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The FDA’s Lax Generic Drug Rules Can Put Patients’ Lives at Risk (truthout.org)

submitted 3 months ago by tonytins@pawb.social to c/news@lemmy.world

2 comments fedilink hide all child comments

Wrapped in a flashy fur coat she’d found at a thrift store for the occasion, Hannah Goetz blew out the candles on her favorite red velvet cheesecake. It was her 21st birthday. The celebration with her family that evening in February 2023 was a milestone not just for her age, but because she was alive.

Three and a half years before, her lungs had collapsed from cystic fibrosis. She was saved by a double-lung transplant that had been allowing her to breathe deeply. Hannah had slowly worked her way back to stable health, overcoming infections and, every day, taking a crucial medication to protect her donated lungs from rejection. Her doctors were optimistic.

Hannah had been feeling well enough to sing karaoke, work as a nanny while taking college classes and begin her first adult relationship, with a Navy sailor. Her 21st birthday gift from her mom was a trip to Nashville, Tennessee, where the two of them and their friends could explore the city’s music scene and cavort in its bars.

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[–] FirstCircle@lemmy.ml 5 points 3 months ago (1 children)

Almost from the beginning, some transplant doctors had raised concerns that patients on Dr. Reddy’s tacrolimus were faring worse than those on other generics. The Cleveland Clinic was so alarmed that it banned Dr. Reddy’s generic for its transplant patients in 2013. Later, at the Tulane Transplant Institute, doctors found that patients taking generic tacrolimus by any drugmaker had a higher chance of organ rejection, and the hospital decided to use only the brand drug.

Holly knew none of this when she picked up her daughter’s tacrolimus at the local Kroger grocery store after Hannah’s discharge in the fall of 2019. (Kroger didn’t respond to requests for comment.) Unlike with Hannah’s medical care, where Holly could research and choose a doctor or hospital, the brand of generic tacrolimus Hannah received was out of her hands. She would get whichever one that pharmacy happened to have in stock.

Inova’s transplant team had typed, in the electronic prescription that it sent to Kroger, “do not dispense Dr. Reddy.” But that’s what Hannah received.

[–] thesohoriots@lemmy.world 5 points 2 months ago

Always check the label before you leave the pharmacy. I do that with one I only get from Northstar. There have been a few times the pharmacy blew past the order, and I make sure to take it out at the counter in case I need to send it back (they won’t take it back otherwise).