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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:

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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: 2) by Runaway1956 on Tuesday April 07 2020, @03:13PM (1 child)

    by Runaway1956 (2926) Subscriber Badge on Tuesday April 07 2020, @03:13PM (#979971) Journal

    Doc always asks about allergies. Work, pain, needles, anything with a "z" in the brand name . . . which is one reason I don't ride a Suzuki.

    • (Score: 5, Funny) by crafoo on Tuesday April 07 2020, @05:05PM

      by crafoo (6639) on Tuesday April 07 2020, @05:05PM (#980010)

      Just do what I do and pronounce it, "0.998 liter Sooky Gixxer peepants machine". My hands get sweaty just thinking about my old ride to work and back.

  • (Score: 0) by Anonymous Coward on Tuesday April 07 2020, @03:15PM

    by Anonymous Coward on Tuesday April 07 2020, @03:15PM (#979972)

    You're supposed to cure heartburn, not kill people. If you want to kill people, go work for Purdue.

  • (Score: 2, Redundant) by exaeta on Tuesday April 07 2020, @03:51PM (23 children)

    by exaeta (6957) on Tuesday April 07 2020, @03:51PM (#979983) Homepage Journal
    All this over trace amounts of carcinogens? Pulling a product people use and need because it *might* contain trace amounts of a subtance that *might* cause cancer? Let me remind you NDMA is not even a prove carcinogen, unlike, e.g. bacon which has been proven to cause cancer. Just slap a warning label on it and leave it at that. Maybe continue to study the drug and see if these trace amounts actually promote cancer, but this knee jerk reaction is harming real people.
    --
    The Government is a Bird
    • (Score: 4, Informative) by JoeMerchant on Tuesday April 07 2020, @04:43PM

      by JoeMerchant (3937) on Tuesday April 07 2020, @04:43PM (#980003)

      This looks like an ongoing pissing contest, they tried the "informed consent" thing earlier, but I'm guessing the company has done jack-all to address the problem so FDA is flexing on them to get them to take it seriously.

      --
      🌻🌻 [google.com]
    • (Score: 0) by Anonymous Coward on Tuesday April 07 2020, @05:13PM (6 children)

      by Anonymous Coward on Tuesday April 07 2020, @05:13PM (#980014)

      All this over trace amounts of carcinogens? Pulling a product people use and need because it *might* contain trace amounts of a subtance that *might* cause cancer?

      You *might* have noticed that many of us are under house arrest at this moment, because there is a virus that *might* be hazardous to boomers.

      • (Score: 4, Informative) by Anonymous Coward on Tuesday April 07 2020, @05:21PM (4 children)

        by Anonymous Coward on Tuesday April 07 2020, @05:21PM (#980015)

        Right now, about 40% of the hospitalizations are for people aged 20 to 40.

        That Spring Break thinking about it being an old person's problem is not correct.

        • (Score: 0) by Anonymous Coward on Tuesday April 07 2020, @08:08PM (3 children)

          by Anonymous Coward on Tuesday April 07 2020, @08:08PM (#980059)

          Cite?

          • (Score: 3, Informative) by kazzie on Tuesday April 07 2020, @08:42PM (2 children)

            by kazzie (5309) Subscriber Badge on Tuesday April 07 2020, @08:42PM (#980068)

            Not the AC, but this article [cnn.com] (first result in my ddg search) claims it's nearer 20% for the USA.

            • (Score: 0) by Anonymous Coward on Tuesday April 07 2020, @10:14PM (1 child)

              by Anonymous Coward on Tuesday April 07 2020, @10:14PM (#980098)

              CNN is not a reliable source. They are in the business of stoking panic for political goals.

              There's also the disconnects in data between total infections, noticeably ill patients, the proportion of those that get tested and whom the hospital decides to treat.

              I consider the CDC authoritative, here is one of their statements:

              As of March 16, a total of 4,226 COVID-19 cases had been reported in the United States, with reports increasing to 500 or more cases per day beginning March 14 (Figure 1). Among 2,449 patients with known age, 6% were aged ≥85, 25% were aged 65–84 years, 18% each were aged 55–64 years and 45–54 years, and 29% were aged 20–44 years (Figure 2). Only 5% of cases occurred in persons aged 0–19 years.

              Among 508 (12%) patients known to have been hospitalized, 9% were aged ≥85 years, start highlight36%end highlight were aged 65–84 years, 17% were aged 55–64 years, 18% were 45–54 years, and 20% were aged 20–44 years. Less than 1% of hospitalizations were among persons aged ≤19 years (Figure 2). The percentage of persons hospitalized increased with age, from 2%–3% among persons aged start highlight≤19end highlight years, to ≥31% among adults aged ≥85 years. (Table).

              Among 121 patients known to have been admitted to an ICU, 7% of cases were reported among adults ≥85 years, 46% among adults aged 65–84 years, 36% among adults aged 45–64 years, and 12% among adults aged 20–44 years (Figure 2). No ICU admissions were reported among persons aged ≤19 years. Percentages of ICU admissions were lowest among adults aged 20–44 years (2%–4%) and highest among adults aged 75–84 years (11%–31%) (Table).

              Among 44 cases with known outcome, 15 (34%) deaths were reported among adults aged ≥85 years, 20 (46%) among adults aged 65–84 years, and nine (20%) among adults aged 20–64 years. Case-fatality percentages increased with increasing age, from no deaths reported among persons aged ≤19 years to highest percentages (10%–27%) among adults aged ≥85 years (Table) (Figure 2).

              In summary:

              This first preliminary description of outcomes among patients with COVID-19 in the United States indicates that fatality was highest in persons aged ≥85, ranging from 10% to 27%, followed by 3% to 11% among persons aged 65–84 years, 1% to 3% among persons aged 55-64 years,

              Available at https://www.cdc.gov/mmwr/volumes/69/wr/mm6912e2.htm [cdc.gov]

              • (Score: 1, Insightful) by Anonymous Coward on Wednesday April 08 2020, @02:03AM

                by Anonymous Coward on Wednesday April 08 2020, @02:03AM (#980171)

                Right now, about 40% of the hospitalizations are for people aged 20 to 40. That Spring Break thinking about it being an old person's problem is not correct.

                Not the AC, but this article [cnn.com] (first result in my ddg search) claims it's nearer 20% for the USA.

                CNN is not a reliable source. They are in the business of stoking panic for political goals. [...]

                I consider the CDC authoritative, here is one of their statements:

                Did you even read the CNN article before complaining about them so self-righteously? Did you even read the CDC statement you pasted in, all impressed with yourself?

                First of all, the CDC statement you quoted said pretty much exactly what your parent poster said: "Among 508 (12%) patients known to have been hospitalized, [...] 20% were aged 20–44 years."

                Second of all, the CNN article consisted mostly of a summary of that same CDC statement. They linked to it. The article called it a "big part" of hospitalizations, which I guess you could complain about, but it is larger than the narrative that you Trumpfucks have been peddling. The rest of the article was just quoting Dr. Deborah Birx, who is some sort of Trumpian hero.

                But you just had to randomly whine about CNN, didn't you? While not even having any idea what was in the article? That's pretty much all the Trumpfucks seem to do these days. Sob without having the slightest idea what you are talking about, or the slightest desire to know.

      • (Score: 0) by Anonymous Coward on Tuesday April 07 2020, @09:27PM

        by Anonymous Coward on Tuesday April 07 2020, @09:27PM (#980081)

        You *might* have noticed that many of us are under house arrest at this moment, because there is a virus that *might* be hazardous to boomers.

        Poor victim!

    • (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.

      • (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.

        --
        🌻🌻 [google.com]
    • (Score: 0) by Anonymous Coward on Tuesday April 07 2020, @05:31PM

      by Anonymous Coward on Tuesday April 07 2020, @05:31PM (#980021)

      I'm always kind of curious about why they draw the line where they do. This isn't the first medication that I've taken that was pulled. I used to be on a very effective medication for cramping that was subsequently pulled. I'm not entirely sure why it was pulled, but I do know that nothing they offered afterwards worked as quickly, effectively or with as few side effects. But, from what I understand enough other people were having issues that it had to be pulled.

      And yet the one medication that I had a severe reaction to, is still on the market, presumably, the reaction I had wasn't common enough to justify yanking.

      As far as the ranitidine goes, it does work, but there are other things that can be used as well. Depending upon the situation, neutralizing the acid may work, and there are other proton pump inhibitors that are sometimes used. I personally use prilosec on the rare cases where I'm needing tums more than one or two days in a short period.

      But, generally speaking, you're better off trying to figure out why you're having indigestion or gerd and addressing that directly when possible.

  • (Score: 2) by SemperOSS on Tuesday April 07 2020, @04:00PM

    by SemperOSS (5072) on Tuesday April 07 2020, @04:00PM (#979986)

    This is too much. It gives me tummy aches … heartburn. I just   c a n ' t   take it any more!


     

    --
    I don't need a signature to draw attention to myself.
    Maybe I should add a sarcasm warning now and again?
  • (Score: 3, Touché) by All Your Lawn Are Belong To Us on Tuesday April 07 2020, @04:08PM (2 children)

    by All Your Lawn Are Belong To Us (6553) on Tuesday April 07 2020, @04:08PM (#979989) Journal

    … you could be entitled to compensation! Just call 800-4-DA-LOOT!"

    In 5... 4.... 3.... 2.....

    --
    This sig for rent.
    • (Score: 0) by Anonymous Coward on Tuesday April 07 2020, @04:19PM (1 child)

      by Anonymous Coward on Tuesday April 07 2020, @04:19PM (#979995)

      I took it every day from 2005 to 2012. I'm fucked.

      • (Score: 2) by All Your Lawn Are Belong To Us on Monday April 13 2020, @09:42PM

        by All Your Lawn Are Belong To Us (6553) on Monday April 13 2020, @09:42PM (#982244) Journal

        Be the first one to file the class action! You would actually get, not a lawyer cut but, a decent cut of the loot.

        Though you're almost certainly too late now and others would have beaten you to the punch.

        --
        This sig for rent.
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