FDA may yank acetaminophen-enhanced painkillers off the market

July 1, 10:19 PMPolitical Buzz ExaminerJames Hyde

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FDA may yank acetaminophen-enhanced painkillers off the market. If you regularly take Tylenol, Vicodin, Hydrocodone or Percocet, you need to read this story. Why?

Two reasons: 1. WebMD.com  is reporting that the U.S. Food and Drug Administration (FDA) may yank Vicodin, Hydrocodone, Lortab, Maxidone, Norco, Zydone, Tylenol with codeine, Percocet, Endocet, Darvocet and other drugs like them off the market; 2. According to CNN.com, Foxnews.com, ABCnews.com, the panel making that recommendation points to the overdose risk which could result in liver failure.

Let the lobbying begin.

You can bet that pharmaceutical companies manufacturing acetaminophen, or products containing that drug, will be pulling out all the stops to keep the FDA from taking their products off the shelves. Although some doctors are aghast at the idea, there’s good reason to pull them.

The FDA’s raison d’etre is to be our guardian against unsafe food and drugs. They wield a big stick and put pharmaceutical companies through some stringent paces before a single pill hits store shelves.

Because of it’s massive role as a federal regulator and the enormous variety of drugs it approves and reviews even after a drug has been available for years, the FDA relies on government panels of medical experts to make recommendations about new drugs or studies of drugs that have proven to be dangerous over time or if used in excess.

According to WebMD.com, a government panel making the recommendation to the FDA cites a study that revealed that, during the 1990s, overdoses of acetaminophen resulted in 56,000 emergency room visits, 26,000 hospitalizations and 458 deaths.

But those numbers recorded a decade ago don’t take into account the more recent surge in teenage “medicine cabinet” junkies who take Vicodin or Percocet prescribed for other family members or buy it off the streets. Both drugs with Hydrocodone have become the social highs of choice, and their acetaminophen content is posing some unsettling health risks.

If you take acetaminophen, better known by the brand name Tylenol, once in a while, the likelihood of liver toxicity is remote. If you take it, or any drug containing it, regularly, you should talk to your doctor about alternatives.

Acetaminophen is included not only in prescription painkillers, but in many over-the-counter drugs, such as NyQuil, myriad similar cold remedies, Excedrin, and aspirin-free Anacin, among many others. Because people may take several of these drugs in tandem, they’re at higher risk of damaging their livers without realizing it.

Great show, poor depiction

If you watch the hit TV show, House, you know that it’s weekly storyline has Dr. Gregory House, who lost part of his leg to surgery and suffers constant pain, pouring Vicodin from a pill container directly into his mouth without regard to the number of pills landing on his tongue or the frequency with which he does this. While the show has numerous “longcomings,” the depiction of Vicodin abuse is its greatest shortcoming.

House is the Einstein of “differential diagnoses.” It is he, with his fellowship students, who figures out what’s wrong with patients after other doctors have given up playing “pin the diagnosis on the symptoms.” While he and his crack team always get what disease a patient has, he pops Vicodin as if it’s Pez candy. That gives viewers who take Vicodin the idea that they can follow suit and take as much as they want as often as they want. Very bad idea.

Worse, the show, which sometimes focuses on his addiction and drug abuse, treats the issue as if it’s a wink-and-nod flaw in the character that doesn’t seem to affect his performance. Nor does the show offer any disclaimers about the indiscriminate use of the drug. It portrays House as appearing completely unaffected by his dependency, perfectly lucid and clear-headed, and depicts him driving to and from work on a motorcycle.

Uh, if you’re on Vicodin and you get pulled over, you could get hammered for DUI if the cop figures out that you’re on it.

Prescription combined drugs

Painkillers like Vicodin, Hydrocodone and Percocet are opiates that are combined with acetaminophen to enhance the narcotic’s efficacy. The problem is that, over time, Vicodin and Percocet addicts don’t know that acetaminophen can destroy their livers. And because of their addiction, their chances of getting a liver transplant are right up there with walking to the moon. Demand for new organs far outstrips the supply, and those without drug dependencies and who live otherwise healthy lives, rise up the list. Addicts generally don’t even make the list.

A potentially deadly fake suicide concern

I worked in a Connecticut hospital while putting myself through college. I can remember vividly at least three ER cases involving teenage girls who deliberately overdosed on Tylenol in desperate attempts to rekindle relationships with boyfriends by whom they’d been dumped.

Since acetaminophen is a commonly used drug considered safe and effective for temporary relief of minor pain and fever reduction, many perceive it to be a perfect drug to engage in “attention-getting” but fake suicide attempts, the effects of which are easily counteracted. One of the girls told me that she figured we could just pump her stomach or give her something to counteract it. She was clueless about its toxicity to the liver.

What happens next is up to the FDA

Because its core duties within the government are many, varied and time consuming, the FDA relies on special government panels comprising groups of medical practitioners to review how dangerous, helpful and/or efficacious a given drug is, even long after it has made its market debut. Comprising as many as 30 to 40 or more medical professionals, these panels review studies of drugs, then vote on what to recommend to the FDA.

According to ABCnews.com, the panel in this case was an amalgam of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee, which voted 17 to 12 to have the “prescription combined drugs” taken off the market to reduce the incidence of liver damage.

What seems dichotomous about this is that the panel did not include in their recommendations non-prescription “over-the-counter drugs or combined drugs,” such as NyQuil, Tylenol, Pamprin and Allerest, among others. However, according to WebMD.com, “The panel of 37 doctors and other experts also said that the maximum total dose for 24 hours, now at 4,000 milligrams, should be decreased.”

That may well be because such drugs are taken only for short periods and intermittently by people who have colds and other short-term health issues. As such, acetaminophen presents no long-term-use liver damage potential. But, it is used ubiquitously in other over-the-counter of drugs, which, if taken together, increase the risk of potential liver toxicity.

And CNN.com is reporting that the CDC (Centers for Disease Control and Prevention) tapped acetaminophen as the likeliest cause of most acute liver failures.

While the FDA relies on such panels for recommendations to provide guidance about what to regulate and how, it is not obligated to comply with the recommendations, but almost always does.

For those who suffer from chronic pain and who take Vicodin, Percocet or Hydrocodone for long durations and in higher doses than they would if taking Tylenol alone, should discuss options with their doctors. If Vicodin, Percocet and Hydrocodone are pulled, they’ll need a replacement anyway. Regardless, according to the panel, you’re safer without it.

Opiate painkillers used by chronic pain sufferers are prescribed for long-term use for moderate to severe pain or as relief of what’s called “breakthrough pain.” Many patients who suffer from acute chronic pain, such as back pain, are put on a long-acting and stronger narcotic such as morphine or Fentanyl patches. If their pain “breaks through” the barriers provided by those medications, the patient takes a breakthrough painkiller, such as Vicodin or Percocet.

Alternatives

There are good alternatives to “prescription combination drugs,” so call your doctor to discuss them whether or not the FDA pulls the acetaminophen-enhanced drugs.