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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: 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.