Pfizer Antidepressant Recalled

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The world’s largest pharmaceutical company, Pfizer Inc, has recalled three lots of the antidepressant Effexor XR, 150mg (generic name: venlafaxine HCl) because of suspected contamination with Tikosyn 0.25mcg (generic name: dofetilide) a heart drug used to treat atrial fibrillation. The two drugs are contraindicated: interaction between the two may cause serious adverse health consequences and is potentially fatal.

Pfizer issued the antidepressant’s recall based on a report by a pharmacist that indicated a single bottle of Effexor was found to contain a capsule of Tikosyn. Pfizer recalled the three lots of Effexor out of caution, stating that it is unlikely that other bottles were contaminated; however, all three lots were run on the same packaging line. The specific lot numbers affected by the recall are: V130142, V130140 (both labeled Effexor XR 150mcg, to expire in October 2015) and lot number V130014 (Greenstone-branded Venlafaxine HCl, due to expire in August 2015).  The three lots total about 104,450 bottles; approximately 65,800 have already been distributed.

Pfizer has informed its customers, including hospitals, pharmacies, government agencies, and distributors about the recall, and requested the customers immediately stop distribution and promptly return any recalled product to Stericycle Inc. Patients with questions about returning the product should call Stericycle at 1-888-345-0481 (Monday to Friday, 8 a.m. to 5 p.m. ET). Pharmacists have been asked to discontinue distribution of any of the recalled lot numbers in their possession, and to quarantine and return the recalled products. Pharmacists have also been requested to notify any of their customers who may have received the products.

Effexor is an antidepressant prescribed for treating patients with social anxiety, general anxiety, panic disorder, and major depressive disorder. Effexor XR can be reasonably distinguished from Tikosyn by sight: Effexor XR 150mg is an orange capsule, 22mm long, imprinted with the words “Effexor XR 150.” Tikosyn 0.25mcg is also an orange capsule, lighter in color than Effexor but only 14mm in length, and imprinted “PFIZER TKN 250.”  Consumers of the medication are instructed to contact a doctor or hospital if they experience any sign of a fast or abnormal heartbeat, faintness or dizziness, or any other problems that may be related to taking the drug. Adverse reactions experienced by patients using this product may be reported either online, by regular mail or by fax to the FDA’s MedWatch Adverse Event Reporting program. Patients with questions about the recall can call Pfizer Medical Information at 1-800-438-1985 (Monday to Thursday, 9 a.m. to 8 p.m. ET, or Friday, 9 a.m. to 5 p.m. ET).

Investors with an interest in Pfizer worried about the potential financial impact of the antidepressant’s recall on the pharmaceutical giant may be reassured.  Pfizer’s patent on Effexor XR’s expired in 2008 and Effexor XR generics became available two years later. Effexor XR brought in $2.5 billion a year before the generics made their debut, but dropped 61 percent the first year the generics became available. The drug still racked up a respectable $114 million in global sales in 2013, up 37 percent from 2012, but nonetheless a relatively small proportion of Pfizer’s total profits of $13.56 billion in 2013.

By Laura Prendergast

Medscape Medical News

Wall Street Journal

Businessweek

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