STAT+: Pharmalittle: We’re reading about Sanofi’s Olympics bet, Singulair problems, and more

Good morning, everyone, and how are you today? We are doing just fine, thank you. Given that this is already the middle of the week and we have survived this far, no reason not to continue, yes? Just consider the alternatives. In fact, this modest accomplishment calls for celebration. So please join us in quaffing a ritual cup of needed stimulation. Our choice today is coconut rum. Or grab a bottle of water, if you prefer. Meanwhile, here are a few items of interest to help you along. Once again, we hope you have a successful day and, of course, keep in touch. We enjoy hearing your tips and tidbits. …

In 2020, the U.S. Food and Drug Administration responded to decades of escalating concerns about Singulair, a widely prescribed drug for asthma and allergies, by adding a stark warning on the labeling that it could cause aggression, agitation and even suicidal thought. But that barely dented use: The drug was still prescribed to 12 million people in the U.S. in 2022, The New York Times writes. The episode illustrates systemic gaps in the FDA approach to addressing troubling side effects from drugs approved long ago, and to warning the public and doctors when serious issues arise. The FDA flagged the warning to physician groups, but had not required doctors be educated about the side effects.

Bayer disclosed encouraging results in two Phase 3 trials for its menopause drug candidate, elinzanetant, meant to treat hot flashes, STAT notes. The results follow the recent market launch of Veozah, Astellas Pharma’s groundbreaking non-hormonal treatment for hot flashes, which was approved by the FDA last spring and received approval in the U.K. in December. The news of another potential drug to treat menopause is more evidence of a growing trend, according to Kelly Casperson, an urologist and menopause specialist. “Menopause is turning into big business,” she says.

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