• 23
  • January
    2012

The European Union's drug regulator announced Friday that it will follow the U.S.'s footsteps in evaluating the safety of the multiple-sclerosis pill Gilenya after one woman died after taking the pill once in November. The American woman was 59-year-old when she took Gilenya and died less than 24 hours later. Her death is still unexplained.

Following the patient's death, the U.S. Food and Drug Administration said that they will conduct a comprehensive safety review of the Novartis medication before issuing any conclusions about the pill. Their review conclusions are expected to be announced in March, although they are not required to follow any specific timeline for their review.

The EU reported that they will also investigate the "benefits and risks" of Gilenya in the wake of the woman's death. The EU medical product regulator urged medical professionals to monitor patients' heart if they prescribe Gilenya to treat MS.

Defective medical products and medication can cause serious patient harm. The FDA has recently come under fire for not conducting stringent enough tests prior to allowing medications to be prescribed to patients throughout the U.S. After the release of the FDA review, the agency will likely consider whether to issue a warning on the Novartis medication.

Source: Wall Street Journal, "EU Regulator Reviews Novartis MS Pill," Sten Stovall and Jennifer Corbett Dooren