Acella Pharmaceuticals is recalling two lots of its thyroid drugs due to subpotency, the Alpharetta, Ga.-based drugmaker said Sept. 17.
The drug may contain as little as 87 percent of the amount of levothyroxine the label says it has, Acella said. Levothyroxine is used to treat hypothyroidism, a condition in which thyroid glands don’t produce enough of certain crucial hormones. It can cause a number of health problems, such as obesity, joint pain, infertility and heart disease, according to Rochester, Minn.-based Mayo Clinic.
Patients taking the drug to treat hypothyroidism may experience symptoms including fatigue, slow heart rate, depression and swelling of the thyroid gland. There is a risk of serious injury in newborn infants or pregnant women with hypothyroidism who take the drug. Elderly patients and patients with underlying cardiac disease may experience cardiac pain, palpitations or cardiac arrhythmia, Acella said.
Acella has received four reports of adverse events that it says are possibly related to the recall.
Read the full news release here.
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