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Zelnorm Lawsuits - FDA Recall by Michael Monheit, Esq. - Philadelphia Lawyer
The FDA has taken action against Zelnorm and has provided a Q&A on the subject. Here is our take on those questions, the answers, and what remains to be answered through the Zelnorm Lawsuits which we are filing.
What prompted FDA to work with Novartis to alert the public to new safety information about Zelnorm?<
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This is the first thing that the FDA discusses in their initial web Q&A on Zelnorm. The FDA advises that after they allowed Zelnorm on the marlet (August 2002), that patients started to have adverse reactions.
The questions we have are, "Why did the drug Zelnorm get on the market in the fist place? And Why did it take from 2002 until 2007 to figure out that the drug was causing heart attacks?" Aren't these the things that Novartis should have found before Zelnorm was used in the first place? Reports or problem have been coming in from 2002 and as early as 2004, some patients has adverse events led to hospitalization, surgery, and even death.
According to the FDA, Zelnorm is a medicine used for the short-term treatment of women who have irritable bowel syndrome (IBS) with constipation (hard stools or difficulty passing stools) as their main bowel problem.
Before the recent recall, changes were made to the Zelnorm label. Did they warn of these heart attacks?
No. The prior change to the Zelnorm label included a new warning about diarrhea and other forms of intestinal ischemia.
Could the FDA have taken Zelnorm off the market sooner?
Yes. But in 2004, when they had the chance to do so, the FDA did not think of taking Zelnorm off the market. They only added information about potential risks, and even then they did not warn of the heart attack risk.
Could the FDA have restricted the use/marketing of Zelnorm like they did Lotronex?
Yes. But the FDA did not request any restrictions on the marketing or distribution of Zelnorm until the recent discontinuance. While the FDA said it would continue to carefully evaluate post-marketing reports in patients receiving Zelnorm, it is not clear why it took 3 more years for the drug to be pulled from marketing. We intend to file a Freedom of Information Act request on Zelnorm to get to the bottom of the FDA thinking on waiting until 2007 to request that marketing cease for Zelnorm.
Did the FDA call for more studies by Novartis? It is not clear. It seems that what the FDA decided to do was gather safety information about Zelnorm by only asking that doctors and patients report cases of suspected adverse effects from Zelnorm to FDA's MedWatch Program at: www.fda.gov/medwatch and click on "How to Report" or by calling 1-800-FDA-1088.
What happened to cause the FDA to finally ask Novartis to pull Zelnorm off the market? What is known now? When was it first known? When was it first knowable?
The FDA says that its request was based on newly available information. It does not say that the information was new, but that the availability was new. What has been "made available" is that there is an increased risk of serious cardiovascular adverse events, including myocardial infarction (heart attack), unstable angina (chest pain), and stroke, associated with use of the drug Zelnorm. It could be new information to the FDA, but when were signs of this first known by Novarts?
February 22, 2007, Novartis told the FDA of an increased cardiovascular risk detected in a pooled analysis of 29 short-term (e.g., 1-3 months), randomized, controlled clinical trials involving over 18,000 patients. SO it did not take long to figure this out: 1-3 month studies.
The pooled analysis demonstrated a higher risk of serious cardiovascular adverse events (e.g., angina, heart attacks, and strokes) associated with use of Zelnorm compared to placebo treatment. While the overall number of serious cardiovascular adverse events reported was small, patients treated with Zelnorm were more likely to have these adverse events than patients treated with placebo. The pooled analysis included over 11,600 patients treated with Zelnorm and over 7,000 patients treated with placebo. There were 13 Zelnorm-treated patients (or 0.1%) with confirmed cardiovascular ischemic events, and only 1 placebo-treated patient (or 0.01%) with an event. FDA has concluded, based on these data, that the benefits of this drug no longer outweigh the risks. After completing its review of these data, FDA asked Novartis on March 28, 2007, to discontinue marketing of Zelnorm.
How can I report a serious side effect with Zelnorm to FDA?
FDA encourages anyone aware of a serious adverse reaction, including consumers, to make a Med Watch report.
You can report an adverse event in two ways:
Visit www.fda.gov/medwatch and click on "How to Report" Or Call 1-800-FDA-1088
Who manufactures Zelnorm?
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ 07936-1080
Where can I get more information relating to the discontinuation of Zelnorm? The FDA has information on the above as follows: Zelnorm QA 2007 and Zelnorm QA.
About the Author Michael Monheit, Esq. is an attorney with the Philadelphia based lawfirm of Anapol Schwartz. The firm is actively investigating Zelnorm heart attack and stroke lawsuits.
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