Zelnorm Essay Assignment paper

Zelnorm Essay Assignment paper

Zelnorm Essay Assignment paper

Zelnorm, a drug produced and marketed by Novartis, is used for short-term medication of women with irritable bowel syndrome with constipation. Moreover, patients below 65 years of age with chronic constipation used Zelnorm for their treatment (Novartis, 2008). After a clinical study, various illnesses related to the intake of the drug were discovered forcing the company and the U.S. FDA to issue a recall order.Zelnorm Assignment Essay There were nearly 500,000 people using the drug when it was withdrawn from the market in 2007 (MedTV, 2008).

The recall order was issued after the analysis of U.S. Food and Drug Authority on data gathered from 29 clinical trials that involve more than 18,000 patients. These results were compared to those patients using placebo (MedTV, 2008). The data shows that majority of the patients using Zelnorm experienced serious cardiovascular adverse incidence, including but not limited to angina, heart attacks, severe chest pain, fainting, fast heart rate, and shortness of breath. A variety of discomforts and sicknesses were also blamed to Zelnorm such as sudden weakness, urinary tract infection, bloating, dizziness, diarrhea, insomnia, intestinal gas, nausea, vomiting, unexplained rush, leg pains, difficulty to walk or talk, and even stroke. The company’s review of the results of the clinical trials forced the pharmaceutical company to conduct its own assessment of the drug (Anapol Schwartz Attorneys at Law, 2004). This will later lead to the recall of the drug in the market in United States and Canada.

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