Sunday, May 11

FDA Issues Warning Letters Over Tysabri, ‘Lipodissolve’ Injections

(Posted By: Josi Creek)

The FDA today disclosed several warning letters it had sent to drug makers and weight-loss spas for “false” and-or “misleading” claims for their products. Here’s a rundown:
  • Biogen Idec was cited for a promotional Webcast involving the multiple sclerosis drug Tysabri because it minimized the risk of a serious brain infection, the FDA said. The letter also cited the company for failing to submit the Webcast for FDA review 30 days in advance. Tysabri is sold jointly by Biogen and Elan.
  • Gilead Sciences was cited for a print ad for involving its HIV drug Truvada, which the FDA said overstated the effectiveness of the products and minimized the risks associated with the
  • Half a dozen spas offering “lipodissolve” injections to get rid of small fat deposits received letters because the FDA said the therapy hasn’t been cleared by regulators. “The claims made for your lipodissolve products are false and misleading in that they are not supported by substantial evidence or substantial clinical experience,” one letter said.