FDA Urges Tighter Rein on Hydrocodone Medication While Simultaneously Approving Another Addictive Painkiller

Story at-a-glance

  • In the year 2011, more than five billion hydrocodone-containing pain pills were prescribed to an estimated 47 million American patients
  • In little over one decade (1999-2010), deaths from prescription painkiller overdose—whether accidental or intentional—increased by 400 percent among women and 265 percent in men
  • Prescription drug deaths have far surpassed deaths from illicit street drugs, accounting for about three-quarters of all drug overdose deaths in the US
  • The FDA has announced its intention to reclassify hydrocodone-containing painkillers from a Schedule III to a Schedule II drug. The reclassification will affect how hydrocodone-containing drugs can be prescribed and refilled
  • Ironically enough, FDA just approved the first drug containing pure hydrocodone for the US market, aimed at patients who need around-the-clock pain relief


This is an older article that may not reflect Dr. Mercola’s current view on this topic. Use our search engine to find Dr. Mercola’s latest position on any health topic.

By Dr. Mercola

In the year 2011, more than five billion hydrocodone-containing pain pills were prescribed to an estimated 47 million American patients.

According to a recent report1 from the US Centers for Disease Control and Prevention (CDC), in little over one decade (1999-2010), deaths from prescription painkiller overdose—whether accidental or intentional—leapt up 400 percent among women and 265 percent in men.

Last year, CNN's chief medical correspondent, Dr. Sanjay Gupta also reported that:2

“Distribution of morphine, the main ingredient in popular painkillers, increased 600 percent from 1997-2007, according to the U.S. Drug Enforcement Administration.3

In the United States, we now prescribe enough pain pills to give every man, woman and child one every four hours, around the clock, for three weeks.”

Not surprisingly, deaths from these addictive and dangerous drugs have ballooned and become a significant societal problem. Overall, prescription drug deaths have far surpassed deaths from illicit street drugs, accounting for about three-quarters of all drug overdose deaths in the US.

Funny how among all this prescription drug carnage, American politicians still have the gall to single out dietary supplements as the threat to public health to be curbed through more stringent regulations and safety testing...

Among women, the overdose death rate is currently highest among 45 to 54-year olds, suggesting that at least a portion of these drugs are probably prescribed appropriately for pain. Unfortunately, many fail to realize just how addictive these drugs are, and how they affect other systems in your body.

How Pain Killers Can Take Your Life

Most prescription pain killers work by binding to receptors in your brain to decrease the perception of pain. But they also create a temporary feeling of euphoria, followed by dysphoria, which can easily lead to addiction.

This may drive some people to take larger doses in order to regain the euphoric effect, or escape the unhappiness caused by withdrawal. Others find they need to continue taking the drugs not only to reduce withdrawal symptoms but to simply feel normal.

Large doses of these kinds of drugs can cause sedation and slowed breathing to the point that breathing stops altogether, resulting in death.4 A relatively pleasant way to go if you have to go early, but you are still dead.

But these people do not have a death wish; they’re not suicidal, and have no idea that they’ll never wake up again after taking their medication and going to bed. Sadly, and far too often, that’s exactly what happens, courtesy of too much of the medication in their system... As stated by Dr. Gupta:5

“[A]ter just a few months of taking the pills, something starts to change in the body. The effectiveness wears off, and patients typically report getting only about 30 percent pain relief, compared with when they started. Even more concerning, a subgroup of these patients develop a condition known as hyperalgesia, an increased sensitivity to pain.

As you might guess, all of this creates a situation where the person starts to take more and more pills. And even though they are no longer providing much pain relief, they can still diminish the body's drive to breathe.

If you are awake you may not notice it, but if you fall asleep with too many of these pills in your system, you never wake up. Add alcohol, and the problem is exponentially worse. People who take pain or sleeping pills and drink a couple glasses of wine are playing Russian roulette.”

Despite This, FDA Approves Yet Another Addictive Painkiller

Among the most commonly abused medications are:

  • Opioids, such as Vicodin, OxyContin, Percocet, codeine and Fentora, which are used for pain relief
  • Benzodiazepines, such as Xanax, Valium and Ativan, which are used as sedatives to induce sleep, prevent seizures and relieve anxiety
  • Amphetamine-like drugs, such as Ritalin, Concerta and Adderall, which are used to treat attention deficit hyperactivity disorder (ADHD)

The opioid pain relievers are by far the most troublesome, causing nearly three out of four prescription drug overdoses.6 That said, ADHD drugs such as Ritalin, Vyvanse, Strattera, and Adderall (and their generic equivalents) are also becoming increasingly misused. This drug category saw a greater than 400 percent increase in ER visits due to adverse reactions in a mere six years,7 and are now responsible for nearly 23,000 emergency room visits annually. 

With more people now dying from prescription drug overdoses than from motor vehicle crashes, public health agencies are being forced to sit up and take notice. The US Food and Drug Administration (FDA) recently recommended tighter controls on painkiller prescriptions,8 and have previously paid lip service to less addictive treatments.

The agency has now announced its intention to reclassify hydrocodone-containing painkillers from a Schedule III to a Schedule II drug.  The drug schedule system classifies medications based on their potential for abuse and addiction, as well as other medical criteria.

The reclassification will affect how hydrocodone-containing drugs can be prescribed and refilled. Doctors will only be allowed to prescribe a 90-day supply of the drug per prescription, and they will no longer be permitted to phone in refills; rather the patient has to bring the prescription with them to the pharmacy. The new regulations are expected to take effect as early as next year.

Ironically enough, while talking about the need for stricter controls and less addictive painkillers, it just approved the first drug containing pure hydrocodone for the US market, called Zohydro ER (Zogenix). All other hydrocodone-containing painkillers on the market are mixed with other non-addictive ingredients. Zohydro ER was approved for patients who need around-the-clock pain relief. As reported by Bloomberg:9

“The approval came as a surprise since an FDA panel of outside advisers gave the drug an overwhelmingly negative review last year. The panel of pain specialists voted 11-2, with one abstention, against approving the drug. It questioned the need for a new form of one of most widely-abused prescription drugs in the United States. The approval also came a day after the FDA said it would support stronger restrictions on combination drugs containing hydrocodone.”

Beware of Taking These Common Painkillers if You Value Your Heart Health

Another commonly used type of pain killer is nonsteroidal anti-inflammatory drugs, or NSAIDS. Millions of Americans depend on NSAIDS to relieve pain from arthritis, headaches, injuries and countless other conditions that cause chronic pain, and these drugs are also clearly dangerous.

The deadly painkiller Vioxx was in this category. It was pulled from the market in 2004 after 60,000 people had died from its increased heart risks. Later that same year, the FDA warned that other NSAIDS, such as the Cox-2 inhibitors Bextra (which was pulled from the market in 2005) and Celebrex, as well as over-the-counter varieties like Aleve, Ibuprofen and aspirin, also lead to an increased risk of cardiovascular problems.

Two years ago, researchers at the University of Bern in Switzerland revealed that NSAIDs lead to a two to fourfold increase in the risk of heart attacks, stroke or cardiovascular death, noting that it would only take 25-50 patients being treated with NSAIDs for one year to lead to an additional heart attack or stroke. Aside from significantly increasing your heart risks, NSAIDs are also linked to serious gastrointestinal risks, like bleeding of the digestive tract, increased blood pressure and kidney problems.

It’s really quite difficult to find a drug-based method of pain relief that is not saddled with severe side effects. Even acetaminophen-containing prescription products are now required to limit the amount of the drug to 325 milligrams or less per tablet, as taking too much acetaminophen is the most common cause of acute liver failure in the US.

Carefully Ascertain Your Need for a Narcotic Pain Killer...

Some now insist that the proposed FDA reclassification of hydrocodone-containing pain killers will pose too great a burden on people who are in pain, and the doctors who will have to see them more frequently.  Few are talking about the elephant in the room, however, which is that there are many other, safer pain relief options.

How about trying them out as a first resort, before resorting to addictive drugs? It is extraordinarily hard to believe that nearly 50 million Americans being in such dire chronic pain as to require a narcotic painkiller... Clearly, these drugs are being over prescribed and misused by many, and I believe the vast over reliance on them as a first line of defense for pain is a major part of the problem.

Remember, no matter what type of painkiller you choose, it will come with potentially serious risks to your health. Unfortunately, most conventional physicians’ tend to address chronic pain with a long-term treatment plan that typically includes a drug-combination approach, using narcotics, anti-inflammatory drugs, anti-convulsants, muscle relaxants, and possibly other types of pain medication as well. In other words, the answer for pain relief is drugs, drugs and more drugs -- each one raising your risk of suffering potentially lethal side effects.

I believe there’s a better way. If you are suffering from pain, I suggest you work with a knowledgeable health care practitioner to determine what's really triggering your pain, and then address the underlying cause. Make sure you do your homework regarding the risks and benefits of taking them, and understand that they are a temporary solution at best. Not long term. 

Non-Drug Options for Pain Relief

Remember, along with exposing you to potentially deadly risks, medications only provide symptomatic relief and in no way, shape or form address the underlying cause of your pain. Still, I realize that pain can be debilitating so you don't need to suffer unnecessarily while you get to the bottom of your pain issues.

The following options can often provide excellent pain relief when you are dealing with a mild, annoying type of pain, without any of the health hazards that prescription (and even over-the-counter) painkillers carry.  If you have chronic pain, you might want to consider trying these first.

  1. Emotional Freedom Techniques (EFT) is a drug-free approach for pain management of all kinds. EFT borrows from the principles of acupuncture, in that it helps you balance out your subtle energy system. It helps resolve underlying, often subconscious, negative emotions that may be exacerbating your physical pain. By stimulating (tapping) well-established acupuncture points with your fingertips, you rebalance your energy system, which tends to dissipate pain.
  2. Ginger: This herb has potent anti-inflammatory activity and offers pain relief and stomach-settling properties. Fresh ginger works well steeped in boiling water as a tea or grated into vegetable juice.
  3. Cetyl Myristoleate (CMO): This oil, found in fish and dairy butter, acts as a "joint lubricant" and an anti-inflammatory. I have used this for myself to relieve ganglion cysts and a mild annoying carpal tunnel syndrome that pops up when I type too much on non-ergonomic keyboards. I used a topical preparation for this.
  4. Cayenne Cream: Also called capsaicin cream, this spice comes from dried hot peppers. It alleviates pain by depleting the body's supply of substance P, a chemical component of nerve cells that transmits pain signals to your brain.
  5. Methods such as yoga, Foundation Training, acupuncture, meditation, hot and cold packs, and other mind-body techniques can also result in astonishing pain relief without any drugs.


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