir.com.
Norvir is indicated in adults in combination with other anti-retroviral
agents for the treatment of HIV infection. Norvir has
also been cleared by the FDA for use in children between the ages of 2
and 16 based on safety and pharmacokinetic data.
Norvir may not be right for everyone, including people with liver
disease, hepatitis, or hemophilia. Elevated blood sugar
levels have been reported in patients taking protease inhibitors.
Allergic reactions ranging from mild to severe have been
reported. Common adverse reactions include fatigue, vomiting, diarrhea,
loss of appetite, abdominal pain, taste disturbance,
tingling sensation or numbness in the hands, feet, or around the lips,
headache and dizziness. Frequently observed adverse
events may diminish as therapy is continued. Norvir should not be used
with certain medications including some
non-sedating antihistamines, sedative hypnotics, antiarrhythmics, or
ergot alkaloid preparations.
Posted 8/28/98
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