Web Video for Chronic Pain Drug is Misleading, FDA Says

An Internet video advertisement for the chronic-pain drug Ultram ER is misleading and does not adequately discuss the risks associated with the drug, the FDA said.

The video for the Johnson & Johnson drug is in “serious” violation of FDA rules for drug advertising because it overstates the effectiveness of the drug, according to a letter from the FDA posted on the agency’s website. The FDA forbids drug advertising that is misleading or not truthful.

Known side effects of Ultram (and its generic form tramadol) include seizures, particularly in people with a history of seizures or head injuries, metabolic disorders, or people taking certain antidepressants, muscle relaxers, or medications for vomiting and nausea.

Ultram ER is approved by the FDA to treat moderate to severe chronic pain in adults who require 24-hour-a-day treatment for an extended period of time.

The web ad in question has been pulled and is no longer available to the public, at the request of the FDA, officials said. Johnson & Johnson said it is still reviewing the FDA letter about the Ultram ER ad and deciding how to respond by the deadline of May 27.

The video first appeared in July 2008, officials said. It featured Michael Schatman of Pacific Northwest University and U.S. Olympian Nikki Stone, who won the gold medal at the 1998 Winter Olympics in Nagano, Japan as an inverted aerial skier.

In the video, which appeared on the website www.painsawareness.org, Schatman and Stone talk about the consequences of chronic pain and how Ultram ER can help reduce those symptoms, the FDA said.

However, while the ad talks about how effective the drug is, the side effects are only discussed briefly at the end of the ad using text in a small font that scrolls by, the FDA said.

According to the FDA, the ad “greatly misrepresent(s)” the proven effectiveness of Ultram ER by suggesting it can improve a patient’s mood and interpersonal relationships.

Ultram and Ultram ER, the extended release form of the same drug, earned Johnson & Johnson about $224 million in sales in 2008, officials said.

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