Pfizer Inc. Recalls Thyroid-Disorder Drug Over Odor Problem
Published: Apr 05, 2013
Pfizer stopped shipping the drug in February after learning of the odor problem, and may not have new supply available until 2014 because any changes to the product may take time to evaluate, spokeswoman Lauren Starr said. The product has been added to the U.S. Food and Drug Administration's list of drug shortages.
The uncharacteristic odor in the Levoxyl bottles was caused by an oxygen-absorbing canister that is packaged in the 100-tablet and 1,000-tablet bottles to enhance product stability. An odor that has been described as "plastic-like" may result while the canister collects oxygen from the air, Ms. Starr said.
The New York-based drug maker said the odor problem is unlikely to cause any health problems, but after discussing the situation with the FDA, Pfizer decided to issue a voluntary recall "out of an abundance of caution." No adverse health consequences have been reported. The canister hasn't been used in other Pfizer products.
Levoxyl is approved to treat hypothyroidism, a condition in which the thyroid gland doesn't produce enough hormones, and to prevent certain types of goiter. Pfizer acquired the product with its $3.6 billion purchase of King Pharmaceuticals in 2011.
Pfizer does not disclose sales of Levoxyl, but Ms. Starr said the supply disruption doesn't affect the company's 2013 financial forecast.
Some patients have recently been unable to fill prescriptions for Levoxyl, according to Barbara Rath Smith, executive director of the American Thyroid Association, whose members include specialist doctors known as endocrinologists. The group is advising patients to contact their doctors to get prescriptions for suitable replacement products.
Alternatives include Synthroid from AbbVie (>> AbbVie Inc) and generic drugs that contain the same active ingredient as Levoxyl, Ms. Smith said.
"We are working with the FDA to resolve the issue as quickly as possible," Ms. Starr said.
The Levoxyl recall is the latest in a series of recalls related to malodorous drugs. Pfizer previously has recalled bottles of cholesterol-drug Lipitor and pain reliever Advil after reports of strong odors. Johnson & Johnson (>> Johnson & Johnson) and Glenmark Pharmaceuticals also have issued separate drug recalls because of uncharacteristic odors.
In some cases, odors described as musty or moldy were traced to a chemical preservative applied to wood pallets used to transport and store packaging for the drugs. The Levoxyl odor problem is unrelated to the chemical preservatives.
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