Final Rule for Over-the Counter Pain Relievers and Fever Reducers

By: Amanda Zanetti, CIS Compliance Associate
amandazanetti@cis-partners.com

Manufacturers of over-the-counter pain relievers and fever reducers may need to revise their labeling practices within the next year, due to the April 28th Final Rule[i] issued by the Food and Drug Administration requiring manufacturers to prominently display active ingredients and include warnings of potential safety risks associated with taking pain relievers and fever reducers.[ii] According to Matthew Holman, the FDA's Deputy Director for the Division of Nonprescription Regulation Development, those at the FDA “believe the new labeling requirements will add information concerning severe adverse effects of over-the-counter pain relievers and fever reducers that many consumers may not be aware of.”[iii]

The final rule targets acetaminophen, which is found in brands like Tylenol, and nonsteroidal anti-inflammatory drugs, which include aspirin, ibuprofen, naproxen, and ketoprofen. Products containing acetaminophen and NSAIDS must warn customers of the potential risks which include stomach bleeding (NSAIDs) and severe liver damage (acetaminophen). In addition, manufacturers must include a warning on products containing acetaminophen, instructing consumers to ask a doctor before taking the blood thinning drug Warfarin.[iv]

So how is this rule going to impact pharma companies? To start, while some manufacturers have taken the initiative to voluntarily change labeling to include safety warnings for their products, in most cases, these new labels do not address all of the requirements issued in the FDA’s new rule. This means that within the next year, manufacturers are going to have to revise their current labels, costing them considerable time and money. In addition, the new warning labels have the potential (which I feel is unlikely but still, it could happen) to deter potential consumers. For some, the safety warning may cause consumers to shy away and choose a more natural substitute.

Sources:
[i] http://edocket.access.gpo.gov/2009/pdf/E9-9684.pdf

[ii] http://www.fiercepharma.com/story/fda-requires-stronger-otc-pain-med-labels/2009-04-28
[iii] http://www.reuters.com/article/healthNews/idUSTRE53R4Z020090428
[iv] http://www.fda.gov/bbs/topics/NEWS/2009/NEW02004.html