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Prescription and over-the-counter (OTC) non-aspirin NSAID Drug Facts labels will soon contain updated information regarding heart attack and stroke, which can occur within a week of beginning NSAID use.

Food and Drug Administration (FDA) bolstered warnings about the use of non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) and the associated risk of heart attack or stroke.

Acetaminophen has been recommended as an alternative pain reliever, but is not without its own risks and FDA updates.

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In 2010, arthritis accounted for approximately $128 billion in U. expenditures, with 49.9 million adults ≥ 18 years having self-reported, doctor-diagnosed arthritis.

The FDA Arthritis Advisory and Drug Safety and Risk Management Committees met in February 2010 to discuss NSAID cardiovascular safety, and review literature published since 2005.

The maximum daily therapeutic dose of 3900–4000 mg was established in separate actions in 19, respectively, via the Food and Drug Administration (FDA) monograph process for nonprescription medications.

The FDA has conducted multiple advisory committee meetings to evaluate acetaminophen and its safety profile, and has suggested (but not mandated) a reduction in the maximum daily dosage from 3900–4000 mg to 3000–3250 mg.

To market the product, a manufacturer merely needs to comply with the conditions of the monograph, which include parameters such as indications and dosage; no additional pre-market approval is necessary.

Acetaminophen is a classic example of a pharmaceutical that is subject to the nonprescription drug monograph process as found in the ‘Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use’ monograph.[] The monograph specifies that single-ingredient acetaminophen-containing products that contain 325 mg should be administered in a dose of 325–650 mg every 4 hours while symptoms persist, not to exceed 3900 mg in 24 hours for not more than 10 days (approved July 8, 1977).

Mc Neil Consumer Healthcare, the Extra-Strength Tylenol® manufacturer, has also updated labeling to include a maximum daily dose of 3000 milligrams.

In response to pediatric overdoses attributed to confusion between acetaminophen concentrated drops and acetaminophen oral liquid, the FDA issued final guidance on OTC pediatric acetaminophen solutions on August 5, 2015, requiring all single-agent products to have a concentration of 160 mg/5 m L with dosing directions provided only in m L.

The most recent advisory committee meeting, which dealt with the issue of adult acetaminophen overdose, was conducted in 2009 and formed the basis for current decisions that are being made by the FDA and industry about how to dose acetaminophen in both nonprescription and prescription products.[]To address the issues surrounding acetaminophen toxicity, the FDA Center for Drug Evaluation and Research (CDER) prepared an internal report that formed the basis for discussion at the 2009 advisory committee meeting.

The committee members were asked to vote upon several recommendations, which included reducing the total daily acetaminophen dose from 4000 mg to 3250 mg, limiting tablet strength to 325 mg/tablet, and switching the 500 mg strength to prescription status.[] As with all advisory committees, the committee was purely ‘advisory’ to the FDA, and its recommendations were not binding to the FDA.

For many patients, however, acetaminophen remains a viable option to aid in the reduction of NSAID use in pain treatment.

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