Risperdal is also approved for bipolar disorder and behavioral problems in people with autism, including irritability in children (10 to 17 years of age) with autistic disorder. As of April 2005, Risperdal carried a black box warning stating that older adults with dementia who take antipsychotic medications may have an increased risk of death, stroke or mini-stroke during treatment. Risperdal is also approved to treat irritability in children as young as five years of age with autistic disorder. Research indicates that off- label use of Risperdal to treat ADHD is increasing.
Risperdal Warning & Risperdal Lawsuits
Risperdal is prescribed orally in pill form and Risperdal Consta is administered by injection for patients suffering from Bipolar I disorder who require longer-term medication treatment. A batch of injectable Risperdal Consta, which is manufactured by Alkermes PLC and marketed by Janssen, was recalled in September 2013 over mold concerns.
The antipsychotic drug has also been linked to an increased risk of young males developing gynecomastia, an increase in breast tissue. This condition is thought to be caused by increased levels of prolactin, a hormone involved in lactation and increased in Risperdal patients. In November 2008, The Wall Street Journal reported that Risperdal can stimulate the production of prolactin.
Risperdal Gynecomastia (Breast Development in Males)
Although Risperdal carries a warning about the risk some doctors have called on the FDA to strengthen the warning. Boys who have developed gynecomastia may experience pain or nipple discharge. Mild cases can be resolved with liposuction, while more severe cases will require a mastectomy.
According to reports, two boys had mastectomies to decrease their breast tissue after taking Risperdal (see Risperdal lawsuits below).
Research published in 2006 in the Journal of Clinical Psychopharmacology found that the risk of Risperdal male breast growth was stronger compared to other atypical antipsychotics. The same study also found that some girls taking Risperdal begin to lactate before they reach puberty. The co-author of the 2006 Duke University study also asserts that Risperdal (Risperidone) side effects in children can’t be considered harmless.
By September 2012 more than 130 Risperdal and/or Invega (another atypical antipsychotic medication also made by Janssen) lawsuits involving gynecomastia in boys and young men had been filed against Johnson & Johnson and Janssen Pharmaceuticals.
Risperdal Gynecomastia lawsuits
In 2008, six teenage boys sued the giant drug company after they developed breasts while taking Risperdal. Two of the boys in the lawsuit required mastectomies.
In July 2010 a Risperdal Gynecomastia lawsuit was filed by a 21-year-old man (Banks vs. v. Janssen Pharmaceuticals,Philadelphia Court of Common Pleas, January Term 2010, No. 00618) who claimed that he suffered emotional trauma from breast growth. The man took Risperdal from 1999 to 2004—from age 9 to 14—when the medication had not been approved for use in children. As well as suffering psychological trauma he required surgery to remove the breast tissue. Johnson & Johnson agreed to settle in September 2012—on the first day of the trial.
In October 2012, Bloomberg.com reported that Johnson & Johnson had agreed to settle five gynecomastia Risperdal lawsuits filed in Pennsylvania state court.
Since 1999 Risperdal has been linked to diabetes. Researchers found that about 50 percent of patients taking Risperdal in a study comparing its risk to Eli Lilly & Co.’s Zyprexa antipsychotic drug developed diabetes after a year on the medication. Diabetes can lead to other serious health risks including stroke, heart attack and other cardiovascular diseases.
Risperdal Diabetes and Risperdal Heart Disease
The Janssen website warns that elderly patients are at an increased risk of cardiovascular death with increased use of Risperdal Consta long-acting injection.
Risperdal has not been approved for the treatment of dementia in the elderly. The FDA determined that the elderly who suffer from dementia and have used Risperdal were 1.6 to 1.7 times more likely to die of various ailments, including heart disease. (In November 2013, Johnson & Johnson agreed to pay $2.2 billion in civil and criminal fines to settle claims it improperly marketed Risperdal, including the elderly with dementia.)
Risperdal PTSD Study A study conducted by the Department of Veterans Affairs and published in the Journal of the American Medical Association suggests that Risperdal may be no more effective than a placebo at treating veteran PTSD. Researchers found that five percent of veterans with PTSD who were given Risperdal and five percent who were given a placebo reported a fully recovery. Meanwhile, between 10 percent and 20 percent of both groups reported some improvement of their condition. The group that was given Risperdal, however, was reportedly more likely to suffer side effects including weight gain.
Other Risperdal Side Effects
Risperdal and Invega Floppy Iris Syndrome Alert Health Canada in conjunction with Janssen Inc. issued new safety information in November, 2013, regarding the risk of Intraoperative Floppy Iris Syndrome (IFIS) associated with the use of RISPERDAL®, RISPERDAL® M-TAB®, RISPERDAL® CONSTA® (risperidone), INVEGA® (paliperidone) and INVEGA SUSTENNA® (paliperidone palmitate). The risk of IFIS is associated with the use of risperidone- or paliperidone-containing products, which are primarily prescribed for the treatment of schizophrenia--however, the risk applies to all patients undergoing cataract surgery, who have been exposed to these products, irrespective of indication. IFIS is characterized by a triad of intraoperative signs (billowing of a flaccid iris stroma, progressive intraoperative pupil constriction and a propensity for iris prolapse) that may present with varying degrees of severity and is associated with an increased rate of cataract surgical complications.
Risperdal Consta, which is injected, is stored and given to patients at clinics. In September 2013 Risperdal Consta was recalled after discovering mold during routine quality testing. According to J&J, the 25 mg liquid dose of Risperdal Consta was recalled from lot No. 309316 and outsourced to another company, Alkermes Inc. It was shipped from Jan. 14 to May 20, 2013. Risperdal Consta is one of J &J's top-selling drugs, with $1.4 billion in sales last year.
Risperdal Consta Recall
January 2010: Whistleblowers, state attorneys general, and the Department of Justice filed a Risperdal lawsuit against Johnson & Johnson claiming the drug company paid $50 million in kickbacks to Omnicare, a pharmaceutical supply company, for bogus services. Omnicare used the money to market Risperdal to doctors, urging them to prescribe the drug to nursing home residents. J&J settled with the government for $112 million.
Risperdal Lawsuits Time Line
August 2011: Massachusetts and several other states filed suit against J&J alleging it promoted Risperdal for off-label treatments and failed to disclose serious Risperdal side effects including diabetes and an increased risk of death in elderly patients.
January 2012: Bloomberg reported that J&J settled a Risperdal fraud lawsuit brought by Texas on behalf of its Medicaid program for $158 million.
August 2012: J&J entered a guilty plea for a misdemeanor after U.S. Securities and Exchange Commission filings indicated that the government had investigated the company’s sales practices.
Risperdal Legal HelpIf you or a loved one has suffered a stroke while taking Risperdal, please click the link below to send your complaint to a Risperdal lawyer for a free case evaluation.
Last updated on Oct-16-14