by Caroline von Fluegge-Chen
I just read an article on CNN that the FDA has advised taking Vicodin and Percocet, two powerful painkillers, off the market because patients who take these drugs risk addiction, overdose and liver damage. Maybe I am just a little bit too logical, but answer this question for me: How do these drugs even get ON the market in the first place? The FDA has the power to take them off the market and the power to put them on the market. So at what point did the FDA say, “Hey, this is really great stuff, let’s make it available to everyone…” And then to turn around and say, “Hey, guess what? We were wrong. This is really terrible stuff. A few people have really messed up their health. Hmmm. Maybe we should pull it off the market.” How many dealths/addictions/complications does it take for a drug company to realize they have just ruined the lives of a certain number of people? Did they not anticipate the dangers BEFORE they put these drugs on the market?
Yeah. I know. Not everyone takes Vicodin or Percocet. However, this recall situation is not uncommon. It happens every day. Just look on line. Go to the New York Times health section. Read the headlines. A drug company is busted for falsifying data. Doctors are busted for prescribing drugs they should not be prescribing – tell me, how did Michael Jackson die? Kids are selling Ritalin as a street drug. Pharmaceutical companies are schmoozing with the FDA and paying off doctors to promote their brands. And the list goes on. In fact, this spring I was in Piedmont Park at the Dogwood Festival and a 20-something year old girl with an Allegra t-shirt was passing out samples of allergy medications. What is up with THAT?
Sure, there is a time and a place for medications in a crisis – when your body cannot figure out what to do anymore. When patients tell me on their health history form they are taking pain killers to alleviate their symptoms, I make this certain gesture: I tip my head to the left a bit and look up at the patient – sort of like that Jack Russell terrier from the RCA music label. I look inquisitive that way, I think. Then I put on a slight Southern drawl and say, “C’mon John (or Mary or whomever), you know that ain’t right.” Immediately the patient gets (without feeling rotten) that their way of dealing with health issues (covering up symptoms) is not really that smart, logical, effective, or practical.
It took time to pulverize your spine and it is going to take time to correct it – that is, if your spine is not beyond repair. There is no short cut when it comes to your health. Healing is a process. Either you are going to do what it takes to correct the issue from its root cause, or you are going to turn a blind eye, cross your toes and hope for the best. Keep listening to the drug ads, keep believing what they say, keep taking what they tell you to take and let’s check in with you 30 years from now. Are you feeling fantastic and zipping right along, or do you have a list of health problems ten miles long?
My commitment is to bring out more of what is working well in your body and to address and correct the cause of your health concerns. I would rather empower you to understand your body better and treat it with care. After all, your life depends on it.
Here is the CNN article.
A government advisory panel voted Tuesday to recommend eliminating prescription drugs that combine acetaminophen with narcotics — such as Vicodin and Percocet — because of their risk for overdose and for severe liver injury. Acetaminophen, found in drugs such as Tylenol, is one of the most commonly used drugs in the United States.
Acetaminophen, found in drugs such as Tylenol, is one of the most commonly used drugs in the United States.
The panel, assembled by the Food and Drug Administration, voted 20 to 17 to advise the FDA to remove such prescription combination drugs from the market.
The group recommended that the FDA “send a clear message that there’s a high likelihood of overdose from prescription narcotics and acetaminophen products,” Dr. Sandra L. Kweder of the FDA’s Office of New Drugs said at a news conference after Tuesday’s meeting.
The panel was meeting for the second day to vote on recommendations to reduce the risk of serious liver injury associated with acetaminophen, which is found not only in prescription drugs, but also in over-the-counter medications such as Tylenol and NyQuil.
It also advised the FDA to lower the maximum daily dose of acetaminophen in over-the-counter and prescription medications, and to address the formulations and dosing recommendations for children.
Kweder said the FDA is already “well on the road” to addressing the pediatric concerns.
The FDA is not required to follow the recommendations of its advisory committees, although the agency typically does.
If the agency does not choose to eliminate prescription combination drugs, the panel said the FDA should lower the amount of acetaminophen in the drugs and also take some action to ensure that subscribers and patients are aware of potential liver damage posed by taking these products, Kweder said.
In another vote, the panel had voted to advise the FDA to put a boxed warning on the prescription combination drugs.
Although acetaminophen is one of the most commonly used drugs in the United States for treating pain and fever, overdoses of acetaminophen have been linked to 56,000 emergency room visits, 26,000 hospitalizations and 458 deaths during the 1990s, according to the FDA, citing one study.
The agency cited another study, a 2007 Centers for Disease Control and Prevention population-based report, that estimated acetaminophen was the likely cause of most of the estimated 1,600 acute liver failures each year.
The advisory panel could have voted to recommend pulling over-the-counter drugs that use acetaminophen in combination with other ingredients — such as NyQuil, Pamprin and Allerest — but it chose not to.
Some panelists cited data that suggests that combination over-the-counter drugs account for less than 10 percent of acetaminophen overdoses.
Kweder said families should carefully read medicine labels to know what is in the medicine and how much should be taken.
Abbott Laboratories, which makes the brand-name Vicodin, which has also been available as a generic since the mid-1980s, said in a statement that “today’s discussion is an important continuation of the dialog around balancing patient safety with the need for treatment options for patients in pain.”
It said, “Pain affects 75 million Americans, more than diabetes, cancer and heart disease combined” and added that it would follow the FDA’s final determination.
Endo Pharmaceuticals, which makes the brand-name Percocet, did not immediately return a phone call seeking comment. Percocet is also available as a generic.