We start with this drug safety question: Despite a possible benefit to some limited patient population, is allowing IBS drug Zelnorm back on the market really warranted in view of the potential cardiovascular safety signal, with suicidal ideation and behavior being another issue?
For where things seemed to stand at the conclusion of an October 2018 FDA Advisory Committee meeting about Zelnorm, we get the following form a Medscape news report, “”FDA Panel OKs Tegaserod for IBS With Constipation in Women With Low CV Risk”:
“Given the potential for reintroduction of [Zelnorm] in various subpopulations of interest, elucidating the benefits and risks in the presence of a potential [cardiovascular (CV) as well as suicidal ideation and behavior (SI/B)] safety signal is of particular clinical importance, as patients with IBS-C may have need for additional treatment options but may also be at risk of [adverse events (AEs),” the FDA explains in its briefing document.
“I do think that the CV signal is real, but I think the magnitude of the signal is small,” said temporary voting committee member John Teerlink, MD, professor of medicine, University of California San Francisco; director, Heart Failure, and director, Echocardiography, Section of Cardiology, San Francisco Veterans Affairs Medical Center, California.
On October 17, 2018 the FDA’s Gastrointestinal Drugs Advisory Committee of the US Food and Drug Administration (FDA) voted to recommend that Zelnorm (tegaserod maleate) be approved for the treatment of irritable bowel syndrome with constipation (IBS-C) in women.
We point out that the FDA is not obliged to follow recommendations of its advisory committees but it usually does.
So now we wait to see whether Zelnorm is allowed back on the US market 11 years after the FDA mandated a Zelnorm recall for safety reasons.[Read article in full at original source]