Last month, a Miami Herald article began with the line “Acella Pharmaceuticals can’t seem to get its thyroid medicine right.” Indeed, during the previous 13 months, the pharmaceutical company has recalled its thyroid prescription medication, NP Thyroid, three times. The most recent happened in May when 35 commercial lots of the drug were recalled for being sub potent. Routine testing found less than 90% of the labeled ingredients liothyronine (T3) and/or levothyroxine (T4), which are both thyroid hormones, present in the medication.
NP Thyroid is widely prescribed by physicians and/or filled by pharmacies, but the recent voluntary recalls from Acella Pharmaceuticals have some questioning whether it is safe. The Alpharetta, Georgia-based company generates $120 million annually in revenue and manufactures more than 40 medications. In September 2020, the drug wholesaler voluntarily recalled one lot of 15-mg and one lot of 120-mg NP Thyroid for having less-than-advertised potency. An earlier recall in May 2020 had the opposite problem. It was recalled for being overly potent and having 115% of a labeled ingredient.
What Does NP Thyroid Treat?
NP Thyroid treats hypothyroidism, enlarged thyroid glands, and thyroid cancer. Hypothyroidism is caused when the thyroid gland doesn’t produce enough of certain hormones. It can lead to fatigue, weight gain, metabolism problems and mood swings. More than 10 million people in the U.S., primarily older women, live with the condition. Uncontrolled hypothyroidism can lead to peripheral nerve damage, infertility, birth defects and even comas.
The medication is made from porcine (pig) thyroid glands, and it works by providing more thyroid hormones for someone with hypothyroidism. Like most medications, it can cause unwanted effects like hair loss, irregular heartbeat, muscle pain, cramps and diarrhea. For those who need it, the benefits usually outweigh the possible side effects.
Reasons for the NP Thyroid Recall
Acella recalled the medication after receiving dozens of reports of adverse effects possibly related to the sub potent dosage. According to the official FDA announcement, people who take the recalled thyroid drug might experience “fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight.” Additionally, pregnant women face risks like early miscarriage, fetal hypothyroidism, or fetal skeletal and neural development problems.
According to a doctor quoted by Endocrine Web, the continued problems with the quality of the drug are unsurprising to some experts. “This is one of the reasons that endocrine organizations do not recommend use of animal-harvested organs,” said Elena Christofides, M.D., FACE, in an interview. “These products are by their very nature inconsistent, as there is no actual manufacturing process or controls. They are considered supplements and do not undergo the same scrutiny as real pharmaceuticals.”
In addition to the inconsistency issue, NP Thyroid has never been approved by the FDA as safe and effective, and even more surprising, as of August 2020, Acella had not even obtained the required biologics license that would allow the company to legally sell the medication in the United States. After inspecting Acella’s facilities in 2019 and 2020, the FDA sent the company a warning letter that stated:
Based on the information your firm submitted to FDA’s electronic Drug Registration and Listing System and the information collected during the December 17, 2019 – January 7, 2020 inspection, FDA has determined that your firm is distributing NP Thyroid, a biological product, without FDA approval or a valid biologics license.
If you are currently taking NP Thyroid, talk to your healthcare provider to determine whether you need to stop taking the medication. You can also review the FDA’s notice to learn which lots and labels are affected.
If you feel you have suffered an injury due to NP Thyroid, the Georgia-based law firm of Childers, Schlueter & Smith can help you determine your legal options. Call us at 1-800-641-0098 or contact us online for more information or free case consultation.
At Childers, Schlueter & Smith, our attorneys are dedicated to helping victims of personal injury and/or those who have lost a loved one to wrongful death determine their legal options. We are a distinguished law firm that is driven by years of experience and exceptional results. If you or someone you know has been injured due to another’s negligence, please contact our firm to discuss your legal options.