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Weekly Drug News Round-Up: December 9, 2015

Pfizer’s QuilliChew ER Approved for ADHD

Children and adults can suffer with ADHD symptoms such as difficulty paying attention, impulsivity and being overly active Read More…

The FDA has approved Pfizer’s QuilliChew ER (methylphenidate hydrochloride), an extended-release central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). QuilliChew ER met treatment effects across all time points with statistical significance in placebo-controlled clinical trials in children ages 6 to 12 with ADHD. The product will be available in 20 and 30 mg scored and 40 mg unscored chewable tablets and can be taken once-daily with or without food. QuilliChew ER is expected to be available in pharmacies in the first quarter of 2016.

FDA Approves First Treatment for Rare Lysosomal Enzyme Deficiency

Common side effects included diarrhea, vomiting, fever, rhinitis, anemia, cough, headache, constipation, and nausea Read More...

This week, the FDA approved Alexion Pharmaceutical’s Kanuma (sebelipase alfa), the first enzyme replacement therapy for the treatment of lysosomal acid lipase deficiency (LAL-D). Also known as Wolman disease, patients rarely survive their first year of life with LAL-D. The condition results in a build-up of fats that can lead to liver and cardiovascular disease and other complications. Kanuma is a purified biologic produced in egg whites from genetically-engineered chickens that replaces the defective LAL protein. In clinical trials, six of nine infants (67 percent) treated with Kanuma were alive at 12 months of age, whereas none of the 21 infants in the historical control group survived.

Vonvendi Wins Approval for von Willebrand disease

No safety concerns were identified in the trials; itching as the most common side effect Read More...

VWD is the most common inherited bleeding disorder, affecting approximately one percent of the U.S. population. Patients with von Willebrand disease (VWD) can develop severe bleeding from the nose, gums, intestines, muscles and joints. This week the FDA approved Vonvendi [von Willebrand factor (Recombinant)], the first recombinant von Willebrand factor for on-demand (as needed) use for treatment and control of bleeding episodes in adults diagnosed with VWD. In two clinical trials, Vonvendi was found to be safe and effective for the on-demand treatment and control of bleeding episodes from a variety of different sites in the body.

SGLT2 Inhibitors: Labeling for Diabetes Drug Class Undergoes Safety Update

SGLT2 inhibitors are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes Read More...

The FDA has determined that the diabetes drug class known as sodium-glucose cotransporter-2 (SGLT2) inhibitors require label updates warning of the risks of too much acid in the blood (ketoacidosis) and of serious urinary tract infections. The FDA review revealed multiple cases of ketoacidosis in patients with type 1 or type 2 diabetes treated with SGLT2 inhibitors, as well as life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections. Hospitalization was required in some cases. Medicines in the SGLT2 inhibitor class include canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance).

Warfarin Plus Certain Diabetes Treatments Ups Risk of Hospitalization

After studying nearly 466,000 Medicare patients, researchers found the risk was especially high for men aged 65 to 74 Read More...

A known drug interaction between warfarin and the type 2 diabetes sulfonylurea drugs glipizide (Glucotrol) or glimepiride (Amaryl) has been studied by researchers at USC. The study, published in BMJ, reports that taking the blood thinner warfarin with these diabetes drugs led to a 22 percent increased risk of emergency room visit or hospitalization for low blood sugar (hypoglycemia). Experts suggest clinicians be extra vigilant when a sulfonylurea is added to a regimen that includes warfarin, as well as when a patient who is taking both has a change in their medical status. Patients need to be aware that blood sugars may need to be monitored more frequently.