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What is betahistine called in the US?: Availability, Alternatives, and Key Differences

4 min read

While betahistine is widely used in more than 80 countries for managing vertigo, it has not been commercially available in the United States for decades. As such, there is no standardized US brand name for betahistine on the commercial market, though it may be obtained through specific channels.

Quick Summary

Betahistine, a medication for Meniere's disease and vertigo, is not commercially sold in the US after its initial FDA approval was rescinded. It can be obtained with a prescription via compounding pharmacies or from some international sources.

Key Points

  • US Availability: Betahistine has no commercial US brand name and is not sold over-the-counter; it is only available via a compounding pharmacy with a prescription.

  • FDA Status: Initial US FDA approval for betahistine was withdrawn in 1971 due to insufficient evidence of effectiveness, though it remains widely used abroad.

  • US Alternatives: FDA-approved alternatives for vertigo and Meniere's disease in the US include antihistamines like meclizine and diuretics.

  • Compounding Process: A US patient needs a doctor's prescription to have betahistine specially prepared by a compounding pharmacy, and insurance often does not cover it.

  • Mechanism of Action: Unlike sedating antihistamines, betahistine is a histamine analog that is thought to improve blood flow to the inner ear and modify vestibular nerve signals.

  • Common Side Effects: Reported side effects for betahistine are generally mild and can include headache, nausea, and indigestion.

In This Article

Why Betahistine Has No US Brand Name

Betahistine was initially approved by the U.S. Food and Drug Administration (FDA) in the 1970s to treat Meniere's disease. However, that approval was later withdrawn because the FDA determined that the clinical evidence provided for its efficacy was insufficient. This decision means that pharmaceutical companies cannot legally market or sell betahistine as a mass-produced drug in the United States.

This is a major difference from countries like the UK, where betahistine is a common prescription drug often sold under brand names like Serc. For US patients, the lack of commercial availability can be confusing, especially when researching treatments used globally for vestibular disorders.

The Compounding Pharmacy Option

Despite not being commercially available, betahistine can still be obtained in the US through a compounding pharmacy. Compounding pharmacies are specialized facilities that prepare customized medications for individual patients based on a doctor's prescription.

Key aspects of obtaining compounded betahistine in the US:

  • Requires a prescription: A licensed US physician must write a prescription for the compounded medication.
  • Cost and insurance: Compounded medications are typically not covered by health insurance plans, and patients should expect to pay out-of-pocket. The cost can vary by pharmacy.
  • Availability: Not all pharmacies offer compounding services. Patients may need to research and find a specialized compounding pharmacy in their area or one that ships to their state.
  • Legality: Obtaining compounded betahistine with a prescription from a licensed US physician is legal.

Comparing Betahistine and Common US Alternatives

For patients with Meniere's disease or vertigo, US doctors will often prescribe alternative medications that have full FDA approval. These can include antihistamines and diuretics, which treat the symptoms of dizziness and nausea.

Feature Betahistine (Compounded) Meclizine (Antivert, Bonine) Diuretics (e.g., HCTZ)
Availability in US Compounding Pharmacy Only Commercially Available (OTC/Prescription) Commercially Available (Prescription)
Primary Mechanism Histamine H1 agonist & H3 antagonist; improves inner ear blood flow. H1 antihistamine; blocks histaminergic signals to the brain's vomiting center. Reduce fluid buildup in the body, potentially lowering inner ear pressure.
Effect on Vestibular System May enhance blood flow and improve vestibular function. Suppresses vestibular system to reduce spinning sensation. Addresses inner ear fluid pressure imbalance.
Sedative Effects Non-sedating. Can cause drowsiness. Typically not sedating.
Typical Use Long-term management of vertigo and Meniere's disease symptoms. Short-term relief for motion sickness and acute vertigo attacks. Long-term management of Meniere's symptoms.

Common US Alternatives for Vertigo and Meniere's Disease

For those who do not pursue the compounding route, several other treatment options are available in the US. These are determined based on the patient's specific symptoms and diagnosis, and should always be discussed with a healthcare provider.

Prescription Alternatives:

  • Meclizine (Antivert): A widely available antihistamine used to reduce the sensation of spinning and manage nausea associated with vertigo.
  • Diuretics: These medications, such as hydrochlorothiazide, help reduce overall fluid in the body, which can decrease pressure in the inner ear for patients with Meniere's disease.
  • Benzodiazepines: Drugs like lorazepam or clonazepam may be used in severe cases to suppress the central vestibular system, though they carry risks of dependence and sedation.
  • Corticosteroids: During acute attacks, a short course of steroids like prednisone can help reduce inflammation.

Non-Prescription and Non-Pharmacological Options:

  • Antihistamines: Over-the-counter options like dimenhydrinate (Dramamine) can help with motion sickness and milder vertigo symptoms.
  • Ginger Supplements: Some individuals find ginger helpful for managing nausea related to dizziness.
  • Vestibular Rehabilitation Therapy (VRT): A physical therapy approach that involves specific exercises to retrain the brain to process balance information more effectively.
  • Dietary Changes: Adopting a low-sodium diet is a common lifestyle modification recommended for Meniere's disease to help reduce fluid retention.

Conclusion: Finding the Right Path to Treatment

Betahistine has a complex history in the US, leading to its current non-commercial status despite its popularity elsewhere. For a US patient asking, “What is betahistine called in the US?”, the simple answer is that it has no mainstream commercial name. However, with a doctor's prescription, it is accessible through the specialized process of compounding. Patients must weigh this option against FDA-approved, commercially available alternatives like meclizine, diuretics, or physical therapy. Choosing the right path involves a detailed discussion with an ENT or other specialist to consider factors like cost, potential side effects, and the severity of symptoms. For some, the compounded version of betahistine may offer benefits not found in other treatments, while for others, a combination of standard therapies is the most effective approach.

For more information on vestibular disorders and their management, a reputable resource is the Vestibular Disorders Association (VeDA) at https://vestibular.org/.

Potential Side Effects and Considerations

While generally considered safe, betahistine can cause side effects. Awareness of these is important for anyone considering compounded medication.

Common side effects include:

  • Nausea and upset stomach
  • Indigestion
  • Headache
  • Bloating or abdominal discomfort

Less common side effects can include allergic skin reactions, such as rash and itching. Individuals with a history of peptic ulcers or asthma should use caution and consult their doctor, as betahistine is a mild H2 agonist and could potentially exacerbate these conditions.

Summary of Key Takeaways

  • No Commercial US Name: Betahistine is not sold under a commercial brand name like Serc in the United States.
  • Available via Compounding: A doctor's prescription allows a patient to get betahistine from a compounding pharmacy in the US.
  • FDA Approval Withdrawn: The FDA rescinded approval for betahistine in the 1970s due to insufficient evidence of efficacy, unlike its status in Europe.
  • US Alternatives: Common treatments in the US for vertigo and Meniere's include FDA-approved medications like meclizine (Antivert) and diuretics.
  • Less Sedating Than Antihistamines: Betahistine is not associated with the same sedative effects as traditional antihistamines like meclizine.
  • Discuss with a Specialist: Choosing the right treatment requires a thorough consultation with an ear, nose, and throat (ENT) specialist or other qualified healthcare provider to discuss options and risks.

Frequently Asked Questions

The US Food and Drug Administration (FDA) withdrew its approval for betahistine in 1971, citing a lack of sufficient evidence regarding its effectiveness.

There is no direct US equivalent to betahistine that is commercially available. US doctors may prescribe alternative medications like meclizine (Antivert) or diuretics for managing vertigo and Meniere's disease symptoms.

With a prescription from a licensed US physician, you can obtain betahistine through a specialized compounding pharmacy.

Serc is a brand name for betahistine used in many countries, such as the UK, but it is not available commercially in the US.

Compounded medications, including betahistine, are typically not covered by health insurance policies, and patients usually pay out-of-pocket.

Betahistine is a histamine analog that improves inner ear blood flow and is less sedating, while meclizine is an antihistamine that suppresses the vestibular system and can cause drowsiness.

Common side effects include nausea, headache, indigestion, and upset stomach, which are generally mild. Taking the medication with food can help reduce some of these effects.

References

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Medical Disclaimer

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