Pfizer, Inc. has issued the second recall this year of the drug Levoxyl, a drug used in the treatment of hypothyroidism and for the prevention of goiter.
Low potency issues
The second Levoxyl recall May of this year, comprising 84 lots of Levoxyl, was triggered by Pfizer’s routine testing of the batches of Levoxyl produced from a previous formulation. And results of the routine testing revealed that the potency of the tablets tested were below the standard specifications of the company.
Pfizer spokesperson, Lauren Starr, disclosed that although only three of the batches that were tested for stability and potency produced results that were below standard potency specifications, Pfizer decided to issue the second Levoxyl recall of all the 84 lots of Levoxyl as a conservative measure to protect consumers and patients.
Risk to patients
Hypothyroidism, one of the disorders that are treated with Levoxyl, is the most common type of thyroid disorder. It is also coined “underactive” thyroid disease, because the thyroid gland produced insufficient amounts of the thyroid hormone. It is a disease that is more common in women and in people over the age of 60.
Hypothyroidism is usually characterized by dry skin, brittle nails, constant body malaise, constipation, weakness and depression, and memory problems.
And the low potency of the tablets containing Levoxyl can pose serious effects on patients who are dependent on them for their near normal thyroid functions. For one, this can lead to the suboptimal management of thyroid disorders and potential exacerbation of the condition. Patients will not be relieved of the symptoms. And because of the ineffectiveness of their medications, some patients may opt to in-take more than their usual dose just to relieve symptoms that this will potentially lead to serious drug overdose.
No relation to first recall
According to Pfizer the Levoxyl recall, which is already the second this year, has no relation the previous recall issued last March.
The first recall was not due to issues on potency, but was due to increasing complaints from consumers of the uncharacteristic, plastic-like odors exuding from the product. The said odor problem, as Pfizer explains, was due to the oxygen-absorbing canisters that were packaged inside the bottles. These canisters are usually used to prolong product stability and shelf life of drug products. The foul odor, however, was not reported to cause any serious and harmful side effects.
Uninterrupted 2013 financial forecast
Although Levoxyl accounts for one of Pfizer’s lead selling products, the Levoxyl recall will not affect Pfizer’s financial forecast for 2013.
It has, however, lead to the shortage of the drug. Levoxyl is now on the list of FDA’s shortage list.
Pfizer is already on reformulating Levoxyl but will not be supplying the drug again until 2014.