Acetaminophen Isn’t Such a Choice Drug Anymore: Looking at Pharmacy Compounding Options

Acetaminophen Isn’t Such a Choice Drug Anymore: Looking at Pharmacy Compounding Options

i-pillAcetaminophen is one of those OTC drugs that most people have on hand and take for headaches and other pain without second thoughts. It turns out, those second thoughts might be the difference between good health and a devastating emergency. Recent studies show that acetaminophen is more toxic than previously thought1, specifically with respect to the liver. Patients who took more than the prescribed dosage of acetaminophen in a short period, or who took the drug with alcohol, are known to suffer from severe liver poisoning. Many of these patients end up hospitalized or even in the emergency room.

But that’s not the whole story. It turns out that not only can acetaminophen cause severe liver damage, but it can dampen pleasure and emotional response2, too.

Geoffrey Durso, lead author of a study looking at how acetaminophen affects patient’s emotional perceptions, writes3, “Rather than just being a pain reliever, acetaminophen can be seen as an all-purpose emotion reliever.” Not only did these patients have a blunted emotional response to different stimuli but they didn’t even appear to know it.

In two studies conducted on college students, participants were asked to take a pill (either acetaminophen or a placebo) and then view 40 photographs selected to elicit emotional responses. The results showed that participants who took acetaminophen rated all the photographs less extremely than did those who took the placebo. That is, positive photos were not seen as positively under the influence of acetaminophen and negative photos were not seen as negatively.

“People who took acetaminophen didn’t feel the same highs or lows as did the people who took placebos,” Baldwin Way, a co-author of the study, said.

But that doesn’t happen across the board. Said Dr. Durso, “Acetaminophen may blunt individuals’ broader judgments of everything, not just things having emotional content.” Given this new information, maybe acetaminophen isn’t the right choice for our patients after all.

What Does This Mean for Pharmacy Compounding?

In terms of avoiding liver toxicity, the FDA has already taken the lead by revising their dosing guidelines4 last year to recommend lower dosages of acetaminophen per pill and per day. Healthcare providers have been asked to discontinue prescribing drugs that contain more than 325 milligrams of acetaminophen per tablet, with any drug manufacturers already complying.

Pharmacy compounding to keep up with these guidelines is a no-brainer, especially since we have a number of pain relief options at our disposal. The easiest switch is to recommend aspirin or ibuprofen to treat common aches and pains. We can also incorporate natural remedies into our compounding. And, since acetaminophen may have a large impact on emotional health, transitioning to NSAIDs and SSRIs may be the better option. Even if patients prefer acetaminophen, we can compound the suggested lower dosage along with glutathione, an antioxidant that protects the liver5, which can be delivered through many mechanisms, including transdermal creams and troches.

We also have to consider emotional health, even if the FDA has not focused on that aspect so far. Many of our patients may suffer from anxiety, mood disorders, or side effects from other drugs. They don’t need another complication, in the form of acetaminophen, especially if they are likely to need good emotional health to make judgments on significant life events, such as divorce or changing jobs. Pharmacy compounding for personalized medicine to treat individual patients needs seems like a better fit here than taking an OTC drug wrought with so many significant side effects.

Added to that is the fact that compounding alternatives to acetaminophen might not even be a choice for us soon. Next month, the Pharmacy Compounding Advisory Committee to the FDA will be holding a public meeting to discuss whether acetaminophen6, along with three other drugs, should be on the ‘Do Not Compound’ list. The meeting agenda is loosely focused on the Committee’s task of providing scientific, technical, and medical information on the drug at hand. This is a perfect time for pharmacy compounding agencies and interested individuals to consider what treatment options are currently available, what the need is, and what gaps acetaminophen may the only solution for.

In the meantime, it’s on us to give our patients a safer options to reach for to relieve basic aches and pain. A simple choice for simple conditions will help everyone in the long run here.

Research changes constantly and Pharmaceutica North America is committed to keeping up with the latest information. We pledge to provide you with the best quality ingredients for your compounded medications. Please contact us today so we can provide you with safe compounding ingredients.

Show 6 footnotes

  1. “Acetaminophen Toxicity,” June 24, 2014, http://emedicine.medscape.com/article/820200-overview
  2. “Your pain reliever may also be diminishing your joy,” April 13, 2015, www.sciencedaily.com/releases/2015/04/150413091647.htm
  3. “Over-the-Counter Relief From Pains and Pleasures Alike: Acetaminophen Blunts Evaluation Sensitivity to Both Negative and Positive Stimuli,” 10 April 10, 2015 http://pss.sagepub.com/content/26/6/750
  4. “Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement – Recommendation to Discontinue Prescribing and Dispensing,” January 14, 2014, http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm381650.htm
  5. “Novel Mechanisms of Protection Against Acetaminophen Hepatotoxicity in Mice by Glutathione and N-Acetylcysteine,” Jan 2010, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2977522/
  6. “FDA Considers Compounding Restrictions on Four Drugs, Including Acetaminophen,” May 21, 2015, http://www.raps.org/Regulatory-Focus/News/2015/05/21/22228/FDA-Considers-Compounding-Restrictions-on-Four-Drugs-Including-Acetaminophen/
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