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posted by martyb on Tuesday April 07 2020, @02:56PM   Printer-friendly
from the ingredients-going-bad-is-enough-to-give-you-heartburn dept.

FDA Requests Removal of All Ranitidine Products (Zantac) from the Market:

EspaƱol

The U.S. Food and Drug Administration today announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.

[...] NDMA is a probable human carcinogen (a substance that could cause cancer). In the summer of 2019, the FDA became aware of independent laboratory testing that found NDMA in ranitidine. Low levels of NDMA are commonly ingested in the diet, for example NDMA is present in foods and in water. These low levels would not be expected to lead to an increase in the risk of cancer. However, sustained higher levels of exposure may increase the risk of cancer in humans. The FDA conducted thorough laboratory tests and found NDMA in ranitidine at low levels. At the time, the agency did not have enough scientific evidence to recommend whether individuals should continue or stop taking ranitidine medicines, and continued its investigation and warned the public in September 2019 of the potential risks and to consider alternative OTC and prescription treatments.

New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers. The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.

With today's announcement, the FDA is sending letters to all manufacturers of ranitidine requesting they withdraw their products from the market. The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products. Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA. To date, the FDA's testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).

In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location but follow the specific disposal instructions in the medication guide or package insert or follow the agency's recommended steps, which include ways to safely dispose of these medications at home.


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  • (Score: 5, Interesting) by Immerman on Tuesday April 07 2020, @05:28PM (12 children)

    by Immerman (3985) on Tuesday April 07 2020, @05:28PM (#980018)

    >Pulling a product people use and need because it *might* contain trace amounts of a subtance that *might* cause cancer?
    There's a whole lot of options for treating heartburn, Zantac isn't some sort of magical cure that people *need*. And the fact that the impurities form after shipping means patients have no way of knowing if the pill they're about to take contains trace amounts, or if it sat around in a hot warehouse long enough that there are now large amounts of NDMA in it.

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  • (Score: 0) by Anonymous Coward on Tuesday April 07 2020, @05:36PM (5 children)

    by Anonymous Coward on Tuesday April 07 2020, @05:36PM (#980023)

    This is true, I used to use Zantac years ago, but my doctor switched me over to Prilosec, I don't remember why exactly, but it had nothing to do with this.

    For short term, tums and the like are often times fine. Prilosec and the like are often times taken daily to allow the stomach lining a chance to regrow. Longer term for patients that have gerd or difficulty keeping stomach acid in their stomach.

    This is just the latest situation which should be leading people to question why we allow our medications to be produced overseas. It's not like we're seeing any discounts as a result. If we're going to pay the highest costs for medications, then we might as well produce them in the US where we can keep a closer eye on what's going on in the manufacturing process and have Americans doing the work.

    • (Score: 2) by Immerman on Tuesday April 07 2020, @05:53PM (4 children)

      by Immerman (3985) on Tuesday April 07 2020, @05:53PM (#980027)

      What does overseas production have to do with anything? This isn't an impurity that was included at the factory, it's one that forms when the drug is stored improperly.

      • (Score: 2) by Rich26189 on Tuesday April 07 2020, @08:10PM (1 child)

        by Rich26189 (1377) on Tuesday April 07 2020, @08:10PM (#980061)

        My first thought was the OP was referring to shipping time via container ship but, they might ship those drugs via air. What a waste of precious cargo space, instead of meds those planes should be loaded with kiwi fruit and such, you know, things we can't grow in appreciable quantities here in the US.

        More generally speaking, why do so many companies want us USasians to buy their products but don't want us to make those products? It's not like we don't (or didn't) have the capability to make these things here.

        My idea is a regressive tax (import duty?) with the intent to spur local production. Anything that'll sell for under, say $100, has a 300% tax/import duty. From $101 - $200, say a 100% tax. $201 - say $500 say, 50% tax. Think of all those items sold at Walmart, *Christmas Tree and your $Dollar stores.

        * Think cheap throw away items like holiday decorations, toys and some home goods. These may only be a thing here in the northeast.

        • (Score: 2) by Immerman on Wednesday April 08 2020, @01:37AM

          by Immerman (3985) on Wednesday April 08 2020, @01:37AM (#980164)

          >why do so many companies want us USasians to buy their products but don't want us to make those products?

          For the exact same reason that we want to buy those products, but most will consistently buy the ones that are 20% cheaper because they're made in a country with far worse worker and/or environmental protections.

          Personally I think a great idea would be a broad import duty on all products not made in a manner consistent with US environmental and labor laws would do the job nicely - raising the price proportionally to the projected cost of compliance with our laws. Seems to me any other option becomes either protectionist, with all the trade-war fun that tends to evoke, or leads us into a race to the bottom, where we export the most damaging effects of unrestrained capitalism, and leave ourselves unable to compete.

      • (Score: 0) by Anonymous Coward on Tuesday April 07 2020, @09:45PM (1 child)

        by Anonymous Coward on Tuesday April 07 2020, @09:45PM (#980090)

        There's an entire supply chain involved with these products from manufacturing the reagents to actually handing over the pill vial to the patient. If anything is done improperly along the way there's the possibility of issues like this. Overseas production facilities don't get watched the same way that domestic ones are.

        The shipping itself can lead to medications being stored under conditions that are not conducive to medicines remaining stable. Not to mention any storage prior to the ship actually leaving port and again when it enters the US and has to clear customs, there's potential lag there as well. This can total up to months.

        • (Score: 0) by Anonymous Coward on Wednesday April 08 2020, @12:17AM

          by Anonymous Coward on Wednesday April 08 2020, @12:17AM (#980146)

          Agree with you, but regarding the shipping, drug companies often use use disposable sensors on every case/pallet that monitor conditions which are then checked and logged before receiving into active inventory stateside. Whether US warehouse workers doing mandatory overtime and making low wages do their job properly is another question. As is actual real world scenarios wrt the storage facility.

  • (Score: 5, Interesting) by stormreaver on Tuesday April 07 2020, @07:23PM (4 children)

    by stormreaver (5101) on Tuesday April 07 2020, @07:23PM (#980046)

    There's a whole lot of options for treating heartburn....

    My all-time favorite is baking soda and water. It cures my heartburn in seconds, and costs a penny (or less) per dose:

    1) Mix half a teaspoon of baking soda with a cup of water.
    2) Stir until the water is clear.
    3) Drink quickly.
    4) Burp when done.

    Heartburn is gone.

    • (Score: 0) by Anonymous Coward on Tuesday April 07 2020, @07:59PM (3 children)

      by Anonymous Coward on Tuesday April 07 2020, @07:59PM (#980056)

      Good for you.
      Your heartburn is very, very mild.

      • (Score: 2) by stormreaver on Tuesday April 07 2020, @08:14PM (2 children)

        by stormreaver (5101) on Tuesday April 07 2020, @08:14PM (#980064)

        If feeling like my heart is going to explode is mild heartburn, then yes, it's very, very mild.

        • (Score: 0) by Anonymous Coward on Tuesday April 07 2020, @08:36PM

          by Anonymous Coward on Tuesday April 07 2020, @08:36PM (#980067)

          I think he may mean that your heartburn sounds infrequent, and it wouldn't be too much of a hassle to mix up some baking soda. Mine is more frequent, and sometimes I may have to eat a chalk tablet every 20 minutes.

          My doctor prescribed a prescription strength PPI, one of those could suppress my GERD for a few days. I didn't want to keep running to get the prescription renewed, and was concerned about long term use of a PPI, so if I expect to have to deal with heartburn, I'll eat an H2-antagonist (famotidine). One of those is good for a day or so.

        • (Score: 0) by Anonymous Coward on Wednesday April 08 2020, @12:21AM

          by Anonymous Coward on Wednesday April 08 2020, @12:21AM (#980152)

          Yes, that is very very mild. The real stuff is much worse, and prevents eating or even drinking liquids entirely, and causes you to actually puke and shit fire all day and night long. And antacids don't work.

  • (Score: 2) by JoeMerchant on Tuesday April 07 2020, @11:33PM

    by JoeMerchant (3937) on Tuesday April 07 2020, @11:33PM (#980125)

    I worked grocery stock for a while, I can tell you: in Florida, in the Summer, that stock roasted in the truck, roasted on the dock, and roasted in the unairconditioned stock room before it got put on the shelf. Warehouse may not hold stock for long, but the simple transit from warehouse to store is an unbelievably hot process.

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