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FDA Seeks Tougher Regulation Of Opioids

Posted by Chrissie Cole
Tuesday, February 10, 2009 10:25 AM EST
Category: Major Medical
Tags: FDA and Prescription Drugs, Painkillers, Opioids, Narcotics, Drug Abuse


IMAGE SOURCE: © Wikimedia Commons / U.S. Food and Drug Administration logo / author: David Vasquez

U.S. regulators announced Monday that they are stepping up efforts to reduce the misuse of 24 powerful painkillers, which cause hundreds of deaths each year.

Letters have been sent to 16 drug companies that collectively manufacture opioids that are subject to review, including oxycodone, methadone, morphine, fentanyl patches and related drugs.

The FDA is targeting both patch and pill forms, which generally feature extended-release formulas that are designed to give long-lasting effects. But, regulators warn that potency carries serious health risks.

“We are focusing on these products because they contain powerful doses of the drugs and they need to be used carefully and with caution,” said Dr. John Jenkins, the FDA’s chief of new drugs.

In 2007, 21 million prescriptions were dispensed for the 24 opioid products, used by 3.7 million Americans. The drugs are commonly used by patients that require constant treatment, such as cancer patients, for moderate to severe pain. While these types of drugs have the ability to relieve chronic pain, they can also be highly addictive and are often abused for their euphoric effects.

The agency is implementing this new program, because the “rates of abuse and misuse of opiates has risen over the past decade,” Jenkins said. The FDA Amendments Act of 2007 authorizes the agency to require Risk Evaluation and Mitigation Strategies, or REMS, "to ensure that the benefits of the drugs outweigh the risks," Jenkins said.

To that end, the FDA is working to strike an “appropriate balance” between legitimate patient needs for access to such drugs and the threat posed by their abuse and intentional/unintentional misuse.

The Substance Abuse & Mental Health Services Administration (SAMHSA) released data on Monday that showed adults aged 18 to 25 currently using pain relievers for non-medical reasons increased from 4.1 percent in 2002 to 4.6 percent in 2007. During that same period, non-medical use increased to 1.6% from 1.3% in Americans 26 and older.

Overall, 5.2 million people aged 12 years or older reported using prescription pain relievers non-medically in the past month in 2007.

An initial meeting between the agency and drug manufacturers is scheduled for March 3. #


Posted by Austin
Tuesday, February 10, 2009 11:24 PM EST

The FDA effort is laudable. As a pragmatist, I expect the population, on occasion, to make medication mistakes and get into health status trouble. Also, I expect drug abusers to find new and creative ways to get around drug supply controls, and manufacturing formulation techniques intended to discourage drug manipulation and abuse. Austin

Anonymous User
Posted by BRM
Thursday, February 12, 2009 9:08 AM EST

Laudable? Are you kidding? They concede that close to 4 million people use these drugs each year, while only a few hundred (and it's in the low 1-2 hundreds each year) people suffer deaths involving these drugs. You need to know that this includes people who are taking the drug and are hit by a drunk driver - not their fault at all. It also includes people misusing these opioid drugs by ingesting large quantities of alcohol. If a person dies and they have the stuff in their blood - regardless of the facts - it is an "opioid-related death." So that greatly inflates the number of deaths. Deaths resulting from proper use of these drugs is zero.

Meanwhile, tens of thousands of people die each year from simple acetaminophen overdose.

But the problem is these drugs are already highly overregulated, resulting in inadequate paincare due to opiophobia among physicians. At the end of the day, if you read between the lines, it is classic drug diversion which they seek to address with this massive new bureaucratic program. Stopping the illegal sharing/selling of opioids is the DEA's job, not the FDA's, and it has nothing to do with proper/improper/necessary/unnecessary prescribing of these medications. It has to do with intrinsically high street prices of these drugs DUE TO PROHIBITION and demand. When someone has no health insurance, can you really blame them for selling a couple Oxycontin pills for $100 per pill to a neighbor to offset the cost of their $900 prescription? I'm not saying it's right, I'm just saying some people may have no choice in the matter.

Like usual, it's the opioids that are demonized. Other Schedule-II controlled substances, like amphetamines such as Adderall, which our society overprescribes to stuff down our children's throats in bucketloads so they will sit down, shut up, and do better in their English class, is not being addressed by this new "program" oddly enough. Gee I wonder why.

There is nothing laudable about the FDA's effort to waste millions of dollars in taxpayer money to cause more suffering for pain patients, more headaches and worries for doctors willing to treat pain, all under the guise of preventing "diversion" to save about 150 lives each year - the lives of people who are intentionally misusing thes medications by mixing them with vodka. As for the "opioid-related deaths" of people taking these medicines who, while walking down the street, have pianos dropped on their heads - no regulation can directly reduce those numbers... numbers which are illegitimately counted, anyway. Only less prescriptions of opioids will drop all the "bad" statistics they make up. And that's what they're trying to do. It's disingenuous and it's unnecessary and it's a waste of taxpayer money and it's an abuse of their power.

Anonymous User
Posted by TB
Friday, February 13, 2009 6:58 PM EST

BRM articulated my sentiments exactly. Thank you.

Comments for this article are closed.

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