By Peter Loftus
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.
Write to Peter Loftus at peter.loftus@wsj.com
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