Earlier this year, the U.S. Food and Drug Administration was sued in Pennsylvania federal court. The suit claims that the FDA barred a law firm from turning over confidential Risperdal documents, which were obtained through the discovery process. This directly resulted in the denial of a citizen petition asking that Johnson & Johnson publicize documents relating to the dangers of the antipsychotic drug Risperdal. The petition in question wanted Johnson & Johnson to publically release documents detailing the connection between breast growth in adolescent boys and their popular drug, Risperdal. They also wanted the FDA to change the labeling of Risperdal and revoke its pediatric indication. None of that occurred, however, because the FDA banned the use of specific documents obtained in discovery.
What were these documents? These documents were the analyses of a report by ex-FDA Commissioner David Kessler that challenged a study commonly touted by Johnson & Johnson regarding the correlation between their drug and adverse side effects. In other words, the law firm had information that J&J and Janssen knew of the data linking Risperdal to incidences of breast growth in adolescent boys long before the medication’s label was updated to show the risk - as early as 6 years before the label was changed.
Risperdal and Gynecomastia
Risperdal has been associated with an abnormal development of breast tissue in men and young boys. This is known as gynecomastia and it can be traumatic for young adolescent boys and young men. Many of these men have experienced severe mental pain and anguish and embarrassment, as well as undergoing painful mastectomies.
Other Side Effects of Risperdal
Risperdal was believed to have a lower risk of movement disorders than older antipsychotics, yet many Risperdal patients have experienced the following:
- Restlessness;
- Inability to move;
- Hesitant movements;
- Abnormal movement of face, shoulders, arms and legs;
- Parkinson's-like tremors, and
- Stiffening of the tongue, causing difficulty breathing.
Risperdal has also been associated with an increased risk of the development of diabetes. In those who already have diabetes, Risperdal can cause a worsening of symptoms. Mortality in elderly patients has also been associated with the use of Risperdal, and, in fact, the FDA has mandated a Black Box Warning on Risperdal related to use in the elderly.
Less severe side effects of Risperdal may nonetheless cause a decrease in the quality of life. These symptoms include:
- Sedation;
- Increased risk of falls;
- Restlessness;
- Anxiety;
- Tremors;
- Nausea and vomiting;
- Drooling, and
- Difficulty swallowing.
All in all, Risperdal has one of the longest histories of problems of any medication on the market. Injury related to Risperdal use was seen as early as 2001, with the litigation still going on. While physicians are allowed to prescribe medications for off-label, the manufacturer may not promote medications for any indication other than those approved by the FDA. Janssen and Johnson & Johnson have done just that, and may be responsible for injury to thousands of American consumers.
National Risperdal Lawsuit Lawyers
Men, who have suffered from swollen or painful breasts, gynecomastia, mastectomy, or liposuction after taking the dangerous drug Risperdal, may be able to file a lawsuit against Johnson & Johnson. The Philadelphia defective drug lawyers at Golomb Legal are currently evaluating claims from men who were prescribed Risperdal and have suffered serious side effects as a result. We believe in holding negligent pharmaceutical companies responsible for their actions and will fight aggressively for you and your family.
To learn more about your rights and legal options, call the Philadelphia defective drug lawyers at Golomb Legal today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.