ONE of the functions of the United States Food and Drug Administration (FDA) is to monitor and evaluate drugs for efficacy, quality, and safety. Whenever it discovers impurities or contamination, it notifies the manufacturer and recall of the product is expected or imposed. Usually, the pharmaceutical company affected initiates the voluntary recall.
Lately, the popular anti-diabetesT2 pill, Metformin 500 mg Extended Release version of the tablets from some manufacturers (not all), has been found to contain the impurity N-nitrosodimethylamine (NDMA), a carcinogen (cancer producing substance) above the acceptable intake level. The regular immediate acting variety of Metformin is not affected by this recall. This generic Metformin comes in various brand names (Glucophage, Glucophage XR, Fortamet, and Glumetza). The basic active ingredient in Metformin is fine; it is the contaminant, NDMA, that is the impurity which must be eliminated, or, at least, reduced to an acceptable safe level by the manufacturer.
Is my Metformin part of the recall?
To find out if the Metformin Extended Release you are taking is part of the recall, go to the FDA website and check on Drug Recalls. So far, the subject of the recalls are Apotex Corp, Amneal Pharma, and four other yet unnamed firms, which are the producers of the contaminated Extended Release version of Metformin. The Tagi Pharma, which is Costco’s supplier of Metformin ER in Las Vegas, has not been implicated in the recall at this time. When FDA informs the drug stores a certain drug is under recall, the pharmacists automatically call the patient-customers. Recalls usually do not result in drug supply shortage.
What is the risk for Metformin users?
FDA states it “does not expect nitrosamines to cause harm when ingested at or below the acceptable intake limit levels (such low levels of nitrosamines are present in foods in low levels and ingested as part of usual diets) even over a long period of time (such as a 70-year lifespan). Nitrosamine impurities may increase the risk of cancer if people are exposed to them at above acceptable levels over long periods of time, but we do not anticipate that shorter term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer. We are working to ensure medicines on the U.S. market do not exceed the acceptable intake limit.”
What to do if your Metformin ER is recalled?
When your Metformin Extended Release is part of the recall, contact your physician who would deal with your new prescription. In the meantime, while waiting for your physician’s advice, the FDA recommends not to stop the Metformin you are taking until the replacement prescription has been filled. The recalled tablets may be returned to the pharmacist when getting your new medication.
How long has this contamination been?
The FDA does not have science-based information as to how long this NDMA impurities have been in the Metformin Extended Release tablets, but it started its investigation in December 2019 and found Singapore, among other countries, was a source of the supply of the NDMA contaminated Metformin Extended Release sold in the USA.
What is FDA’s new mandate?
The FDA “is also asking all manufacturers of extended release versions of metformin to evaluate their risk of excessive NDMA and to test at-risk product before each batch is released onto the U.S. market. If testing shows NDMA above the acceptable intake limit, the manufacturer must inform the agency and should not release the batch to the U.S. market.”
Zantac is also tainted
The popular OTC stomach acid reducer Zantac (Ranitidine) has also been recalled. The FDA 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 the contaminant 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 temperature, 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.”
Blood pressure pill recall
The FDA has advised the public about its ongoing investigation about the recent voluntary recalls of various generic angiotensin II receptor blocker (ARB) drugs used for high blood pressure and heart failure. According to the US-FDA “Hetero Labs Ltd. in India has announced a recall of 87 lots of losartan potassium tablets (25 mg, 50 mg and 100 mg). The recalled losartan potassium tablets made by Hetero Labs and distributed by Camber Pharmaceuticals contain the impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The impurity is a known animal and potential human carcinogen. This is the first ARB recall resulting from the presence of NMBA, which is the third type of nitrosamine impurity detected in ARB medicines. Recent testing of these recalled lots of losartan potassium tablets showed NMBA levels higher than the FDA’s interim acceptable intake limits. The FDA’s evaluation suggests that the nitrosamines found in ARBs may be generated when specific chemicals and reaction conditions are present in the manufacturing process of the drug’s Active Pharmaceutical Ingredient (API), and may also result from the reuse of materials, such as solvents.”
Not all manufacturers of Losartan Potassium are subject of this recall, and not all generic or brand name Losartan are contaminated. To find out if the ARB you are taking is part of the recall, contact your pharmacist.
Other recalled items
Some of the other tainted common products recalled by the US-FDA include: various homeopathic products, Cannabidol CBD Complex, Curcumin Complex, Cannabidol Plus Curcumin, Watermelon CBD oil, Active Male capsules, male enhancement capsules, Bull Platinum 30,000 sex pills, Finasteride Plus 1.25mg capsules, Tertracycline Hydrochloride 250 and 500mg, Alka Seltzer Plus, Ketorolac, and 95% Ethyl Alcohol by Lake Michigan Distilling company.
Some of the 2020 food recalls include contaminated Conagra Brands Frozen Not-Ready-To-Eat Chicken and Turkey Bowl products, Evans Food Group Ready-To-Eat Pork skin products, Nestle Prepared Foods Lean Cuisine Fettuccini Alfredo, Ideal Foods Meat and Poultry Flatbread Pizza, Amity Packing Products RAW GROUND Beef. Google for other recalls.
Giant medical device maker Medtronic has recalled the auto-registration feature of their StealthStation Deep Brain Stimulation Software (brain neurostimulator pacemaker – used for Parkinson’s, essential tremors, dystonia) due to inaccuracies which could be serious or life-threatening to the patient.
Indeed, the US-FDA, like the Philippine BFAD (renamed FDA in 2009), has the duty and responsibility to protect the nation and the people by constantly monitoring the quality and safety of consumer items in the market and advising the public accordingly in a timely fashion to safeguard and maintain the good health of the people.
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Philip S. Chua, MD, FACS, FPCS, a Cardiac Surgeon Emeritus based in Northwest Indiana and Las Vegas, Nevada, is an international medical lecturer/author, a Health Public Advocate, and Chairman of the Filipino United Network-USA, a 501(c)3 humanitarian foundation in the United States. Websites: philipSchua.com and FUN8888.com; Email: [email protected]