What exactly is a "black box" warning? Simply put, it's the strongest warning that the U.S. Food and Drug Administration (FDA) can require on a drug's packaging. The FDA requires the black box warning when studies suggest a drug can cause a serious or life-threatening side effect. The text of the warning is set apart from other information in a black box, so that doctors, pharmacists, and patients can easily see it. What did the FDA advisory panel recommend? The FDA itself hasn't made a decision about acetaminophen, but an FDA advisory panel has made 10 recommendations concerning the drug. Among those recommendations, the panel voted to remove acetaminophen-containing painkillers such as Vicodin, Tylenol 3, and Percocet from the nation's formularies. It also voted in favor of removing all acetaminophen-containing prescription drugs from the market. But the panel voted to keep over-the-counter (OTC) pills that combine acetaminophen and other ingredients, su...
Yesterday the U.S. Food and Drug Administration announced that it is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 mg (milligrams) in each tablet or capsule. Acetaminophen is probably best known by the brand name Tylenol. Outside the U.S., it is often called paracetamol and on prescriptions it may be labeled as APAP (For example, hydrocodone APAP). The drugs most affected by this action are opioid pain relievers that are combined with acetaminophen like codeine (Tylenol #3), hydrocodone (Vicodin, Lortab) and oxycodone (Percocet). “FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use,” said Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER). “Overdose from prescription combination products containing acetaminop...
Generic Name: ACETAMINOPHEN - INJECTION Pronounced: (a-SEET-a-MIN-oh-fen) Acetaminophen IV Interactions
Drug interactions may change how your medications work or
increase your risk for serious side effects. This document does not contain all
possible drug interactions. Keep a list of all the products you use (including
prescription/nonprescription drugs and herbal products) and share it with your
doctor and pharmacist. Do not start, stop, or change the dosage of any
medicines without your doctor's approval.
Products that may interact with this drug
"blood thinners" (such as warfarin)
Acetaminophen is an ingredient in many nonprescription
products and in some combination prescription medications. Check the labels on
all your medicines (such as pain relievers, fever reducers, or cold products)
because they may also contain acetaminophen. See also maximum daily dose in
Side Effects section.
This medication ma...
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