# The Wall Street Journal - Your Drug Gets Pulled -- What Now?



## Jeffrey Roberts (Apr 15, 1987)

Your Drug Gets Pulled -- What Now?Irritable-Bowel PatientsTry Variety of OptionsAs FDA Faults ZelnormBy JEANNE WHALENApril 5, 2007; Page D4Mary Ellen McDonald, a 55-year-old in Florida, has taken Zelnorm for three years to treat her abdominal pain and constipation. Now that the drug's maker is pulling the medicine from the U.S. market over safety concerns, Ms. McDonald says she is going to try to buy Zelnorm online from overseas.Zelnorm was one of few drugs approved by the U.S. Food and Drug Administration to treat irritable bowel syndrome, a digestive disorder that affects as many as 20% of adults in the U.S., though only some have severe symptoms, according to the National Institutes of Health. Swiss drug maker Novartis AG recently suspended sales of the drug in the U.S. at the request of the FDA, which was concerned that Zelnorm could be tied to risks including angina, heart attack and strokes.With drug regulators growing increasingly concerned about side effects, more medicines are being pulled from the market, leaving patients scrambling to find alternative treatments.Some IBS patients say they have been calling the FDA asking for the drug's return to market. Jeffrey Roberts, founder of the Irritable Bowel Syndrome Self Help and Support Group, says he is encouraging the Web-based organization's 20,000 members to write to the FDA to complain.See the full article here: http://online.wsj.com/article/SB117572192519260070.htmlCopyright 2007 Dow Jones & Company, Inc. All Rights Reserved


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## 14040 (Mar 31, 2007)

I wrote


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## Tiss (Aug 22, 2000)

Jeff, who exactly are we supposed to send our letters to?


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## Kathleen M. (Nov 16, 1999)

Here is the post with a bunch of contact information.http://ibsgroup.org/groupee/forums/a/tpc/f...261/m/376105203


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## Jeffrey Roberts (Apr 15, 1987)

Tiss,You can send your letters directly to the FDA or you can send them to me and I will forward through my contact at the FDA.I would address your letters/comments tor. Stephen K Galson, M.D., M.P.H.Director, Center for Drug Evaluation and ResearchU.S. Food and Drug Administration5600 Fishers Lane, Rockville MD 20857-0001and/orDouglas Throckmorton, M.D.Deputy Director, Center for Drug Evaluation and ResearchU.S. Food and Drug Administration5600 Fishers Lane, Rockville MD 20857-0001


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## GailSusan (Dec 23, 2000)

Hi Jeff,I am writing a letter, but it is taking me a while as I want it to be clear and compelling.In the meantime, I found a letter to doctors on Zelnorm's website that may be helpful for people to bring to their doctors as it explains that only 13 people out of 11,614 on Zelnorm had cardiac incidents and ALL of them had pre-existing cardiac disease. http://www.zelnorm.com/Dr_Doctor_Letter.pdfI plan to take this to as many doctors as I can find until one of them writes a prescription. Unfortunately, if you go onto the Internet you'll see a ton of law firms gearing up for class action suits against Novartis. And, I don't know what the implications are for doctors with their malpractice insurance for prescribing non-FDA approved drugs.Novartis does say that a Treatment IND will be intiated to provide access to Zelnorm for appropriate patients. Now to find a doctor willing to go through the onerous paperwork involved in an IND process!


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## mem3452 (Apr 2, 2007)

GailSusan,What is a Treatment IND and what is involved in getting one?


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## Jeffrey Roberts (Apr 15, 1987)

An update. Letters should go tor. John JenkinsDirector Office of New DrugsU.S. Food and Drug Administration5600 Fishers Lane, Rockville MD 20857-0001 Ph: 301-796-0700Fax: 301-796-9856


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