According to a technical amendment to FDA’s final rule for internal analgesics, acetaminophen products sold in stick packs and sachets must carry warnings about the risk of liver injury by April 29, 2010,.
Warnings on immediate containers such as sachets and stick packs are important because "consumers may routinely remove these packages from the outer carton and, therefore, fail to see the liver injury and stomach bleeding warning if they are only printed on the carton," FDA says in the technical amendment.
By requiring the stick pack/sachet warning, FDA refuses a request from manufacturers.
FDA acknowledged requests that the agency should exempt certain immediate containers from the labeling requirement because of limited space, but disagrees, saying stick packs and sachets have "adequate space to accommodate the required warnings."
Finally, FDA clarifies products with acetaminophen introduced within a year before the final rule's effective date - April 29, 2010 - must include a "see new warnings" flag for at least one year from the launch date.
Products launched after the effective date do not need the new warnings flag.
FDA maintains the rule will not have a "significant economic impact on a substantial number" of businesses.
According to the Tan Sheet, “Acetaminophen marketers could face more burdensome restrictions down the road, including removing certain doses from the market, if FDA follows the advice of an advisory panel convened in April to discuss ways to reduce the risk of hepatotoxicity related to the ingredient.”
