The widely prescribed antipsychotic drug Risperdal has been linked to gynecomastia (abnormal male breast growth) leading some patients and their families to file lawsuits against the manufacturer and distributor, Johnson & Johnson (J&J).
What is Risperdal?
The U.S. Food and Drug Administration (FDA) initially approved Risperdal (generic name risperidone) in 1993 for the treatment of various psychological problems including schizophrenia, bipolar disorder, and autism. All medications have their side effects and it is vital to weigh the benefits compared to the risks. Some Risperdal side effects include dizziness, fatigue, anxiety, involuntary motion, nausea, and skin rashes.
Janssen Pharmaceuticals, a subsidiary of J&J made several attempts to expand the drug’s approval for uses to include children and the elderly with other conditions. The FDA at first, denied Janssen’s application due to some significant side effects for children and elderly people. In August 2007, the FDA granted approval for children between 13 and 17 to take Risperdal to treat schizophrenia and children from 10 to 17 were approved to take Risperdal to treat bipolar disorder.
In November 2008, the Wall Street Journal issued a report alleging that Risperdal stimulated the production of prolactin in boys. Prolactin is a hormone that promotes lactation (secretion of milk). Approximately 70 percent of all cases of gynecomastia in children that were analyzed were linked to Risperdal.
Risperdal and Gynecomastia
The New Zealand Medicines and Medical Devices Safety Authority discovered that more than 90 percent of Risperdal patients have increased or elevated levels of prolactin. This can increase the possibility of developing hyperprolactinemia (a condition of elevated prolactin), which may potentially lead to the development of gynecomastia.
The excessive production of prolactin may lead the pituitary gland to enlarge which may lead to the development of pituitary tumors. A study which analyzed the FDA’s adverse effects database discovered that Risperdal was associated with 70 percent of pituitary tumors. Most of these tumors were benign, but may lead to other serious health complications.
Although gynecomastia is not life-threatening, it can be very traumatic for boys and men, and for some creating significant psychological problems. Gynecomastia is the enlargement of breast tissue, and not excess fat. The only effective treatment for gynecomastia is surgery to restore the masculine form to the chest.
Additional Serious Risperdal Side Effects
Reports of severe risperidone side effects began to surface as early as 2006. The issues reported by patients and scientific studies included diabetes, heart problems, and gynecomastia. In 2003, a study published in Pharmacotherapy reported that treatment with antipsychotic drugs such as risperidone may increase the risk of diabetes and high blood sugar. The FDA required a warning put on package inserts in 2004, alerting doctors and patients of these risks.
A potentially fatal syndrome is Neuroleptic Malignant Syndrome (NMS), with symptoms including irregular pulse and blood pressure, tremor, and muscle rigidity. In 14 cases at least, NMS has been linked to the use of Risperdal.
Tardive (delayed) dyskinesia (abnormal movement) is an incurable movement disorder that may result in grimacing, lip smacking, spasms and other uncontrollable muscle movements. A number of cases of the condition have been reported associated with the use of Risperdal.
In 2013, a study revealed a rise in the risk of ischemic (restricted blood flow to the brain) stroke with the use of risperidone in patients over 64 years of age. Reports of at least 37 individuals who experienced a stroke, including 16 deaths connected with Risperdal, have been documented. A previous study in 2003 published in the British Medical Journal (BMJ) reported that all antipsychotics are linked to an increased risk of stroke, with the risk higher in those using newer medications such as Risperdal.
Past Lawsuits Involving Risperdal
Gynecomastia lawsuits against Johnson & Johnson have been filed by hundreds of boys and men who have experienced negative Risperdal side effects. By September 2012, patients who were allegedly injured after taking Risperdal led to 400 cases filed in courts across the United States. Four Risperdal lawsuits that have gone to trial have resulted in large jury awards for the plaintiffs. In the first lawsuit, the jury awarded the plaintiff $2.5 million in July 2015. In November 2015, the next jury award was $1.75 million. The third verdict awarded $500,000 in December 2015. In the fourth Risperdal case, a boy was awarded $70 million in July 2016.
Legal Help for Risperdal Users
Attorneys at Parker Waichman LLP are highly experienced in drug injury lawsuits. If you or someone you know has been negatively affected by Risperdal, contact Parker Waichman for a free, no-obligation case evaluation. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).