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FDA News Briefs for Monday, February 26, 2018

February 26, 2018

These Food and Drug Administration (FDA) developments came in last week:


FDA Safety Communication on Biaxin

The FDA has released a safety communication advising caution before prescribing the antibiotic Biaxin (clarithromycin; AbbVie Inc.) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later. The recommendation is based on review of the results of a 10-year follow-up study of patients with coronary heart disease from a large clinical trial that first observed this safety issue. More Information.


FDA Safety Alert: Hospira Labetalol for Injection

The FDA has announced that Hospira is voluntarily recalling 3 lots of labetalol hydrochloride injection, 100 mg/20 mL vial (NDC 0409-2267-20), and one lot of labetalol hydrochloride injection, USP, Novaplus (NDC 0409-2267-25) due to the discovery of cracks on the rim surface of vials for these lots, which is covered by the stopper and crimp seal. Cracked vials may result in a lack of sterility assurance for the product. Use of or exposure to a non-sterile product may be associated with adverse events such as fever, chills, sepsis or invasive systemic infections in patients. More Information.