FDA may establish Acetaminophen Package limits for OTC Products

Current Situation

Acetaminophen can be purchased OTC in large amounts, including bottles that contain hundreds of doses.

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Options

More than one potential option exists under this general category.

• Limit the number of acetaminophen doses that can be contained in each package of OTC acetaminophen product

• Require acetaminophen tablets to be packaged in blister packs instead of bottles

• Impose restrictions on sales to limit the amount of acetaminophen that may be purchased by an individual at any one time.

Intended Effect

• To decrease the incidence of intentional ingestion of large overdoses by making it more difficult to accumulate large numbers of tablets.

• Blister packs could also help consumers track how many pills they have taken.

Considerations Related to Incidence of Hepatotoxicity (liver injury)

• Limits on amounts of OTC acetaminophen that could be purchased at one time could reduce incidence of overdose due to intentional injury.

• Limiting the availability of acetaminophen could move consumers to use other analgesics to treat pain with their attendant risk of adverse effects.

 Considerations Related to Implementation

• Limiting package size could cause substantial inconvenience to consumers, particularly to those who use OTC acetaminophen routinely under a doctor’s care to treat chronic pain or arthritis.

• Blister packs could further adversely affect consumers (especially those with arthritis) because of the extra effort it takes to open blister packs.

• Manufacturer repackaging, whether in smaller container sizes, or blister packs could be costly and such costs could be passed on to consumers.

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM164897.pdf

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