The U.S Food and Drug Administration has warned GlaxoSmithKline plc (NYSE:GSK) over misleading letters the company sent to health professionals promoting its breast cancer drug, Tykerb.
The FDA found that the letters sent out by Glaxo "are misleading in that they omit and minimize the most serious and important risk information" and "selectively present efficacy information for Tykerb, thereby overstating the efficacy of the drug. Most important, the letters minimize the important risk of decreased left ventricular ejection fraction," a measure of the amount of blood pumped out of one section of the heart, the FDA said in a letter to Glaxo.
The FDA letter, six pages in all, also states that the information contained in Glaxo's promotional letters is misleading because they "fail to present the most serious and important risk information" about the drug including warnings about patients with liver problems and pregnancy.
Glaxo was asked to stop using the letters, or any similar information, and to submit a plan to send corrected information to those that received the original letter. "We are particularly concerned that these materials, which were disseminated to healthcare professionals during the product's launch and formed the basis of their first impressions of the drug, suggest to healthcare professionals that Tykerb is safer and more effective than has been demonstrated," the FDA said.
Glaxo "takes seriously the concerns outlined in the FDA letter, and we will work with the agency to address its concerns," company spokeswoman Sarah Alspach said via e-mail.
Tykerb, generic name lapatinib, was approved by the FDA in March 2007. It is a once-a-day pill that is indicated for certain patients with advanced breast cancer. Glaxo has hopes that the medication will rival Hereptin.
[Source: ReutersHealth]
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