Pfizer manufactures anti-depressants including Effexor and has initiated a nationwide voluntary recall of two lots of pfizer’s Effexor XR® 150 Mg extended-release capsules and one lot of Greenstone’s Venlafaxine HCl 150 Mg extended-release capsules due to the possible presence of Tikosyn® capsules.
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.
The recall was initiated as a pharmacists reported that one bottle of Pfizer’s Effexor XR contained one capsule of Tikosyn® (dofetilide) 0.25mg in addition to the Effexor XR capsules. 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.
The products were distributed nationally to wholesalers, distributors, certain government agencies, patient assistance programs and retailers, such as pharmacies and hospitals and involves Pfizer lot numbers V130142 and V130140, which both expire in October 2015, and Greenstone lot number V130014, which expires in August 2015.
Patients with questions regarding the return of product should contact Stericycle at 1-888-345-0481 (Monday to Friday 8am to 5pm ET). Patients with questions regarding this recall can contact Pfizer Medical Information at 1-800-438-1985 (Monday to Thursday 9am to 8pm ET or Friday, 9am to 5pm ET).
Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.
Complete and submit the report online: www.fda.gov/medwatch/report.htm
Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
MacKay Jimeson, 212.733.2324
Ryan Crowe, 212.733.8160