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Hundreds of lawsuits have been filed against Janssen Pharmaceuticals and parent company Johnson & Johnson (J&J) concerning the anti-psychotic drug, Risperdal (risperidone). Plaintiffs claim the companies failed to provide adequate warnings concerning the side effects of the drug. Gynecomastia, the abnormal growth of breast tissue in males, is one of the most concerning of these side effects, particularly when it occurs in young boys.

Now, a new study suggests that the elderly, as well, may be at risk for serious Risperdal side effects.

Study Shows Risperdal Increases Risk of Kidney Failure

Published in the Annals of Internal Medicine, the study looked at three different antipsychotic medicines, including risperidone (Risperdal), quetiapine (Seroquel), and olanzapine (Zyprexa). Researchers wanted to investigate the risk for acute kidney injury (AKI) and other potential side effects from these drugs.

Adults age 65 years and older who received prescriptions for one of these three drugs were included in the study, and matched with adults the same age who were not taking the drugs. Data was gathered between 2003 and 2012.

The main adverse event that occurred was hospitalization with AKI within 90 days of prescription for the antipsychotic drugs. After analysis, researchers determined that all three antipsychotics doubled the risk of AKI and death, and nearly doubled the risk for hypotension (dangerously low blood pressure) and acute urinary retention. The risk of all-cause mortality was also twice as high for those taking the drugs.

“The findings support current safety concerns about the use of these drugs in older adults,” the researchers wrote.

Some Nursing Homes Allegedly Abusing Antipsychotic Drugs

Concern over the use of antipsychotics in the elderly population is not new. In May 2011, the New York Times reported that “nearly one in seven elderly nursing home residents, all of them with dementia, are given powerful atypical antipsychotic drugs even though the medicines increase the risk of death and are not approved for such treatments.”

According to the full report, between January and June 2007, a surprising 51 percent of Medicare claims for these drugs were erroneous, amounting to $116 million. The authors of the report recommended that the Centers for Medicare & Medicaid Services (CMS) “explore alternative methods beyond survey and certification processes to promote compliance with Federal standards regarding unnecessary drug use in nursing homes.”

In September 2014, the CMS announced plans to reduce the use of antipsychotic medications in nursing homes by 25 percent at the end of 2015, and by 30 percent at the end of 2016. CMS chief medical officer Dr. Patrick Conway stated, “We know that many of the diagnoses in nursing home residents do not merit antipsychotics but they were being used anyway.”

Drug Makers Paying for Illegal Marketing

J&J agreed to a $2.2 billion dollar settlement with the government in November 2013, to put to rest claims that they had illegally marketed Risperdal, overpromoting its benefits while downplaying the risks. Plaintiffs who have filed Risperdal lawsuits often make similar claims, stating that the company improperly marketed the drug to children long before the FDA approved the drug for use in that population. A mass tort proceeding is currently taking place in the Philadelphia Court of Common Pleas.

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