More than 9,500 bottles of the antipsychotic risperidone orally disintegrating tablets, 2mg dosage, made by Zydus Pharmaceuticals are being recalled in the United States and Puerto Rico due to a “known degradant,” according to the Food and Drug Administration (FDA).
The recall is listed as a Class III, which is initiated in situations in which use or exposure to the volatile product is not likely to cause adverse health consequences.
Zydus’ risperidone is a generic version of Risperdal, a medication commonly prescribed to treat adults and children with schizophrenia, bipolar disorder and irritability with autism. The medication is often prescribed off-label for other behavioral conditions including attention deficit hyperactivity disorder (ADHD) and Tourette’s syndrome.
Risperdal has been linked to side effects including weight gain caused by increased appetite and type 2 diabetes. The medication has also been linked to more serious side effects including a movement disorder called tardive dyskinesia and a life-threatening neurological disorder known as neuroleptic malignant syndrome.
In adolescent boys, it can also cause the increase of prolactin, a hormone that can lead to the development of female breasts, a condition known as gynecomastia. In some cases, boys taking risperidone can grow breasts so large that liposuction or mastectomies are needed to remove the breast tissue. Gynecomastia can be both emotionally and physically scarring.
Hundreds of lawsuits have been filed against the makers of the brand-name Risperdal, Johnson & Johnson’s Janssen Pharmaceuticals, claiming the drug company knew it antipsychotic could cause boys to develop gynecomastia but concealed side effects data, choosing profits over patients.
Source: Economic Times