In April 2019 we learned that the FDA is allowing Zelnorm back on the market 12 years after there was an FDA-mandated Zelnorm recall. 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 … [Read more...]
Will FDA Allow Zelnorm To Return After 2007 Recall For Safety Reasons?
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 … [Read more...]