The FDA sent a warning letter to St. Jude Medical’s Implantable Electronic Systems Division as a follow-up to an inspection of the division’s Sylmar, Calif., facility in which the agency reported it observed nonconformities with Current Good Manufacturing Practice.

Subcutaneous implantable cardioverter-defibrillators (S-ICDs) have the potential to become a breakthrough therapy, according to Robert G. Hauser, MD. But until the technology proves its mettle against its transvenous cousins, it should be limited to a select group of patients, he wrote in the Jan. 8 issue of the Journal of the American College of Cardiology.

Researchers comparing patients who received implantable cardioverter-defibrillators (ICDs) in clinical trials and patients in an ICD registry found no significant differences in survival rates between the two groups, but ICD patients had significantly improved survival rates over those patients in clinical trials who received medical treatment only. The Journal of the American Medical Association published these findings Jan. 2.

The end of the year has proved to be joyous for Bristol-Myers Squibb and Pfizer, whose anticlotting drug apixaban (Eliquis) received back-to-back approvals by the FDA in the U.S. and the Ministry of Health, Labor and Welfare in Japan.

The FDA is informing healthcare professionals and the public that the anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim Pharmaceuticals) should not be used to prevent stroke or major thromboembolic events in patients with mechanical heart valves, or mechanical prosthetic heart valves.

The FDA is notifying healthcare professionals and patients about a change to the container and carton labels for heparin products, which will require manufacturers of Heparin Lock Flush Solution, USP and Heparin Sodium Injection, USP to clearly state the strength of the entire container of the medication followed by how much of the medication is in 1 mL.

The FDA is notifying healthcare professionals, particularly surgery and oncology specialists, that the 32 mg, single intravenous (IV) dose of the anti-nausea drug ondansetron hydrochloride (Zofran, GlaxoSmithKline) will no longer be marketed because of the potential for serious cardiac risks.

Hemorrhage rates in older atrial fibrillation (AF) patients exceed those reported in clinical trials, according to a study published online Nov. 26 in the Canadian Medical Association Journal, and risks are especially high during the first 30-days of treatment.