What You Need to Know About Risperdal
Thousands of children and adults are prescribed antipsychotics on the advice of their doctors. If your doctor told you that you or your child should take Risperdal, you’d want to know as much as you could about it and what it’s done to other people, and to other people’s children.
What is Risperdal?
Risperdal is a brand name for the antipsychotic drug, Risperidone, sold in the United States by Janssen Pharmaceuticals.1
Risperdal is an ‘atypical antipsychotic.’ Atypical antipsychotics are thought to work by blocking the movement of a chemical in the brain called dopamine. Dopamine is thought to control the brain’s reward and pleasure centers and to regulate movement and emotional response.2
Risperdal is approved to treat schizophrenia in adults and adolescents over 13 years of age and bipolar mania in adults and children over 10 years of age.3
Does Risperdal work?
A review of 45 studies of Risperidone (Risperdal) found that it produced more side effects than other drugs of its kind – weight gain, cardiac effects and seizures. The review noted that the large proportion of patients leaving studies early due to side effects and incomplete reporting of outcomes of the studies made it difficult to make conclusions about whether it was effective and noted there were no large studies comparing Risperidone with other new drugs.4
A 2010 review of Risperidone (Risperdal) studies concluded that Risperidone appears to have a marginal benefit over placebo in the first few weeks of treatment but the reviewers’ opinion was that the studies were poorly reported and probably biased in favor of Risperidone. The review also noted that Risperidone did no better on one scale of results, and that about 24% of patients experienced extrapyramidal side effects (having to do with the nervous system or motor control).5
What should I ask my doctor about before I decide to take Risperdal?
Like all antipsychotics, Risperdal has some very serious side effects.
As of August 2012, Risperdal’s maker, Janssen Pharmaceuticals, and its parent company, Johnson and Johnson, had about 420 suits against them for injuries caused by Risperdal. About 130 of those lawsuits are by men and parents of boys who say Risperdal made them grow breasts.6
Lawyers for plaintiffs in cases against Risperdal say Janssen intentionally marketed Risperdal for off-label uses for children, despite the fact that the FDA didn’t approve the drug for those uses. Boys, and girls, as young as four years, have experienced growth of breast tissue and even lactation (the production of breast milk). The only treatment to remove the breast tissue in males is a mastectomy.7
Janssen Pharmaceuticals was sued by the State of Oregon and 36 other states for unfair and deceptive practices, off-label marketing of Risperdal and three other antipsychotic drugs for children and the elderly, and agreed to an $181 Million settlement in August, 2012.8
Johnson and Johnson targeted doctors treating elderly patients and juveniles for Risperdal, marketing for uses for which it was not approved and for which there was no evidence it was medically useful. In the case of elderly dementia patients, the FDA had warned Johnson and Johnson that atypical antipsychotics are harmful and can even cause death.9
In addition to the states’ suit, above, Johnson and Johnson has faced court cases brought by ten other states. In March 2012, Johnson and Johnson agreed to a $158 million settlement with the state of Texas over claims that it defrauded the state’s Medicare program by promoting Risperdal for off-label uses, including for children. In June, 2012, a South Carolina court order the company to pay $327 million for Risperdal marketing and in October 2010, a Louisiana jury ordered the company to pay $257 million over Risperdal sales.10
What if I’m already taking Risperdal?
Never stop taking a prescription drug without talking to your doctor. If you are concerned about Risperdal or you experience any side effects, especially symptoms of an allergic reaction, talk to your doctor.
Learn everything that you can about Risperdal before you start taking it.
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1 http://www.risperdal.com/
2 Psychology Today, “Psych Basics, What is Dopamine?” (retrieved 17 July 2012), http://www.psychologytoday.com/basics/dopamine
3 Food and Drug Administration, Highlights of Prescribing Information, (June 2009) http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf
4 Cochrane Database System Rev. “Ripseridone versus other atypical antipsychotics for schizophrenia,” 19 January 2011) http://www.ncbi.nlm.nih.gov/pubmed/21249678
5 Cochrane Database of Systematic Reviews , Rattehalli RD, Jayaram MB, Smith M, “Risperidone versus placebo for schizophrenia,” (20 January 2010), http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006918.pub2/abstract
6 Bloomberg.com, Feeley J and Fisk MC, “J&J Settles Risperdal Lawsuit on Opening Day of Trial,” (10 September 2012), http://www.bloomberg.com/news/2012-09-10/j-j-settles-risperdal-lawsuit-on-opening-day-of-trial.html
7 Cbsnews.com, Edwards J.,“Claim: J&J Wrongly Marketed Antipsychotic Drug Risperdal to Kids” (3 August 2011), http://www.cbsnews.com/8301-505123_162-42849344/claim-jj-wrongly-marketed-antipsychotic-drug-risperdal-to-kids/?tag=mncol;lst;4; CBS News, http://www.cbsnews.com/video/watch/?id=5038367n%3fsource=search_video
8 Oregon Department of Justice, “Oregon Attorney General and 36 Others Reach $181Million Risperdal Settlement,” (30 August 2012), http://www.doj.state.or.us/releases/2012/rel083012.shtml
9 Bloomberg, Fisk MC et al, “J&J Pushed Risperdal for Elderly after U.S. Warning, Files Show,” (10 March 2010) http://www.bloomberg.com/apps/news?pid=newsarchive&sid=ag4Ya8UOIob0
10 Bloomberg Business Week, Fisk MC and Shanon K, “J&J’s $158Million Settlement with Texas Approvaed by Court,” (27 March 2012) http://www.businessweek.com/news/2012-03-27/j-and-j-s-158-million-settlement-with-texas-approved-by-court