Different lots of brand-name and generic versions of extended-release venlafaxine are being recalled because of a report that one bottle contained a capsule of the antiarrhythmic drug dofetilide, according to the Food and Drug Administration.
A statement posted March 7 on the agency’s MedWatch site said that Pfizer has issued a voluntary recall of one lot of 30-count venlafaxine 150-mg extended-release capsules (marketed as Effexor XR), one lot of 90-count Effexor XR 150-mg capsules, and one lot of 90-count Greenstone LLC brand of venlafaxine 150-mg extended release capsules.
The recall was spurred by a pharmacist’s report that a 0.25-mg capsule of dofetilide (Tikosyn) was found in a bottle of Effexor XR.
"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 notice said.
Tikosyn, also manufactured by Pfizer, is a class III antiarrhythmic drug that is approved for treating atrial fibrillation/atrial flutter. The drug’s label includes a black box warning that recommends patients start treatment in a facility where they can be closely monitored, to minimize the risk of a dofetilide-induced arrhythmia. There is also a Risk Evaluation and Mitigation Strategy (REMS) in place that addresses this risk. The affected venlafaxine XR products are Pfizer lot numbers V130142 and V130140, which both expire in October 2015; and Greenstone lot number V130014, which expires in August 2015. Patients who have the affected product are being advised to call their physicians and/or return the product to their pharmacies. The FDA advises patients with questions to call Stericycle at 888-345-0481 (Mon.-Fri., 8 a.m. to 5 p.m., Eastern time); or Pfizer, at 800-438-1985 (Mon.-Thur., 9 a.m. to 8 p.m., Eastern time or Fri., 9 a.m. to 5 p.m., Eastern time).
Adverse events associated with the use of these products should be reported to MedWatch at or 800-332-1088.