Everything You Need to Know About the NP Thyroid Medication Recall

This past week, Acella Pharmaceuticals, LLC announced that it was issuing a voluntary recall of a popular thyroid medication used to treat hypothyroidism.

With Elena Christofides MD and Jenn Dyer MD

NP Thyroid Recall

The medication, known as NP Thyroid, was recalled after testing from the Food & Drug Administration (FDA) found that certain lots of NP Thyroid were sub-potent, containing far less medication than the amount shown on the label. In some cases, the FDA found, the medication had as little as 87 percent of the labeled amount of a chemical called levothyroxine, or L-T4. Acella Pharmaceuticals recalled one lot of 15 milligram NP Thyroid tablets and one lot of 120 milligram NP Thyroid tablets. 

Acella NP Thyroid Medications Recall

What is the reason for the thyroid medication recall?

The Acella Pharmaceuticals recall is the most recent, but it's far from the only one. Earlier this month, another manufacturer called RLC Labs recalled 483 lots of two thyroid medications called WP Thyroid and Nature-Thyroid for sub-potency. In May 2020, Acella Pharmaceuticals recalled 13 lots of NP Thyroid tablets due to super-potency. In other words, the tablets had more than the labeled amount of ingredients in the product. FDA testing found that those thyroid tablets had up to 115% of the labeled amount of Lirothyronine, or T3.

According to endocrinologist Elena Christofides, MD, FACE, these recalls come as no surprise. "Natural thyroid medications," she says,  “are by their very nature impure, imperfect, and inconsistent products.” They're made from desiccated (dried) animal thyroids. While desiccated thyroids provide a therapeutic amount of T3 and T4, they're more unstable and harder to keep consistent among different batches of medication.

"Recalls are also sometimes related to filler ingredients, which can affect the potency of the drug," says Dr. Jen Dyer, a pediatric endocrinologist based in Columbus, Ohio. “We know that certain brand-name medications are more consistent in terms of potency than their competitors,” she says. “In a child with thyroid disfunction, we insist that they use brand-name medications, because having a consistent thyroid level in children is so important for their brain growth.”

Another reason for the recalls, says Christofides? “It doesn't hurt that it's an election year,” she says. “The FDA needs to look like they're doing their job, or else they'll all get the axe if a new president is elected.”

What does your thyroid do? 

The thyroid is an endocrine gland located at the base of your neck. Your thyroid produces two crucial hormones called T3 and T4 that, in addition to regulating your body's temperature, help control things like hair and nail growth, how quickly food is metabolized, and other bodily functions such as heart rate.

“What I tell my patients is that the thyroid is like the thermostat for the body,” says Dyer. “It affects everything from our cell turnover to how quickly we burn calories and lose weight.”

Acella NP Thyroid Medication Recall

What is hypothyroidism? 

Hypothyroidism is a condition where the thyroid gland fails to produce enough T3 and T4 for the body to run properly. Hypothyroidism has several causes, tends to run in families, and affects women more than men.

“The main cause of thyroid dysfunction is a condition called Hashimoto's," Dyer explains, which is an immune condition where the body mistakenly attacks and damages the thyroid. Other causes of hypothyroidism are radiation treatments, Down Syndrome, or removal of the thyroid. Because people with hypothyroidism aren't able to produce adequate T3 or T4 (or both), they take synthetic thyroid hormones instead. Without adequate levels of T3 and T4, several symptoms tend to develop.

“It's pretty miserable,” Dyer says of hypothyroidism symptoms. “You retain water, your face tends to look swollen and doughy, your hair falls out, and you're exhausted, even if you're getting a good amount of sleep.” Thyroid disfunction can also cause heavy and frequent periods as well as fertility issues and miscarriages. Other symptoms of hypothyroidism include constipation, weight gain, and increased sensitivity to cold temperatures. If a thyroid medication is sub-potent, Dr. Dyer says, a patient could experience a resurgence of these symptoms or, if they're new to the medicine, no improvement in their symptoms at all.

“It takes about a month of medication before hormone levels get to a point where you notice a difference,” says Dyer. “If the medicine is sub-potent, you'd just keep increasing your dose and not notice any changes, without knowing why.”

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Acella Pharmaceuticals: NP Thyroid Medication Recall