Prior to the recall, which Novartis implemented in the U.S. at the urging of the FDA, the only primary adverse affect was the potential for serious diarrhea. Zelnorm is sold in other countries as well, but the FDA only has jurisdiction in the United States. Other countries, including Switzerland, have also recalled the drug - in the latter's case, literally months after it was first introduced.
It should be noted that while the FDA urged Novartis to recall Zelnorm, it left the door open for a potential, limited return of the drug at a later date.And therein lay the makings of the manic history of Zelnorm, during its brief five years on the U.S. market.
When Zelnorm was introduced in 2002, it was indicated for use by women suffering from Irritable Bowel Syndrome (IBS) with a focus on easing symptoms of constipation. In lay terms, Zelnorm is a stool-softener that aids the progression of otherwise rock-hard stools that would be the basis for abdominal pain. Zelnorm was approved for short-term use only, and not approved for use by men. The risk for diarrhea was a known adverse effect, and women prone to diarrhea were not to use the drug.
IBS patients were applauding the introduction of Zelnorm, as there weren't many alternatives out there. With Novartis reporting 4.5 million Americans suffering from constipation most of the time, the market potential for Zelnorm was huge.
With that kind of reach, you have to wonder why the company would allow a grossly misleading ad to appear in the New York Times Magazine. Perhaps the answer is obvious. Nonetheless, on March 16th 2003 an advertisement that never once mentioned Zelnorm but was plainly referring to the drug, told the story of Gloria:
"Ever since Gloria Swanson was 19 - and that was over thirty years ago - she's missed out on a large part of life. Trips, time with have a life-threatening disease. She has Irritable Bowel Syndrome (IBS) with constipation. The abdominal pain, bloating and constipation were often crippling. But today, we see a new Gloria. Her pain and suffering are over, thanks to her doctor and a treatment from Novartis. Together, they stopped her 30 years of pain in just three days. Now she and her husband Charles are making up for a lot of lost time. Nova bringing real help to patients and their families. Millions of women suffer from IBS with constipation, and their symptoms vary from mild to severe. In Gloria's case, we're happy her thirty years of pain have ended. Think what's possible."
(Source: the official web site of the Food and Drug Administration)
A photograph under a huge headline "Beating IBS" depicts a happy couple, blissfully joyful over discovering a cure for a chronic, 30-year scourge in just 3 days. Missing from the ad was any mention of Zelnorm, its indications, or risks.
The FDA was not happy. The agency's Department of Health and Human Services forwarded a strongly worded letter to Novartis indicating that the ad was false, misleading and in violation of the Federal Food, Drug and Cosmetic Act. In effect, the ad inferred that the miracle un-named cure from Novartis constituted a cure for IBS, which it is not.
The communiqué went out to the manufacturer on June 27th, 2003.
Fast-forward a year. By August 20th, 2004 it is obvious that the FDA and Novartis have kissed and made up, as a release has appeared from Novartis heralding the FDA approval of a new supplemental indication for Zelnorm. Specifically, it can now be used by men, as well as women 65 years of age or younger. A new, and exhaustive clinical study has confirmed that the only adverse effect worth mentioning is the presence of diarrhea, which in some patients can be serious.
"We are very pleased the FDA has found Zelnorm safe and effective and has approved it for treatment of patients with chronic constipation," states the release, in part. "Novartis believes it will help bring relief to millions of patients."
Within three years, the drug is recalled over concerns about the risk for heart attack and stroke.
READ MORE LEGAL NEWS
Zelnorm was a big seller for Novartis, with sales in the U.S. alone totalling $488 million last year. It has been reported that Zelnorm had been tagged as a blockbuster for Novartis, with expectations of $1 billion in sales by 2011.
In view of the recall, those figures may not be achievable, as the FDA has slammed the door and directed Novartis to pull Zelnorm from the U.S. market. However, the slam notwithstanding, the door is not completely shut. With Novartis believing that Zelnorm has a potential benefit for "appropriate patients," the FDA has left the door open for a limited return at some future date.
The door is open, it appears, because Novartis has its' foot firmly planted in it.
The company is co-operating fully with the FDA.
