Acetaminophen is one of the most commonly utilized medications in the United States, and is widely available in a variety of over-the-counter (OTC) and prescription products designed to reduce pain and/or fever. Commonly prescribed prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin®) and oxycodone with acetaminophen (Percocet®). Over-the-counter products that contain acetaminophen include Tylenol®, NyQuil®, and several Sudafed® products. On January 13, 2011, the Food and Drug Administration (FDA) released a statement that drug manufacturers have been asked to limit the amount of acetaminophen contained in combination prescription products.
This requirement would limit the amount of acetaminophen to 325 mg per dosage unit. The FDA's request is intended to make these products safer for patients, and to reduce the risk of liver injury due to acetaminophen overdose. The FDA reported an estimated 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths annually between 1990-1998 as a result of acetaminophen overdose, with 48% of overdoses between 1998-2003 being accidental. This appeal to drug manufacturers will be gradually implemented, with a 3-year timeline (January 14, 2014) currently in place. Prescription drug products containing acetaminophen will also be required to have a black box warning stating the drug's potential for causing severe liver injury.
At this time, the FDA appeal does not include the numerous over-the-counter acetaminophen products currently available for pain, fever, cough, and cold. The FDA states that liver injury as a result of acetaminophen overdose most commonly occurs when individuals are using multiple products containing acetaminophen, or when alcohol is consumed with concurrent acetaminophen use. Many patients do not realize their prescription pain reliever contains acetaminophen and end up combining it with another over the counter product which also contains acetaminophen. This is partly because acetaminophen is often times abbreviated on prescription labels or bottles as APAP. Some patients will also take too much of the opioid and acetaminophen combo to try and control their pain and end up with toxic acetaminophen doses.
This FDA announcement came as a result of the Joint Meeting of the FDA Drug Safety and Risk Management Advisory Committee held in June 2009. The three year implementation period was designed to prevent the risk of any drug shortages as a result of this announcement. To view additional information from the FDA website, click here.
There are products already on the market which contain the lower doses of acetaminophen. These products are available as generics or brand name (Norco, Anexsia, etc) and come in a variety of opioid doses. These new regulations may mean more brand name agents coming to the market to help fill the void left by the departure of the higher dose acetaminophen combination products. With hydrocodone/acetaminophen 5/500 being one of the top drugs for prescription counts this may affect plan spend in the future.
*Article provided by Husch Blackwell Sanders LLP