FDA Petitioned to Release Sealed Risperdal Records

A request has been filed with the FDA, asking the federal drug regulators to release documents about the antipsychotic medication Risperdal, which the petitioner suggests will show that the manufacturer knew the drug was not safe for children.

The citizen petition was filed by plaintiffs’ attorney Stephen Sheller, who obtained certain “sealed” documents during discovery in a Risperdal lawsuit filed against Johnson & Johnson, which alleges that the drug maker failed to warn about the potentially harmful side effects of Risperdal for children.

At the request of Johnson & Johnson, the judge presiding over the case has ordered that the documents obtained in the proceedings are sealed and may not be disclosed to others or the media Therefore, Sheller filed a petition with the FDA last year, indicating that the federal regulators have access to the information and the authority to release documents without violating the court’s directive.

According to a recent report by the Philadelphia Inquirer, Sheller is now accusing the FDA of dragging its feet on the request.

FDA officials have indicated that the agency is actively reviewing the petition, and officials from Johnson & Johnson have released a statement indicating that after Sheller’s request the FDA asked the company turn over all available documents regarding the use of Risperdal among children.

Risperdal (risperidone) is an atypical antipsychotic that was originally introduced by Johnson & Johnson in 1994. It is commonly used for treatment of schizophrenia, bipolar disorder and behavior problems. While originally only approved for use among adults, the FDA did not approve Risperdal for use among children until 2006.

Although doctors are free to prescribe any approved medications for uses they see fit, drug makers are prohibited from marketing non-approved uses and Johnson & Johnson has previously been accused of illegally promoting the medication for use among children prior to FDA authorization. As a result of illegal promotion of Risperdal for uses that were not approved as safe and effective by the FDA, Johnson & Johnson has previously agreed to pay substantial fines and received huge jury verdicts in cases brought by various state governments.

Johnson & Johnson also currently faces a number of Risperdal breast growth lawsuits brought in courts throughout the United States on behalf of boys who received the antipyschotic as a child and developed a condition known as gynecomastia, which involves the development of breasts among boys.

The complaints involve similar allegations that Johnson & Johnson failed to adequately research the medication or warn about the gynecomastia from Risperdal side effects among teen boys who are given the antipsychotic.