Sunday, February 23, 2014

Pfizer Resumes Levoxyl Shipping

Pfizer Inc. will resume shipping a thyroid-disorder drug that was in short supply for the past year after a manufacturing-quality lapse prompted a recall, one of many drug shortages that have dogged the industry in recent years.

Pfizer said in a letter to doctors this month it expected the drug, Levoxyl, to be available in U.S. retail pharmacies around March 3. The company said in its letter it is offering eligible patients a 30-day free trial of Levoxyl, in an apparent effort to win back market share lost during the shortage. Pfizer didn't immediately provide further comment.

The Levoxyl shortage was disruptive because it forced patients and doctors to switch to alternative drugs. Some patients said they experienced new side effects with other drugs, such as hair loss, or had to pay higher out-of-pocket costs for alternatives.

Levoxyl is approved to treat hypothyroidism, a deficiency in the body's production of certain hormones, and to treat and prevent goiter. Patients typically take the drug every day on a continuing basis.

Pfizer stopped shipping the drug in February 2013 after receiving complaints of uncharacteristic, plasticlike odors in the product. Pfizer attributed the odor problem to an oxygen-absorbing canister packaged in certain bottles to enhance product stability. The company recalled about 52,000 bottles of the product because of the odor.

When Pfizer suspended shipments last year, it said Levoxyl may not become available again until mid-2014 because it would take time to evaluate and implement changes to the product.

Pfizer has corrected the problem with the oxygen-absorbing canister and has resumed manufacturing of the product, it said in its letter to doctors this month.

Pfizer acquired Levoxyl with its $3.6 billion purchase of King Pharmaceuticals in 2011. The company doesn't disclose sales of the product.

Some alternatives for patients include AbbVie's Synthroid and generic drugs that contain the same active ingredient as Levoxyl.

Jeffrey Garber, an endocrinologist with Harvard Vanguard Medical Associates in Boston, said his practice had to switch about 1,000 Levoxyl users to alternative drugs including Synthroid and a generic drug made by Mylan Inc. The practice hired a part-time staffer to help notify patients they needed to switch and then undergo blood tests to ensure the new drug was working properly.

Dr. Garber said some patients complained of not feeling right after switching to alternatives, with some experiencing side effects such as hives. But many have adjusted to new medications, he said.
Citing the cumbersome process of switching, Dr. Garber said he is unlikely to proactively switch patients back to Levoxyl unless they specifically ask for it. "What would possess anyone to switch again?" he said.

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