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☆ N.Y. Attorney General Urges Stricter Warnings for Asthma Drug
▼ + stars: | 2024-02-22 | by ( Christina Jewett | Benjamin Mueller | ) www.nytimes.com time to read: +1 min

The New York attorney general on Thursday urged the Food and Drug Administration to “take immediate action” and renew alerts to doctors and patients about the dangerous effects of Singulair for children, saying that the current warnings about the drug’s psychiatric side effects were not sufficient. In a letter, the attorney general, Letitia James, also called on the federal agency to consider discouraging the prescription of Singulair, an asthma and allergy drug, to children. Thousands of patients and parents have complained to the F.D.A. about symptoms of anxiety, rage, hallucinations and other psychiatric problems that they linked to the drug, which is also known in its generic form as montelukast. in 2020 to order its most stringent warning on instructions for the drug’s usage.

Persons: Letitia James Organizations: New, Food and Drug Administration, New York Times Locations: New York

Accounts of suicidal thoughts linked to this class of drugs are drawing increasing scrutiny, including an investigation by European regulators announced in July. More than half of the narrative summaries describe suicidal thoughts appearing shortly after the person started the medicine or increased the dose. Wegovy’s U.S. prescribing label, produced with FDA approval, says suicidal thoughts or attempts have been reported in clinical trials for other weight-loss medicines. Sanofi's Acomplia, which never won U.S. approval, was withdrawn in Europe in 2008 after being linked to suicidal thoughts. She said she has not experienced any suicidal thoughts on that drug.

Persons: Dawn Heidlebaugh, Megan Jelinger, ”, Heidlebaugh, Eli Lilly, Thomas J, Moore, aren't, It’s, Novo, Dr, Erick Turner, Turner, Novo’s, drugmakers, Sanofi's, Sanofi, Contrave, John Amos, Lilly, Reuters weren’t, Lisa Wood, ” Wood, Sarah Sobol, you’re, Sobol, ’ ” Katherine, Jayson Chesnutt, Chesnutt, Robin Respaut, Chad Terhune, Maggie Fick, Ludwig Burger, Michele Gershberg, Brian Thevenot Organizations: REUTERS, Novo, U.S . Food, Drug Administration, Reuters, FDA, Johns Hopkins Bloomberg School of Public Health, Oregon Health & Science University, Novo Nordisk, U.S ., European Union, European Medicines Agency, U.S, Currax Pharmaceuticals, Vivus, Facebook, Thomson Locations: Findlay , Ohio, U.S, Ohio, Novo, Canada, Europe, Carolina, Buffalo , New York, North Carolina, Indiana

☆ A son died, his parents tried to sue. How U.S. courts protect Big Pharma
▼ + stars: | 2023-06-26 | by ( ) www.reuters.com time to read: +26 min

His parents soon started exploring a lawsuit against Merck, the developer of the blockbuster asthma and allergy drug, Singulair, along with the manufacturer of the generic version their son took. That meant Merck had written the warning label, with federal approval, on the generic version of Singulair that Nicholas England took. But his parents couldn’t sue Merck, either, because their son had never taken its name-brand version of Singulair. The generic drug manufacturer that made the pills England took, Teva Pharmaceuticals, did not respond to inquiries. Since Merck’s patent on Singulair expired in 2012, major generic drug manufacturers have sold millions of prescriptions under the drug’s scientific name, montelukast.

Persons: Nicholas England, Nicholas, Merck, ”, Jennifer England, Nicholas’s, ” Merck, Organon, “, George W, Bush, Daniel Troy, Troy, Medtronic, Nicholas England’s, Adam Zimmerman, ” Zimmerman, Jay Lefkowitz, Ellis, shouldn’t, Bayer, drugmaker Wyeth, Phenegran, Jan Gilpin’s, mumbling, ” Gilpin, ” “, hadn’t, Singulair, Gilpin, Stephane Bissonnette, suicidality, Dr, Judith Kramer, Duke, Robert England, Robert said, Kim Beck Organizations: Merck, U.S, Teva Pharmaceuticals, Reuters, U.S . Food, Drug Administration, FDA, Big, Corporate America, Corporations, Administration, ”, New, University of Southern California’s Gould School of Law, Norfolk, Union Pacific, Federal Railroad Safety, Pacific, GlaxoSmithKline, Monsanto, Bayer, Parent Locations: Virginia, England, U.S, New York, Kirkland, East Palestine , Ohio, Louisiana, Atlanta, Vermont, Wise , Virginia, Wisconsin

[1/6] Jan Gilpin poses with a bottle of the asthma and allergy drug Singulair, first prescribed to her son when he was three-years-old, at her home in Newton, Massachusetts, U.S., June 21, 2023. That team found in 2015 that the drug’s distribution into the brain was more significant than its label described. Lawsuits filed against Merck cite this 1996 patent as evidence of Merck’s knowledge of the drug’s potential brain impacts. Marschallinger and her colleagues in Austria came away with a different finding when they reviewed Merck’s original research and did some of their own. Marschallinger said it would have been logical for the FDA to require Merck to investigate the brain impacts more thoroughly once reports of mental-health problems emerged.

Persons: Jan Gilpin, Singulair, Brian Snyder, Merck, Julia Marschallinger, Marschallinger, ” Marschallinger, “ It’s, Robin Respaut, Dan Levine, Janet Roberts, Brian Thevenot Organizations: REUTERS, Brian Snyder Companies Merck, Co, FDA, Molecular Regenerative, Singulair, Merck, Thomson Locations: Newton , Massachusetts, U.S, Austria

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