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Jan-17-2011 13:28printcomments

FDA Implements Changes for Acetaminophen, What About Oxycontin?

"I never give them hell -- I just tell the truth -- and they think it's hell" - Harry S. Truman

Dangerous pills
The FDA is making changes, but are they the right ones?

(MYRTLE BEACH, S.C.) - On 13 January 2011, the FDA announced that it is asking manufacturers of prescription acetaminophen combination products to limit the maximum amount of acetaminophen in these products to 325 mg per tablet, capsule, or other dosage unit.

The FDA believes that limiting the amount of acetaminophen per tablet, capsule, or other dosage unit in prescription products will reduce the risk of severe liver injury from acetaminophen overdosing, an adverse event that can lead to liver failure, liver transplant, and death.

I was invited by email to participate in the teleconference on January 13 which was to involve a presentation by Sandra Kweder, MD, Deputy Director, Office of New Drugs, Center for Drug Evaluation and Research (CDER), FDA, and Gerald Dal Pan , M.D, Director, Office of Surveillance and Epidemiology, CDER, FDA. The presentation was to be followed by a Question and Answer session.

For additional information on the changes in acetaminophen prescription combination products, visit

After the presentation, I was invited to ask my question. It was similar to the question I asked John Jenkins, MD of the FDA during the teleconference regarding Darvocet being pulled off the market. I wrote an article about Dr. Jenkins giving me the wrong answer to my question in an article on November 22, 2010. I have to give Dr. Jenkins credit -- he did attempt to answer my question. This was not the case on January 13, 2011.

I asked Dr. Kweder if the FDA would be reclassifying OxyContin for severe pain only -- not for moderate pain -- in view of the epidemic of death and addiction throughout the country especially of our young people. I recognized that there were issues of liver damage with Acetaminophen, but the devastation OxyContin continues to have in death, addiction, drug abuse and pill mills cropping up in many states should be causing the FDA to step up to the responsibility they have to the American people to keep them safe from dangerous drugs.

Unfortunately, Dr. Kweder became annoyed with me and refused to answer my question since it did not pertain to Acetaminophen. So I am asking Dr. Kweder to let me know when she would like to answer my question. The teleconference pertaining to the dangers of liver damage and Acetaminophen is behind us. I can be available for a conference call at a mutually convenient time -- but will give her a bit of an advantage. Here are the questions, I would like her to give me answers to:

Does the FDA have the statistics from medical examiners all over the country as to the liver damage of the victims of OxyContin whose bodies have been in morgues since OxyContin reigned its destruction of life? I'm wondering if liver damage takes precedent over death in the eyes of the FDA. Are the pill mills that are cropping up all over Florida of concern to the FDA? For that matter, is the FDA at all concerned with the loss of life due to OxyContin -- especially of our young people -- in states such as Maine, Vermont, Massachusetts, Florida and Ohio?

OxyContin is referred to as synthetic Heroin and has almost the same molecular components as Heroin. Heroin is an illegal drug -- OxyContin is a legal drug. Something seem wrong here, Dr. Kweder?

Why is OxyContin manufactured in quantities beyond the requirements for legitimate pain patients and finding its way onto the streets -- and to pill mills pushing quantities of the drug to addicts?


In 2002, Dr. Kweder's colleague, Dr. Jenkins testified in front of the U.S. Senate and said

The Agency recognizes OxyContin as a valuable product when used properly. We need to do all we can to ensure that the prescriptions get to the appropriate patients and that labeling and promotion are appropriate for the product. FDA is working closely with the manufacturer to take appropriate action to curb the misuse and abuse of  OxyContin.  In addition, FDA is involved in the strong interagency effort to address this issue and we are aware we cannot solve this problem by ourselves."

Yes Drs. Kweder and Jenkins it appears that the FDA cannot solve "this problem" by themselves.  Not taking responsibility for the safety of the American people by protecting them from one of the most dangerous drugs ever introduced to our country is beyond a safety and health issue -- it is a moral and life saving issue. 

Since Dr. Kweder did not find it appropriate to answer my question last week on OxyContin and the deaths as a result of the drug, I have provided contact information below for anyone wanting to contact the doctor.  Maybe parents of young people in every state in the country who have experienced the loss of their children because of OxyContin being criminally marketed will be more successful in having Dr. Kweder answer their questions -- since I must have caught the good doctor on a bad day.

Last name Kweder
First name Sandra
Middle name L
Agency FDA
Organization DHHS/FDA/CDER/OND
Building WO22
Room 6306
Duty station Silver Spring MD 20993
Phone 301-796-0700
Fax 301-796-9856
Internet e-mail

The greatest gift in life is to love and to be loved in return -- and the greater gift is to have someone believe in you.

_________________________________ Reporter Marianne Skolek, 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 has been involved in her work for the past 8-1/2 years and is currently working on a book that exposes Purdue Pharma for their continued criminal marketing of OxyContin.

Marianne is a nurse having graduated in 1991 as president of her graduating class. She 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.

Marianne Skolek
National Activist for Victims of OxyContin and
Purdue Pharma - a criminally convicted pharmaceutical company
Staff Writer,

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Ada January 17, 2011 6:47 pm (Pacific time)

The FDA's priorities are absolutely ridiculous. How crazy is this...The FDA needs to be overhauled with new staff. Everyone should be outraged by this insanity and should be responding with an outcry. The citizens of each state should be pressuring their politicians to reign back the supply of opioids and begin providing safe and effective treatment to those addicted. With the devastation of addiction and death where are the public health warnings and declarations of epidemics and emergencies across the country? I will be writing to Dr. Kweder.

Luke Easter January 17, 2011 2:03 pm (Pacific time)

Too much money being made in Oxy. Why change what rakes in BOB, billions of bucks? Reminds me of, "Robo Cop" when Ronnie Cox told Peter Weller, he had a 30 year contract with the military for Ed-309, maintenance and repair. Who cared if it worked? So much money funneled into rehab clinics and drugs to combat Oxy plus the money spent on the drug itself, then there's the illegal trade. I get your point but we live in a country where $$ is first. Ah, Exon Valdez, BP Oil Spill, Haliburton? Etc., etc...

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