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What is the American name for pizotifen?: Pizotyline and US Availability

4 min read

While the United States Adopted Name (USAN) for the antimigraine agent pizotifen is pizotyline, the drug is not approved for use by the U.S. Food and Drug Administration (FDA). This means that despite having a designated American name, the medication is not commercially available to patients in the United States.

Quick Summary

The USAN for pizotifen is pizotyline; however, the drug lacks FDA approval and is unavailable in the U.S. It is used internationally for migraine prophylaxis, with US patients relying on other FDA-approved treatments.

Key Points

  • American Name: The United States Adopted Name (USAN) for pizotifen is pizotyline.

  • FDA Approval: Pizotifen has not been approved by the U.S. Food and Drug Administration (FDA).

  • US Availability: The medication is not commercially available for prescription in the United States.

  • International Brand Names: Outside the US, pizotifen is sold under brand names like Sandomigran and Mosegor.

  • Migraine Prophylaxis: Pizotifen is an antimigraine agent, specifically a serotonin antagonist, used for the prevention of recurrent migraines.

  • US Alternatives: FDA-approved alternatives for migraine prevention in the US include anticonvulsants (e.g., Topiramate), beta-blockers (e.g., Propranolol), and CGRP inhibitors (e.g., Aimovig).

In This Article

Pizotifen, known under the brand name Sandomigran in many countries, is a prescription medication primarily used for the prophylactic management of recurrent migraines and cluster headaches. It belongs to a group of compounds known as tricyclic agents and functions by blocking serotonin receptors in the brain. While effective in reducing the frequency and severity of headaches for many international patients, the story is different in the United States, where it cannot be prescribed.

Pizotifen vs. Pizotyline: Understanding the Names

In the world of pharmacology, a single drug can have multiple names. The generic name, often recognized internationally, is called the International Nonproprietary Name (INN). For this drug, the INN and British Approved Name (BAN) is pizotifen. In the United States, a different system is used to designate a drug's nonproprietary name, known as the United States Adopted Name (USAN). The USAN assigned to pizotifen is pizotyline. This is the key answer to the question of what is the American name for pizotifen. It's important to remember that this is simply a naming convention and does not indicate US market availability.

The FDA and Pizotifen's Unavailable Status

The reason pizotifen, or pizotyline, is not commercially available in the U.S. is its lack of approval from the U.S. Food and Drug Administration (FDA). The FDA is responsible for evaluating the safety and efficacy of all medications before they can be sold to the public. For various reasons, including the development of newer alternatives and potential side effects, pizotifen was never brought to market in the U.S.. This situation isn't uncommon, as many drugs available in Europe, Canada, and other regions do not receive FDA approval.

Mechanism of Action and Side Effects

As a serotonin (5-HT) antagonist, pizotifen blocks the action of serotonin receptors in the brain, particularly the 5-HT2A and 5-HT2C receptors. This action prevents the dilation of cranial blood vessels, which is believed to play a role in the development of migraines. Pizotifen is also known for its antihistamine, sedative, and appetite-stimulating effects. It's these latter properties that lead to some of its most notable side effects, specifically drowsiness and significant weight gain.

American Alternatives for Migraine Prophylaxis

For US patients seeking preventative migraine treatment, a healthcare provider will recommend one of the many FDA-approved alternatives. These medications fall into several classes, and the best choice depends on a patient's specific health profile and response to treatment.

Comparison of Pizotifen and US Alternatives

Feature Pizotifen (Pizotyline) Topiramate Propranolol CGRP Inhibitors (e.g., Aimovig)
US Availability Not available (Not FDA-approved) Yes (FDA-approved) Yes (FDA-approved) Yes (FDA-approved)
Mechanism Serotonin antagonist Anticonvulsant Beta-blocker Blocks CGRP pathway
Common Side Effects Drowsiness, weight gain Paresthesia (tingling), cognitive issues, weight loss Fatigue, dizziness, low blood pressure Injection site reactions, constipation
Formulation Oral tablet Oral tablet Oral tablet Injection

FDA-Approved Alternatives Available in the US

  1. Anticonvulsants: Topiramate (brand name Topamax) and valproic acid are commonly used for migraine prevention. They work by stabilizing brain activity to reduce the likelihood of a migraine attack.
  2. Beta-Blockers: Drugs like propranolol and metoprolol are effective for some patients. They work by reducing blood pressure and heart rate, which can prevent migraine onset.
  3. CGRP Inhibitors: This newer class of drugs, which includes injectables like Aimovig, Ajovy, and Emgality, targets the calcitonin gene-related peptide (CGRP) pathway, a key component in migraine pathophysiology.
  4. Botox Injections: For chronic migraine sufferers, botulinum toxin type A injections into specific head and neck muscles can provide relief.
  5. Older Antidepressants: Amitriptyline, a tricyclic antidepressant, is sometimes used off-label for migraine prevention due to its similar profile to pizotifen, though with careful consideration of side effects.

When a healthcare provider prescribes a migraine preventative medication in the US, they weigh factors such as a patient's medical history, coexisting conditions, side effect profile, and potential drug interactions. Many of these alternatives offer effective relief for patients who would otherwise consider a medication like pizotifen.

Navigating Treatment When a Drug is Unavailable

For those accustomed to pizotifen or who have read about its benefits, discovering its unavailability in the US can be frustrating. However, the FDA-approved alternatives are well-studied and widely used. The key is to work closely with a neurologist or primary care physician who specializes in headache management. They can assess your individual needs and guide you toward the most appropriate treatment plan using available medications, potentially avoiding adverse effects associated with unavailable options.

Conclusion

The American name for pizotifen is pizotyline. However, due to its lack of FDA approval, this medication is not prescribed or sold in the United States. US patients seeking preventative migraine treatment have a robust selection of FDA-approved alternatives, including anticonvulsants, beta-blockers, CGRP inhibitors, and other therapies. Consulting with a healthcare provider is the essential first step to developing an effective migraine management strategy with the medications available in the US.

Frequently Asked Questions

Pizotifen is the International Nonproprietary Name (INN) for the drug, used in many countries. Pizotyline is the United States Adopted Name (USAN). They refer to the same chemical compound.

No, you cannot get a prescription for pizotifen in the US. The drug is not approved for sale or use by the U.S. Food and Drug Administration (FDA).

Pizotifen has not received approval from the FDA to be marketed in the U.S. due to various regulatory and commercial factors. Newer drugs may have also emerged as preferred alternatives.

Internationally, common brand names for pizotifen include Sandomigran and Mosegor. These brand names are not available in the US.

Common side effects of pizotifen include drowsiness, fatigue, increased appetite, and associated weight gain.

For migraine prevention, US alternatives include beta-blockers (e.g., propranolol), anticonvulsants (e.g., topiramate), and CGRP inhibitors. These are often used as alternatives when pizotifen is unavailable.

No, pizotifen is not a triptan. It is a serotonin antagonist used to prevent migraines. Triptans are a different class of drugs used to treat an active migraine attack, not for prevention.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.