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Weekly Drug News Round-Up: January 11, 2017

FDA Approves Egalet’s Arymo ER for Severe Pain

Arymo uses a physical and chemical barrier for abuse deterrence without an opioid antagonist Read More...

The U.S. Food and Drug Administration (FDA) has approved Egalet's long-acting and abuse-deterrent opioid, Arymo (morphine sulfate) extended-release (ER) tablets. Arymo is used in the management of pain severe enough to require daily, around-the-clock, long-term treatment when other treatments aren’t adequate. Egalet's proprietary Guardian Technology results in increased resistance to cutting, crushing, grinding or breaking compared to non-abuse-deterrent morphine sulfate extended-release tablets. Arymo ER is expected to make abuse via injection difficult, too. The U.S. launch of the 15 mg, 30 mg and 60 mg strengths is planned for the first quarter 2017.

Lucentis Cleared for Serious Eye Disorder

Myopic choroidal neovascularization is believed to affect approximately 41,000 people in the U.S. Read More...

The FDA has approved Genentech's Lucentis (ranibizumab injection) 0.5 mg for myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness. In studies at 3 months, Lucentis provided superior visual acuity gains (more than 12 letters) in people with mCNV compared to verteporfin photodynamic therapy (1.4 letters). Lucentis, a humanized anti-VEGF antibody fragment, is the first US-approved anti-vascular endothelial growth factor (VEGF) therapy to treat mCNV. This is the fifth indication for Lucentis since its launch in 2006. Other uses include: wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

One-Third With Atrial Fibrillation Don't Take Blood Thinners: Study

Atrial fibrillation is an irregular heartbeat that can raise the risk of a blood clot or stroke Read More...

Patients with atrial fibrillation (AF) are usually prescribed blood thinners (anticoagulants) to help prevent a stroke. In more than 700 people with AF who took the blood thinner warfarin (Coumadin), nearly 37 percent stopped the drug within one year, according to a new study. Researchers also found that more than 54 percent of those who had either cardioversion or radiofrequency ablation to restore normal heart rhythm also stopped warfarin after one year. However, study participants who didn't have these procedures were more likely to continue the blood thinner. Researchers say warfarin side effects like bruising, or required blood tests, may have led patients to stop the medication.

USPSTF Restates Folic Acid Needed Before & During Pregnancy

Neural tube defects are serious birth defects of the brain, spine, or spinal cord Read More…

Planning a pregnancy? Many women don't get the recommended amount of needed folic acid through their diet, according to U.S. Preventive Services Task Force (USPSTF) guidelines published this week in Journal of the American Medical Association (JAMA). Lack of folic can lead to neural tube defects such as spina bifida in the developing embryo. Folic acid supplements are most beneficial if taken one month before becoming pregnant and continued for the first three months of pregnancy. The experts said women who are pregnant or able to get pregnant should take a daily supplement that contains between 400 and 800 micrograms of folic acid to prevent these potentially fatal birth defects.

Do Heartburn Meds Used in Pregnancy Cause a Child’s Asthma? Study

This is an early study, therefore pregnant women should follow their doctor’s advice for heartburn treatment Read More...

Can popular heartburn medications like Tagamet, Zantac, Prilosec, Nexium or Pepcid lead to asthma in children of women who took the drug in pregnancy? In a new study published in the Journal of Allergy and Clinical Immunology, investigators evaluated 8 studies with more than 1.3 million children. Researchers found a one-third higher incidence of reported asthma symptoms in kids born to mothers who were prescribed heartburn drugs in pregnancy. Researchers state H2-receptor antagonists and proton pump inhibitors are currently considered safe in pregnancy as they don’t affect fetal development. While this study shows an association with asthma, it does not prove a cause-and-effect relationship.

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