Related Experiment Videos
Is my antihistamine safe?
1Mercer University's Southern School of Pharmacy, Atlanta, GA 30341-4155, USA.
Home Care Provider
|June 1, 1997
Summary
The FDA is withdrawing approval for terfenadine (Seldane) and related products due to cardiac risks. Fexofenadine (Allegra), its active metabolite, was approved after benefits were weighed against these risks.
Area of Science:
- Pharmacology and Drug Safety
- Regulatory Affairs
- Cardiovascular Toxicology
Background:
- Terfenadine (Seldane) and its combination product Seldane D, along with generic versions, faced scrutiny for serious cardiac effects.
- The U.S. Food and Drug Administration (FDA) previously assessed the risk-benefit profile of terfenadine.
Purpose of the Study:
- To inform stakeholders about the FDA's decision regarding the withdrawal of terfenadine and its associated products.
- To highlight the regulatory pathway and safety considerations for antihistamines.
Main Methods:
- Regulatory review and decision-making by the FDA.
- Assessment of drug safety data, including potential cardiac adverse events.
Main Results:
- The FDA announced its intent to withdraw marketing approval for terfenadine, terfenadine with pseudoephedrine (Seldane D), and generic terfenadine.
- Fexofenadine (Allegra), the active metabolite of terfenadine, was approved by the FDA.
Conclusions:
- The FDA's decision reflects a re-evaluation of terfenadine's safety profile, prioritizing patient well-being.
- The approval of fexofenadine signifies a safer alternative, with its benefits deemed to outweigh its risks.