Janssen Pharmaceuticals is accused of withholding data on the side effects of Risperidone, a drug used to treat autism, according to a report in Medpage Today. The allegations against Janssen, a Johnson & Johnson subsidiary, arise from documents produced in lawsuits against the company. The documents, from a 2003 study on Risperidone by Janssen, showed a high risk of male breast enlargement among autistic boys who took the drug. Janssen withheld these documents when seeking the U.S. Food and drug Administration’s (FDA) approval to label Risperidone for pediatric use states Medscape. Janssen marketed Risperidone under the name Risperdal.
Risperidone is an antipsychotic traditionally used to treat schizophrenia in adults. The FDA approved Risperidone to treat irritability in children with autism in October 2006. However, the drug was prescribed “off label“ to children with autism prior to the FDA approval. Several lawsuits were filed against the company because children developed gynecomastia or male breast enlargement after taking Risperidone.
Austin Pledger sued Janssen after growing size 44DD breasts. He asserted that the breast growth resulted from taking Risperdal for autism symptoms as a child. He claimed Janssen did not warn him adequately of this side effect. Earlier this year a jury awarded Pledger $2.5 million in damages. Despite the jury’s award, Janssen’s representative Robyn Reed Frenze stated Janssen did adequately warn Pledger. She said Pledger’s “quality of life was significantly improved during the time he was taking Risperdal.”
During this lawsuit, Pledger’s attorneys uncovered two tables of research data showing a direct link between Risperidone and gynecomastia. In a related case, Ivo Caers, a VP of Neuroscience Development at Janssen Research & Development, testified that Janssen did not give these two tables or related safety information to the FDA.
In his expert report, former FDA commissioner, David Kessler, says that Johnson & Johnson knew as early as November 2000 that “the risk of gynecomastia was significantly higher than the rate it reported. …” Kessler states that the ultimate responsibility for a drug’s safety rests with the manufacturer and not the FDA. Janssen was required to correct Risperidone’s labeling as soon as it knew the risk of gynecomastia was higher than reflected on the drug’s label, according to Kessler.
Kessler accuses Janssen of misleading doctors and the scientific community by “failing to include the fact that there was a statistically significant increase in the number of patients who had both prolactin levels above the upper limit of normal” in a published article “Prolactin levels during long-term risperidone treatment in children and adolescents.”
In 2013, Johnson & Johnson agreed to pay $ 2.2 billion to resolve civil and criminal complaints against it arising from Risperidone and other drugs. The complaints, filed by the FDA and others, accused Johnson & Johnson of promoting Risperidone for unapproved uses, “making false and misleading statements about the safety and efficacy of Risperdal and paying kickbacks to physicians to prescribe Risperdal.”