Pacemakers, skin sanitizers recalled


Recalls, alerts, label changes

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.

Art 1

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.

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.

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, and thus 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 lots 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 these 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.

Approvals

Caldolor, an injectable ibuprofen. Available for hospital use only, it is approved for 400-mg to 800-mg doses over 30 minutes, every six hours for acute pain. For fever, the drug is approved in a 400-mg dose administered over 30 minutes, followed by 400 mg every four to six hours, or 100 to 200 mg every four hours, as necessary. It should be used cautiously in patients with congestive heart failure and kidney impairment, and with those at risk of blood clots and/or who have a history of ulcers or gastrointestinal bleeding.

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.

Miscellaneous

An FDA analysis has determined there isn't a higher mortality risk with cefepime (Maxipime) compared to similar drugs. The analysis was triggered by a journal article suggesting a higher rate of death in cefepime patients. The FDA will continue to review the safety of cefepime using hospital drug utilization data and will report results in about a year.