Replies to post #23860 on Intellipharmaceutics International Inc. (IPCI)

[doogdilinger]

Exactly, which is why it's been flying through the NDA approval process and was just granted the Sept 2017 PDUFA date agreed Tek:)

[WeeZuhl]

That's a pretty terrible analogy.

The blue dye doesn't affect anything or cure anything, it is easy to see it's not the active ingredient.

What if you just give it a sugar coating so it taste sweet, is that going to be a big problem with the advisory committee too? Ok, so no one had done that with opioid drugs before, we should probably require additional testing to make sure the sugar coating is safe?

We added some blue dye so that when crushed, you're going to get stained blue. That's not any different than making it taste sweet by adding some sugar or any food additive.

The purpose of the dye is to flag signs of abuse. It function as a marker. The FDA has no reason to be concerned with the dye.

Do you know of any sugars that have been implicated in the deaths of dozen+ patients? Do you know of any sugars that are potent mitochondrial poisons? Do you know of any sugars that have their very own FDA Advisory? Terrible analogy.


And, once again, if IPCI can somehow prove that the blue dye prevents chewing, then they might have a case, but then they would have to admit that Rexista can be chewed and that is why the blue dye is necessary. But think about it-- once the pill is crushed, the blue dye useless. An abuser would put the blue powder in capsule or Kleenex ("parachute") and swallow it so there will be no blue discoloration of anything visible. Likewise, they could snort it with a straw high enough in the nasal cavity that nothing visible will turn blue.


Either the pill is chewable and therefore the blue dye is needed, or the pill is not chewable and the blue dye superfluous. Once the pill has been crushed, the blue dye has been bypassed as an abuse deterrent, but it still has all of its bioactive properties, including potent inhibition mitochondrial respiration. Likewise, even if the legitimate user swallows the pill whole as intended, that potent mitochondrial poison is released into the G.I. tract where it could be absorbed under the right conditions and lead to a very quick death before anyone could ever seek medical attention.


Read the above paragraph over and over until it starts to sink in why Rexista will go down at AdComm 20-0.




http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditivesinSpecificProducts/InMedicalDevices/ucm142395.htm

FDA Public Health Advisory: Subject: Reports of Blue Discoloration and Death in Patients Receiving Enteral Feedings Tinted With The Dye, FD&C Blue No. 1

September 29, 2003


Dear Health Care Professional:

The Food and Drug Administration (FDA) would like you to be aware of several reports of toxicity, including death, temporally associated with the use of FD&C Blue No. 1 (Blue 1) in enteral feeding solutions. In these reports, Blue 1 was intended to help in the detection and/or monitoring of pulmonary aspiration in patients being fed by an enteral feeding tube. Reported episodes were manifested by blue discoloration of the skin, urine, feces, or serum and some were associated with serious complications such as refractory hypotension, metabolic acidosis and death. Case reports indicate that seriously ill patients, particularly those with a likely increase in gut permeability (e.g., patients with sepsis), may be at greater risk for these complications. Because these events were reported voluntarily from a population of unknown size, it is not possible to establish the incidence of these episodes.

[mopar44o]

Nevermind the fact that there are numerous blue dyes that aren't a concern. There are many natural blue dyes that could work in that way.