Pain is a common problem for millions of Americans. Treatment is usually an over-the-counter (OTC) or prescription pain reliever. These medicines help when used as directed but they carry risk of injury and death when misused or abused.
The recent announcement that FDA is teaming with the Office of National Drug Control Policy (ONDCP) and the Drug Enforcement Administration (DEA) is one of many significant actions FDA's Center for Drug Evaluation and Research (CDER) has taken to help curb public health issues related to the misuse of opioids and acetaminophen.
Long-Acting and Extended-Release Opioids
In 2006, about 50,000 emergency room visits were related to opioids. In 2007, FDA estimates that more than 33 million Americans age 12 and older misused long-acting (LA) and extended-release (ER) opioids. In 2009, 257 million prescription opioids were filled -- almost enough prescriptions for every person living in the United States.
On April 19, 2011, CDER joined ONDCP and DEA to announce the Obama Administration’s Epidemic: Responding to American’s Prescription Drug Abuse Crisis – an action plan to address problems with prescription drug abuse.
The Administration’s plan includes action in four major areas: education, monitoring, proper disposal, and enforcement. CDER is requiring manufacturers to comply with a new risk evaluation mitigation strategy (REMS) to ensure that patients who use LA and ER opioids know about the safe and appropriate use, storage, and proper disposal of these medicines. The new REMS also requires manufacturers to provide training to prescribers and to develop information for prescribers and pharmacists to give and guide discussion when counseling patients about the risks and benefits of LA and ER opioids.
The manufacturers of hydromorphone, oxycodone, morphine, oxymorphone, methadone, transdermal fentanyl, and transdermal buprenorphine are impacted by the new REMS requirements; brand-names include, OxyContin, Acvinza, Dolophine, and Duragesic.
Prescription Acetaminophen Combination Products
Acetaminophen overdose remains the most common cause of drug-induced liver injury in the United States.
On January 13, 2011, CDER announced that manufacturers of oral prescription acetaminophen combination medicines will have three years to limit the maximum amount of acetaminophen to 325 mg per tablet, capsule, or solution or suspension dose. Limiting the amount of acetaminophen in these medicines will reduce the risk of liver injury caused by an overdose, an event that can lead to liver failure, liver transplant, and death.
To communicate to healthcare professionals, FDA required a new boxed warning be added to the label of all oral prescription drug products that contain acetaminophen. This boxed warning describes the risk of severe liver injury. A boxed warning is FDA's strongest warning on drug labels.
Acetaminophen is the most common active ingredient in OTC and prescription medicines. It is found in more than 600 pain relievers and fever reducers, and some allergy, cold and flu, and sleep-aid medicines. It is generally safe and effective for most healthy people when used as directed. By limiting the maximum amount of acetaminophen in oral prescription medicines, patients will be less likely to overdose if they mistakenly take too much. People who have liver disease, use an anti-coagulant drug such as warfarin (known by the brand name Coumadin), or drink alcohol should inform their doctor before using a medicine that contains acetaminophen.
To comply with the new requirements, companies that market higher strengths of oral acetaminophen medicines must limit the amount or withdraw the product. CDER believes this action will not affect patient’s management of pain or access to their pain medicines.
CDER's Safe Use Initiative is working with the National Association of Boards of Pharmacy (NABP) and other stakeholders on a National Council for Prescription Drug Programs to provide recommendations to the pharmacy system industry and pharmacies on how to label acetaminophen on prescription container labels so that consumers can recognize when their prescription medicines contain acetaminophen. Removing acronyms, abbreviations and shortened versions for acetaminophen and spelling out acetaminophen on pharmacy container labels should make it easier for consumers to compare active ingredients on their prescription and over-the-counter labels, and avoid taking two medicines with acetaminophen, which can lead to an overdose.
CDER launched a national consumer education campaign: "The Safe Use of Acetaminophen." Education materials outline how to safely use acetaminophen and give it safely to a child. A number of products are available for download or linking. To view all the educational materials online go to: www.fda.gov/acetaminophen and click “Consumer Education” at the bottom of the page.
Finally, CDER’s Safe Use staff and its Office of Communications are advisors to the Acetaminophen Awareness Coalition, a team of government and non-government members brought together to generate key messages and materials for consumers about the safe use of acetaminophen. For more information about CDER’s regulatory and non-regulatory activities related to opioids, acetaminophen, safe storage and disposal, go to www.fda.gov/drugs.