Zelnorm Recalled by FDA, Linked to Heart Problems and Stroke

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At The Law Offices of Michael A.
DeMayo, L.
L.
P.
, we work tirelessly to keep a pulse on the most recent news and information that may affect our clients.
One area that we are particularly attentive to is the area of dangerous drugs.
Most recently our focus has been on Zelnorm.
On March 30, 2007 the FDA issued an advisory informing the public that Novartis is complying with an FDA request to suspend marketing of Zelnorm.
This request was made as a result of the drug being linked to an increased risk of heart attack, stroke and unstable angina.
Just a few days later, on April 2, 2007 the FDA took stronger action and removed Zelnorm from the market subsequent to analyzing the results of an extensive study of the drug's performance.
The analysis included data gleaned from more than 18,000 patients, most of whom were treated with Zelnorm but some of whom received a placebo.
The conclusion was that the benefits of the drug do not outweigh the risks.
Those risks include serious cardiovascular adverse events such as heart attacks and strokes.
Zelnorm has also been linked to severe cases of diarrhea, ischemic colitis and potentially death.
Zelnorm was initially marketed in the U.
S.
from August of 2002 through March 2004.
During that period the FDA adverse reporting system did receive reports of patients who experienced serious adverse events.
These reports included 21 that presented with serious consequences for diarrhea, 20 patients that were diagnosed with ischemic colitis and 3 patients diagnosed with other types of intestinal ischemia.
In some patients, these adverse events have led to hospitalization, surgery and even death.
Since being approved by the FDA in 2002, Zelnorm, manufactured by Swiss drug maker Novartis AG, has been prescribed as a short term medication for women coping with irritable bowel syndrome.
The primary symptom is constipation.
The drug increases the movement of stools through the bowels.
It does not cure irritable bowel syndrome but it has been shown to help the condition in some regards.
Zelnorm was marketed in 55 countries and was the first drug the FDA approved for the treatment of irritable bowel syndrome.
Prior to being recalled it was under prescription to about 500,000 people and in 2006 alone the drug generated just under five hundred million dollars in revenues for the company.
The FDA made the following announcements in its Public Health Advisory: ·Patients being treated with Zelnorm should contact their physician to discuss alternative treatments for their condition.
·Patients who are taking Zelnorm should seek immediate medical treatment if they experience any of the following symptoms:severe chest pain, shortness of breath, dizziness, any known symptoms of a heart attack or stroke.
·Physicians who prescribe Zelnorm should work with their patients to find appropriate alternative treatments.
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