In its third voluntary withdrawal in the last year, Acella Pharmaceuticals has announced a nationwide withdrawal of specific batches of its popular hypothyroid treatment NP thyroid tablets USP, this time after routine testing, the pills were subpotent.
Specifically, the affected batches were found to contain less than 90% of the two labeled ingredients of the drug to treat hypothyroidism: liothyronine (LT3) i / o levothyroxine (LT4).
Affected batches include formulations of 15 mg, 30 mg, 60 mg, 90 mg and 120 mg of NP thyroid tablets, packaged in bottles of 100 and 7.
The list of specific batches withdrawn is published on the Food and Drug Administration website.
Acella reports that, to date, 43 reports of serious adverse events have been received that could be related to the withdrawal.
Symptoms that suggest that patients may have received a subpotent batch include common signs of hypothyroidism, such as fatigue, increased sensitivity to cold, constipation, Dry Skin, Swollen Face, Hair Loss, Slow Heart Rate, depression, swelling of the thyroid gland and / or unexplained weight gain or difficulty losing weight, according to Acella.
“There is a reasonable risk of serious injury in newborns or pregnant women with hypothyroidism, even early miscarriage, fetal hyperthyroidism, and / or alterations in the neuronal and skeletal development of the fetus, “the company warns in the withdrawal statement.
Acella adds that toxic cardiac manifestations of hyperthyroidism can occur, including heart pain, palpitations, or cardiac arrhythmia in elderly patients and patients with underlying heart disease.
Although Acella notifies affected parties to discontinue the distribution of recalled products, it advises that patients currently taking NP Thyroid from the recalled batches “should not stop using it without contacting their healthcare provider to obtain more guidance and / or a replacement recipe “.
In November 2020, a withdrawal of NP Thyroid was released after FDA tests found subpotent levels, as low as 87% of the labeled amount, of LT4 in some batches.
And earlier, in May 2020, the company recalled 13 batches of tablets due to excessive potency, with FDA tests showing that some tablets contained up to 115% of the labeled amount of LT3.
NP thyroid is a type of product for the dried animal thyroid that was for a long time the standard of care for hypothyroidism before the advent of the synthetic hypothyroidism drug, Synthroid (sodium levothyroxine), now the most commonly used hypothyroidism treatment.
On his website, Acella refers to the NP thyroid as a “natural choice for thyroid therapy,” as it is often referred to as the dried thyroid.
However, one of the most common concerns about dried thyroid is the tendency to have unreliable concentrations of active ingredients, as reported by the American Thyroid Association. recommendations.
“The amounts of T4 and T3 can vary in each batch of dried thyroid, making it more difficult to maintain the correct blood levels,” the ATA states.
“Finally, even dried thyroid pills contain chemicals (binders) to keep the pill together, so they are not completely ‘natural’.”
Consumers with withdrawal questions are encouraged to email Acella Pharmaceuticals at [email protected] or call 1-888-424-4341, Monday through Friday from 8:00 a.m. to 5:00 p.m. ET.
This article originally appeared on MDedge.com, which is part of the Medscape professional network.
