FDA asks manufacturers to pull Zantac products amid cancer concerns
Source: The Hill
The Food and Drug Administration (FDA) on Wednesday said it is requesting the withdrawal of all prescription and over-the-counter ranitidine, a medication sold under the brand name Zantac for treatment of ulcers and acid reflux, over concerns about an impurity that may increase over time above room temperature.
The impurity, N-Nitrosodimethylamine (NDMA), is listed as a probable human carcinogen if ingested in "unacceptable" amounts, although people commonly consume it in lower levels in food and water.
We didn't observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don't know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement.
The agency is sending all ranitidine manufacturers letters requesting they withdraw the products from the market, according to the FDA, and also advising consumers to stop taking the products in tablet and liquid form.
Read more: https://thehill.com/policy/healthcare/490618-fda-asks-manufacturers-to-pull-zantac-products-amid-cancer-concerns
The agency noted that other products cleared for similar usage include famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
woodsprite
(11,913 posts)where the others were ones you needed to get in your system for a few days before they'd actually take effect.
left-of-center2012
(34,195 posts)It takes 3 or 4 days to start working, but I'd be in terrible pain without it.
woodsprite
(11,913 posts)Growing up with GERD, he's been pretty good about watching what he eats and meal timing. The dr. didn't want him on some of the other meds because they can cause bone growth issues in young people.
Marrah_Goodman
(1,586 posts)I had bariatric surgery last summer and have a tiny stomach now, so without it I am miserable.
Sgent
(5,857 posts)Zantec is an H2 antagonist which has a more immediate mode of action -- but there are other H2 antagonists, including famotidine / Pepcid. PPI's (Prilosec, Nexium, Aciphex, etc.) work using a different method and are more for long term use.
If you need to use either of these drugs regularly, especially the longer term ones, you should see your doctor when this is all over. PPI's are very effective but can have some long term effects and should only be taken under the care of a physician.
sinkingfeeling
(51,454 posts)doctor told me to take a 20mg. Prilosec every day for the terrible reflux I had. I did that for over 7 years, and then articles were warning that long term use was bad. So, I switched to Zantac. Took it until news broke that it could cause cancer. Back with my daily Prilosec. Guess I'll be taking it for life.
generalbetrayus
(507 posts)after the news about Zantac came out, and it works just as well for me. My acid reflux is so bad that I have to take 24-hour Nexium in the morning AND Pepcid in the evening.
GeorgiaPeanut
(360 posts)The problem was in one of the intermediary chemicals from China needed to manufacture ranitidine - so all brands of ranitidine were affected.
generalbetrayus
(507 posts)on advice of my gastroenterologist. It seems to work just as well for me. I'm glad the FDA is finally catching up.
GeorgiaPeanut
(360 posts)BlueIdaho
(13,582 posts)And my hiatal hernia. Omeprizole and their ilk have their own set of warnings about prolonged use. Pepcid is a close second - but only works for me if I take it about an hour before I eat. Same is true for Tagamet. If I have a serious fire breathing episode - ranitidine will put the fire out in about 15 - 20 minutes.
Adding something like Tums can help and it doesnt interfere with heavy hitters.
Rebl2
(13,498 posts)pulled that off the shelves last fall.