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Articles Tagged with pharmaceuticals

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RisperdalThe Huffington Post is in the midst of publishing a 15-part series that details Johnson & Johnson’s push of the anti-psychotic drug Risperdal. The drug was approved for sale in 1994 for patients with psychosis, but was not approved for use in adolescent or elderly patients. Skirting the Food & Drug Administration and the law became the crux of Johnson & Johnson’s aggressive marketing plan, which was designed to make Risperdal the best-selling anti-psychotic drug on the market.

The series is a bombshell. Three chapters of the 15-chapter series have been published by The Huffington Post so far. Every day brings a new chapter – and more tales of how one of the world’s largest pharmaceutical companies pursued sales at all costs. Selling the drug to approved patient groups for FDA-approved uses wasn’t enough for Johnson & Johnson. Drug sales representatives pushed the drug onto doctors who dealt with psychiatric illnesses in children and elderly, and pushed them to prescribed the drug for symptoms such as agitation in the elderly, which is not an approved use.

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2015-05-01 15.52.57For people who take a medication, the warnings that comes along with it are the most important protection they have from harmful side effects. New information emerges every day about drugs and its potential side effects. Under the current Food and Drug Administration regulations, getting a proper warning included with drug information is harder than it should be for makers of generic drugs, and the Food and Drug Administration is considering steps to fix that.

Since November 2013, the FDA has been considering new rules for generic drugs that would allow manufacturers to expedite the process of revising labels to add warnings or information that is critical for consumers taking these drugs. This can include updating dosage amounts, safety and efficacy information.

Under the current rules, generic drug manufacturers must follow the warning labels provided by the brand name drug.  The proposed changes would allow generic drug manufacturers to change the warning labels on drugs if new information is discovered regarding dangerous side effects of the drug.

The FDA plan is called Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. The FDA recently accepted public comments about this change and held a public hearing on it. The American Association for Justice supports this change to allow generic drug manufacturers to update information packaged with their products. AAJ’s comments to FDA are available here.

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Risperdal

Risperdal

Plaintiffs seeking a judgment against Johnson & Johnson, the makers of the drug Risperdal, saw a big victory this week out of Philadelphia. A jury sided with the family of an autistic boy who grew size 44 DD breasts after taking Risperdal in 2002. The Wall Street Journal, along with many other publications, wrote about the verdict, which was handed down on February 24, 2015.

Growing breasts was one of several risks that Johnson & Johnson knew about but hid from the Food and Drug Administration, lawyers said. The condition is called gynecomastia. Some patients have been forced to undergo surgery to remove the breasts.

Due to the widespread use of this drug, our firm believes there are many patients who have taken Risperdal and may very well have suffered similar problems, or other side effects. ELPO is accepting cases against Johnson & Johnson, the maker of Risperdal, representing children and their families who have been harmed by Risperdal. The drug treats the symptoms of psychiatric disorders. In addition to gynecomastia, there is an increased risk of stroke and diabetes for patients taking Risperdal.

We want to help patients protect their rights, and encourage anyone who has taken Risperdal or who has a family member who has done so to contact us as soon as possible.

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