Key takeaway:
- The FDA announced levothyroxine recalls after testing showed certain tablets contained less active medication than indicated on the label.
- Patients should not stop taking levothyroxine; instead, check the recalled lot numbers and contact a pharmacist or doctor.
- Subpotent doses may cause hypothyroidism symptoms and pose greater risks for pregnant women, infants, and thyroid cancer patients.
The U.S. Food and Drug Administration has announced levothyroxine recalls affecting certain nationwide batches of levothyroxine sodium tablets, after testing revealed they were subpotent. The issue raises concerns about reduced treatment effectiveness for millions of patients with hypothyroidism, particularly those at higher risk.
The FDA has classified the action as a Class II recall, meaning use of the affected products may cause temporary or medically reversible health effects, while the likelihood of serious adverse consequences remains low.
The recall applies to specific lots of levothyroxine sodium tablets distributed by Major Pharmaceuticals. The affected products include strengths of 25 mcg, 50 mcg, 75 mcg, 88 mcg, 112 mcg, 125 mcg and 150 mcg packaged in 100-tablet cartons and 10-count blister packs.
According to the FDA, testing found the recalled tablets contained less active thyroid hormone than required under approved potency specifications. Patients receiving lower-than-prescribed doses may not achieve adequate thyroid hormone replacement.
“The use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” the FDA said in describing a Class II recall.
FDA says lower potency may reduce treatment effectiveness
Levothyroxine is prescribed to replace thyroid hormone in people whose thyroid gland does not produce enough naturally. Even small differences in dosage can affect treatment because thyroid hormone regulates metabolism and influences nearly every organ system.
Health experts warn that patients taking subpotent tablets could experience symptoms of hypothyroidism, including fatigue, weight gain, feeling unusually cold, constipation, depression, brain fog, dry skin and a slower heart rate.
Pregnant women, infants and people receiving treatment for thyroid cancer may face greater risks if thyroid hormone levels fall below recommended amounts. Inadequate replacement therapy also could interfere with thyroid cancer management in some patients.
Patients should verify medication before making changes
The FDA advises patients not to stop taking levothyroxine without consulting a health care professional. Abruptly discontinuing therapy may worsen hypothyroidism and increase the risk of complications.
In light of the levothyroxine recalls, patients should check their medication’s lot number against the recalled batches, consult their pharmacist or physician if affected, and obtain a replacement when necessary. Treatment should continue unless advised otherwise by a health care provider.
Pharmacists and physicians can help determine whether a patient’s prescription is part of the recall and advise on appropriate replacement options.
Separate recall affects cetirizine tablets
In a separate action, the FDA recently recalled four lots of Cetirizine Hydrochloride Tablets USP 5 mg manufactured by India-based Unique Pharmaceutical Laboratories because of potential cross-contamination with ranitidine.
The manufacturer said it has not received reports of adverse reactions linked to the recalled cetirizine tablets. However, the FDA said the contamination could present a risk for people who are allergic or hypersensitive to ranitidine.
The levothyroxine recall underscores the importance of quality control for medications used daily to manage chronic conditions. Health officials encourage patients to review FDA recall notices and consult their pharmacist or physician if they have questions about their prescriptions.
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