Is Fioricet (butalbital, acetaminophen, and caffeine) safe for adolescents?

From the Guidelines

Fioricet is not recommended for teenagers due to the potential risks associated with its components, particularly butalbital, which can cause dependence and have sedative effects, as well as acetaminophen, which poses risks of liver damage 1. The American College of Physicians guideline on pharmacologic treatments of acute episodic migraine headache in outpatient settings advises against using butalbital for the treatment of acute episodic migraine, highlighting the importance of considering safer alternatives for managing headaches in teenagers 1. Some key considerations for managing headaches in teenagers include:

• Evaluating the teenager by a healthcare provider to recommend age-appropriate treatments
• Considering over-the-counter pain relievers with proper dosing
• Implementing lifestyle modifications such as adequate hydration and sleep
• Teaching stress management techniques
• Identifying and avoiding headache triggers
• Closely monitoring any medication use in teenagers by healthcare professionals to ensure safety and appropriate treatment. Given the potential risks and the availability of alternative approaches, it is crucial to prioritize the safety and well-being of teenagers when managing headaches, and Fioricet should not be considered a first-line treatment option for this age group.

From the FDA Drug Label

Safety and effectiveness in pediatric patients below the age of 12 have not been established The FDA drug label does not answer the question about teenagers specifically, as it only mentions patients below the age of 12.

• Key point: The label does not provide information on the safety of the drug for teenagers.
• Clinical decision: Due to the lack of information, it is uncertain whether Fioricet is safe for teenagers, and caution should be exercised when considering its use in this age group 2.

From the Research

Safety of Fioricet for Teenagers

• Fioricet is a medication that contains butalbital, acetaminophen, and caffeine, commonly used to treat headaches [(3,4)].
• The use of butalbital-containing medications, such as Fioricet, can lead to medication overuse headache (MOH), a challenging disorder that causes decline in quality of life and physical symptoms 3.
• Butalbital can produce intoxication, hangover, tolerance, dependence, and toxicity, and its use should be limited and carefully monitored 4.
• There is limited evidence on the safety and efficacy of butalbital-containing medications, such as Fioricet, in pediatric patients 5.
• Providers at the Pediatric Headache Program at Boston Children's Hospital recommend prescribing triptan-based medications instead of butalbital-containing medications for pediatric headache relief, due to the known negative side effects of butalbital on the general population and the uncertain longitudinal trajectory on developing brains 5.

Potential Risks for Teenagers

• Medication overuse headache due to butalbital, acetaminophen, and caffeine tablets is a relatively common cause for chronic daily headache in migraine patients 6.
• The development of MOH is associated with both frequency of use of medication and behavioral predispositions 3.
• Butalbital-containing medications can produce drug-induced headache, tolerance, and dependence, and higher doses can produce withdrawal syndromes after discontinuation 4.