OTC pain relievers

OTC pain relievers (5)

 

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Hover over each number for an important Fast Fact about acetaminophen related to the featured number.

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iStock heart.medicineNonsteroidal anti-inflammatory drugs (NSAIDs) have been associated with an increased risk of heart attack and stroke (except low-dose aspirin). Over-the-counter NSAIDs include aspirin, naproxen (Aleve, Naprosyn, Anaprox, others), and ibuprofen (Motrin, Advil, Nuprin, others). For people without a history of heart disease, the risk of a heart attack and stoke is doubled when taking most NSAIDs. For those with heart disease, the risk is increased 10-fold. NSAIDs are not recommended for those who have already had a heart attack.

In 2004, the US Food and Drug Administration (FDA) pulled Vioxx (rofecoxib), a prescription NSAID, off the market due to a high risk of heart attack and stroke in those taking the drug. Since then, FDA beefed up the warnings about heart safety risks on all NSAIDs, including OTC NSAIDs (naproxen, ibuprofen).

However, FDA released early in 2014 a review that said naproxen may pose a lower risk of heart attack and stroke than ibuprofen.1 The review was based on the results of a very large study of 350,000 people taking different pain relievers that concluded naproxen does not carry the same heart risks as other NSAIDs. A panel of outside experts has been pulled together by FDA to discuss the study results and recommend whether naproxen should be relabeled to note its lower heart safety risks than other NSAIDs. Although not required, FDA usually follows expert group recommendations.

If that happens, Aleve and other naproxen medicines could become the first choice for people taking an NSAID, particularly those with a higher risk for heart problems. However, NSAIDs will continue to carry warnings about bleeding and ulcers—two other serious side effects.

Reference
1) Aleve (naproxen sodium), Naprosyn (naproxen), & Anaprox (naproxen sodium) briefing document for US Food and Drug Administration Advisory Committee Meeting. Bayer Healthcare LLC, Consumer Care Division, Hoffmann-La Roche Inc. January 10, 2014. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ Drugs/ArthritisAdvisoryCommittee/UCM383181.pdf

 

acetaminophenAcetaminophen, aspirin, and ibuprofen are three common pain relievers available over-the-counter. Aspirin is the oldest, used for practically every ache and pain until the availability of two alternatives, nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen and naproxen) and acetaminophen, which cause less stomach irritation. All three have benefits and uses that make them unique, but the problems with their use are just as diverse. In this section, learn about acetaminophen safety with children, which includes fast facts about the medicine. You will also find information on a national Know Your Dose campaign that stresses the importance of recognizing acetaminophen as an ingredient in more than 600 different prescription and OTC medicines. Another section discusses aspirin and aspirin containing products, which includes a list of safety tips to follow. Also learn more about the heart risks associated with nonsteroidal anti-inflammatory medicines.

Acetaminophen is the most common medicine used for infants and children to treat pain and fever. You may know this medicine as Tylenol, but it is also widely sold under its generic name, acetaminophen. When used as directed, it is safe and effective. But giving your child more than directed is an overdose and can lead to liver damage.

There used to be two strengths of acetaminophen liquid—a higher strength (80 mg per 0.8 mL) of concentrated drops for infants and a lower strength of elixir for children (160 mg per 5 mL). After years of serious mix-ups between these two strengths, companies are now making just the lower strength (160 mg per 5 mL) of acetaminophen. But the older concentrated drops may still be in your medicine cabinet. A dosing error can happen if your child’s doctor gives you directions for using the new lower strength acetaminophen, but you are still using the old higher strength concentrated drops. Acetaminophen overdoses can lead to serious liver damage. To avoid errors, toss out acetaminophen drops in the higher strength (80 mg per 0.8 mL) and use only the new lower acetaminophen strength (160 mg per 5 mL).

Acetaminophen is also available in both OTC and prescription medicines, combined with other ingredients. This includes cough and cold medicines, allergy medicines, and sleep aids. On prescription labels, acetaminophen may be abbreviated as APAP, but it will never be abbreviated and will always say acetaminophen on OTC medicine labels. The “Active Ingredient” section of the Drug Facts label lists the ingredient or ingredients that make the medicine work. Acetaminophen will be listed here, either by itself or with other active ingredients in the product. It may be highlighted. Always check this section to see if your medicine contains acetaminophen.

Use only the dosing device provided with the purchased product in order to correctly measure the right amount of liquid acetaminophen. If your child’s medicine does not come with a measuring device, or if it comes with a dosing cup, ask your pharmacist to recommend an oral syringe to use. For children under 2 years of age, parents and caregivers must consult their healthcare provider for dosing instructions. The Drug Facts label on the packaging does not include dosing instructions for this age group. Your pediatrician can provide you with your child’s age and weight appropriate dose via a phone call or office visit.