Weekly Roundup 8.15.14

It is hard to believe that I see on Facebook many of my friends who are parents  talking about their kids headed back to school this week.  Back to school?  Back to school? Why when I was a lad, which was really not that long ago, school never began until the day after Labor Day.  I know because my birthday is the week before and it left me bitter that I never got to partake in the cupcakes in honor of my birthday that everyone else got during the school year.  As you can tell, I have never gotten over that.

What I have gotten over is this past week. Here is a little bit of what happened:

  • Fraudulent Ebola Products Alert FDA issued a statement alerting consumers that they should be aware that there are products being sold online that are claiming to prevent or treat the Ebola virus.  The agency reminds consumers that, while there are experimental treatments under investigation, there are no products approved for use either as a treatment or vaccine.  The release refers to sources promoting the unapproved and fraudulent products but does not name them.
  • New Sleep Drug ApprovedThe agency announced approval of a new, first-in-class drug to treat insomnia called Balsomra (suvorexant).  Balsomra is an orexin receptor antagonist.  The agency states that the drug alters the signaling action of orexin in the brain – with orexin being a chemical that is involfved in regulating the sleep-wake cycle.  The most common side effect reported was drowsiness and the agency has asked the manufacturer to study next-day driving performance in people who take the drug.  The product will be accompanied by a Medication Guide.
  • FDA Approves First Non-Invasive DNA Colorectal Cancer Screening Test – Cologard was approved by FDA this week and it is the first stool-based colorectal screening test that would detect the presence of red blood cells along with DNA mutations that could be indicative of the presence of either cancers or precursors to cancers.  The test requires a stool sample and will detect the presence of hemoglobin and if a positive test is received, the patient will be recommended for a diagnostic colonoscopy, offering patients a new option in their approach to screening but does not change the current practice guidelines for colorectal cancer screening.

That’s it for me this week folks.  Have a good, safe and pleasant weekend.  Next week we will take a look at FDA enforcement around DTC advertising.  Watch for it!

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