Novartis, Switzerland's largest drugmaker, stopped selling its Zelnorm irritable bowel syndrome treatment in the U.S. at a regulator's request after finding people taking the medicine had more heart attacks and strokes.
A review of data from 18,000 patients showed that a statistically significant number had cardiovascular problems.
A review of data from 18,000 patients showed that a statistically significant number had cardiovascular problems.
Zelnorm was approved in 2002 for irritable bowel syndrome and constipation, and brought in $561 million in last year. The U.S. Food and Drug Administration asked Novartis to stop sales, and today the agency said it would consider a ``limited re- introduction'' if benefits are proven.
Novartis revised its net sales outlook to more than 5 percent for the whole company and to low- to mid-single digit rate for the drug division.
``This is a serious blow to the company,'' Denise Anderson, an analyst with Kepler Equities in Zurich said in a telephone interview today.
More at Bloomberg
Novartis revised its net sales outlook to more than 5 percent for the whole company and to low- to mid-single digit rate for the drug division.
``This is a serious blow to the company,'' Denise Anderson, an analyst with Kepler Equities in Zurich said in a telephone interview today.
More at Bloomberg
2 comments:
The US FDA is widely considered to be the best food and drug regulatory agency in the world. However, the withdrawal of Zelnorm begs the questions: Is the FDA moving too fast?
Also, Zelnorm was originally targeted to women. It is well known in the industry that the usual subjects of clinical trials tend to be young men. This new debacle also begs the question: Are women being short changed in clinical trials? Are we exposing them to risks without adequate testing?
http://philawdelphia.wordpress.com/2007/03/30/too-fast-too-soon/
Two issues here:
1. Yes Zelnorm was approved only for the treatment of IBS in women becasue they seem to suffer more from this condition and the studies were done in women only. Does nayone think that Novartis did not promote this drug for anyone with IBS, men included. The ads were showing women and man in the background like in this one, but make no mistake the drug was promoted off label too wherever and to whoever to they could.
2. Is Novartis going to stop selling this now "dangerous" drug everywhere in the world, immediately or they are going to wait till the local regulatory authorities do as FDA has done, order them to stop sales and promotion. It will be interestng to see but one can bet that they will wait and in fact they may not even mention this fact via their sales reps in other countries except if some doctor asks about it. That is the way all big pahrma does their seling, brag about the good side but say as little as possible about the bad. Preferably nothing till they ask you or challenge you.
The big pharam call themeslves:"Ethical busines". What a laugh!
ps. Zelnorm was hailed by Novartis at launch as a miracle drug that would bring in billions as a blockbuster drug.
What it was in reality a very expensive lexative that might have worked somewhat better in some patients than your 10c over the counter peoven and safe lexative.
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