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

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 www.fda.gov/acetaminophen

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?