Warnings for varenicline, bupropion; pacemaker recalled

A summary of approvals, recalls, warnings and alerts digested by ACP Internist from the Food and Drug Administration's alerts.

Recalls, alerts, label changes

A stronger boxed warning about potential overdose with drugs containing propoxyphene (Darvon, Darvoc), as well as a patient medication guide about proper use of the drugs.


A boxed warning for smoking cessation drugs varenicline (Chantix) and bupropion (Zyban, Wellbutrin) about the risk of serious mental health events, including changes in behavior, depressed mood, hostility and suicidal thoughts. Providers should monitor patients who start these drugs for changes in mood or behavior.

A Class 1 recall for some Medtronic Kappa Series 600/700/900 and Sigma Series 100/200/300 pacemakers due to a separation of wires that connect the electronic circuit to other pacemaker components. Patients with these models should determine if their pacemaker is part of this recall by contacting Medtronic at 1-800-505-4636. Malfunctioning pacemakers may lead to fainting or lightheadedness and, in rare cases, serious injury or death.

A recall of several brands of skin sanitizer and skin protectant made by Clarcon Biological Chemistry Laboratory Inc. due to high levels of disease-causing bacteria in the products. Some of the bacteria can cause opportunistic infections of the skin and underlying tissues that may require medical attention and/or result in permanent damage. Products affected by the recall include Citrushield Lotion, Dermasentials DermaBarrier, Dermassentials by Clarcon Antimicrobial Hand Sanitizer, Iron Fist Barrier Hand Treatment, Skin Shield Restaurant, Skin Shield Industrial, Skin Shield Beauty Salon Lotion, Total Skin Care Beauty and Total Skin Care Work.

Mortality may increase in stable liver transplant patients after conversion from a calcineurin inhibitor (CNI)-based immunosuppressive regimen to sirolimus (Rapamune), according to clinical trial data by manufacturer Wyeth. The FDA will continue to examine the data to determine whether a labeling change is needed; in the meantime, doctors should use the drug's professional labeling as a therapy guide.

A risk of serious liver injury, including liver failure and death, in adult and pediatric patients taking propylthiouracil. Thirty-two patient reports of serious liver injury with propylthiouracil have been made to the FDA's Adverse Event Reporting System (AERS), compared to five reports with methimazole. Patients on propylthiouracil therapy should be closely monitored for symptoms and signs of liver injury, especially during the first six months after the start of therapy.

A request to manufacturers of leukotriene modifiers to include a precaution on labels about reports of neuropsychiatric events (behavior, mood changes) in people taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR).

A public health advisory that stolen vials of long-acting Levemir (generic: insulin detemir) have reappeared and are being sold in the U.S. market. About 129,000 vials were stolen and may not have been stored or handled properly; thus, they may not be safe to use. At least one patient has suffered an adverse event due to poor glucose control after using a stolen vial. Affected lot numbers are XZF0036, XZF0037, and XZF0038.

An alert that Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size have been linked with long-lasting or permanent anosmia in more than 130 reports. Though the products have been discontinued, some consumers may still have them in their homes.

A manufacturer's recall of erectile dysfunction supplement Stamina-Rx, because an analysis found a sample contained benzamidenafil, which isn't FDA-approved. The affected lot number is 08141578, but all lots are being recalled.


Dronedarone (Multaq) tablets, to help maintain normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter. The drug is approved for patients whose hearts have returned to normal rhythm or who will undergo drug or electric shock treatment to restore a normal heartbeat.

Pemetrexed (Alimta), the first drug available for maintenance therapy of advanced or metastatic lung cancer. Reported adverse events include damage to blood cells, fatigue, nausea, loss of appetite, tingling or numbness in the hands and feet, and skin rash.