Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

ADF Wars-- Some Hard-Shell ADFs Are Unsafe


http://www.jsonline.com/news/health/more-blood-clotting-disorders-reported-after-abuse-deterrent-opana-introduced-b99494142z1-303197871.html

The blood-clotting disorder has been limited to the abuse-deterrent formulation of Opana, which drug-maker Endo Pharmaceuticals put on the market in early 2012.

That newer version of the drug was intended to be harder to abuse. An outer coating was supposed to make it too hard to crush, so that it couldn't be snorted, and it was supposed to turn into a thick gooey gel if it was dissolved or melted so it couldn't be drawn up into a syringe and injected.

Those determined to abuse the drug couldn't foil the anti-snorting mechanism, but they found a way to melt it down and inject it, with the help of larger-gauge needles that could channel the thicker substance into veins.

A MedPage Today/Milwaukee Journal Sentinel analysis of data from the FDA's adverse events reporting system found that blood-clotting disorders tied to Opana have grown in the wake of the new abuse-deterrent formulation.

In the four years before reformulation, there were two cases of blood-clotting disorders with Opana as the primary suspect. But in 2012, there were 53 cases — accounting for some 5% of all adverse event reports where Opana was the primary suspect.