Expanded approval on rivaroxaban, reassurance on dabigatran

Details on recalls, warnings and approvals.

Recalls, warnings, label changes

A recall of all products distributed by Ameridose, LLC, due to a lack of sterility found in an ongoing FDA inspection. No infections have been reported with any of Ameridose's products. Six of the recalled products are on the FDA critical shortage list: injections of sodium bicarbonate, succinylcholine, atropine sulfate, bupivacaine hydrochloride, lidocaine hydrochloride and furosemide.

Photo by Thinkstock
Photo by Thinkstock.

A class I recall of Baxter Healthcare Corporation's buretrol solution sets because the ball-valve component is allowing air to flow past the valve and enter the tubing once the pre-measured amount of fluids is completely administered to the patient. If the air is not removed, the air present in the tubing may enter the patient's vascular system, potentially causing an air embolism and serious adverse health consequences, including death.

A recall of some of Ventlab Corporation's manual resuscitators because they have been found to potentially deliver little to no air/oxygen through the patient valve to the patient, which could result in life-threatening health consequences including hypoxia and hypoventilation.

A class I recall of Hospira's Symbiq infusion systems because infusion pump LCD touch screens may not respond, possibly resulting in a delayed response and/or the screen registering a different value from the one selected.

A class I recall of Ethicon Endo-Surgery circular stapler sets because of difficulty users have had firing the stapler devices, resulting in incomplete firing stroke and incomplete staple formation, which can result in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, and occlusion of the rectal canal.


An expanded indication for rivaroxaban (Xarelto) to include treating deep venous thrombosis (DVT) or pulmonary embolism (PE) and to reduce the risk of recurrent DVT and PE following initial treatment. The drug is already approved to reduce the risk of DVTs and PEs after knee or hip replacement surgery and the risk of stroke with nonvalvular atrial fibrillation. Approval is based on three studies finding that rivaroxaban was as effective as the combination of enoxaparin and a vitamin K antagonist for treating DVT.

Tofacitinib (Xeljanz) to treat adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to, or who are intolerant of, methotrexate. A pill taken twice daily, it works by blocking Janus kinases. Safety and effectiveness were evaluated in seven clinical trials in which patients experienced more improvement in clinical response and physical functioning than on placebo. The drug has a boxed warning about the risk of serious infections.

Perampanel (Fycompa) to treat partial-onset seizures in patients with epilepsy ages 12 years and older. Three clinical trials showed improvement in seizure control compared to placebo. The most common adverse reactions reported in clinical trials include dizziness, drowsiness, fatigue, irritability, upper respiratory tract infection, weight increase, vertigo, ataxia, gait disturbance, balance disorder, anxiety, blurred vision, aggression, and hypersomnia. The drug carries a boxed warning about the risk of serious neuropsychiatric events.

An expanded indication for the Sapien Transcatheter Heart Valve (THV) to include patients with aortic valve stenosis who are eligible for surgery but who are at high risk for serious surgical complications or death. The Sapien THV was approved in 2011 for patients with inoperable aortic valve stenosis. The expanded approval was based on a study of surgical patients who received the Sapien THV and similar patients who received aortic valve replacement through open-heart surgery. Both groups had similar death rates at one month, one year, and two years after the procedures.

Ocriplasmin (Jetrea), the first drug approved to treat symptomatic vitreomacular adhesion (VMA). An enzyme that breaks down proteins in the eye responsible for VMA, ocriplasmin is an alternative to vitrectomy. Safety and effectiveness were established in two clinical studies in which 26% of patients randomly assigned to receive a single injection of the drug had VMA resolve compared to 10% with placebo.