FDA Slow to Review Reports of Risperdal Side Effects

According to a July 11, 2013 report in the Philadelphia Inquirer, the FDA is not acting fast enough to address the concerns surrounding Johnson & Johnson’s anti-psychotic drug Risperdal. Though over 400 Risperdal lawsuits have been filed in courts throughout the country, the agency has not strengthened warnings on the drug since 2005, when they required a black box warning concerning the use of the drug in elderly patients with dementia.

A citizen petition submitted to the FDA last year asked the agency to obtain data on the drug that was revealed during litigation, but has since been sealed under court orders. The agency has the authority to demand safety-related documents for review, but has not done so thus far.

Information discovered during Risperdal lawsuits

According to the news report, the FDA is “actively reviewing” the citizen petition, and has asked the manufacturer to submit all available data regarding the use of Risperdal and another similar medication, Invega, in children and adolescents. So far the agency has declined to answer questions about the matter.

Information disclosed in litigation motivated the submission of the citizen petition in the first place. J&J has stated, however, that “no legitimate purpose would be served by declassifying the documents identified by plaintiffs.” Plaintiffs’ counsel, however, wants to provide some of that information to the press as it may shed light on adverse side effects of Risperdal.

Risperdal side effects

The FDA approved Risperdal in 1993 to treat schizophrenia, symptoms of bipolar disorder, and symptoms of irritability in autistic children. The drug is assumed to work by affecting serotonin and dopamine in the brain, interfering with communication between them to help calm negative symptoms like hallucinations and delusions.

Some doctors have also used Risperdal for off-label, non-approved purposes, such as to treat obsessive-compulsive disorders, stuttering, Tourettes syndrome, and severe dementia. Reports of Risperdal side effects have included occurrences of tardive dyskinesia, diabetes, sexual dysfunction, gynecomastia (enlargement of male breasts), cardiovascular problems, stroke, and even death.

Injured patients file Risperdal lawsuits

Plaintiffs who suffered injuries allegedly caused by Risperdal (risperidone) have filed claims in an attempt to recover damages. One of the most common allegations made in these lawsuits is that the drug causes breast enlargement, or gynecomastia in boys.

In a study published in 2006 in the Journal of Clinical Psychopharmacology, researchers stated that risperidone administered to adolescents at doses commonly used for the treatment of psychotic symptoms can increase prolactin levels, which is a hormone that stimulates breast development in women. Clinical consequences included gynecomastia, or abnormal breast development in boys or men.

Current estimates are that over 130 Rispderdal lawsuits have been filed by patients claiming to have suffered gynecomastia.

J&J has also faces litigation based on charges that the company illegally promoted the drug for off-label uses. As recently as May 2013, the Kentucky attorney general filed another claim charging the manufacturers with hiding and minimizing Risperdal side effects like diabetes and weight gain, and concealing evidence that Risperdal causes increased levels of a hormone that stimulates breast development and milk production in children.