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The Convicted Criminals Have Reformulated OxyContin, But is it Safer?Marianne Skolek Salem-News.com
The United States has been involved in this epidemic of OxyContin addiction, abuse and death for well over a decade now.
(MYRTLE BEACH, S.C.) - Last week I was invited by the FDA to participate in a teleconference on the reformulation of the drug, OxyContin.
The teleconference began with Bob Rappaport, M.D. giving a brief talk on the reformulated drug. Dr. Rappaport is the director of the Division of Anesthesia and Analgesia Products in the FDA's Center for Drug Evaluation and Research.
He was quoted as saying "Although this new formulation of OxyContin may provide only an incremental advantage over the current version of the drug, it is still a step in the right direction. As with all opioids, safety is an important consideration.
Prescribers and patients need to know that its tamper-resistant properties are limited and need to carefully weigh the benefits and risks of using this medication to treat pain."
The Food and Drug Administration has approved this new oxycodone formula; which releases the drug more slowly into the system OxyContin can be broken down, crushed, heated or dissolved and used by drug abusers for its opioid pain killer properties. The new formulation is released over the course of a day to “discourage misuse and abuse of the medication” says the FDA in a news release.
The FDA warns the drug can still be abused by taking larger quantities than recommended.
Manufacturer, Purdue Pharma of Stamford, Connecticut submitted the new formulation to the FDA for review in September 2009. Purdue Pharma must conduct post marketing evaluation of the new formula to determine if the reformulation has resulted in less use by abusers.
When the presentation by Dr. Rappaport was completed and comments were offered by those invited to participate in the teleconference, I indicated that I had a comment and in short time, I was called upon and below is a synopsis of what I said.
I don't have to tell the FDA that the United States has been involved in this epidemic of OxyContin addiction, abuse and death for well over a decade now. The reformulation of OxyContin is too little, too late for the victims of this drug. The FDA has indicated that Purdue Pharma will be required to conduct a postmarket study to collect data on the extent to which this new formulation reduces abuse and misuse of OxyContin, as well as a Risk Evaluation and Mitigation Strategy regarding the appropriate use of OxyContin in the treatment of pain. That is my concern. I wouldn't believe any study conducted by Purdue Pharma. How is the FDA going to safeguard that the data submitted by Purdue Pharma is not slanted and is accurate? I am going to make a recommendation to the FDA today -- and will be working with them diligently -- that OxyContin be reclassified immediately for severe pain only -- and the labeling changed to reflect that it is not to be prescribed for moderate pain. This company cannot be allowed to further ruin the lives of scores of innocent victims under the watch of the FDA.
In the meantime, Purdue Pharma posted the below release on their website regarding the reformulation of OxyContin. My problem with this press release is the line "Purdue elected to reformulate OxyContin® to be bioequivalent to the original formulation and in an effort to make the tablet more difficult to manipulate for the purpose of intentional misuse and abuse, however, there is no evidence that the reformulation of OxyContin is less subject to misuse, abuse, diversion, overdose or addiction."
So in Purdue Pharma's words, if there is no evidence that the reformulation of OxyContin is less subject to misuse, abuse, diversion, overdose or addiction -- what was reformulated?
My guess is that the gatekeeper at Purdue Pharma, J. David Haddox, dentist turned psychiatrist and currently Vice President, Risk Management & Health Policy will be involved in the post marketing data submitted to the FDA on this new reformulated OxyContin.
Since I wouldn't believe anything Haddox says -- even if his tongue were notarized, I will be closely following the data submitted to the FDA by Purdue Pharma on the reformulated OxyContin.
STATEMENT OF PURDUE PHARMA L.P. REGARDING FDA'S APPROVAL OF REFORMULATED OXYCONTIN® (OXYCODONE HCl CONTROLLED-RELEASE) TABLETS
April 5, 2010 - The U.S. Food and Drug Administration (FDA) approved Purdue Pharma L.P.'s New Drug Application for a reformulation of OxyContin® (oxycodone HCl controlled-release) Tablets.
The reformulation has met FDA criteria for bioequivalence to the original formulation, which means there is no significant difference in the rate and extent of absorption of the therapeutic ingredient.
While similar in appearance to the original formulation, the reformulated tablets have a different marking ("OP") than the currently marketed tablets (marking "OC") and the 60 mg and 80 mg tablets are slightly larger in size than the currently marketed tablets.
Purdue elected to reformulate OxyContin® to be bioequivalent to the original formulation and in an effort to make the tablet more difficult to manipulate for the purpose of intentional misuse and abuse, however, there is no evidence that the reformulation of OxyContin is less subject to misuse, abuse, diversion, overdose or addiction.
OxyContin® continues to be a CII controlled substance with all the attendant risks of Schedule II opioids, specifically that the drug has a high potential for abuse. Use, misuse, or abuse of the drug may lead to physical dependence or addiction (addiction is sometimes referred to as "psychological dependence"). In addition, alteration of the tablet in any manner poses significant risks of overdose and death. The Full Prescribing Information contains warnings about the potential for abuse, diversion, overdose and addiction, including a boxed warning (see below).
Indications and Usage
Limitations of Usage
OxyContin® is not intended for use on an as-needed basis.
As used here, "moderate" and "moderate to severe" pain do not include commonplace and ordinary aches and pains, pulled muscles, cramps, sprains, or similar discomfort.
OxyContin® is not indicated for the management of pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. OxyContin® is indicated for postoperative use following the immediate post-operative period only if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.)
OxyContin® is not indicated for pre-emptive analgesia (preoperative administration for the management of postoperative pain).
OxyContin® is not indicated for rectal administration.
Important Safety Information
Opioid analgesics have a narrow therapeutic index in certain patient populations, especially when combined with CNS depressant drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension. Use low initial doses of OxyContin® in patients who are not already opioid-tolerant, especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications.
Serious adverse reactions which may be associated with OxyContin® Tablet therapy in clinical use are respiratory depression, apnea, respiratory arrest, and circulatory depression, hypotension, or shock. The most common adverse reactions (>5%) include: constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, asthenia, and sweating.
"We will work with distributors and pharmacies for a smooth transition to the reformulation that will maintain product supply and protect patient access," said John H. Stewart, President and CEO of Purdue Pharma L.P.
About Purdue Pharma L.P.
The professional product labeling for OxyContin® Tablets contains the following boxed warning:
WARNING: IMPORTANCE OF PROPER PATIENT SELECTION AND POTENTIAL FOR ABUSEOxyContin contains oxycodone which is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine. (9)
OxyContin can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OxyContin in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. (9.2)
OxyContin is a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. (1)
OxyContin is not intended for use on an as-needed basis. (1)
Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.
OxyContin 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in opioid-tolerant patients, as they may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory-depressant or sedating effects of opioids. (2.7)
Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. All patients receiving opioids should be routinely monitored for signs of misuse, abuse and addiction. (2.2)
OxyContin must be swallowed whole and must not be cut, broken, chewed, crushed, or dissolved. Taking cut, broken, chewed, crushed or dissolved OxyContin tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone. (2.1)
The concomitant use of OxyContin with all cytochrome P450 3A4 inhibitors such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir) may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse effects and may cause potentially fatal respiratory depression. Patients receiving OxyContin and a CYP3A4 inhibitor should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted (7.2).
Full prescribing information for OxyContin is available at
Salem-News.com 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.
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