September 3, 2010 / 12:10 PM / 9 years ago

Factbox: Ads for sleep aid, HIV drug among those warned by FDA

This factbox is part of a special report on the FDA's efforts to regulate drug marketing. The full report can be seen here:

By Susan Heavey

WASHINGTON (Reuters) - The following are details of some recent FDA warnings sent to drugmakers over misleading or inappropriate advertising, along with the dates the letters were made public.


August 4, 2010

Novartis received one of the FDA’s first warning letters targeting what the agency considered an inappropriate Facebook widget on the drugmaker’s website for Tasigna, a chronic myelogenous leukemia therapy.

FDA said the widget, which the social networking website uses to share content with its Facebook users, was misleading because it told people about the drug’s benefits but not its risks.

“By failing to disclose any risk information for Tasigna, the shared content misleadingly suggests that Tasigna is safer than has been demonstrated,” the FDA wrote to the drugmaker.

Novartis said it immediately removed the widget software application and plans to assess all of its webpages based on the FDA’s concerns.




June 17, 2010

FDA warned Sepracor Inc over a 60-second television commercial featuring a sleepless woman whose bed appears to be a boxing ring. She falls asleep after taking Lunesta and is tucked in by the company’s trademark butterfly.

Sepracor, acquired by Dainippon Sumitomo Pharma Co Ltd in October, suggested the sleep aid was “clinically superior” to other insomnia treatments, the agency said.

An announcer says: “If you’ve taken your sleep aid, and you’re still fighting to sleep in the middle of the night, why would you go one more round using it? ...Lunesta is different.” The FDA said it was unaware of data to back up that claim.

The FDA called on the drugmaker to immediately stop using the commercial. Sepracor said it cooperated with the FDA’s requests and that the agency considered the matter closed.




May 4, 2010

Novartis received a warning letter for two websites it sponsors that the agency said are clearly linked to its leukemia drug Gleevec even though the drug’s name is never mentioned.

The websites, and, made claims about the drug’s benefits but failed to mention serious side effects such as congestive heart failure. They also promoted an unapproved use of the drug and made unproven claims about dosing, the FDA said.

“These websites are concerning from a public health perspective,” the FDA wrote. It also sought details about Novartis’ role with another website,, that the FDA said may not comply with agency rules.

Novartis said it suspended the two websites as well as the use of all related promotional materials for the groups.




January 12, 2010

In February 2009, bloggers touted Bayer-sponsored events for “frazzled moms” where a style expert offered fashion tips and a nurse gave a pitch about the company’s Mirena birth control device.

FDA took issue with the drugmaker’s script for the events, saying the nurse downplayed the intrauterine device’s (IUD) risks and oversold its benefits. In a letter to Bayer Healthcare, part of Bayer AG, the agency faulted the drugmaker for telling women its IUD would help boost intimacy and could help them “look and feel great,” the FDA wrote.

Both bloggers later wrote about the events on their websites

here and here

Bayer has said it stopped holding the gatherings 10 months before it received the agency’s letter.




September 16, 2009

Allergan Inc saw a letter from the FDA last year citing the drugmaker for its website promoting its controversial eyelash-boosting drug Latisse.

FDA said various webpages on the company’s website did not tell consumers about possible risks like extraneous hair growth wherever the drug touches the skin and downplayed possible allergic reactions. Although Allergan pointed consumers to full prescribing details on two other webpages, that did not make up for not mentioning the risks, the FDA wrote.

Allergan said it would work with the FDA to address the concerns and that one set of promotional material was no longer in use.




July 22, 2009

Last year, the FDA warned Abbott Laboratories over a promotional DVD featuring former basketball star and HIV patient Earvin “Magic” Johnson.

In it, Johnson is interviewed about what it was like to have HIV and his experience taking Abbott’s Kaletra drug. “The promotional DVD minimizes the serious risks of the drug, overstates the efficacy of Kaletra, and includes unsubstantiated claims,” the agency wrote.

Abbott has said it discontinued its use of the DVD earlier in 2009 before the warning letter was made public.


Promotion: Not Available on FDA website

Reporting by Susan Heavey, editing by Claudia Parsons

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