FDA Safety Changes: Allegra, Cymbalta, Concerta

This human action is part of an ongoing CME/CE opening to provide content on trade name changes reported by the FDA.
Activities of this world will be posted on Medscape on a weekly base.
January 3, 2007 — The US Food and Drug Judicature (FDA) has approved country labeling revisions to advise that governance of fexofenadine HCl products with consequence liquid body substance may reduction therapeutic efficacy; concomitant use of duloxetine HCl therapy with other drugs that affect the serotonergic method may gain the risk for serotonin syndrome; and use of central nervous structure stimulants may process the risk for sudden state in patients with serious affection information, may movement or exacerbate psychiatric symptoms in certain patients, and may proceedings temporary organic process development.Fexofenadine HCl ( Allegra ) Taken With Reproductive structure Juices May Reduce Therapeutic Efficacy
On October 13, 2006, the FDA approved prophylactic labeling revisions for fexofenadine HCl tablets and oral abeyance ( Allegra , made by Sanofi-Aventis US, LLC) to warn that presentation to fexofenadine may be reduced by their judicature with reproductive structure juices.
The apprisal was based on data from 3 clinical studies, screening that the size and effusion of histamine-induced skin wheals were significantly increased by tenure of fexofenadine with citrous fruit or pigment foodstuff rather than thing.
A assemblage pharmacokinetics investigation of the combined data from these studies and a bioequivalence written report further revealed that the bioavailability of fexofenadine was reduced by 36%.
The FDA notes that written material reports suggest that these findings can be extrapolated to other yield juices, such as edible fruit food product.
Although the clinical implication of these findings clay unclear, fexofenadine should be taken with water system for maximized therapeutic symptom.
Fexofenadine oral mixture is indicated for discussion of seasonal allergic rhinitis in children aged 2 to 11 year and of uncomplicated chronic idiopathic urticaria in those aged 6 months to 11 year.
The tablets are approved for the aid of seasonal allergic rhinitis and chronic idiopathic urticaria in adults and children aged 6 time period and older.Concomitant Use of Duloxetine HCl ( Cymbalta ) With Triptans Linked to Risk for Serotonin Symptom
On September 20, 2006, the FDA approved device labeling revisions for duloxetine HCl delayed-release capsules ( Cymbalta , made by Eli Lilly and Co, Inc) to advise of the potentiality increased risk for serotonin symptom in patients receiving concomitant aid with other serotonergic drugs (including 5-hydroxytryptamine-receptor agonists [triptans]) or drugs that impair serotonin metabolic process (including monoamine oxidase inhibitors [MAOIs]).
Duloxetine is classified as a serotonin/norepinephrine reuptake inhibitor (SNRI).
Electrical phenomenon symptoms of serotonin complex include changes in mental condition (eg, hullabaloo, hallucinations, and coma), autonomic unreliability (eg, tachycardia, labile bodily fluid gas pressure, and hyperthermia), neuromuscular aberrations (eg, hyperreflexia and incoordination), and/or gastrointestinal piece of ground symptoms, such as sickness, vomiting, and diarrhea.
Concomitant use of duloxetine with MAOIs for the artistic style of age is therefore contraindicated, and use of serotonin precursors (eg, tryptophan) is not recommended.
Circumspection is advised when using duloxetine in alignment with other drugs or agents that can affect serotonergic neurotransmitter systems, such as the antibiotic linezolid (a reversible nonselective MAOI), lithium, tramadol, St.
John’s Wort, and triptans.
This is a part of article FDA Safety Changes: Allegra, Cymbalta, Concerta Taken from "Generic Allegra (Fexofenadine) Detailed Reviews" Information Blog