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Weekly Drug News Round Up - June 17, 2015

GSK’s Potiga: FDA Says Labeling Adequate for Level of Risk

FDA has required GlaxoSmithKline to conduct a long-term observational study to further explore pigment changes Read More...

Potiga (ezogabine) is an anti-seizure medication used with other therapies to treat partial-onset seizures in difficult-to-control adult patients. Patient-supplied safety reports had indicated pigment changes in the retina with possible vision loss and skin discoloration. After additional review, the U.S. Food and Drug Administration (FDA) has determined that the retinal pigment changes do not affect vision and skin discoloration is only a cosmetic effect. A modification of the Risk Evaluation and Mitigation Strategy (REMS) is not needed to ensure that the benefits of Potiga outweigh the risks of retinal and skin pigment changes. Healthcare providers should follow the current recommendations in the 2013 Potiga labeling.

Impax’s Zomig Spray Approved for Ages 12 and Up

The recommended starting dose for Zomig Nasal Sprays in pediatric patients 12 years of age and older is 2.5 mg Read More…

The U.S. Food and Drug Administration (FDA) has approved Zomig (zolmitriptan) Nasal Spray for patients 12 years of age and older for acute migraine with or without aura. Nasal sprays may offer an advantage to patients who experience nausea or cannot take oral forms. Clinical trials demonstrated that Zomig Nasal Spray 5 mg is significantly more effective than placebo in providing relief of symptoms of migraine in pediatric patients with a safety profile similar to that in adults. The maximum recommended single dose of Zomig is 5 milligram (mg), with a maximum daily dose of 10 mg in any 24 hour period.

Promacta Gains New Pediatric Indication

ITP, characterized by a low platelet count and increased bleeding risk, affects 5 in 100,000 children each year Read More...

The U.S. Food and Drug Administration (FDA) has approved Promacta (eltrombopag) for the treatment of children six years and older with chronic immune thrombocytopenia (cITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta was approved by the FDA in 2008 for use in adult patients with the same condition. Promacta, a once-daily oral thrombopoietin (TPO) receptor agonist, is used to to raise platelet counts in order to lower the risk for bleeding. In clinical trials, Promacta significantly increased and sustained platelet counts among some pediatric patients with cITP, and some patients were able to lower doses or stop corticosteroid medications.

Undertreatment of Kids With Migraines is a Concern: Study

Girls were more likely than boys to receive medications, as were older teens Read More...

A review of electronic health records in over 40,000 children age 6 to 17 years with severe headache has found these young patients often do not receive medications. In this study, researchers found 18% of kids were diagnosed with migraine, 37% were diagnosed with headache, while 46% weren’t given any diagnosis. Nearly half seeking treatment for the first time weren’t given a prescription or over-the-counter (OTC) treatment recommendation. Approved, evidence-based medicines for migraine include the class called triptans, some NSAIDs, and pain relievers. Experts note doctors should not leave patients undiagnosed and untreated if they're unsure about prescribing migraine medications.

Americans May Not Understand New Sunscreen Labels

The survey suggests the terminology on sunscreen labels may still be confusing to consumers Read More...

The recent blazing heat reminds us that preventing sunburn and skin cancer should be a top health goal for everyone. New wording on sunscreen labels was instituted by the FDA in 2011 to emphasize broad spectrum protection. However, a new study released this week reveals that the myriad of acronyms on sunscreen labeling - UV-A, UV-B, SPF - may confuse consumers. A study of 114 patients found that most had purchased sunscreen in the last year, but only 43 percent of the participants understood the definition of SPF value. Review the Drugs.com slideshow on top sun-safety tips to help clear up the confusion.

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