Risperdal

risperidone

Risperdal is approved as a treatment for bipolar disorder or manic depression, schizophrenia, and aggression and self-injury in teenagers and children who have autism. The drug works by changing the activity of specific natural substances in the brain.

Some common side effects seen in patients using Risperdal are:

• drowsiness
• dizziness
• diarrhea
• constipation
• heartburn
• dry mouth
• increased appetite
• weight gain
• stomach pain
• anxiety
• agitation
• restlessness
• dreaming more than usual
• difficulty falling asleep or staying asleep
• decreased sexual interest or ability
• runny nose
• cough
• sore throat
• muscle or joint pain
• dry or discolored skin
• difficulty urinating

A doctor should be immediately called if a patient experiences any of the following serious side effects:

• fever
• muscle stiffness
• confusion
• fast or irregular pulse
• sweating
• unusual movements of your face or body that you cannot control
• faintness
• seizures
• slow movements or shuffling walk
• rash
• hives
• itching
• difficulty breathing or swallowing
• painful erection of the penis that lasts for hours

Source: “Risperidone,” MedlinePlus Drug Information, April 1, 2007.

POTENTIAL Risperdal RECALL TIMELINE

A timeline: Antipsychotic medications like Seroquel may raise death rates in elderly

June 2005 - Health Canada, the Canadian regulatory agency similar to the Food and Drug Administration (FDA) in the United States, issued a request to manufacturers of certain atypical antipsychotic medications to include a warning on medication labeling for elderly patients with dementia. Studies of these types of drugs, which are normally prescribed for schizophrenia, have shown elderly patients with dementia have a 1.6-times higher death rate than other elderly patients when taking the drugs Seroquel, Zyprexa, or Risperdal. While no studies were done with a similar antipsychotic, Clozaril, Health Canada requested that Clozaril’s labeling also contain the warning. Should the U.S. FDA have immediately followed Health Canada or issued a Seroquel recall? Should Canadians have filed a Seroquel lawsuit against the drug’s maker?

Sources: Anne Winstanley, Toronto 680 News, June 15, 2005; Canadian Press, June 16, 2005.

October 2005 - A study published in the Journal of the American Medical Association found Zyprexa, Risperdal, Seroquel, and Abilify, drugs used to treat schizophrenia, may raise the death rates in elderly patients taking the drugs to treat dementia. These drugs are produced by some of the biggest drug companies in the world, including Eli Lilly and Company (Zyprexa), Janssen Pharmaceutical (Risperdal), AstraZeneca Pharmaceuticals (Seroquel), and Bristol-Myers Squibb * and *Otsuka America Pharmaceuticals (Abilify). An analysis of 15 separate drug studies and more than 5,000 patients found that 3.5 percent of those taking schizophrenia drugs for an average of eight to twelve weeks died, compared with 2.3 percent of patients on placebos. The findings came on the heels of risks first disclosed by the FDA in April 2005 concerning these drugs. Lead researcher Lon Schneider, professor of psychiatry at the University of Southern California’s Keck School of Medicine, said that doctors may want to take elderly patients off these drugs more quickly if they fail to improve immediately, given the findings. Do Dr. Schneider’s suggestions warrant a Seroquel recall or would they strengthen a Seroquel lawsuit?

Source: Michelle Fay Cortez, “Lilly, J&J, AstraZeneca Dementia Drugs Boost Deaths in Study,” Bloomberg.com, October 18, 2005.

January 2007 - The FDA issued a Public Health Advisory associating the use of certain atypical antipsychotic medications in elderly patients suffering from dementia with increased mortality in those patients. Across a total of seventeen placebo-controlled trials performed with the drugs Zyprexa (olanzapine), Abilify (aripiprazole), Risperdal (risperidone) and Seroquel (quetiapine), fifteen trials showed numerical increases in mortality in the drug-treated group compared to the group treated with a placebo. Several analyses of the trial results have demonstrated an approximately 1.6 to 1.7-fold increase in mortality in these patients. Most deaths were due to heart-related events such as heart attack, heart failure or sudden cardiac death, or infections such as pneumonia. The findings prompted the agency to demand that the manufacturers of these drugs include a boxed warning in their labeling describing this risk to patients with dementia. The label also warns that Zyprexa, Abilify, Risperdal, Seroquel, Clozaril, Geodon and Symbyax are not approved for the treatment of elderly dementia patients. Did the drug manufacturers know their products could be dangerous before they put them on the market? How would that information play into a Seroquel class action lawsuit?

Sources: Rob Waters, “Suit: Janssen Pharmaceutica misled Texas officials on drug,” Bloomberg News, December 29, 2006, accessed January 4, 2007; Miranda Hitti, “Invega Extended-Release Tablets Include a Newly Approved Chemical,” WebMD Medical News, December 20, 2006, accessed January 4, 2007.

Do you need a Risperdal Lawyer? – Free Call, No Obligation

If you or someone you love has been taking Risperdal, the FDA has issued new warnings about the medicine. Contact our personal injury law firm today. A consultation with a product liability lawyer may be in your best interest. If Janssen Pharmaceutica knew the risks of taking Risperdal were more dangerous than it claimed, you may be entitled to compensation for the injuries you may have suffered as a result. Our lawyers are investigating the circumstances of this case. Your information will be reviewed by a lawyer who may be able to help you gain compensation from a Risperdal lawsuit.

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