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Weekly Drug News Round-Up: October 5, 2016

Orkambi Approved for Cystic Fibrosis in Younger Age Group

Children must inherit two defective CFTR genes, one from each parent, to have CF Read More...

Cystic fibrosis (CF) is caused by defective or missing cystic fibrosis conductance regulator (CFTR) proteins resulting from mutations in the CFTR gene. CF eventually leads to chronic lung infections, lung damage and death. This past week, the U.S. Food and Drug Administration (FDA) approved Orkambi, (lumacaftor/ivacaftor) from Vertex Pharmaceuticals, for use in children with cystic fibrosis between ages 6 and 11 who have two copies of the F508del mutation. Orkambi was previously approved by the FDA for use in patients 12 years and older with the same mutation. The F508del mutation represents the largest population of those with CF.

Certain Hepatitis C Treatments Can Reactivate Hepatitis B

Patients should not stop taking their hepatitis medicine without first talking to their doctor Read More...

Without treatment, hepatitis C virus (HCV) can lead to severe liver disease and death. FDA has identified 24 cases of hepatitis B virus (HBV) reactivation in HCV/HBV co-infected patients treated with direct-acting antivirals (DAAs) from November 2013 to July 2016, but there are likely more cases. DAAs include treatments such as Harvoni, Epclusa and Viekira Pak. Because of this concern, Boxed Warnings and consumer documents will be update to include the risk of HBV reactivation. Providers should screen and monitor for HBV in all patients receiving DAA treatment.

FDA to Consumers: Stop Using Homeopathic Teething Tablets & Gels

Homeopathic teething tablets and gels have no proven benefit and are not approved by the FDA Read More…

The FDA is issuing an ongoing warning to consumers that homeopathic teething tablets and gels should not be used and they should dispose of any tablets or gels in their possession. Serious side effects, such as seizures in infants and children have occurred. The FDA warned about these products in 2010, as well. The FDA is currently investigating this issue, including testing product samples, and will update the public as more information is known. Homeopathic teething tablets and gels are distributed by CVS, Hyland’s, and possibly others, and are sold in retail stores and online.

Many Parents Think a Flu Shot Unnecessary: Study

Flu causes more deaths among American children than any other vaccine-preventable disease Read More...

With flu season approaching, and flu shots easily available right now, a new study suggests that parents who skip the flu vaccine for their kids may do so because they don’t see the need. The study, performed during the 2012-2013 flu season, involved 131 parents with children ranging from 9 months to 18 years. The three most common reasons parents gave for not getting flu protection for their children were: believing such vaccination was not needed, fear of possible side effects, and forgetting or not getting around to it. Plus, parents who have never experienced the flu may not understand the need for the vaccine.

Botox Good Option for Urinary Incontinence: Study

Botox works by relaxing the overactive bladder muscles that lead to incontinence Read More...

Bladder incontinence can be a disruptive and embarrassing condition that greatly affects the quality of a woman’s life. Researchers at Duke University, who published in the Journal of the American Medical Association (JAMA) this week, say the use of Botox (onabotulinumtoxinA) is statistically slightly better than the use of a nerve stimulator implant called InterStim. In a head-to-head comparison, women given Botox saw their daily overactive bladder episodes decrease by four, compared to three for women who received the implant. However, women who received Botox had a greater risk of urinary retention requiring catheter use and urinary tract infections.