Several medications used to treat hypothyroidism have been recalled according to an announcement earlier this month by the U.S. Food and Drug Administration (FDA).
Westminster Pharmaceuticals LLC, a company that manufactures levothyroxine (LT4) and liothyronine (LT3) voluntarily recalled these medications.
What is hypothyroidism?
Hypothyroidism, or underactive thyroid, is when the thyroid gland doesn’t make enough thyroid hormones for your body’s needs. The thyroid gland resides in your neck. The hormones it produces are used to control the way the body utilizes energy.
Most cases are mild. Around 4.6 percent of the U.S. population over the age of 12 has hypothyroidism, estimates the National Institutes of Health.
The recall comes after the Florida-based Westminster Pharmaceuticals used ingredients that were found to have deficiencies in conjunction with the FDA’s current good manufacturing practices.
Westminster Pharmaceuticals obtained its thyroid medication active ingredient from Sichuan Friendly Pharmaceutical Co. Limited, based in China — a company that was cited with an Import Alert for poor manufacturing practices during an FDA inspection.
During the visit to Sichuan Friendly’s facility in 2017, inspectors found an incorrect formula used to calculate the potency of the active pharmaceutical ingredient.
Additionally, multiple batches of the thyroid medication had analysis certificates with inaccurate potency and stability data.
The FDA found that the substandard practices could be risky due to inconsistent levels of the active ingredient. Inconsistent levels of medication could lead to risks associated with over- or undertreating hypothyroidism, which the FDA notes “could result in permanent or life-threatening adverse health consequences.”
It’s believed that Westminster Pharmaceuticals purchased the active pharmaceutical ingredient before the actual enforcement of the Import Alert on Sichuan Friendly.
What should patients do if they’re using these medications?
“Medication recalls can be anxiety-provoking, which is understandable,” said Dr. Minisha Sood, an endocrinologist at Lenox Hill Hospital in New York City.
In a released announcement by the FDA, Westminster Pharmaceuticals recommends that since these products may be used to treat serious medical conditions, “patients taking the recalled medicines should continue taking their medicine until they have a replacement product.”
Levothyroxine and liothyronine are medications derived from porcine (pig) thyroid glands. They’re not associated with serious adverse reactions.
Westminster Pharmaceuticals has recalled the 15, 30, 60, 90, and 120 milligram versions of levothyroxine and liothyronine at wholesale level. The company is notifying its direct accounts by phone and email directly to discontinue the distribution of the products.
Additionally, they’re encouraging these companies to ask their sub-wholesalers to do the same.
“While we stand behind the quality of our product, we are taking the utmost precaution by recalling our Thyroid, USP Tablets only to the wholesale level due to a recent inspection by the FDA at one of our active ingredient manufacturers,” said Westminster Pharmaceuticals owner and CEO Gajan Mahendiran on the company’s website.
Although Westminster Pharmaceuticals has recalled the medications at the wholesale level, healthcare professionals and patients are encouraged to report any adverse events to the FDA’s MedWatch Adverse Event Reporting Program.
So far, the company “has not received any reports of adverse events related to this product,” according to the company announcement by the FDA.
“Patients should be reassured that there have not been any adverse events reported thus far and that this is a voluntary recall,” Sood said. “They should continue taking their medication until they can get an appropriate substitute medication from their doctor or their healthcare provider.”
Rajiv Bahl, MD, MBA, MS, is an emergency medicine physician and health writer. You can find him at www.RajivBahlMD.com.