Pfizer recalled one lot of 30-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules, one lot of 90-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules and one lot of 90-count Greenstone LLC-branded Venlafaxine HC1 150 mg extended-release capsules. A pharmacist reported that one bottle of Pfizer’s Effexor XR contained one capsule of Tikosyn (dofetilide) 0.25mg in addition to the Effexor XR capsules. These three lots are being recalled as a precaution because they were packaged on the same line.
The use of Tikosyn by an Effexor XR/Venlafaxine HCl patient, where the contraindications and drug-drug interactions with Tikosyn have not been considered by the prescribing physician, could cause serious adverse health consequences that could be fatal.
Effexor XR is a prescription antidepressant indicated for the treatment of major depressive disorder, general anxiety disorder, social anxiety disorder, and panic disorder with or without agoraphobia. Tikosyn is a Class III (cardiac action potential duration prolonging) antiarrhythmic drug. It is used to treat irregular heartbeats (such as atrial fibrillation (AF) and atrial flutter (AFL)) and to maintain normal sinus rhythm (normal heartbeat) in patients with AF or AFL of greater than one week duration who have been converted to normal sinus rhythm.
Tikosyn can cause serious side effects, including a type of abnormal heartbeat called Torsade de Pointes, which can lead to death. If an Effexor XR/Venlafaxine HCl patient thinks they may have mistakenly ingested a Tikosyn capsule, they should immediately contact their physician or hospital. Patients should also watch for signs of abnormal heartbeat, and inform their physician or hospital if they feel faint, become dizzy, or have a fast heartbeat.
This recall involves Pfizer lot numbers V130142 and V130140, which both expire in October 2015, and Greenstone lot number V130014, which expires in August 2015. These products were distributed nationally to wholesalers, distributors, certain government agencies, patient assistance programs and retailers, such as pharmacies and hospitals.
See the FDA Announcement
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication