Join Now!      Login

Whole Person Wellness Program
 
healthy.net Wellness Model
Skip Navigation Links
 
 
FREE NEWSLETTER
   
   
   
 
Health Centers
Key Services
 
Breathing ?
Which of the following health conditions is not directly benefited by breathing exercises?
Anxiety
Fatigue
Diabetes
High blood pressure

 
 
 What Doctors Don't Tell You: IBS drug linked to five deaths may soon be back 
 
What Doctors Don't Tell You © (Volume 13, Issue 3)
A drug for irritable bowel syndrome (IBS) which was linked to the deaths of at least five patients, within nine months of being licensed, may soon be back on the market.

An advisory panel to the Food and Drug Administration (FDA), the American drug regulator, is recommending the reintroduction of Lotronex (alosetron hydrochloride), manufactured by GlaxoSmithKline.

The panel says that there should be restrictions on who can prescribe it, and patients need to be carefully followed up. The FDA may not endorse the panel’s recommendations, but it is likely to do so.

Lotronex was withdrawn in November 2000 - just nine months after it received a licence - following reports of five deaths and 70 cases of serious adverse reactions. These reactions included ischaemic colitis (fever and gut pain caused by an insufficient blood supply) and severe constipation.

Peter Traber, chief medical officer of the drug company, described the panel’s recommendation as 'a very positive step forward for patients who need this drug'. This view was countered by Sidney Wolfe, of Public Citizen’s Health Research Group, a medical watchdog group in the States, who said the decision would 'lead to more cases of ischaemic colitis and more deaths'.

Lotronex was the first drug required to come with a full treatment guide under ‘patient-power’ regulation. The guide warned that the principal side-effect revealed in trials was constipation.

Hailed as 'a promising aid for irritable bowel syndrome' (Drug Infoline, December 1999), a 12-week trial of 370 IBS sufferers found that the drug was effective in women compared with a placebo.

As well as being a drug intended only for women, it was also only supposed to treat the diarrhoea form of IBS.

However, the trial didn’t pick up the serious adverse reactions with Lotronex that were soon reported to the FDA. These included cases of intestinal damage due to a reduced blood flow, and severely obstructed or ruptured bowels as a complication of severe constipation.

Within four months of its launch, six women needed hospital treatment and three of those underwent surgery after taking the drug.

By the time GlaxoWellcome agreed to withdraw it, 34 patients had been treated in hospital, 10 others had undergone surgery and three had died (Lancet, 2002; 359: 1491-2).

 Comments Add your comment 

 About The Author
What Doctors Don't Tell You What Doctors Don’t Tell You is one of the few publications in the world that can justifiably claim to solve people's health problems - and even save lives. Our monthly newsletter gives you the facts you won't......more
 
 From Our Friends
 
 
 
Popular & Related Products
 
Popular & Featured Events
Integrative Healthcare Symposium 2015
     February 19-21, 2015
     New York, NY USA
 
Wellness Inventory Certification Training (Level I)
     February 24-May 26, 2015
     Teleclass, CA USA
 
Additional Calendar Links
 
Stevia Products & Info
 
Dimensions of Wellness
Wellness, Breathing, dimension!

Home       Wellness       Health A-Z       Alternative Therapies       Find a Practitioner       Healthy Products       Bookstore       Wellness Inventory
Healthy Kitchen       Healthy Woman       Healthy Man       Healthy Child       Healthy Aging       Wellness Center       Nutrition Center       Fitness Center
Free Newsletter      What Doctor's Don't Tell You      Stevia.com      Discount Lab Tests      First Aid      Global Health Calendar      Privacy Policy     Contact Us
Disclaimer: The information provided on HealthWorld Online is for educational purposes only and IS NOT intended as a substitute for professional medical advice, diagnosis, or treatment. Always seek professional medical advice from your physician or other qualified healthcare provider with any questions you may have regarding a medical condition.
Are you ready to embark on a personal wellness journey with our whole person approach?
Learn More/Subscribe
Are you looking to create or enhance a culture of wellness in your organization?
Learn More
Do you want to become a wellness coach?
Learn More
Free Webinar