Vivus ED drug info lacking - FDA
US health regulators have accused Vivus of misleading consumers by downplaying risks associated with its little-used erectile dysfunction treatment, Muse.
US health regulators have accused Vivus of misleading consumers by downplaying risks associated with its little-used erectile dysfunction treatment, Muse.
Vivus failed to include risk information and made false claims about the drug's effectiveness both on its Web site and in television advertisements that ran last year, the FDA said in a letter dated May 25. It said Vivus did not list any risk information about the drug on the main part of its Web site. 'Although the risk information is available in certain areas of the website, there is no signal that the links will lead the reader to this information,' wrote Thomas Abrams, head of drug marketing division at the FDA.
In the letter, the FDA said the TV ad omitted the warning that Muse should not be used by men with heart problems and could also cause abnormally low blood pressure or restrict blood to the brain, causing a loss of consciousness.
The ad also did not include the 'material fact' that Muse is a manually inserted pellet, the FDA said. 'The method of administration is also pertinent to the ad's comparative claims to other (erectile dysfunction) treatments that are available as oral tablets,' FDA's Abrams wrote.
Vivus spokesman Louis Villalba said the company was reviewing the letter and planned 'to work with the agency.' But Villalba said the Mountain View, CA-based company had 'no plans to change the Web site in the near future', although currently the web page for Muse is 'under review to provide better consumer information.' The television ads, which ran last year, are no longer being used, he said.
Sales of Muse have all but disappeared in the face of its well-known oral rivals, including Viagra from Pfizer Inc., Cialis, by Eli Lilly & Co. and Icos Corp., and Levitra, from GlaxoSmithKline and Bayer AG.
In 1997, Muse saw sales of $130m in its first year. Since then, sales have dropped to about $20m a year. The FDA sends dozens of warning letters to companies every year. Most cases are resolved without regulatory action, but some can result in fines, injunctions and other penalties.
Source: Reuters