By Peter Loftus
Pfizer Inc. (PFE) issued its second recall of thyroid-disease treatment Levoxyl in recent weeks, this time because some tablets didn’t meet potency standards.
Pfizer said Friday that Levoxyl is no longer available, and may not return to the market until mid-2014. 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.
The drug maker said the latest recall was unrelated to a March recall of about 52,000 bottles of Levoxyl arising from complaints of uncharacteristic, plastic-like odors in the product. Pfizer attributed the odor problem to an oxygen- absorbing canister packaged in certain bottles to enhance product stability.
The newer recall, of 84 lots of Levoxyl, was triggered by Pfizer’s routine testing of Levoxyl batches made with a previous formulation, which revealed some tablets with potency that declined slightly below Pfizer’s standard.
“Although only three batches tested for stability produced results outside of our quality specifications, as a conservative measure the company decided to recall all batches at the retail level,” said spokeswoman Lauren Starr.
In an April 30 letter to customers, Pfizer said the use of less potent Levoxyl tablets carries a remote risk of serious adverse events due to suboptimal management of hypothyroidism.
Pfizer acquired Levoxyl 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 alternatives for patients include AbbVie’s (ABBV) Synthroid and generic drugs that contain the same active ingredient as Levoxyl.
Pfizer said previously that a new supply of Levoxyl may not be available until 2014 because any changes to the product could take time to evaluate. The drug has been added to the Food and Drug Administration’s list of drug shortages.