Fiorinal and Fioricet are medicines for tension-type headaches. Fiorinal contains aspirin and Fioricet contains acetaminophen. They both contain butalbital and caffeine. Codeine is sometimes also added to this combination. Butalbital, a barbiturate sedative, is habit-forming.
These medications should not be used on a daily basis because dependency on them can develop. Regular use, more than 2 days per week, can cause rebound headache, which may not respond to usually effective acute and preventive treatments.
Some patients are wondering why Fioricet is not controlled but Fiorinal is controlled. The reasons is that Fiorinal contains aspirin but fioricet only contains non-aspirin pain killer and barbiturate butalbital. The potential for abuse is decreased if a sufficient amount of a non-controlled substance (e.g., aspirin or acetaminophenn) is added.
The ratio required for exemption is 70 mg of acetaminophen to 15 mg of butalbital. In contrast, the ratio of aspirin to butalbital is 188 mg to 15 mg. The acetaminophen to butalbital ratio is approximately 97 mg to 15 mg in Fioricet, thus it is exempt from being controlled. Another reasons is that drug abusers can easily perform an “acid wash” to remove the aspirin (acetylsalicylic acid) component in Fiorinal but It is much more difficult to remove the acetaminophen component in Fioricet.
Why Fioricet is not Controlled Substance ?
Fioricet, which typically contains butalbital, acetaminophen, and caffeine, is not classified as a controlled substance under federal law in the United States. However, certain states may regulate it more strictly. The reasons Fioricet is not a controlled substance at the federal level, unlike Fiorinal, include:
Differences in Formulation and Perception
- Aspirin vs. Acetaminophen:
- Fiorinal: Contains butalbital, aspirin, and caffeine. Aspirin is considered a stronger analgesic and anti-inflammatory compared to acetaminophen.
- Fioricet: Contains butalbital, acetaminophen, and caffeine. Acetaminophen is primarily an analgesic and antipyretic, and it does not have the anti-inflammatory properties of aspirin.
- Historical and Regulatory Differences:
- The classification of drugs can sometimes be influenced by historical and regulatory decisions that may not solely be based on pharmacological differences.
- Historically, Fiorinal has been regulated more strictly due to the combination of butalbital with aspirin and its perceived higher potential for abuse.
- Clinical Use and Abuse Potential:
- Perception of Abuse Risk: Fiorinal’s combination with aspirin has historically been seen as having a higher abuse potential, possibly due to the stronger analgesic properties of aspirin compared to acetaminophen.
- Regulatory Decisions: The DEA (Drug Enforcement Administration) and FDA (Food and Drug Administration) have not classified Fioricet as a controlled substance at the federal level, potentially reflecting a perception of lower abuse risk compared to other barbiturate-containing medications.
- State Regulations:
- It’s important to note that while Fioricet is not controlled at the federal level, some states have chosen to classify it as a controlled substance due to concerns about abuse and dependence.
Clinical Considerations
- Butalbital Content:
- Both Fiorinal and Fioricet contain butalbital, which is a barbiturate with sedative and anxiolytic properties that contribute to their effectiveness in treating tension headaches. However, the presence of butalbital does present a risk for dependency and abuse.
- Risk of Dependence and Abuse:
- Fiorinal: Its controlled status is largely due to the butalbital component, combined with aspirin and caffeine, leading to concerns about abuse, dependence, and addiction.
- Fioricet: While it also contains butalbital, the combination with acetaminophen instead of aspirin has not been classified as controlled by the DEA, possibly reflecting a lower perceived risk of abuse. However, the butalbital component still poses similar risks for dependency and abuse as in Fiorinal.
Why Fiorinal is Controlled Substance ?
Fiorinal is classified as a controlled substance primarily due to its butalbital component, a barbiturate, which has the potential for abuse, dependency, and addiction. Here’s a detailed explanation:
Components of Fiorinal
Fiorinal is a combination medication that typically includes:
- Butalbital: A barbiturate with sedative and anxiolytic properties.
- Aspirin: A nonsteroidal anti-inflammatory drug (NSAID) that relieves pain and reduces inflammation.
- Caffeine: A central nervous system stimulant that enhances the effectiveness of pain relievers and can counteract the sedative effects of butalbital.
Reasons Fiorinal is a Controlled Substance
- Butalbital’s Abuse Potential
- Euphoric Effects: Butalbital can induce feelings of euphoria, which may lead individuals to misuse the medication.
- Tolerance and Dependence: Regular use of butalbital can lead to tolerance (needing more of the drug to achieve the same effect) and physical dependence (experiencing withdrawal symptoms if the drug is not taken).
- Addiction: The psychological craving for butalbital can lead to addiction, where individuals compulsively seek out the drug despite negative consequences.
- Central Nervous System Depression
- Sedation: Butalbital’s sedative effects can impair cognitive and motor functions, increasing the risk of accidents and injuries.
- Respiratory Depression: In high doses, butalbital can depress respiratory function, potentially leading to life-threatening breathing problems.
- Risk of Overdose
- Narrow Therapeutic Window: Barbiturates, including butalbital, have a narrow therapeutic window, meaning the difference between a therapeutic dose and a toxic dose is small. Overdose can lead to severe consequences, including coma and death.
- Combination with Other Substances: The risk of overdose increases when butalbital is combined with other central nervous system depressants, such as alcohol, benzodiazepines, or opioids.
- Regulatory Control
- Schedule III Classification: In the United States, Fiorinal is classified as a Schedule III controlled substance under the Controlled Substances Act. This classification indicates that the drug has a moderate to low potential for physical and psychological dependence compared to Schedule I and II substances but more than Schedule IV and V substances.
- Prescription Requirements: Due to its controlled status, Fiorinal prescriptions are subject to specific regulations to prevent misuse and diversion, including limits on refills and requirements for secure storage and record-keeping by pharmacies.
Conclusion
Fiorinal’s status as a controlled substance is mainly due to the inclusion of butalbital, a barbiturate with significant potential for abuse, dependence, and addiction. Regulatory controls are in place to minimize the risk of misuse and ensure that the medication is used safely and appropriately under medical supervision.