FDA chastises Novartis for Zelnorm advertising

Saturday, June 28, 2003

WASHINGTON -- The government says an ad campaign implies a drug for irritable bowel syndrome works far better than it really does, and ordered Zelnorm's maker to stop the advertising.

The Food and Drug Administration cited ads by Novartis Pharmaceuticals that pictured a smiling woman and said, "Novartis and Gloria ended 30 years of debilitating abdominal pain, bloating and constipation in just three days."

While the ad doesn't mention Zelnorm's name, it discussed a "treatment from Novartis" that is "beating IBS."

The ad implies Zelnorm cured Gloria and could help millions of women when in fact it's not a cure, doesn't work in just three days, and helps only a very small proportion of patients, FDA officials wrote Novartis on Friday.

"The ads are messages of hope based on true patient experiences," that let people know they should ask doctors about new treatments, said Novartis spokesman Greg Baird.

The ads run periodically and aren't running now, but Novartis will discuss FDA's concerns with agency officials, he said.

Zelnorm was approved last summer to treat women with one form of irritable bowel syndrome, the type associated with constipation. In studies FDA stressed at the time, patients fared only a little better -- 5 percent to 10 percent better -- when taking Zelnorm than when taking dummy pills.

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