Concerns About Potential Cardiovascular Safety Signal As Well As Suicidal Ideation And Behavior Were Involved With Zelnorm Recall
In October 2018 we wrote this article, “Waiting To See Whether FDA Approves Zelnorm In 2018 After Zelnorm Was Withdrawn In 2007 For Safety Reasons”, in which we asked this question: Despite a possible benefit to some limited patient population, is allowing Zelnorm back on the market really warranted in view of the serious and still-lingering drug safety concerns?
While we had to wait until April 2019 to get the answer, it turned out our FDA thinks the answer should be “Yes”, and so it is.
For some details about Zelnorm being allowed back on the US market 12 years after there was an FDA-mandated Zelnorm recall, we turn to this April 2, 2019 Medscape article, “FDA OKs Reintroduction of Tegaserod (Zelnorm) for IBS-C in Women Under 65”.
[Zelnorm (tegaserod)] for [irritable bowel syndrome with constipation (IBS-C)] has had a checkered past. The drug was first approved by the FDA in 2002 for the short-term treatment of women with IBS-C. It was suspended from the US market in March 2007 due to potential cardiovascular (CV) safety concerns.
In July 2007, the FDA announced that it would allow restricted use of the drug for IBS-C and chronic idiopathic constipation in women younger than 55 years with no history of heart problems.
Last October, following a safety review, the FDA's Gastrointestinal Drugs Advisory Committee (GIDAC) recommended overwhelmingly (11 yes, 1 no) to recommend reintroducing tegaserod for IBS-C in women without a history of CV ischemic disease and who have no more than one risk factor for CV disease.
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From this April 3, 2019 Healio article, "FDA approves reintroduction of Zelnorm for IBS-C in certain women", we get this significant point:
Sloan Pharmaceuticals [(the responsible drug company)], a subsidiary of U.S. WorldMeds, acknowledged in [a press release] that there remains an increased risk for cardiac events, including myocardial infarction and stroke, when using [Zelnorm (tegaserod)].
For more background on this recent development, you can read our above-referenced October 2018 article about whether the FDA should allow Zelnorm back on the market and whether this would be a good idea as regards the matter of drug safety.
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