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PRAC Reviews Hydroxyzine-Containing Drugs

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Jarod Cassidy3 years ago

The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) has launched a review of hydroxyzine-containing drugs, sold as Vistaril and Atarax,  due to concerns of cardiac events.

About the Hydroxizine Review

According to Medscape, the PRAC review was initiated in response to safety monitoring data and published experimental studies which indicate that hydroxizine-containing drugs can result in increased risk of altercations to the electrical activity of the heart and arrhythmia.

Hydroxizine-containing medications are approved in the U.S. and most European Union countries and are often prescribed for the treatment of pruritus, anxiety, and sleep disorders.

The review will revisit all available data on the risks and benefits of hydroxyzine-containing drugs, and PRAC will issue an opinion on whether marketing authorizations should continue for current indications.

Until the review is completed, patients are advised to speak to their pharmacist or physician about any concerns.

Hydroxyzine Side Effects

The following adverse events have been recorded in patients taking hydroxyzine-containing medications:

  • Suicide
  • Toxicity
  • Renal failure
  • Toxic skin eruption
  • Tremor
  • Rash
  • Poisoning
  • Depression
  • Stevens-Johnson syndrome
  • Anaphylactic shock
  • Death


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