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Is Diamox being discontinued?: Navigating the medication landscape

4 min read

In 2014, the FDA determined that the brand-name Diamox tablets and intravenous solution were not withdrawn for safety or effectiveness reasons, despite being listed as discontinued. This clarification is crucial for patients asking, 'Is Diamox being discontinued?' because the active ingredient remains widely available.

Quick Summary

The brand name Diamox has been discontinued for certain formulations, but the active ingredient, acetazolamide, is widely produced as a generic drug. Supply shortages can occur, but bioequivalent alternatives and other treatments are accessible for patients.

Key Points

  • Brand name discontinued: The original brand-name Diamox tablets and extended-release capsules are no longer marketed in the U.S..

  • Generic version widely available: The active ingredient, acetazolamide, is widely produced by multiple generic manufacturers and remains available in various forms.

  • FDA approved generics: The FDA confirmed the brand's withdrawal was not for safety or effectiveness reasons, allowing generics to thrive.

  • Potential for shortages: Generic acetazolamide can experience intermittent shortages due to supply chain factors, as tracked by health organizations like ASHP.

  • Generic is bioequivalent: Generic acetazolamide is proven to work the same way as the brand name, providing equivalent therapeutic efficacy and safety.

  • Alternative treatments exist: For conditions like glaucoma and altitude sickness, other drug classes and treatment options are available if acetazolamide is not suitable.

  • Consult your pharmacist: When facing a shortage, speaking with a pharmacist can help locate stock from different manufacturers or find pharmacies with current inventory.

In This Article

For years, patients and healthcare providers have had to contend with confusion surrounding the availability of Diamox. The short answer to the question "Is Diamox being discontinued?" is that while the specific brand-name version from Teva Pharmaceuticals is no longer on the market in the U.S., the drug's active ingredient, acetazolamide, is still readily available from numerous generic manufacturers. This distinction is vital for patients relying on this medication for a variety of critical conditions.

Discontinuation of the Brand Name

In 2014, the Food and Drug Administration (FDA) issued a notice confirming its determination that the brand-name products—Diamox (acetazolamide) intravenous and Diamox (acetazolamide) tablets—were not withdrawn from sale for safety or effectiveness reasons. Rather, the brand's manufacturer, Teva, made a business decision to stop producing these versions. The FDA's decision was an important step that ensured the approval process for generic equivalents could proceed, allowing multiple companies to produce and market their own versions of acetazolamide. This decision prevented the loss of a key medication from the market.

Separately, the extended-release capsule version, known as Diamox Sequels, also saw its brand name discontinued in the U.S.. The manufacturer of this formulation confirmed the discontinuation, but again, generic versions were made available to fill the void.

Understanding Generic Acetazolamide

When a drug's patent expires and the brand-name version is discontinued, generic manufacturers can produce and market their own versions, provided they are proven to be bioequivalent. Bioequivalence means the generic drug contains the same active ingredients and is absorbed by the body at the same rate and to the same extent as the original brand-name drug.

Multiple Generic Manufacturers

Today, a number of pharmaceutical companies manufacture generic acetazolamide. This includes a variety of dosage forms to meet patient needs. A key benefit of this competition is the significantly lower cost of generic medications compared to their brand-name counterparts. Patients seeking acetazolamide for conditions like glaucoma or altitude sickness can typically obtain the generic version at a lower price point, offering significant long-term savings.

Efficacy and Safety

Studies have confirmed that generic acetazolamide is therapeutically equivalent to the brand-name version. While some patients may report perceived differences in side effects or efficacy, these are often related to inactive ingredients, not the active component. The FDA rigorously tests all generic medications to ensure they meet the same high standards for safety and efficacy as brand-name drugs.

Navigating Shortages and Supply Issues

While the active ingredient remains available, the supply chain for generic drugs can be subject to its own challenges, leading to intermittent shortages. For example, reports from the American Society of Health-System Pharmacists (ASHP) have indicated recent shortages for acetazolamide injection. These supply disruptions can arise from manufacturing delays, raw material availability, or increased demand.

Tips for managing potential shortages:

  • Communicate with your pharmacist: Pharmacists are often aware of supply issues and can help locate stock at other pharmacies or from different manufacturers.
  • Explore different dosage forms: If one form (e.g., extended-release capsules) is in short supply, your doctor may be able to prescribe an immediate-release tablet as an alternative, though the dosing schedule may differ.
  • Consider online pharmacies: Some online healthcare platforms and pharmacies can help patients obtain prescriptions and ship medications directly.

Brand-Name Diamox vs. Generic Acetazolamide

This comparison table helps clarify the differences for patients concerned about the change from brand-name Diamox to generic acetazolamide.

Feature Brand-Name Diamox Generic Acetazolamide
Availability Discontinued in the U.S. for tablets and intravenous injection. Diamox Sequels capsules also discontinued. Widely available as tablets, extended-release capsules, and injections from various manufacturers.
Cost Was significantly more expensive due to initial research, development, and marketing costs. Substantially cheaper, offering cost-effective treatment for patients.
Efficacy Proven effective and set the standard for treatment. Proven to be therapeutically equivalent and effective, delivering the same clinical outcomes.
Inactive Ingredients Contained specific fillers and dyes used by the original manufacturer. May contain different inactive ingredients (e.g., fillers, dyes), which can sometimes affect tolerability for sensitive patients.
Manufacturer Teva Pharmaceuticals (no longer produced). Produced by numerous companies including Zydus, Heritage, Accord, and others.

Alternative Medications

For patients who cannot tolerate or find a suitable acetazolamide product, there are therapeutic alternatives depending on the condition being treated.

Glaucoma

For glaucoma, acetazolamide is just one option among a range of medications designed to lower intraocular pressure. Alternatives include:

  • Prostaglandin Analogs: Such as latanoprost (Xalatan) and bimatoprost (Lumigan).
  • Beta-Blockers: Such as timolol (available generically).
  • Topical Carbonic Anhydrase Inhibitors: Such as dorzolamide (Trusopt) and brinzolamide (Azopt).
  • Rho Kinase Inhibitors: Such as netarsudil (Rhopressa).

Altitude Sickness

Acetazolamide is highly effective for preventing and treating altitude sickness. While it is the standard, some patients may consider other options under a doctor's supervision:

  • Ibuprofen: Shown to be effective for altitude sickness, though potentially less so than acetazolamide.
  • Ginkgo Biloba: Though sometimes suggested, it has not been proven as an effective alternative for preventing altitude sickness.

Conclusion

While the brand-name Diamox is no longer manufactured, the active pharmaceutical ingredient, acetazolamide, is widely available through multiple generic drug manufacturers. Patients should not interpret the brand's discontinuation as a loss of access to this important medication. While supply chain issues can lead to temporary shortages, diligent communication with pharmacists and doctors can help ensure continued access. Generic versions are bioequivalent, more affordable, and thoroughly regulated by the FDA. For those unable to use acetazolamide, a range of alternative medications exists for treating conditions such as glaucoma. Patients should always consult their healthcare provider to navigate the best treatment options for their specific needs, especially when dealing with potential supply chain variations or considering therapeutic alternatives. For further information on drug availability, authoritative sources like the American Society of Health-System Pharmacists provide regular updates on shortages.

Frequently Asked Questions

No, the original brand-name Diamox tablets and intravenous solution from Teva Pharmaceuticals have been discontinued. The brand-name extended-release capsules (Diamox Sequels) were also discontinued in the U.S..

Yes, generic acetazolamide contains the same active ingredient and is considered bioequivalent by the FDA. It is expected to produce the same therapeutic effect as the original brand-name drug.

The brand name was likely discontinued for business reasons, not due to any issues with the medication's safety or effectiveness. The FDA explicitly stated it found no safety or effectiveness concerns during its review.

Shortages can occur due to various factors affecting the drug supply chain, including manufacturing delays, unexpected increases in demand, raw material availability, and distribution challenges.

You should speak with your pharmacist about ordering from a different generic manufacturer or explore online options. Contact your doctor to discuss if an alternative drug or dosage form is appropriate.

Yes, several other drug classes are used to treat glaucoma, such as prostaglandin analogs (e.g., latanoprost), beta-blockers (e.g., timolol), and topical carbonic anhydrase inhibitors (e.g., dorzolamide).

No, acetazolamide is a prescription-only medication and is not available over the counter. You must consult a healthcare provider to obtain a prescription.

Yes, the FDA has approved numerous generic manufacturers to produce and market acetazolamide. This process was facilitated by the FDA's 2014 determination that the brand name was not withdrawn for safety reasons.

References

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Medical Disclaimer

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