Proposed regulations on Acetaminophen intended to keep consumers safe will result in substantial burden for manufacturers and could actually restrict consumer access to commonly used OTCs

An FDA advisory committee is weighing in on the safety of OTC acetaminophen, the key active ingredient found in many OTC pain relievers, sleeping aids, and cough and cold medications. The proposed regulations suggest either cutting down dosages of acetaminophen or completely pulling combination drugs that contain acetaminophen off the shelves.

These restrictions or changes in its OTC availability will have huge impacts on costs for manufacturers and the sales and profit opportunities for both manufacturers and retailers.  Furthermore, OTC restrictions on acetaminophen will impact consumers’ costs and access to this medication commonly used for pain relief, fever reduction, and treatment of colds and coughs.

In May 2009 an FDA working group proposed several possible actions in an attempt to reduce the risk of liver damage as a result of acetaminophen overdose or misuse.

If any of the actions were to be imposed they would substantially increase costs for manufacturers for product recalls, reformulations, label changes, repackaging and additional stability tests and efficacy trials for lower doses.  Furthermore, if the 500mg dose acetaminophen product was not allowed to be sold as an OTC drug, firms that make this dosage strength would be forced to submit new drug applications and/or abbreviated new drug applications to switch doses higher than 325 mg to prescription status.

Safety concerns for acetaminophen are not new.  In 1998, the FDA finalized a regulation that required all OTC acetaminophen products to include an alcohol warning on product labeling. The warning stated: ‘‘Alcohol Warning’’: ‘‘If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.’’

In 2002, the FDA convened an Advisory Committee meeting to discuss unintentional liver toxicity related to the use of OTC acetaminophen.

In 2003 makers of OTC combination products that contain acetaminophen voluntarily strengthened product labels to reduce the risk of unintentionally doubling doses by highlighting the ingredient in yellow or a contrasting color on the Drug Facts label and warning consumers not to use other medications with acetaminophen or exceed recommended daily doses.

The FDA admits that acetaminophen is safe and effective when used as directed and that 84% of acetaminophen-related liver injuries were related to medication errors, misuse, or overdose.  The issue central to the debate is how to limit unintentional overdose or misuse without limiting access to this widely-used, cost effective medication can be solved by increasing awareness and education among patients on the risks of misusing acetaminophen.  Rather than imposing such hefty burdens on the manufacturers of this important medication, the industry trade group Consumer Healthcare Products Association (CHPA), favors an enhanced consumer education and product labeling initiative as a viable alternative.

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