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Why was Atarax discontinued? A look into the business and availability of hydroxyzine

5 min read

The brand-name medication Atarax was discontinued in the U.S. in 2021 due to business-related factors by its manufacturer, and not for any safety or effectiveness reasons, according to the FDA. Patients who relied on Atarax should know that its active ingredient, hydroxyzine hydrochloride, remains widely available through generic versions.

Quick Summary

Atarax was discontinued in the U.S. for business reasons and not due to safety or efficacy issues. The generic version, hydroxyzine hydrochloride, remains widely available and is an affordable alternative for patients.

Key Points

  • Business Decision: Atarax was discontinued in the U.S. in 2021 due to business-related factors by its manufacturer, not safety or effectiveness concerns.

  • Generic Availability: The active ingredient, hydroxyzine hydrochloride, remains widely available in affordable generic forms, so patients can still access the medication.

  • Atarax vs. Vistaril: Atarax (hydroxyzine hydrochloride) and Vistaril (hydroxyzine pamoate) contain the same active ingredient but differ in their salt formulation, dosage forms, and historical marketing.

  • Not a Safety Recall: The U.S. FDA has confirmed that the brand-name product was not withdrawn for safety reasons, though international regulatory bodies have noted potential heart rhythm risks at higher doses.

  • Patient Transition: For those who relied on brand-name Atarax, switching to a generic hydroxyzine hydrochloride is a safe and common practice, managed by a healthcare provider.

In This Article

The Shift from Branded to Generic Medication

Atarax, the brand name for hydroxyzine hydrochloride, has been a staple in medicine cabinets for decades. First introduced by Pfizer in 1956, it served as a versatile first-generation antihistamine with sedative properties. It was commonly prescribed for a variety of conditions, including the symptomatic relief of anxiety and tension, and to manage itching associated with allergic skin conditions like chronic urticaria and contact dermatitis. For many patients, the name Atarax became synonymous with hydroxyzine. However, as pharmaceutical patents expire, generic versions of medications often become more prevalent and affordable, a trend that significantly influenced the fate of brand-name Atarax. Generic hydroxyzine hydrochloride, produced by numerous manufacturers, offered the exact same active ingredient and therapeutic effect at a lower cost, leading to a shift in consumer and prescriber preferences.

Why the Brand Name Was Discontinued

The primary reason for the discontinuation of the brand-name Atarax was rooted in business economics, not patient safety. With the market saturated with cheaper generic versions, the economic viability of producing and marketing the branded medication diminished significantly. It is important to emphasize that this was a voluntary business decision made by the manufacturer. The U.S. Food and Drug Administration (FDA) has confirmed that Atarax was not withdrawn from the market for reasons related to safety or effectiveness. This determination is crucial for patients, as it reassures them that the medication itself is not unsafe, and a switch to the generic version is both safe and effective.

Business-related factors for discontinuation

  • Market competition: The rise of multiple generic manufacturers created a highly competitive market, driving down prices for hydroxyzine hydrochloride.
  • Cost-effectiveness: Insurers and patients increasingly opted for lower-cost generic alternatives, reducing the demand for the more expensive brand name.
  • Strategic shift: Companies sometimes choose to discontinue older, less profitable branded products to focus resources on newer, more lucrative medications.

Atarax vs. Vistaril: Understanding the Difference

Patients and healthcare professionals sometimes use the terms Atarax and Vistaril interchangeably or attribute different primary uses to them, but this is a common misconception. Both Atarax and Vistaril are brand names for the same active drug, hydroxyzine, but they utilize different salt forms.

  • Atarax (Hydroxyzine Hydrochloride): A water-soluble formulation typically available as tablets, syrup, and intramuscular injections. This formulation is often perceived as better for allergies and itching, a belief largely based on tradition rather than clinical evidence.
  • Vistaril (Hydroxyzine Pamoate): A less water-soluble, fat-soluble formulation typically available as capsules. It is often perceived as more effective for anxiety due to enhanced central nervous system effects, but both formulations are considered safe and effective for both anxiety and itching by the FDA.

Comparison of Hydroxyzine Formulations

Feature Atarax (Hydroxyzine Hydrochloride) Vistaril (Hydroxyzine Pamoate)
Salt Form Hydrochloride (HCl) Pamoate
Solubility Water-soluble Fat-soluble
Dosage Forms Tablets, Syrup, Injection Capsules
Brand Status Discontinued in U.S. Currently available brand
Availability Only available as generic Brand and generic available
Perceived Use Itching/Allergies (based on tradition) Anxiety (based on tradition)
FDA-Approved Uses Anxiety, itching, sedation Anxiety, itching, sedation

Despite the differences in formulation and historical marketing, the FDA approves both for the same indications. The choice between them often comes down to the desired dosage form and cost, rather than a significant difference in efficacy for a specific condition.

Availability and Cost of Hydroxyzine Today

Despite the discontinuation of brand-name Atarax, the medication is far from gone. Generic hydroxyzine is produced by numerous manufacturers and is readily available at most pharmacies, as confirmed by resources like GoodRx. For patients who were previously taking Atarax, a seamless transition to generic hydroxyzine hydrochloride is standard practice. The generic version is typically much more affordable than the former brand-name product, which is a major advantage for patients paying out-of-pocket or those with high insurance deductibles. Generic hydroxyzine hydrochloride is available as tablets (10mg, 25mg, 50mg), a syrup (10mg/5mL), and as an injection for certain clinical settings. Hydroxyzine pamoate is also widely available in generic capsule form.

Potential Safety Considerations

While the FDA did not cite safety concerns as the reason for Atarax's discontinuation in the U.S., it is worth noting international regulatory actions regarding hydroxyzine. In 2016, Health Canada conducted a safety review after the European Medicines Agency recommended limiting its use due to potential risks of abnormal heart rhythm, specifically QT interval prolongation. This can lead to a condition called Torsade de Pointes, which in rare cases can be fatal. As a result, Health Canada worked with manufacturers to update product information, recommending a shorter duration of use and lower maximum daily doses, particularly for adults and the elderly. These risks are generally associated with higher doses or with specific pre-existing heart conditions and are reflected in current product labeling.

Conclusion: Business Decisions, Not Safety Concerns, Led to Atarax's Exit

For those asking "why was Atarax discontinued?", the answer is straightforward and reassuring: it was a business decision unrelated to its safety or effectiveness. The active ingredient, hydroxyzine, is still widely available in both its hydrochloride and pamoate salt forms through numerous generic manufacturers. Patients can continue to access this medication for anxiety, allergies, and sedation with a simple switch to the generic version. The move away from branded medication towards more affordable generics is a common trend in the pharmaceutical industry, and the case of Atarax is a clear example of this dynamic at play.

For further information on drug shortages and availability, patients and healthcare providers can consult reputable resources like the FDA or the American Society of Health-System Pharmacists (ASHP) Drug Shortage database.

What to do if you were prescribed Atarax

Patients who have a prescription for Atarax or need a refill should consult with their doctor or pharmacist. A transition to the generic hydroxyzine hydrochloride is a simple and standard procedure. The change will not impact the effectiveness of the medication, but it will likely offer a more cost-effective option for the patient. The best course of action is to communicate with your healthcare provider to ensure a smooth and informed transition to the generic alternative.

Frequently Asked Questions

Atarax was a brand name for the drug hydroxyzine hydrochloride. Hydroxyzine is the active medicinal ingredient, and since Atarax was discontinued, it is now only available as a generic medication.

Yes, you can still get the generic version of Atarax, which is called hydroxyzine hydrochloride. It is widely available in tablet, syrup, and injection forms.

No, Atarax was not recalled for safety reasons. The U.S. FDA has confirmed that the discontinuation was due to business decisions made by the manufacturer, and not because of safety or effectiveness issues.

The main difference is their salt formulation and dosage forms. Hydroxyzine hydrochloride (formerly Atarax) is water-soluble and available in tablets, syrup, and injection, while hydroxyzine pamoate (Vistaril) is fat-soluble and available in capsules.

Vistaril is a different brand name for a hydroxyzine formulation (pamoate), while Atarax was for the hydrochloride version. The decision to discontinue the Atarax brand was a specific business choice, and did not impact the availability of Vistaril or generic hydroxyzine.

Yes, hydroxyzine is considered safe when used as prescribed. However, as with any medication, it has potential side effects. Some international regulatory bodies have issued warnings about potential risks of irregular heartbeat, especially at higher doses or in patients with pre-existing heart conditions. Always follow your doctor's instructions.

They contain the same active ingredient and are approved for the same uses. While some historical beliefs and marketing suggested different primary uses (Atarax for itching, Vistaril for anxiety), there is no significant clinical evidence to support one being superior to the other for a specific condition.

Yes, generic hydroxyzine hydrochloride contains the identical active ingredient and offers the same therapeutic effect as the brand-name Atarax. A switch to the generic version should not result in any difference in effectiveness for the patient.

References

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Medical Disclaimer

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