Thursday December 12, 2019
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FDA Remove Sufentanil (Dsuvia) as you did Palladone in 2005! It's Dangerous!Marianne Skolek-Perez Salem-News.com Investigative Reporter
Sufentanil should never be administered to any human.
(MYRTLE BEACH, SC) - In early 2005, I exposed Purdue Pharma, maker of OxyContin, for marketing a dangerous opioid called Palladone.
In July 2005, Palladone was removed from the market following an FDA request because of "safety concerns" An FDA news release stated that "serious and potentially fatal adverse reactions could occur when Palladone (hydromorphone hydrochloride) extended release capsules were taken together with alcohol." (See news release below)
The FDA recently approved yet another dangerous opioid. This one made by AcelRx Pharmaceuticals, Inc. called Sufentanil or Dsuvia.
The opioid is to be administered sublingually (faster absorption) and is approximately 5 to 10 times more potent than its parent drug, Fentanyl and 500 times as potent as morphine. It will be administered to pregnant women in labor as well as wounded military in the battlefield with the condition that physicians "closely" monitor patients for respiratory failure.
It will be used in the treatment of ambiguous chronic pain. Sufentanil or Dsuvia should never be administered to any human.
This dangerous opioid is similar to Palladone in that it should never be taken with alcohol or products that have alcohol. Unsafe and deadly effects may happen -- right off AcelRx Pharmaceuticals description of Sufentanil or Dsuvia.
I will be working fiercely, as I did with Palladone to have the FDA withdraw their approval of Sufentanil or Dsuvia immediately before the death toll to yet another dangerous opioid ravages our country further destroying tens of thousands of lives during an opioid epidemic.
Why would the FDA approve an opioid with such dangerous and life threatening risks? Ask Janet Woodcock.
Janet Woodcock, MD is current FDA Director of the Center for Drug Evaluation and Research. Maybe she can advise under her watch -- during an opioid epidemic in the U.S., why she does not question the dangers of Sufentanil (Dsuvia) being released on the American people -- yet an acting FDA Director of the Center for Drug Evaluation and Research in 2005 recognized the dangers of Palladone and had it pulled.
Next week I will be questioning the FDA on using Lynn R. Webster, MD as an "expert" in the approval of Sufentanil (Dsuvia).
Just a word to the FDA -- I did not go away when it came to Palladone being taken off the market and I am certainly not going away when they arbitrarily expose the American people to an opioid that should never be prescribed to any human being and is not only dangerous, but is life-threatening.
Below is the FDA News Release dated July 13, 2005 regarding the recall of Palladone:
FDA NEWS RELEASE
FDA Asks Purdue Pharma to Withdraw Palladone for Safety ReasonsAfter acquiring new information that serious and potentially fatal adverse reactions can occur when Palladone (hydromorphone hydrochloride) extended release capsules are taken together with alcohol, the U.S. Food and Drug Administration has asked Purdue Pharma L.P., the makers of the drug, to withdraw it from the market.
Palladone is a once-a-day pain management drug containing a very potent narcotic. New data gathered from a company-sponsored study testing the potential effects of alcohol use shows that when Palladone is taken with alcohol the extended release mechanism is harmed which can lead to dose-dumping.
Dose-dumping is a term that describes the rapid release of the active ingredient from an extended release product into the blood stream. The consequences of dose dumping at the lowest marketed dose (12 mg.) of Palladone could lead to serious, or even fatal, adverse events in some patients and the risk is even greater for the higher strengths of the product.
As a result of this potential serious safety risk, the FDA has asked Purdue Pharma, and they have agreed, to suspend all sales and marketing of Palladone in the U.S. pending further discussions with the agency.
"All powerful pain management drugs have serious risks if used incorrectly, but the current formulation of Palladone presents an unacceptably high level of patient risk" said Dr. Steven Galson, FDA Acting Director of the Center for Drug Evaluation and Research.
"Although we have not received reports of serious problems, this product has so far been used in a relatively small number of patients. We are concerned that as more patients take this drug, safety problems will arise since even having one alcoholic drink could have fatal implications.”
The current labeling for Palladone, approved in September, 2004, already includes the standard opioid warning against the use of alcohol and Palladone. However, the FDA does not believe that the risk of serious, and potentially fatal, adverse events can be effectively managed by label warnings alone and a risk management plan.
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