Tuesday, December 16, 2014


While new Hepatitis drugs are very expensive, the FDA now gives US blood banks a tool (a blood cleaning device) so that plasma may be transferred between people and not spread hepatitis, nor West nile. it is called the Intercept Blood system. It uses amotosalen (a synthetic psoralen) and UV light. After 704 people successfully used it, it passed muster.


Source: fda


Monday, December 15, 2014

To all future parents:

According to the 2012 edition of Volume 62, Number 9 of the CDC's "National Vital Statistics Reports" 3,952,841 people were born that year. Of those, 40-100 get an undesirable disease called  Severe Combined Immunodeficiency (SCID) yearly. Why is this relevant? Because if it is not detected the baby's lack of an immune system may result in death. 

This is where a Finish-American company comes in to improve life for babies. There product was able to find 17 positive cases and 6,383 negative cases out of 6,400 cases. It cannot detects related types of immunodeficiency: DiGeorge Syndrome, Omenn Syndrome, leaky-SCID or variant SCID.


It takes a few drops of blood from the baby's pes (trotter, tootsiesdogsboats, or foot) to help count the number of T Cells
The number of births daily is estimated to be 10,829 a day. Hopefully the machine will be printing out 10,829 negative results.

Sunday, December 7, 2014

According to an October article in Forbes the color of a pill may help patients think the pill works. They cited food coloring and made a comparison with salmon color and the type normally purchased. Reminds me of annatto food coloring in cheese. Incidentally that comes from this fruit. Though, it's supposed to be orange or yellow. So much for Wikipedia... though they would say don't look at the red seeds, it really is orange.
     Anyone want to think about the color is the blue and black dress that to some looked white and gold? 
wired.com/2015/02/science-one-agrees-color-dress
http://www.cnn.com/2015/02/26/us/blue-black-white-gold-dress/index.html
File:Bixa orellana fruit open.jpg
http://www.forbes.com/sites/sap/2014/10/22/the-shocking-truth-about-the-influence-of-colors/?sr_source=lift_outbrain

Saturday, December 6, 2014


Want to pay less for a flu shot while being in the Dallas-FW area? Visit Walmart in Denton from 10-6 and give a toy only Dec 12-13.
Source: Dallas Morning News

Toy




Three days ago the FDA approved BLINATUMOMAB (BLINCYTO). It's a cancer drug, so expect side effects. REMS letters get sent out thrice at 6 month intervals to remind patients via their health care providers about cytokine release syndrome. It's typically manufactured in a 35MCG dosage form.
If the association for nurses, RPhs, or MDs requests a copy of the letter the FDA will provide it. The MSLs/drug reps will also have them. If Amgen happens to participate in a scientific meeting they also will be required to provide REMS info there. They also have to keep up http://www.blincytorems.com/ Here's the boxed warnings.
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BOXED WARNING: Cytokine Release Syndrome

  • Serious adverse events that may be associated with CRS included pyrexia, headache, nausea, asthenia, hypotension, increased alanine aminotransferase, increased aspartate aminotransferase, and increased total bilirubin.
  • The highest elevation of cytokines was observed in the first 2 days following start of BLINCYTO infusion.

BOXED WARNING: Neurological Toxicities

  • In patients receiving BLINCYTO in clinical trials, neurological toxicities have occurred in approximately 50% of patients.
  • The median time to onset of any neurological toxicity was 7 days.
  • Grade 3 or higher (severe, life-threatening or fatal) neurological toxicities following initiation of BLINCYTO administration occurred in approximately 15% of patients and included encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders. The majority of events resolved following interruption of BLINCYTO, but some resulted in treatment discontinuation.

Preparation and Administration Errors

  • Preparation and administration errors have occurred with BLINCYTO treatment.
  • It is very important that the instructions for preparation (including admixing) and administration are strictly followed to minimize medication errors (including underdose and overdose).

BLINCYTO Fact Sheet:

A non-promotional REMS Fact Sheet reviewed by the FDA, with more detailed information on the serious risks associated with BLINCYTO is available in the “Materials for Healthcare Providers” section above.

INDICATION:

BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
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From FDA's new drug approval http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails