Statement of National Consumers League

Before the Food and Drug Administration

Nonprescription Drugs Advisory Committee

September 20, 2002

by Rebecca Burkholder, Program Associate

The National Consumers League, America ’s oldest consumer advocacy organization, is pleased to testify today about the potential of gastrointestinal bleeding with the use of non-prescription non-steroidal anti-inflammatory drugs (NSAIDs).     I would like to inform the committee that occasionally the League receives financial support from pharmaceutical companies for specific consumer education projects in which we maintain full editorial control.  In addition, pharmaceutical companies have supported our annual dinners and conferences. This amounts to less than one half of one percent of our annual operating budget.  NCL did not receive any financial incentive to appear at this meeting. 

Recent studies have recognized that the use of non-prescription NSAIDs increases the risk of gastrointestinal (GI) bleeding by as much as two to three times.[i]  Overall, GI bleeding caused by NSAID use is now recognized as the most common serious adverse drug reaction in the United Sates and accounts for as many as 16,000 deaths a year.[ii]   If the FDA determines that the data and studies support the conclusion that consumers are at an increased risk of adverse GI events when using a non-prescription NSAID, then the labeling on these products should contain a clear warning to consumers of this risk, and the packaging should include consumer education on GI bleeding.  

Consumers today are taking a more active role in their health care, including self-diagnosing and self-medicating.  Because of this trend to self-medicate, it is important that over-the-counter (OTC) medications that pose a significant risk to consumers have a specific clear warning about the risk on its label, and that consumer education include details of the potential adverse events.

According to surveys conducted on consumer use and attitudes about OTC medications, consumers need more education on the proper use of all OTCs.  A survey commissioned by NCL found that one third of consumers do not regularly read the labels of OTC products before purchasing or using them.  One-quarter of those surveyed had some trouble reading and understanding the label.  Another one-third of the consumers reported taking more than the recommended dose some or most of the time, while more than one in five consumers take OTC medicines for longer than recommended.       

A recent survey by the National Council for Patient Information and Education (NCPIE), a patient education advocacy group found that while 95% of the consumers read some portion of the label, they do so selectively.  When buying an OTC product for the first time, only a third look for the active ingredient and one in five seek out warning information.  Over a third of the consumers combine nonprescription medications when they have multiple symptoms.  On a positive note, the survey found that the majority of consumers get their health information about OTC drugs from their health professionals, and that the health professionals were very willing to discuss OTC drug use with patients. 

What is clear from these surveys is that consumers need to be better informed about using OTC products; labels (including warnings) need to be in easy-to-understand language; and the involvement of health professionals could increase consumer understanding of OTC medications.   

If the FDA finds that the increased risk of adverse GI events with use of OTC  NSAIDs is such that consumers should be warned, there are several things NCL would like to see on the NSAID label:  

• An organ specific warning that use of NSAIDs may cause stomach bleeding.  It should be separate from the alcohol warning statement on stomach bleeding since that warning is directed at consumers who drink alcohol. 

• More specific information to consumers on the factors associated with increased risk of GI adverse events, including a high daily NSAID dosage and past history of GI problems.    

• A consumer information leaflet should be included in the OTC NSAID packaging, explaining GI bleeding, and listing the specific symptoms of GI bleeding, including: 1) black or bloody stools, 2) severe stomach pain, 3) vomiting of blood or vomit that looks like coffee grounds.  Consumers should be advised to consult their doctor immediately if they experience these symptoms as they may indicate a more serious condition

In addition to changes in labeling and packaging, an education campaign should focus on proper use of OTC NSAIDs, including proper dosage and the risk of combining OTC NSAIDSs.  This is especially important because studies have found that the risk of GI bleeding increases as the daily dose of the NSAID increases.[iii]   The campaign should encourage consumers to talk with their doctor or other health professional about any questions on taking OTC NSAIDs.  Educating health care professionals, including doctors and pharmacists, on the risks consumers may experience with OTC NSAID use, and how to best explain these risks to consumers, should also be part of the campaign.    

While NCL recognizes that non-prescription NSAIDs are an important part of consumers’ ability to self-treat for headaches, muscular aches, and the minor pain of arthritis, there also needs to be appropriate information on the risks of NSAIDs in order for these products to be used safely and effectively.

The National Consumers League, founded in 1899, is America's pioneer consumer organization. Our mission is to identify, protect, represent, and advance the economic and social interests of consumers and workers. NCL is a private, nonprofit membership organization. For more information, visit www.nclnet.org.

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