#f.d.a

#F.D.A. Halts U.S. Sales of Pelvic Mesh, Citing Safety Concerns for Women - The New York Times
▻https://www.nytimes.com/2019/04/16/health/vaginal-pelvic-mesh-fda.html

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It is the most stringent action the F.D.A. has taken in the lengthy legal and medical battles over vaginal mesh, a synthetic product that has been implanted in millions of women to strengthen weakened pelvic muscles that can cause the bladder, the uterus and other organs to sag into the vaginal area.

The agency issued the decision against the two companies, Boston Scientific and Coloplast, at a time when multimillion-dollar verdicts against manufacturers of the devices continue to be awarded or upheld on appeal.

Litigation over pelvic mesh, also called transvaginal mesh, ranks as one of the largest mass tort cases in the nation’s history in terms of claims filed, number of corporate defendants and settlement dollars. Seven medical device manufacturers, including Boston Scientific and Johnson & Johnson, are paying nearly $8 billion to resolve the claims of more than 100,000 women.

#F.D.A. Did Not Intervene to Curb Risky #Fentanyl Prescriptions - The New York Times
▻https://www.nytimes.com/2018/08/02/health/fda-fentanyl-opioid-epidemic-overdose-cancer.html

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A fast-acting class of fentanyl drugs approved only for #cancer patients with high opioid tolerance has been prescribed frequently to patients with back pain and #migraines, putting them at high risk of accidental overdose and death, according to documents collected by the Food and Drug Administration.

[...]

About 5,000 pages of documents, obtained by researchers at Johns Hopkins University through the Freedom of Information Act and provided to The New York Times, show that the F.D.A. had data showing that so-called off-label prescribing was widespread. But officials did little to intervene.

#complicité #santé #opioides #opiacés

Caffeine Powder Poses Deadly Risks
By MURRAY CARPENTER MAY 18, 2015
▻http://well.blogs.nytimes.com/2015/05/18/caffeine-powder-poses-deadly-risks-2

Sold as a dietary supplement, caffeine powder is virtually unregulated and widely available from online vendors, and in some stores, often marketed alongside vitamins and protein powders to fitness buffs who blend their own supplements. The packages typically include warning labels, but these are voluntary.

In its pure form, caffeine is quite powerful. A teaspoon of caffeine powder is roughly equal to 16 to 25 cups of coffee. Ten grams, about a tablespoon, is a lethal dose for an adult. A 100-gram package — as much caffeine as 400 “tall” cups of Starbucks coffee, 1,250 Red Bulls, or 3,000 cans of Coke — costs about $10.

[...]

Though the federal government has not restricted the sale of powdered caffeine, Jennifer Corbett Dooren, a spokeswoman for the #F.D.A., said the agency “will consider taking regulatory action, as appropriate, to protect consumers.”

Kate Stiner said she could not understand the F.D.A.’s inaction. “I’m frustrated because it seems to be cut and dried to me,” she said. “And I don’t know why the delays, and I don’t know why people would even fight about it. I’m not saying ban coffee.”

#FDA #caféine