RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > Endo Pharmaceuticals Hit With Untitled Warning Letter for Marketing Brochure

Endo Pharmaceuticals Hit With Untitled Warning Letter for Marketing Brochure

Posted 02 October 2012 | By

An untitled letter sent to manufacturer Endo Pharmaceuticals by the US Food and Drug Administration (FDA) accuses the company of promoting Vantas, a subcutaneous implant used as a palliative treatment for advanced prostate cancer, using misleading materials that omit safety information.

The letter, sent 25 September to Endo's Associate Director of Regulatory Affairs Mark Klinger, references a consumer-oriented brochure aimed at the spouses of men suffering from advanced prostate cancer. Entitled, "Caring for a loved one with prostate cancer: A guide to help you help him," the brochure says it is, "Designed to provide you with practical information, resources and suggestions to help you contribute to the management and treatment of his prostate cancer."

That practical information allegedly omitted discussion of serious risk information, explained FDA.

The brochure does mention a number of safety risks, including "the most common side effects": hot flashes, tiredness, skin reactions at the implant site, atrophied testicles, urinary problems, enlarged breasts, erectile dysfunction and constipation.

But that list omits a number of important-and dangerous-side effects, alleges FDA. The agency said the brochure failed to mention that men implanted with Vantas could experience paralysis, hyperglycemia, diabetes, heart attack, sudden cardiac death and stroke.

"As a result, the brochure misleadingly suggests that Vantas is safer than has been demonstrated," remarked FDA, which called on the company to immediately stop the distribution of a brochure and respond to FDA by 10 October 2012.

The brochure does direct consumers to contact their doctor for more information, saying that, "These are not all of the side effects of Vantas."

However, because the brochure discusses the benefits and efficacy of Vantas, FDA said Endo is required to reveal all material facts about the risks facing consumers who use the treatment.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Regulatory Focus™ is doing essential, non-biased journalism during this unprecedented time. We appreciate your support as we bring you the news and intelligence you need to make an impact on global healthcare.

Regulatory Focus™ provides the intelligence you need to impact global healthcare during this crisis. Thank you for your support.