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Weekly Drug News Round-Up: December 14, 2016

Boehringer Ingelheim & Lilly’s Synjardy XR Approved for Type 2 Diabetes

The most common side effects may include urinary tract infection, yeast infections, diarrhea, and nausea/vomiting Read More...

Synjardy (empagliflozin and metformin hydrochloride) is a sodium glucose co-transporter-2 (SGLT2) inhibitor and biguanide combination for the treatment of adults with type 2 diabetes. A long-acting form, Synjardy XR extended-release tablets, has been approved by the U.S. Food and Drug Administration (FDA) for adults with type 2 diabetes to be used alongside diet and exercise. Dosing for Synjardy XR is once daily with a meal in the morning, slowly increasing the dose to reduce metformin stomach side effects. Synjardy XR tablets will be available as a combination tablet containing 1,000 mg of metformin with either 5, 10, 12.5, or 25 milligrams (mg) of empagliflozin.

Eucrisa Clears the FDA for Use in Eczema

Atopic dermatitis is the most common form of eczema and onset typically begins in childhood Read More...

FDA today approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older. In atopic dermatitis, the skin develops red, scaly and crusted bumps, which are extremely itchy and may lead to thickening of the skin. Eucrisa, applied topically twice daily, is a phosphodiesterase 4 (PDE-4) inhibitor, but the exact mechanism is not known. In studies, participants receiving Eucrisa achieved greater response with clear or almost clear skin after 28 days of treatment. The most common side effect of Eucrisa is application site pain; serious side effects include allergic reactions to the active ingredient.

FDA Label Update: Pioglitazone and Increased Risk of Bladder Cancer

FDA first changed the labels of pioglitazone-containing medicines in August 2011 Read More...

As a result of an updated review, the FDA has concluded that use of the type 2 diabetes medicine pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) may be linked to an increased risk of bladder cancer. Pioglitazone is approved to improve blood sugar control, along with diet and exercise, in adults with type 2 diabetes. Health care providers should not use pioglitazone in patients with active bladder cancer, and weight risk versus benefit in patients with a history of bladder cancer. Patients taking pioglitazone should contact their doctor if they notice a red color in the urine, new or worsening urge to urinate, or pain when urinating.

FDA Medwatch: General Anesthetic and Sedation Drugs

This week, the FDA announced new labeling for general anesthetic and sedation drugs Read More...

General anesthesia and sedation is a necessary component of surgery or other painful procedures for infants, children, and pregnant women, especially in the face of life-threatening conditions. However, based on research, new FDA warnings state that use of these drugs in children younger than 3 years or in pregnant women during their third trimester may affect brain development of the child. Caregivers and pregnant women in the third trimester should discuss with their doctors whether procedures with anesthesia and sedation can be safely delayed. Providers should balance the benefits versus risks, especially for procedures over 3 hours or if multiple procedures are required.

Tecentriq Study Shows Improved Survival in Lung Cancer

The patients in the new trial had run out of treatment options Read More...

Early results have been published in The Lancet on survival in patients with non-small cell lung cancer (NSCLC) receiving the immunotherapy drug Tecentriq (atezolizumab). Results from the open label, sponsor-supported study showed Tecentriq extended the survival of lung cancer patients for several months longer than the chemotherapy docetaxel and caused fewer side effects and study drop-outs. Patients who took Tecentriq survived for an average of 13.8 months, compared with 9.6 months for those on chemotherapy. Serious side effects with immunotherapy can include life-threatening autoimmune complications. Other novel immunotherapy agents approved for treatment of advanced NSCLC include Opdivo (nivolumab) and Keytruda (pembrolizumab).