News

FDA has approved a new boxed warning for the anti-seizure drug ezogabine (Potiga) because of the potential risk of vision loss, retinal abnormalities, as well as skin, nail, mucous membrane, and sclera discoloration. The agency recommends that ezogabine use be limited to individuals who have not responded to alternative therapies for seizure control, and when the benefits of treatment are greater than the risks.

Citing the risk of life-threatening blood clots and severe narrowing of blood vessels, FDA has asked Ariad Pharmaceuticals to suspend marketing and sales of ponatinib (Iclusig).

Managing diabetes and preventing microvascular and macrovascular complications requires a more holistic approach that goes beyond glucose, and includes careful management of other risk factors.

Allopurinol, considered the standard of care for gout, may be inadequate to lower uric acid levels in patients with gout, according to new safety and efficacy data from a large study presented at the American College of Rheumatology (ACR) 2013 annual meeting recently in San Diego, Calif.

Fluticasone furoate and vilanterol inhalation powder (Breo Ellipta, GlaxoSmithKline and Theravance) once-daily for chronic obstructive pulmonary disease (COPD), is now available to pharmacies throughout the United States.

GlaxoSmithKline and Community Care North Carolina team up to put medication data to good use “What we found with small data is there are still a lot of barriers to being able to apply data,” says John Easter, senior director in the public policy department at GSK. “Providers may not have right data set or may be using legacy systems that can’t integrate with each other. What this group was able to do is create these models in a lightweight way so they only needed a small amount of data to predict the correct outcomes.”

The FDA is recommending to the U.S. Department of Health and Human Services (HHS) that hydrodone combination products, such as Vicodin, be reclassified as a Schedule II product, placing tighter controls on the pain medications. Hydrocodone is currently a Schedule III drug, according to an FDA announcement.

Severe life-threatening allergic reactions are more common than many thought. Anaphylaxis very likely occurs in nearly 1 in 50 Americans (1.6%), and the rate is probably higher, close to 1 in 20 (5.1%), according to a study published in the Journal of Allergy and Clinical Immunology.

FDA has approved Juvederm Voluma XC, a cosmetic filler by Allergan, to temporarily correct age-related volume loss in the cheek area in adults who are older than 21 years. The product is expected to be available this fall, the manufacturer said.

Five years of the now recommended 2-dose varicella vaccine has dramatically reduced the incidence of chicken pox among all age groups, including among infants too young to be vaccinated.

FDA approved macitentan (Opsumit, Actelion Pharmaceuticals) to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or lung transplantation.