For years, some young male patients using Risperdal® have claimed the medication caused them to develop gynecomastia—a condition in which males develop excessive amounts of breast tissue. Janssen Pharmaceuticals, Inc. and Johnson & Johnson, the makers of the drug, have denied these allegations, but now there may be proof that the medication’s manufacturer hid data indicating there may be a link between Risperdal and gynecomastia.
The Risperdal® drug injury lawyers at Ferrer Poirot Feller Daniel explain that new data was discovered when the results of a study conducted in 2003 were reexamined. Investigators found that certain data and tables in preliminary versions of the study’s conclusions were not present when the study was submitted to the U.S. Food and Drug Administration (FDA) as part of the drug approval process.
According to Forbes, early versions of the study showed a large number of young male patients using Risperdal had increased levels of hormones that play a role in breast development. However, this data was not present when the study was submitted to the FDA. Now, the drug makers behind Risperdal are being accused of hiding the data about Risperdal side effects to get the drug approved and boost sales.