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Fiorinal, Fioricet, and other Butalbital Compounds for Headaches and Migraine

Fioricet, Fiorinal, Fioricet with Codeine, and Fiorinal with Codeine are medications discussed quite frequently on our forums and in our chat room. These medications are both a source of relief to some and a source of problems to others.

An article by Dr. Stephen Silberstein and Dr. Douglas McCrory in the December, 2001, issue of "Headache: the Journal of Head and Face Pain" provides a great deal of information, results of clinical trials, and the answers to many of our questions.1
Analgesic medications containing butalbital, aspirin, acetaminophen, and/or caffeine are used by many "headachers" for tension-type headache (TTH) and Migraine. They have been shown to be effective in placebo-controlled trials conducted with TTH patients, but have not been studied in placebo-controlled trials with Migraineurs.

The use of analgesics containing Butalbital is controversial to say the least. Analgesics with barbiturates such as Butalbital are banned in Germany, and expert advisory panels elsewhere have warned of their potential for abuse.2,3 Some experts warn that butalbital is particularly likely to lead to rebound (analgesic overuse) headache and/or dependence and question whether their benefit outweighs these problems.3 The authors comment:

"Butalbital-containing analgesics may be effective as backup medications or when other medications are ineffective or cannot be used. Because of concerns about overuse, medication-overuse headache, and withdrawal, their use should be limited and carefully monitored."

Clinical Studies, TTH and Migraine:
Duke University researched completed clinical studies to identify and summarize evidence on the efficacy and safety of butalbital-containing combination drugs at the request of the United States Headache Consortium. This was as a supplement to the Agency for Health Care Research and Quality-sponsored technical report on the treatment of acute Migraine. The US Headache Consortium is composed of seven member organizations with an interest in improving the quality of care for people with Migraine disorders. The organizations include the American Academy of Neurology (AAN), the American Headache Society (AHS), the American Academy of Family Physicians (AAFP), the American College of Emergency Physicians (ACEP), American College of Physicians-American Society of Internal Medicine (ACP_ASIM), the American Osteopathic Association (AOA) and the National Headache Foundation (NHF).

Their research located controlled trials of Fiorinal, Fiorinal-PA, Fioricet, Fiorinal with Codeine, and Optalidon. Optalidon contains nonsteroidal anti-inflammatory agents (aminophenazone or propyphenazone) not available in the United States. In the located studies, these butalbital-containing compounds were compared with placebo, Micrainin (meprobamate and aspirin), Tylenol #3 (acetaminophen and codeine), Stadol (butorphanol tartrate nasal spray), and aspirin.

Potential Adverse Reactions:
Butalbital is a barbiturate. Some possible effects of barbiturates are intoxication, hangover, tolerance, dependence, and toxicity. Thus, analgesics with Butalbital can caused rebound (drug-induced) headache, dependence, and tolerance. With higher doses, withdrawal symptoms can occur when the drugs are discontinued.

  • Butalbital intoxication is indistinguishable from alcohol intoxication. Symptoms include "sluggishness, lack of coordination, difficulty thinking, poor memory, slowness of speech and comprehension, faulty judgment, disinhibition of sexual and aggressive impulses, decreased attention, emotional lability, and an exaggeration of basic personality traits."4

  • Tolerance is a reduced response to a medication. It is the result of cellular adaptive changes or enhanced drug metabolism due to extended use of a medication. Tolerance may develop over days, weeks, or months.

  • Addiction is manifested in "behavioral and other responses, including a compulsion to take a drug on a continuous or periodic basis in order to experience its psychic effects and, sometimes, to avoid the discomfort of its absence. Tolerance may or may not be present."

Potential Adverse Reactions (continued):

  • "The reinforcing properties of barbiturates account for their ability to induce dependence."1 We can develop a physical dependence to drugs such as Fiorinal and Fioricet because we can "maintain a high rate of self-administration." Butalbital is a drug of short to intermediate duration of action (half-lives of 10 to 50 hours). Minor withdrawal symptoms occur eight to 36 hours after the last dose, reach their peak at 40 hours, then decrease gradually over a period of two to 15 days. "Symptoms can be severe and include anxiety, involuntary muscle twitching, coarse tremor, weakness and dizziness, distortion of visual perception, nausea and vomiting, insomnia, weight loss, and postural hypotension. Patients may not have all minor signs and symptoms."5

  • "Seizures and/or delirium characterize the syndrome. Seizures occur between 24 and 115 hours after cessation of the drug, and are often multiple. Over half of patients with seizures develop delirium tremens, which lasts from 1 to several days; this is characterized by disorientation to time and place (but not person) and by predominantly visual hallucinations."6

  • "Deaths have been associated with barbiturate withdrawal."7

  • The severity of withdrawal symptoms experienced is directly related to the amounts of medication taken and the duration over which it was taken.

  • In some cases of barbiturate withdrawal, medical treatment with other medications may be indicated and helpful.

Headache and Migraine Treatment with Butalbital/Analgesic Drugs:
It's probably not news to any of us that one of the main concerns with these medications is rebound or "analgesic overuse" headaches. What constitutes "overuse" is still somewhat controversial and often debated. Silberstein and McCrory say:
"...'excessive' use typically is characterized by as few as three daily doses of a given acute agent taken more than 2 or 3 days a week. Medication overuse by patients prone to headache is believed to incite or, at least, reinforce chronic daily headache, with growing dependence on, and habituation to, symptomatic medication and refractoriness to preventative medications ... If the offending acute medication is stopped, this eventually may result in headache improvement (after a period of increased headache during the analgesic washout period)."1

As noted earlier, Silberstein and McCrory comment that these drugs can be effective backup medications for times when other medications don't work or can't be used. They recommend that they be used on a limited basis and carefully monitored. Their recommendation for an individual headache or Migraine attack is that the patient take one or two tablets or capsules initially, and no more than six per attack. They also advise limiting use to no more than two or three days a week. They also note that these medications should not be prescribed for patients who have overused or abused medications in the past.
If you are taking any of the medications discussed here or other medications from which you may be experiencing rebound, talk to your doctor for assistance in breaking the rebound cycle. Your doctor can work with you, not only to break the cycle, but to manage your headaches or Migraine attacks with different classes of drugs to avoid future rebound.

By Medical Review Board

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