Warning on steroids; approval for soft-tissue sarcoma drug

Recalls and warnings

A new warning on testosterone and other anabolic androgenic steroids. As part of class-wide labeling changes, the warning will alert prescribers to the potential for abuse of testosterone and the associated serious adverse outcomes, especially those related to heart and mental health, that have been reported. The label section on abuse and dependence will also include new safety information about the associated risks and adverse outcomes. In addition, the labeling will advise prescribers of the importance of measuring serum testosterone concentration if they suspect abuse.

A new boxed warning on the Essure permanent birth control system that communicates the risk of side effects and adverse outcomes associated with the device. The labeling now also includes a patient decision checklist, as well as updated information in the patient counseling and device removal sections.

A class I recall of 105 HeartWare ventricular assist device pumps because of a design problem with the driveline connector, which could become contaminated and cause electrical issues or pump stops, potentially leading to death or other serious adverse health consequences. Affected products were manufactured between July 31, 2014, and March 30, 2016.* The manufacturer is also recalling 4,564 device controllers because of the potential for loose power connectors, which could lead to corrosion, electrical problems, reduced speaker volume, or connection failures. Recalled devices were manufactured between Sept. 30, 2014, and Feb. 29, 2016.

A recall of some sterile drug products produced by Cantrell Drug Company due to lack of sterility assurance. Recalled products include certain lots of drugs for injection (e.g., heparin, lidocaine) distributed nationwide from May 25 to Oct. 31, 2016.

Approvals

Olaratumab (Lartruvo) with doxorubicin to treat certain adults with soft-tissue sarcoma. It is approved for patients who cannot be cured with radiation or surgery and have a type of soft-tissue sarcoma for which an anthracycline is an appropriate treatment. In a randomized clinical trial of 133 patients, those who received the drug with doxorubicin had a median survival time of 26.5 months, compared to 14.7 months for those who received only doxorubicin. Common side effects include nausea, fatigue, neutropenia, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy, and headache. Serious risks include infusion-related reactions (e.g., low blood pressure, fever, rash) and embryo-fetal harm. The drug was approved through the FDA's fast-track process and is considered an orphan drug.

The Amplatzer PFO Occluder device to prevent recurrent strokes in certain patients. The device reduces the risk of stroke in patients who had a previous stroke believed to be caused by a blood clot that passed through a patent foramen ovale and then traveled to the brain. A randomized study of 499 patients found a 50% reduction in the rate of new strokes in those treated with the device plus blood-thinning medications compared to those taking blood-thinning medications alone. Adverse effects associated with the device or the implantation procedure include injury to the heart, atrial fibrillation, bleeding, stroke, and blood clots in the heart, leg, or lung.

Prasterone (Intrarosa) to treat postmenopausal women experiencing moderate to severe dyspareunia due to vulvar and vaginal atrophy. The once-daily vaginal insert is the first FDA-approved product to contain prasterone (aka dehydroepiandrosterone). In two 12-week trials of 406 postmenopausal women ages 40 to 80 who reported dyspareunia, those who received the drug experienced reduced severity of pain during sex compared with those who received a placebo vaginal insert. In safety trials, the most common adverse reactions were vaginal discharge and abnormal Pap smear results.