Pain and Inflammation: The Importance of Proper Use of OTC Analgesics

OTC GuideJune 2010
Volume 14
Issue 1

For many individuals with chronic conditions, pain is a primary symtpom. The National Center for Health Statistics reports that the incidence of pain affects more Americans (76.2 million), compared with diabetes, heart disease, and cancer combined. Pain is classified as acute or chronic, and they are significantly different.

Acute pain results from disease, inflammation, or injury to tissues. Acute pain is confined to a given period of time and severity. Chronic pain persists over a long period of time, however. More than 50 million Americans experience chronic pain, according to the American Pain Foundation (APF). The most common chronic pain syndromes are back pain, headache, and joint pain caused by osteoarthritis. Furthermore, chronic pain negatively impacts patients’ emotional well-being and quality of life. The burden of pain is also costly, with an estimated $100 billion spent annually in the United States on health care expenses, lost income, and lost productivity, states the APF.

Chronic diseases associated with inflammation are also on the rise. For example, the number of patients with physician-diagnosed arthritis is projected to increase from the currently estimated 46 million US adults to 67 million by 2030, according to the APF.

Treatment for Pain and Inflammation

A variety of OTC analgesics are used in the treatment and management of pain and inflammation associated with backache, headache, muscular aches, fever, toothache, menstrual cramps, the common cold, and minor pain of arthritis. The most commonly used oral analgesics to treat these symtpoms are acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs; eg, ibuprofen, aspirin, naproxen, and ketoprofen).

Studies have shown, however, that a majority of patients who use OTC analgesics do not read the product labels, are unaware of the potential risks associated with taking the drugs, and combine these products with other OTC and prescription medicines.

New Labeling Requirements for Analgesics

The proper use of OTC analgesics has come under scrutinty by the FDA. On April 29, 2009, the FDA issued a final ruling that requires manufacturers of OTC pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks (Table). Since 2006, some manufacturers have voluntarily revised their product labeling to highlight these potential safety risks. The voluntary changes to the labeling did not address all of the labeling requirements in the new ruling, however. All OTC manufacturers of NSAID and acetaminophen products had until April of this year to comply with these labeling requirements.

The new labeling is based, in part, on safety data reported in published litertaure on the use of acetaminophen and NSAIDs. Data indicates that individuals sometimes take more acetaminophen than the labeling recommends. Others unknowingly take multiple products containing acetaminophen at the same time. Exceeding the recommended dose may increase the risk of severe liver damage. Individuals who take NSAIDs who are on warfarin therapy or steroids face an increased risk of stomach bleeding. Stomach bleeding risks also increase for individuals who take multiple NSAIDs at the same time or who take them longer than recommended. The revised labeling also applies to all products that contain an NSAID or acetaminophen, even if combined with other active ingredients, such as cold symptom relievers.

The Pharmacist’s Role

As one of the most trusted and accessible health care professionals, pharmacists should counsel patients in the proper selection and use of OTC analgesics (Sidebar). Before recommending any products, pharmacists should:

• Consider the patient’s medical profile and any history of allergies to prevent possible drug—drug interactions and contraindications.

• Check the ingredients of OTC medicines if patients are buying multiple products, and, if duplicate active ingredients are found, make patients aware and recommend alternative products.

• Recommend patients with preexisting medical conditions consult their physician before using any of these products.

• Encourage patients to ask questions if they are unsure of the proper use of OTC pain relievers.


New Labeling Requirements for OTC Pain Relivers and Fever Reducers



“Acetaminophen” must be highlighted or in bold type and in a prominent print size on the PDP

“NSAID” must be highlighted or in bold type and in a prominent print size on the PDP

Liver warning: Severe liver damage may occur if you take more than the maximum daily dose in 24 hours; take with other drugs containing acetaminophen; and consume 3 or more alcoholic drinks daily while using this product

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding if you are over age 60; have had prior ulcers or bleeding; take a blood thinner or steroid drug, take with other drugs containing NSAIDs (prescription and OTC); have 3 or more alcoholic drinks daily while using this product; and take for longer than recommended

If unsure whether a drug contains acetaminophen (prescription or OTC) ask a physician or pharmacist,

Ask a physician before use if you are at an increased risk for stomach bleeding problems

Ask a physician before use if you have liver disease

Stop use and ask a physician if you experience the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, and have stomach pain that does not resolve

Ask a physician or pharmacist before use if you are taking warfarin

PDP = prinicipal display panel.

Source: Federal register. 2009;74(81):19385-19409.

Counseling Tips for Proper Use of Analgesics

• Remind patients to read and follow label directions.

• Instruct patients to not exceed more than the label prescribes or take longer than recommended on the label.

For patients taking acetaminophen:

• Tell patients that taking a higher dose than recommended will not provide more relief and can be dangerous.

• Tell patients that taking too much acetaminophen can lead to liver damage, and the risk of liver damage is increased when taking acetaminophen-containing products with moderate amounts of alcohol.

For patients taking NSAIDs:

• Encourage patients to read drug labels carefully, because NSAIDs are found in a variety of products.

• Tell patients that taking a higher dose than recommended can cause stomach bleeding.

• Educate patients on the signs and symptoms of stomach bleeding.

• Tell patients that taking a higher dose than recommended of an NSAID can also cause kidney damage. Tell patients that the risk for this adverse event is higher in patients aged 60 years and older; those taking a diuretic; and those with high blood pressure, heart disease, or preexisting kidney disease.

Ms. Koutnik-Fotopoulos is a freelance writer based in Keyport, NJ.

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