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Sep-16-2013 02:54printcomments

FDA Requirement to Change Labels on Painkillers is Weak, Ineffective



(MYRTLE BEACH, SC) - Fed Up Rally in Washington, DC on October 1, 2013 to call on the federal government and in particular the Federal Drug Administration (FDA) to address the loss of life in addiction and death to the over-prescribing of opioids. Please attend and support Fed Up -- they are working hard to save lives.

The Food and Drug Administration (FDA) is making an attempt at requiring pharmaceutical companies to be held accountable for the weak package labels on painkillers warning of the dangers of addiction and death by issuing a directive that they think addresses the opioid epidemic. Am I impressed with the new FDA regulations? Not even close. I still maintain that the FDA needs to be "swept clean" and have everyone from Commissioner Margaret Hamburg to Doug Throckmorton to Bob Rappaport on down replaced by people who recognize we have an epidemic which continues while the FDA and those capable of saving lives -- and not entrenched with the pharmaceutical industry -- have their eyes wide shut.

Previous warning labels for long-acting opioid pain relievers, which include OxyContin, morphine and other narcotic medications, have stated they are for the use of "moderate to severe pain." The new label will suggest the pain killers to only be used for "pain severe enough to require daily, around-the-clock" treatment, according to the FDA statement.

Hamburg - Photo:

"The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the misuse, abuse, addiction, overdose and death from these potent drugs that have harmed too many patients and devastated too many families and communities," FDA Commissioner Margaret Hamburg said in a press release.

"In 2010, an estimated 16,651 people died because of abuse and misuse of opioid drugs," Hamburg said. "There is an increase of more than 300 percent over the past decade. And for each death there is an additional 10 treatment admissions, 32 emergency department visits and 825 nonmedical users of these drugs."

What took you so long Dr. Hamburg? This is not a new problem in every state in the country -- it is an epidemic. Instead of the FDA having their ears tuned to the pharmaceutical industry and their push for opioid prescribing and the FDA being enamored by the deep $$$$$ pockets of pharma -- Dr. Hamburg should have taken action to save lives before there was a 300% increase in deaths and addictions building over the past decade.

Physicians for Responsible Opioid Prescribing (PROP) had filed a Citizen's Petition to the FDA in a push to save hundreds of thousands of lives to careless prescribing of opioids.

PROP had proposed that the allowance for use in treating "moderate to severe pain" be limited to "severe" pain only, The FDA's changes to opioid labeling did not go that far. According to PROP what constitutes "severe enough" is entirely subjective, as was the old language of "moderate to severe". One could say that a mild headache is severe enough to require opioids.

And I'm certain PROP and other organizations throughout the country holding the FDA accountable for their "too little too late" action will not be going away.

The new FDA opioid labels will also include a boxed warning about the risks of opioid withdrawal syndrome in infants who are exposed to the drugs during pregnancy, labor and nursing. Symptoms may include rapid breathing, trembling and poor feeding habits. The prominent "boxed" warning labels will warn that chronic use of the drugs by pregnant women can cause a life-threatening complication in their babies known as neonatal opioid withdrawal syndrome. Newborns go through withdrawal because they are no longer exposed to an addictive drug.

Lynn M. Webster, MD, under US Senate investigation for ties to the pharmaceutical industry and investigation by the Drug Enforcement Agency (DEA) for deaths of up to a couple of dozen deaths at his pain clinic in Salt Lake City, Utah has stated that pain medications can have an appropriate role during pregnancy. “It’s not bad to be on opioids when you’re pregnant if you have good care." He added that more research is needed to determine if women are being treated with opioids appropriately and how pregnancy outcomes would be affected without the drugs. “There are consequences of not addressing pain in women who are pregnant. That has to be kept in mind,” said Dr. Webster, president of the American Academy of Pain Medicine (also under US Senate investigation).

I am not the country's "leading pain specialist" as Webster likes to call himself. But I do have a question for him -- how do you sleep at night?

Next week Part 2 and Russell M. Portenoy, MD medical expertise on treating pediatric patients with opioids for what he refers to as the "undertreatment of pain" in children and his financial ties to Purdue Pharma, the maker of OxyContin.

LP - Two popcorns, tacos with chemical fillers and no chicken bog. You spoil me rotten. Chico's?



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Sean Flynn was a photojournalist in Vietnam, taken captive in 1970 in Cambodia and never seen again.