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. There were nearly 500,000 people using the drug when it was withdrawn from the market in 2007 (MedTV, 2008).
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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.
Zelnorm was initially declined by the U.S. FDA due to insignificant effectiveness and risk on the health of those who will take it. Its known side effects then did not stop the U.S. FDA to issue an approval to allow Zelnorm be sold in the market in 2002. They ordered that the warnings of possible side effects should be put twice in the drug's label. And in 2005, there are more than 2 million prescriptions issued for the drug. The drug was also marketed to nearly 55 countries worldwide (Schimdt & Clark, 2007). Notably, as early as 2001, consumer rights protection group Public Citizen's Health Research Group urged the U.S. FDA to reject Zelnorm for marketing. Also, there are two other drugs, Propolsid and Lotronex, with the same therapeutic claims of Zelnorm that are already recalled from the market (MedTV, 2008).
U.S. FDA asked Novartis on March 28, 2007 to issue a Zelnorm withdrawal on the market. Afterwards the company complied but has not yet issued a recall order until it stops selling the drug in mid-2007. Last July 2007, U.S. FDA and the pharmaceutical company Novartis said that Zelnorm will now only be available to those people who meet the stringent criteria through a special program named "treatment investigational new drug" (treatment IND.) Even after the recall, people with emergency situation can still take Zelnorm. The drug was declared as treatment investigational new drug because there are no other existing treatments of medications to treat irritable bowel syndrome (IBS) or chronic idiopathic constipation (Novartis, 2008).
Yet recently, the drug is no longer prescribed under the treatment as of April 2, 2008. Although, Zelnorm can still be used as an "emergency IND." Patients must have a life-threatening situation or a situation serious enough to require hospitalization that would be treated by the drug before he will be given one under the emergency investigational new drug program. The physician of the patient can apply to the U.S. FDA to avail the program. But the U.S. FDA can reject the application if the patients have any of the following: history of heat attack or stroke, specific type of chest pain known as unstable angina, high blood pressure or hypertension, high cholesterol, diabetes, anxiety, suicidal thinking or behavior, depression or obesity. Moreover, patients over 55 years old and those who smoke can be denied of the special program to use the drug (Schimdt & Clark, 2007).
As a result of the recall and strict restrictions on the availability of the drug, patients who used the drug before was forced to discuss with their health care providers other alternative treatment. In recent times, previous patients who take Zelnorm filed individual liability litigations and class suits against the company. Investors of the company are also considering filing a corporate lawsuit against the company's executives (Anapol Schwartz Attorneys at Law, 2004) . These cases will focus on the liability of key persons of the company on their previous knowledge of the danger of the drugs and later on compelling them to pay damages and hospitalization costs of the patients using thee drug. The claimants' precedent is the successful claims of hundreds of thousands of patients over the same IBS drug Lotronex (Hissey Kientz, LLP, 2006).
U.S. FDA also announced that Novartis agreed to consider restricted re-introduction of the drug in the market. This will be only permitted if a number of patients can be identified and proved that the benefits of the drug already outweigh its risks. However, such re-introduction to the marker would be talked about at a public advisory committee meeting with major concerned groups and sectors invited (U.S. Food and Drug Administration, 2007).
- Anapol Schwartz Attorneys at Law. (2004). FDA Requires Zelnorm Pulled from Market: Zelnorm Lawsuits. Retrieved March 26, 2009, from http://www.anapolschwartz.com/practices/zelnorm/index.asp
- Hissey Kientz, LLP (2006). Zelnorm-Recall. Retrieved March 26, 2009, from http://www.zelnorm-recall.com/zelnorm-lawsuits
- MedTV (2008, July 3) Zelnorm. Retreived March 26, 2009, from http://irritable-bowel-syndrome.emedtv.com/zelnorm/zelnorm.html
- Novartis. (2008, April 2) Zelnorm (tegaserod maleate). Retrieved March 26, 2009
- Schimdt & Clark. (2007). Zelnorms Side Effects and Recall Lawsuit. Retrieved March 26, 2009 from http://www.schmidtandclark.com/Zelnorm/
- U.S. Food and Drug Administration. (2007, March 30). FDA Public Health Advisory Tegaserod maleate (marketed as Zelnorm). Retrieved March 26, 2009, from http://www.fda.gov/cder/drug/advisory/tegaserod.htm