The PAPR Coalition is a multi-stakeholder coalition formed to advocate for public policy to support access to and choice of appropriate OTC pain relief, while educating the public about the responsible use of acetaminophen. Specifically, the PAPR Coalition aims to work collaboratively with FDA and other stakeholders to ensure that the millions of Americans living with pain continue to be able to manage their condition, while educating consumers and healthcare professionals about the appropriate use of prescription and OTC medicines, particularly those containing acetaminophen.
The U.S. FDA may implement restrictions on over-the-counter (OTC) access to acetaminophen for American consumers. If implemented, American would no longer have access to OTC acetaminophen strengths over 325 mg, which include the doses known as Extra Strength, Extended Relief and Arthritis Pain Relief. Acetaminophen is among the most widely used drug ingredients in the United States, with as many as 23% of adults reporting they use acetaminophen-containing products in any given week. When taken as directed, acetaminophen is a safe and effective analgesic option for millions of Americans.
The safety and efficacy of various doses of acetaminophen including 325 mg, 500 mg, 650 mg and 1,000 mg have been well-established in clinical trials and clinical use. When used as directed, acetaminophen has one of the most favorable safety profiles among OTC pain relievers. Studies have also demonstrated a clinically relevant efficacy benefit of a 1000 mg acetaminophen dose compared to a 650 mg dose, and that this benefit is meaningful to consumers using single ingredient acetaminophen medicine that is available OTC.
Because acetaminophen is efficacious and has a unique safety profile, it is commonly recommended as a first-line analgesic for patients with certain medical histories. Acetaminophen is recommended for elderly patients with musculoskeletal pain, those at risk for gastrointestinal bleeding, and patients with multiple other medical conditions including renal disease, cardiovascular and heart disease. It is also recommended for those on aspirin heart therapy, as acetaminophen does not interfere with the cardio-protective benefit of aspirin. Studies indicate that restricting OTC access to certain acetaminophen strengths could put many such patients at increased health risk and lead to undesirable public health and health economics consequences.
The PAPR Coalition is committed to working collaboratively with FDA and other stakeholders to ensure access to safe and effective pain relief and reduce the incidence of unintentional acetaminophen overdose.
Recent efforts to pinpoint root causes and risk factors associated with overdose and liver injury in adults have identified the following concerns:
- Taking more than one acetaminophen-containing medicine at a time (e.g. taking OTC and prescription acetaminophen products concurrently),
- Taking too many tablets at a dosing occasion,
- Taking doses too close together (i.e. failure to observe the dosing interval).
In order to mitigate these factors, the design of targeted interventions to address the risk of an overdose of acetaminophen can be geared toward consumers:
- Lack of knowledge or awareness that a product contains acetaminophen
- Not following label directions
- Taking multiple acetaminophen-containing products at the same time
- Being at higher risk due to poor physical or mental health
The impact of the potential FDA decision to reduce access to certain OTC acetaminophen doses on public health and healthcare costs needs full consideration and open discussion. Acetaminophen is a leading choice of pain relief for millions of Americans, and access to medicine that makes their daily lives more bearable should not be impeded. Existing empirical data sheds light on the root causes of unintentional acetaminophen overdose and efforts to reduce adverse events should target these root causes.
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