Sirukumab Shows Increased Death Rates in Clinical Trials

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Dangerous drugs cause deaths and serious injuries to New York patients each year. An experimental drug for rheumatoid arthritis called sirukumab was reported by reviewers at the U.S. Food and Drug Administration as causing an increased number of deaths when compared to a placebo.

Participants in the clinical trials showed higher rates of death caused by heart conditions, malignancies, and infection. The drug also showed similar issues with immune response suppression that other similar drugs also have, but those other drugs do not demonstrate the increased rates of mortality demonstrated by sirukumab. The drug, originally under development by Johnson & Johnson together with GlaxoSmithKline, is now solely under development by Johnson & Johnson after GSK returned its rights to the drug.

Johnson & Johnson claims that the drug’s benefits outweigh its risks and states that rheumatoid arthritis is a complex disease. Sirukumab is designed for people who either do not tolerate or do not respond to methotrexate, the drug that is most commonly prescribed to sufferers of rheumatoid arthritis. The FDA will soon vote on whether or not to approve sirukumab for the market.

Defective drugs kill or seriously harm many patients each year. When a patient is seriously injured or killed by a dangerous drug, the drug’s manufacturer or designer may be liable to pay damages in a resulting lawsuit based on product liability. Product liability may lie if there were inadequate warnings, labeling problems, or manufacturing defects. A personal injury attorney who is experienced with lawsuits involving defective drugs may review what happened in order to offer assessments of whether or not an individual case may have legally valid claims. If an attorney accepts representation, counsel may then file a civil complaint against the responsible parties and work to recover the maximum amount of damages possible.