Acella Pharmaceuticals voluntarily recalls thyroid drugs over lack of potency

pharmafile | September 21, 2020 | News story | Sales and Marketing thyroid, thyroid drugs 

Acella Pharmaceuticals is recalling two types of its thyroid medication as the drugs may be too weak to properly treat those who take them. 

This follows a similar recall of thyroid medications that was issued by the FDA in recent weeks. Acella’s two drugs are NP Thyroid 15 and NP Thyroid 120, which are sold in 15mg and 120mg strengths, and they contain both the T3 and T4 hormones for those who are able to be treated with synthetic T4 hormone. They have contacted wholesalers by email and phone to discontinue distribution of these two treatments. 

Acella has received four reports of adverse events that were related to these drugs, which are sold in 100 tablet bottles with expiration dates of October and November 2020. The products were available to healthcare offices, pharmacies and direct accounts, and those who have received the pills are advised to continue taking them and to get in contact with their doctor for advice on how to proceed and to get a new prescription.

Patients taking thyroid drugs that are not potent enough may experience symptoms of hypothyroidism, an underactive thyroid, which may cause a variety of symptoms including: fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and unexplained weight gain or difficulty losing weight. 

The risk is particularly serious in newborns or pregnant women and can result in early miscarriage, fetal hyperthyroidism and impairments to fetal, neural and skeletal development. In elderly patients or patients with cardiac diseases there is a risk or pain, palpitations or cardiac arrhythmia.

Conor Kavanagh

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