American Pain Foundation's Position Statement Regarding the FDA Advisory Committee's Recommendations Concerning Acetaminophen

Release Date: September 14, 2009

Background Information:

On June 29th and 30th, 2009 the U.S. Food and Drug Administration (FDA) held an Advisory Committee meeting regarding liver injury related to acetaminophen use in both over‐the‐counter (OTC) and prescription medicines. The Advisory committee voted in favor of a number of potential changes which can have far reaching implications for Americans in pain and those providing their care. These recommendations include:

• Reduction of the maximum recommended daily cumulative dose of acetaminophen
• Reduction of the maximum recommended single dose of acetaminophen
• Elimination of prescription acetaminophen/opioid combination medications

As the largest pain advocacy organization in the United States, American Pain Foundation (APF) has several concerns about the recommendations given by the FDA Advisory Committee including the process and the consequences from the recommendations. Concerns about the process include:

• Several members of the committee commented on the lack of sufficient scientific evidence and data to support any policy statements about the subject. Despite this lack of information, committee members were not given the choice or opportunity to abstain from decision questions
• The questions which the committee was obligated to respond to, and from which the recommendations were drawn, did not include what we consider more reasonable responses to the problem of liver injury related to acetaminophen usage. In other words, there was restriction in the possible recommendations that could come out of the process.

APF also has concerns about what could result in unintended, harmful consequences from the recommendations. Millions of people use the medicines that are referred to in these recommendations. What will they do when these medicines (the 500mg of OTC acetaminophen and the prescription acetaminophen/opioid combination medications) are removed? Many will be driven to take medicines with potentially even greater risks. Banning prescription combination medicines, in essence will eliminate the Schedule III opioids which may result in prescribers choosing not to prescribe Schedule II opioids and choose less regulated and less effective pain relievers. This practice change may be fueled by fear of the stronger opioids or the perceived burden required for prescribers that includes heightened patient monitoring. This could likely result in a diminishment of pain relief and increased suffering for those who live with pain.

In addition to the concerns APF has with the process and the consequences, APF is deeply troubled about how these recommendations, if adopted, would affect people who are currently taking medication that combines hydrocodone and acetaminophen. Currently there is no preparation of hyrodocodone available without acetaminophen. Hydrocodone with acetaminophen is the most commonly prescribed opioid pain reliever commonly used to manage both acute and chronic pain conditions. Banning combination opioids should not be enacted until all currently available opioid options are available as a sole agent.

There is a better way to address concerns about liver damage related to over use of acetaminophen without causing potential harm to millions who use these medicines. Much of problem of inadvertent over use of these medicines stems from the public and health practitioners not being aware of and attending to the risks. Very little information that clearly explains the risks of over use of acetaminophen medications has been disseminated to the public. This is compounded by the fact that labeling of medicines containing acetaminophen is very poor. Some labels refer to acetaminophen as “APAP” when very few members of the public know that “APAP” is a reference to “acetaminophen”.

APF recommends instituting a significant and sustained public awareness and education campaign about the risks and safe use of acetaminophen. We also recommend that all medicines containing acetaminophen be clearly and consistently labeled. These measures will significantly reduce the overuse of acetaminophen without taking important medicines out of the hands of people who benefit from them.

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September 28, 2009: Attached is a compilation [petition summary] of over 3,000 names that represents public opinion from 47 states of the Union, Puerto Rico and the District of Columbia. Several thousand of these comments are in support of a petition asking the FDA to not diminish access to these medicines. Many of the comments are illustrative of the kinds of burdens that could be a consequence of following the FDA Advisory Committee’s recommendations. Millions of people in pain have few options available to them. Many cannot take NSAIDS because of the gastrointestinal and cardiac risks. Many have no or limited insurance coverage and compelling them to visit the doctor for the medicine they get over the counter is an extreme financial burden. Many rely on the acetaminophen/opioid combinations and will not have comparable options for medicines. Many agree that the problems that need to be solved in regard to overuse of acetaminophen medicines can be addressed through better labeling and a sustained public education campaign. All agree with the thoughts in the petition statement.