Pharma

Prostate cancer treatment brochure that leaves out risks of paralysis, diabetes draws FDA ire

When it comes to social media many pharmaceuticals are risk averse to the minefield of compliance issues it poses on the marketing front. But traditional marketing still poses plenty of pitfalls as Endo Pharmaceuticals recently experienced. A brochure from Endo Pharmaceuticals, a division of Endo Health Solutions, for the drug developer’s subcutaneous prostate cancer implant […]

When it comes to social media many pharmaceuticals are risk averse to the minefield of compliance issues it poses on the marketing front. But traditional marketing still poses plenty of pitfalls as Endo Pharmaceuticals recently experienced.

A brochure from Endo Pharmaceuticals, a division of Endo Health Solutions, for the drug developer’s subcutaneous prostate cancer implant treatment, Vantas, incurred the ire of the U.S. Food and Drug Administration’s Office of Prescription Drug Promotion in the Division of Consumer Drug Promotion.

In a letter obtained by pharmaceutical news blog Pharmalot, the regulator points out that the problem is not so much for what the brochure contained as what it left out. The brochure claims its androgen deprivation therapeutic, a gonadotropin releasing hormone agonist, reduces the amount of testosterone the body makes, slowing the growth of prostate cancer cells. According to the letter for which Pharmalot provides a link:

..the brochure fails to state that paralysis may result from the risk of spinal cord compression, and that patients are at increased risk of developing hyperglycemia, diabetes mellitus, myocardial infarction, sudden cardiac death, and stroke. As a result, the brochure misleadingly suggests that Vantas is safer than has been demonstrated.

As Pharmalot points out, it’s not as if the company forgot to include warning information.  But that’s some pretty critical information to leave out.

The letter advises Chadds Ford, Pennsylvania-based Endo to stop distributing the brochure and to respond to the FDA by October 10.

Endo got Vantas as part of its acquisition of Indevus in 2009 to diversify its drug portfolio. Net sales of Vantas were $19 million in 2011, primarily in the U.S., according to Endo Health Solutions’ full year earnings report. It’s been available in the U.S. since 2004.

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