Why is J&J Hiding Study Results for Risperdal Long Term Side Effects in Children?
Written by Stephen Fields on November 10, 2013
Johnson & Johnson, the maker of the atypical antipsychotic Risperdal, has been plagued by lawsuits over the marketing and safety of its drug. In April 2012, an Arkansas judge ordered the company to pay over $1.2 billion in fines, alleging that it had concealed or minimized Risperdal’s long term side effects and risks.
Then, in the fall of 2013, the company agreed to pay a $2.2 billion settlement to the U.S. Department of Justice over accusations that the company illegally marketed the drug for off-label uses. Today, the company continues to field lawsuits concerning this drug, some of which allege male breast growth is caused by the use of Risperdal in children.
Risperdal Documents Sealed by Philadelphia Judge
In the midst of this litigation, a Philadelphia judge has agreed to seal documents which attorneys believe could contain the results of Risperdal clinical studies, including adverse effects. “Sealing” refers to the practice of withholding court records that would otherwise be publicly accessible.
While plaintiffs’ attorneys fight to access these documents, Johnson & Johnson has sought to keep them hidden. It is not clear why J&J has been so strongly opposed to the release of this data, other than the company’s statement that these documents were written for researchers, not the public.
Now, it seems that the FDA has become involved in the battle. According to Johnson & Johnson spokeswoman Teresa Mueller, the FDA has asked J&J “to submit all available data regarding the use of these medicines [Risperdal & Invega, another antipsychotic] in children and adolescents.”
The FDA has confirmed that it is actively reviewing a citizen petition that requests the release of these sealed court documents, but has not yet made any information public.
Risperdal Clinical Data Could Be Invaluable to Families
If these documents do contain clinical data, this data could be invaluable to families about the risks of Risperdal in children. Although prescription medications improve the lives of many, they also come with risks. It is important that doctors and patients fully understand the risks and benefits of a drug so they can determine whether it is a safe and appropriate treatment.
Additional information about Risperdal’s risks could lead families to seek out alternative treatments for their children in the hopes of avoiding side effects like gynecomastia, and the associated costs. Young men affected by gynecomastia often experience serious mental and emotional stress due to their condition, and may need costly corrective surgery.
Many families are already reluctant to start their children on atypical antipsychotics like Risperdal, which can have serious long term side effects. Now, as reports that Risperdal could cause serious side effects like male breast growth, or gynecomastia, emerge, patients and their families are wondering if the drug’s label fully discloses its risks.
Some of these families have filed Risperdal lawsuits against Johnson & Johnson, alleging that the medication was not safe as designed and that they were not sufficiently warned about the potential risks of Risperdal.
If you or your son developed breasts while taking Risperdal, you may be eligible to pursue compensation by filing a lawsuit. For free, personalized legal advice from a Risperdal attorney, contact our offices at 1-888-210-9968. There is limited time to file a claim, so please call at your earliest convenience.