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?????????????????????????????????????????????????Saturday, December 1, 2018
FDA Remove Sufentanil (Dsuvia) as you did Palladone in 2005! It's Dangerous!
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
FOR IMMEDIATE RELEASE
P05-42
July 13, 2005
Media Inquiries:
Suzanne Treviño, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FOR IMMEDIATE RELEASE
P05-42
July 13, 2005
Media Inquiries:
Suzanne Treviño, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Asks Purdue Pharma to Withdraw Palladone for Safety Reasons
After 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.
_______________________________________
Marianne Skolek-Perez, Salem-News.com Investigative Reporter, is
an Activist for Victims of OxyContin and Purdue Pharma throughout the
United States and Canada. In July 2007, she testified against Purdue
Pharma in Federal Court in Virginia at the sentencing of their three
CEO's - Michael Friedman, Howard Udell and Paul Goldenheim - who pleaded
guilty to charges of marketing OxyContin as less likely to be addictive
or abused to physicians and patients. She also testified against Purdue
Pharma at a Judiciary Hearing of the U.S. Senate in July 2007. Marianne
works with government agencies and private attorneys in having a voice
for her daughter Jill, who died in 2002 after being prescribed
OxyContin, as well as the voice for scores of victims of OxyContin. She
is currently working on a book that exposes Purdue Pharma for their
continued criminal marketing of OxyContin.
Marianne is a nurse, graduated in 1991 as president of her class, and
also has a Paralegal certification. Marianne served on a Community
Service Board for the Courier News, a Gannet newspaper in NJ, writing
articles predominantly regarding AIDS patients and their emotional
issues. She was awarded a Community Service Award in 1993 by the
Hunterdon County, NJ HIV/AIDS Task Force in recognition of and
appreciation for the donated time, energy and love in facilitating a
Support Group for persons with HIV/AIDS.
YOUTUBE: youtube.com/watch?v=tmPG1VjD61U&list=UUWoHUEr4ZAbQOfIqtOArjgg&index=6&feature=plcp
FACEBOOK: facebook.com/marianne.skolek