Less-Potent Thyroid Drugs Recalled by FDA!

Did you know? Around 20 million people have some thyroid disorder in the USA. Thyroid disorders can affect the thyroid gland which is a butterfly-shaped gland located in the front of the neck. The thyroid plays an important role in regulating many metabolic processes in the body. 

Hyperthyroidism is known as the most common and critical condition of the thyroid. Hypothyroidism occurs when your body creates too many thyroid hormones including thyroxine (T4) and triiodothyronine (T3) and can be overactive.

FDA Recalled Less-Potent Thyroid Drugs 

Acella Pharmaceuticals declared a nationwide recall of its popular thyroid treatment NP Thyroid tablets USP, after testing the company found the pills are less potent than what has been described on the label.

Particularly, these tablets contain less than 90% of the drug’s two labelled ingredients used in the treatment of hypothyroidism including liothyronine (LT3) and levothyroxine (LT4).

Acela first examined various thyroid drugs back in September 2020 because of a less-potency problem. As per the recent recall which happened at the end of May 2020, the company discovered that these tablets were overly potent.

During this recall, Acella has taken back 35 lots of thyroid pills which are considered potent and it has received 43 reports of “serious adverse events,” as per the notice by the Food and Drug Administration.

The examined lots consisted of 15 mg, 30 mg, 60 mg, 90 mg and 120 mg tablets packed in 100-count and 7-count bottles.

The signs people can experience because of these recalled drugs include common symptoms of hypothyroidism such as increased sensitivity to cold, dry skin, fatigue, constipation, puff face, slow heart rate, hair loss, depression, swelling, according to Acella reports.

This may lead to the reasonable risk of serious injury in newborn baby or pregnant women who have hypothyroidism that include fetal hyperthyroidism, early miscarriage, or impairments to fetal neural and skeletal growth, according to the recall statement. 

Acella further adds about toxic heart problems associated with hyperthyroidism that include heart palpitations, irregular heartbeat or chest pain in elder patients and patients who have heart disease.

Acella is working to stop distributing these recalled drugs and patients who are taking these pills should continue taking them and consult their physicians for further guidance. 

The same tablets were recalled for containing lower than specified potency in November. In May 2020, the company was examined for having 115 %of the labelled amount of LTS.

Here are the tablets which were recalled:

• NP Thyroid 15 mg; NDC #42192-327-01; Lot# M327E19-1; expiration date, October 2020
• NP Thyroid 120 mg; NDC #42192-328-01; Lot# M328F19-3; expiration date, November 2020

 These medicines contain levothyroxine and liothyronine. They are largely used to treat hypothyroidism.