Dabigatran reversal agent approved

Details on the latest recalls, warnings, and approvals.

Recalls, warnings, safety alerts

A safety alert about reduced leaflet motion in some bioprosthetic aortic valves, including both surgical and transcatheter devices. Most advanced imaging studies that detected this reduced motion were in patients without symptoms of abnormal bioprosthetic valve function, and even in valves with reduced motion of 1 or more leaflets, there was acceptable forward blood flow through the valve opening without evidence of stenosis. The definitive cause of reduced leaflet motion remains unknown, although evidence suggests that thrombus deposits on the leaflets may cause restricted motion. At this time, the FDA believes that bioprosthetic aortic valves remain reasonably safe and effective when used for approved indications.

Photo by Thinkstock
Photo by Thinkstock

A warning not to use drug products made and distributed by Chen Shwezin Inc. that were intended to be sterile. Upon inspection of the facility, FDA investigators observed poor sterile production practices. The company, operating as Park Compounding Pharmacy, has agreed to cease sterile operations but has refused to recall its products. The FDA is not aware of any adverse events resulting from use of these products.

A recall of the modular neck of the Profemur Neck Varus/Valgus CoCR because of an unexpected rate of fractures after total hip replacement surgery related to a specific part. If the modular neck fractures, a patient may experience sudden pain, instability, and difficulty walking and performing common tasks. An acute fracture requires revision surgery to remove and replace the neck and stem components of the prosthesis.


Idarucizumab (Praxbind) for emergency situations when there is a need to reverse dabigatran (Pradaxa). The intravenous injection, the first reversal agent approved specifically for dabigatran, works by binding to the drug compound to neutralize its effect. In 3 trials of 283 healthy volunteers taking dabigatran, idarucizumab immediately reduced the amount of dabigatran in participants' blood, and this effect lasted for at least 24 hours. The most common side effect from idarucizumab was headache. In another trial of 123 patients taking dabigatran who had uncontrolled bleeding or need for emergency surgery, the anticoagulant effect was fully reversed in 89% of patients within 4 hours of receiving idarucizumab. The most common side effects in this trial were hypokalemia, confusion, constipation, fever, and pneumonia.

Insulin degludec injection (Tresiba) and insulin degludec/insulin aspart injection (Ryzodeg 70/30) to improve glucose control in adults with diabetes. The former, a long-acting insulin analog for both type 1 and 2 diabetes, is subcutaneously administered once daily at any time of day. The latter, administered once or twice daily, is a mixture of a long-acting insulin analog (insulin degludec) and a rapid-acting human insulin analog (insulin aspart). The most common side effects are hypoglycemia, allergic reactions, injection-site reactions, lipodystrophy, itching, rash, edema, and weight gain. Both drugs are contraindicated for patients with diabetic ketoacidosis.

Combination trifluridine and tipiracil (Lonsurf) for patients with metastatic colorectal cancer who are no longer responding to chemotherapy and biological therapy. In a study of 800 patients with previously treated metastatic colorectal cancer, patients treated with the oral drug lived an average of 7.1 months, compared to 5.3 months for those treated with placebo. Average time to disease progression was 2 months for treated patients, compared to 1.7 months for those receiving placebo. The most common side effects are anemia, neutropenia, thrombocytopenia, physical weakness, fatigue, nausea, decreased appetite, diarrhea, vomiting, abdominal pain, and fever. Clinicians should obtain complete blood counts before starting each treatment cycle and monitor patients throughout treatment, as it may cause myelosuppression.

Aripiprazole lauroxil (Aristada) for adults with schizophrenia. The drug is administered every 4 to 6 weeks using an injection in the arm or buttocks. In a trial of 622 patients with acute schizophrenia who had been stabilized with oral aripiprazole, the drug maintained the treatment effect compared to placebo. The most common side effect is akathisia.

An expanded indication for the Optune device to treat patients with newly diagnosed glioblastoma multiforme (GBM). Initially approved in 2010 for patients with GBM that recurred or progressed after chemotherapy, it may now be given along with temozolomide, following standard treatments including surgery, chemotherapy, and radiation therapy. In a clinical trial of 695 patients, those treated with the device and temozolomide lived on average 3 months longer than those treated with the drug alone. The most common side effect of the device is skin irritation.


The FDA is investigating factors that may play a role in infection transmission associated with duodenoscopes and has ordered the 3 manufacturers of duodenoscopes marketed in the U.S. to conduct postmarket surveillance studies in the clinical setting. These studies will examine the effectiveness of current reprocessing instructions and practices and how the devices are reprocessed in a real-world setting.

A permanent injunction prohibiting the manufacture and distribution of QLaser low-level laser devices unless and until the company obtains premarket approval or FDA clearance. Although the FDA cleared 2 QLaser devices for providing temporary relief of pain associated with osteoarthritis of the hand, the agency has not cleared or approved any of the devices to treat any other medical conditions.