Navigation Links
Constipation Drug Linked to Heart Attack Pulled Out

Novartis AG, the Swiss pharmaceutical giant, has agreed to stop selling Zelnorm, a constipation drug, following complaints that it is linked// to higher chances of heart attack and stroke.

Officials of the Food and Drug Administration (FDA) of the US had advised the firm to pull the drug out of the market. (It is this Novartis that has challenged the rejection of its patent application for a cancer drug by Indian authorities. The suit has been filed in Madras High Court in southern India and the verdict is eagerly awaited as this is the first test case for India’s patent laws under the WTO regime.)

Earlier the FDA had approved Zelnorm, also called tegaserod maleate, for short-term treatment of women with irritable bowel syndrome with constipation.

It could also be used by those suffering from constipation but below 65 years of age.

It had been available in the market since 2002 and the FDA approval was granted in September 2004. Interestingly right at the time it was granting approval, the FDA had warned of diarrhea risks associated with the drug.

It said then that it had received several complaints of ischemic colitis, a condition resulting from reduced blood flow to the intestines, which in some cases can cause serious intestinal damage, and rarely death.

It had gone on to add, 'FDA is not thinking of taking Zelnorm off the market at this time. We are adding new information about potential risks of treatment with Zelnorm to the labeling so that doctors and patients can make informed individual treatment decisions.'

But now it says that it has concluded that the overall risk versus benefit profile for the drug is unfavorable for continued marketing.

Its request to Novartis was based on 'newly available information of an increased risk of serious cardiovascular adverse events, including myocardial infarction (heart attack), unstable angina (chest pain), and stroke, associated with us e of the drug.'

Doctors who prescribe Zelnorm should work with their patients and switch over to more appropriate treatment, the FDA has said.
GP
'"/>




Related medicine news :

1. Link between Constipation and Parkinsons Disease
2. Constipation can be a cause
3. Tegaserod offers relief for Chronic Constipation
4. Biofeedback Treats One Type Of Chronic Constipation
5. Low Cholesterol Linked to Severe Depression and Violent Behavior in Men
6. Cough Syrup Ingredient Linked to Stroke
7. Irregular Periods Linked to Diabetes
8. Hormones Linked To Migraines
9. Triglycerides Linked To Stroke Risk
10. Smoking Linked To Low Infant Birth Weight
11. Nausea Linked To Anxiety And Depression
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:2/12/2016)... ... February 12, 2016 , ... ... new initiative—the Siemens Foundation-PATH Ingenuity Fellowships—to develop the advanced skills needed to ... students from U.S. universities who will draw from Siemens’ deep knowledge of ...
(Date:2/12/2016)... ... ... , Back to the Future , Feb. 25, 2016 — 11:00 a.m. – 12:30 p.m. ... learn from history are doomed to repeat it.” , An analysis of CDRH’s enforcement actions ... takes time. , Take a close look at the warning letters the agency sent ...
(Date:2/12/2016)... ... ... Each year, the American Physical Therapy Association (APTA) offers a Combined Sections ... Center. Almost 10,000 physical therapists across the country are expected to attend this annual ... chosen field and network with their colleagues. As in years past, HydroWorx is ...
(Date:2/12/2016)... ... February 12, 2016 , ... Coco Libre, the maker of coconut ... Events LA GRAMMY’s Style Lounge Event. Coco Libre will offer musicians and celebrities the ... the big event. The invitation-only gifting suite, held this year at the W Hollywood ...
(Date:2/12/2016)... ... 2016 , ... The ThedaCare Center for Healthcare Value is ... April 5-7. The series is a multi-day, multi-workshop event designed to teach leaders ... broad range of topics, including coaching skills, the scientific method of problem solving ...
Breaking Medicine News(10 mins):
(Date:2/12/2016)... and SEOUL, South Korea ... Biosys­tems Menarini and Macrogen, Inc. today announced they ... and innovative procedures for precision medicine in cancer. ... Silicon Biosystems, DEPArray™ digital-sorting technology with Macrogen,s high-throughput ... tests certified under the Clinical Laboratory Improvement Amendments ...
(Date:2/12/2016)... Feb. 12 2016  OMS Supply, a large provider ... practitioners, announced today the recent launching of their new ... variety of features that enhance the user experience and ... --> --> ... new company that started in early 2016, they have ...
(Date:2/12/2016)... 12, 2016 Indiso ... den ungedeckten medizinischen Bedarf bei Lungen- und ... klinischen Forschungsprogramms bekannt. Das Programm, das sich ... ihrer respiratorischen Funktionen und anderer klinischer Parameter. ... Medizintechnikunternehmen, das sich auf den ungedeckten medizinischen ...
Breaking Medicine Technology: