Your medicine cabinet is probably full of various pain killers and over-the-counter (OTC) drugs available when you need them, but there may also be hidden dangers lurking. It is important to check your medications in light of the new FDA (Food and Drug Administration) warnings about medications that may put you at risk. In fact, a recent FDA warning mentions one of the most commonly used OTC pain relievers. Read on to see if you have this medication in your cupboard and for more remedies to avoid. If you take this medication, the US authorities have a new warning for you.
The FDA announced on April 2 that AS Medication Solutions, LLM (ASM) is voluntarily recalling nearly 200,000 bottles of 500 milligram tablets of Acetaminophen Extra Strength. The collected medicine came in white plastic bottles of 100 counts and were included in essential health kits distributed to members of Humana, an American health insurer. These kits also include a bottle of hand sanitizer, a reusable face mask, a bag of cough drops, a digital thermometer and 50 disposable gloves. And for more paracetamol dangers, if you’re taking Tylenol with it, your liver will be in danger, experts say.
According to the FDA, these bottles are being collected because “they contain an incomplete prescription drug label, instead of the mandatory OTC Drug Facts label.” The drugs, which were probably distributed across the country between January 14 and March 15, have only a short Rx drug label on the outside of the bottle, which “does not contain the complete OTC Drug Facts table” from according to the recall announcement. The FDA says that OTC drugs that must follow the Drug Facts label should include the following information: the product’s active ingredients, including the amount in each dosage unit; the purpose of the product; the uses (indications) of the product; specific warnings, including when the product should not be used under any circumstances and when it is appropriate to consult a doctor or pharmacist; dosing instructions; and the inactive ingredients of the product. And for more useful information delivered straight to your inbox, sign up for our daily newsletter.
Without an appropriate warning label, this OTC medicine can be misused in a harmful way. For example, if consumers take more than the recommended dose of paracetamol (which should be included on the label), they may be at risk of liver damage. The FDA also notes that consumers need to be aware if they are allergic to an active ingredient in this drug, which would also be listed on a complete label. According to the FDA, ASM has not yet “received any reports of adverse events related to this recall”. And for more FDA warnings, if you have these supplements at home, the FDA says “destroy them”.
The FDA claims that ASM is notifying its distributors and customers by mail and arranging for all returned products to be returned. If you have this product, ASM is asking you to “stop using it and return it in pre-addressed mail that will be provided by ASM or distributors”. If you have any questions, please contact ASM customer service and if you have any problems that you believe are the result of using this collected medication, you should speak to your doctor or health care professional. The FDA is also requesting that any “adverse reactions or quality problems experienced with the use of this product” be reported to the FDA’s MedWatch Adverse Event Reporting program. And for more concerns about OTC medications, if you are taking this OTC medication more than twice a week, consult a doctor.