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Weekly Drug News Round-Up: May 10, 2017

FDA Approves Radicava to Treat Amyotrophic Lateral Sclerosis

It's been over 2 decades since a new drug was approved for ALS Read More...

The US Food and Drug Administration (FDA) has approved Radicava (edaravone) for amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease. ALS is a rare disease that kills the nerve cells that control voluntary muscles, and most people die from respiratory failure. Radicava is a free radical scavenger that relieves oxidative stress and may affect progression of ALS. In a six-month clinical trial conducted in Japan, 137 participants were randomized to receive edaravone or placebo. At Week 24, individuals receiving edaravone declined less in assessment of daily functioning compared to those taking placebo. Rilutek (riluzole) is the only other prescription drug approved in the U.S. for ALS. The most common side effects reported in studies were bruising and gait disturbance.

Bavencio Cleared for Urothelial Carcinoma Treatment

Serious adverse reactions were reported in 41% of patients Read More...

Urothelial carcinoma are cancers that occur most commonly in the bladder, but also the ureters and renal pelvis. This week, the FDA granted accelerated approval to avelumab (Bavencio), from EMD Serono, for patients with advanced urothelial carcinoma whose disease has progressed during or following platinum-containing chemotherapy or within 12 months of platinum-containing chemotherapy before or after surgery. In studies from enrolled patients followed over 13 weeks, the overall response rate (ORR) was 13.3%. For patients followed for at least 6 months, the ORR was 16.1%. Median time to response was 2.0 months (range 1.3-11). Bavencio is classified as an immune checkpoint inhibitor.

Are EpiPens Still Effective Past Their Expiration Date? Study

Researchers suggest people keep their expired EpiPen if they can’t replace it, as it still may contain a lifesaving dose Read More...

The headlines have been filled with the ongoing controversy over EpiPen (epinephrine injection) cost and generic availability. EpiPens, used to treat life-threatening allergic reactions, have about a one year shelf life and this requires patients to repurchase them frequently when the expiration date hits. This week, an evaluation of almost 40 expired, unused EpiPens brought in by patients revealed that all of the devices contained more than 80 percent of their initial dose of epinephrine. In the study published in Annals of Internal Medicine, researchers still recommend that people replace expired EpiPens if fresh ones are available, as a matter of safety. It is also suggested the FDA re-evaluate how long the pens are viable.

Heart Risks and NSAIDs Linked, Again: Study

This observational study can’t prove that NSAIDs raise the odds for a heart attack, only that a link is seen Read More...

Common over-the-counter (OTC) NSAIDs (nonsteroidal antiinflammatory drugs) like Advil, Motrin and Aleve, often used for arthritis pain or fever, are further linked with heart attack risks in a new study published in BMJ. Overall, researchers found NSAIDs increase the risk of a heart attack by 20 to 50 percent, compared with not using them. The individual increased risk is small, roughly 1%, but from a public health standpoint it’s large, as this drug class is widely used. Risks rose with higher doses and occurred in as little as one week. Patients should be aware of their own risk for heart disease and discuss OTC NSAID use with their doctor.

Asthma, Allergies Not Associated with Low Vitamin D Levels

Taking vitamin D supplements will not lower the risk of these certain conditions Read More...

Exposure to sunlight leads to production of vitamin D in your skin and that’s why it is often referred to as the “sunshine vitamin”. It's also found in certain foods, including fortified dairy products, fatty fish and egg yolks. Low levels of vitamin D are frequently linked with many health conditions, but what is the evidence? A study of over 100,000 people has found that low or normal levels of vitamin D are not linked with asthma, allergies or eczema based on a statistical analysis. Vitamin D, a fat-soluble vitamin, can be toxic to the liver in excess doses, so getting healthcare advice from your doctor based on evidence is important before using vitamin D supplements.

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