Nelfinavir (Viracept) Recall Does Not Include U.S.
On
June 6, Roche announced that was immediately recalling its entire stock of nelfinavir
(Viracept) tablets and powder in countries outside the United States, Canada,
and Japan due to a chemical impurity discovered in some of these formulations.
The recall affects
nelfinavir manufactured at Roche's factory in Switzerland. However, Pfizer, which
manufactures a slightly different formulation of nelfinavir for sale in the United
States, announced that its product was not contaminated and is not affected
by the recall. Nelfinavir marketed by Japan Tobacco is also unaffected.
The
problem came to light after a few patients reported that their supply of nelfinavir
emitted an unusual odor. Certain batches of the drug were found to be contaminated
with ethyl mesylate (methane sulfonic acid ethylester), a byproduct of the manufacturing
process that is usually present in tiny quantities (less than 3 parts per million);
in the worst contamination case discovered so far, the level reached 2,300 parts
per million. The company attributed these larger quantities to "human error"
rather than deliberate tampering. The contamination is a concern because the chemical
in large amounts has been shown to cause cancer in rats.
Roche
recommended that patients currently taking nelfinavir should talk to their healthcare
providers as soon as possible about switching to alternative therapies. The company
predicted it would take several months to replenish its stock of uncontaminated
drug.
Pfizer
Clarification
Below
is the text of an announcement from Pfizer clarifying that the recall does not
apply to nelfinavir sold in the U.S.:
"Roche
announced today that they recalled Viracept 250 mg tablet formulation and powder
due to chemical impurity. Roche has commercialization rights to Viracept everywhere
other than the US, Canada, U.S. territories and possessions, and Japan.
This
recall does not apply to the U.S., Canada, U.S. territories and possessions, or
Japan. Pfizer separately manufactures and commercially markets Viracept at 625
mg and 250 mg formulations in the U.S., Canada and U.S. territories and possessions.
Pfizer has a separate manufacturing process and manufacturing plants. Additionally,
Pfizer manufactures Viracept tablets for Japan Tobacco under a license agreement
and that market is not affected by this recall.
06/12/07
Sources
Roche.
"Viracept Recall: Important Information for Patients." June 6, 2007.
Pfizer.
"Clarification: Roche Recall." June 6, 2007.
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Pfizer
Clarification
