Pfizer Inc said Thursday it was recalling two lots of its antidepressant Effexor XR along with another lot of its generic version of the drug. The announcement comes following a discovery by a pharmacist of a different drug inside an Effexor bottle.
"Although Pfizer has not received any other such reports, these three lots are being voluntarily recalled as a precaution because they were packaged on the same line," Pfizer said in an announcement.
The drug the pharmacist found was Tikosyn, which is used for a common and potentially dangerous irregular heartbeat called atrial fibrillation.
"The use of Tikosyn by an Effexor XR 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," Pfizer said.
Potential serious side effects of Tikosyn include a type of abnormal heartbeat called Torsade de Pointes, which can lead to death.
Pfizer said that among the three lots are about 104,450 bottles of the medicine. Of those bottles, about 65,800 had reached U.S. pharmacies. The recall included one lot of 30-count bottles of Effexor XR, one lot of 90-count bottles of the branded drug and one lot of venlafaxine 150 mg extended release capsules sold by Greenstone LLC, a generic drugmaker owned by Pfizer.
The recall has not affected generic versions of the drug made by other manufacturers.
The FDA has asked pharmacists to immediately quarantine and return all recalled lots, and also notify any customers to whom the recalled products have been distributed. Patients who have the affected capsules should notify their physicians and/or return them to their pharmacies, Pfizer said. Patients should also contact their physician or health care provider if they have noticed any problems that may be related to taking the drug.
Pfizer said that if patients mistakenly take a Tikosyn capsule, they should immediately contact their physician or hospital. They should also watch for signs of abnormal heartbeat and let their physician or hospital know if they become dizzy, feel faint or have a fast heartbeat.
Pfizer said that patients who have questions regarding the return of the product should call Stericycle at 1-888-345-0481. Those with questions regarding the recall can contact Pfizer Medical Information at 1-800-438-1985.
"Pfizer has responded rapidly to this situation to ensure the safety of patients who take our medicines," Pfizer said. "This recall is being conducted with the knowledge of the U.S. Food and Drug Administration."
