Posts Tagged 'acetaminophen warning'

Don’t Overdo It with Acetaminophen

Renewed Warning on Baby Acetaminophen

The FDA is renewing a warning about the potential for dosing errors with liquid acetaminophen products for infants, which may have been compounded by the recent introduction of a new 160 mg/5 mL strength. Ironically, the new strength and the resulting potential for trouble stems from an effort by the U.S. Food and Drug Administration and outside safety experts to reduce exactly this sort of dosing confusion.

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Liquid Acetaminophen marketed for infants: Drug Safety Communication – Potential for Dosing Errors

The FDA is informing the public that an additional concentration of liquid acetaminophen marketed for “infants” (160 mg/5 mL) is now available. Giving the wrong dose of acetaminophen can cause the medication to be ineffective if too little is given or cause serious side effects and, possibly, death if too much is given. Acetaminophen is marketed under brand names such as Tylenol, Little Fevers,  Triaminic, Infant/Pain Reliever, Pedia Care, Triaminic Infants’ Syrup Fever Reducer Pain Reliever and other store brands (e.g., Rite Aid, CVS, Walgreens brand, etc.).

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FDA panel votes for new Tylenol, acetaminophen dosing rules for children

A Food and Drug Administration advisory panel has voted to recommend new dosing instructions for Tylenol and acetaminophen products for children under two years old. The agency is planning to draft new guidelines for drugmakers on instructions for giving acetaminophen to children in order to decrease the risk of overdose.

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FDA orders lowering pain reliever in Vicodin

Federal health regulators are limiting a key ingredient found in Vicodin, Percocet and other prescription painkillers that have been linked to thousands of cases of liver damage each year. The Food and Drug Administration said Thursday it will cap the amount of acetaminophen in the drugs at 325 milligrams per capsule. Current products on the market contain doses of up to 700 milligrams.

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FDA seeks less acetaminophen in prescription drugs

U.S. health regulators are requesting a limit on the amount of acetaminophen in prescription pain medicines in an effort to curb the risk of liver damage. The move announced on on Thursday aims to limit combination drugs such as the opioids Percocet and Vicodin to 325 milligrams of acetaminophen per pill and calls for them to carry a “black box” warning about potential liver failure.

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J&J Is Admonished About Tylenol Recall

The U.S. Food and Drug Administration said a Johnson & Johnson unit should have acted sooner to recall Tylenol and other products after receiving consumer complaints about moldy or mildew-like smells. Agency officials said Friday the company first became aware of a problem in September 2008, but didn’t conduct a full investigation and report the problem to the agency until September 2009.

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FDA: JNJ Unit Failed To Test Tylenol For Contaminants

A Johnson & Johnson unit failed to test whether its pain reliever Tylenol was chemically contaminated despite receiving a heightened number of consumer complaints in 2008 that the pills smelled musty, according to a report by U.S. Food and Drug Administration inspectors. In 2008, J&J’s McNeil Consumer Healthcare received more than 70 musty odor complaints for Tylenol Arthritis Caplets. However, the company didn’t conduct a formal investigation at the time even though more than eight of the complaints suggested the pills caused gastrointestinal problems in patients, the FDA report says.

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FDA panel calls for new regulations of acetaminophen

A Food and Drug Administration advisory committee has recommended new restrictions on acetaminophen and other drugs, citing an increased risk of liver failure and death. Acetaminophen is found in many over-the-counter pain relievers, including Tylenol and Excedrin, as well as prescription pain relievers such as hydrocodone, Vicodin, Percocet and Darvocet.

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Video: Don’t Overdo It with Acetaminophen

Over-the-counter pain relievers are effective for treating minor aches and pains. But they’re only safe if you follow the directions. That’s particularly important with acetaminophen. Acetaminophen is generally safe at recommended doses, but if you take more than that, even just a little more, it can cause serious, even fatal liver damage.

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