These are called Adverse Event Reports and among the complaints on record are those involving an antipsychotic medication called Risperdal, which has been linked to the growth of breasts in men, a condition called gynecomastia.
The FDA is not the only source of Risperdal issues.
A study by a team of medical researchers was recently presented at the American Association for Geriatric Psychiatry (AAGP) meeting in Orlando, Florida, in which data showed that there was a 69 percent higher chance of older men developing breasts with Risperdal than with other antipsychotics.
The specific allegations of a recent wave of Risperdal breast-growth lawsuits also claim a serious link between Risperdal treatment and gynecomastia in male children, adolescents and young men, as well.
How much of this litigation was generated by off-label uses, or treatments not approved by the Food and Drug Administration? Apparently quite a bit.
The FDA and the Justice Department recently announced a guilty plea agreement with Janssen Pharmaceuticals, Inc., (JPI) of Titusville, N.J., and a $400 million criminal fine for introducing Risperdal as a misbranded drug into interstate commerce.
A Johnson & Johnson subsidiary, JPI must also pay $1.25 billion under a separate civil settlement concerning the same drug. The combined criminal plea and civil settlement agreement related to Risperdal totals more than $1.67 billion.
“When pharmaceutical companies ignore the FDA’s requirements, they not only risk endangering the public’s health but also damaging the trust that patients have in their doctors and their medications,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA relies on data from rigorous scientific research to define and approve the uses for which a drug has been shown to be safe and effective. Today’s announcement demonstrates that pharmaceutical manufacturers that ignore the FDA’s regulatory authority do so at their own peril.”
The FDA said it approved Risperdal in 2002 for the treatment of schizophrenia and in 2003 for the short-term treatment of acute mania and for mixed episodes associated with Bipolar 1 Disorder.
But JPI began in March 2002 to market the drug for the treatment of agitation associated with dementia in the elderly, representing that Risperdal was safe and effective for this unapproved indication and subpopulation, according to the announcement.
Federal officials said that JPI also marketed Risperdal for use in children with behavior challenges, despite known health risks to children and adolescents. Until late in 2006, Risperdal was not approved for use in children for any purpose, and the FDA repeatedly advised the company that promoting its use in children was problematic and could be evidence of a violation of the law.