Tylenol Continues to Fail as Osteoarthritis Pain Killer

Tylenol (acetaminophen) has had a very bad couple of year. The negative reviews for back pain and osteoarthritis pain just keep coming in. . . .

Despite being the most recommended drug for back pain, double-blind research shows that acetaminophen is no better than a placebo for back pain (Lancet 2014;doi:10.1016/S0140-6736(14)60805-9). And recent research shows that it doesn’t work for the pain of osteoarthritis either. A meta-analysis of 13 controlled studies confirms that acetaminophen is useless for back pain and added that it confers no clinically relevant benefit for osteoarthritis. The meta-analysis did find that, though it didn’t help, acetaminophen did increase the risk of abnormal results on liver test by more than 4 times (BMJ 2015;350:h1225).

And now a new study has doomed it again. This very large meta-analysis included seventy-four randomized studies of non-steroidal anti-inflammatory drugs (NSAID) or Tylenol for osteoarthritis pain. A total of 58,556 people were included in the meta-analysis.

For most of the NSAIDs, doses below the maximum dose were no better than a placebo at producing clinically meaningful reductions in pain. As to Tylenol, the meta-analysis concluded that there was no role for Tylenol for treating the pain of osteoarthritis no matter the dose.

When taken at the maximum dose, diclofenac and etoricoxib had the highest probability of reaching clinically meaningful benefit. “Nevertheless,” the researchers cautioned, “in view of the safety profile of these drugs, physicians need to consider our results together with all known safety information when selecting the preparation and dose for individual patients.”

And what is the safety profile for NSAIDs? After the FDA undertook a comprehensive review of the latest safety data, it strengthened its label warning that non-aspirin NSAIDs increase the risk of heart attack and stroke. The FDA says NSAIDs increase the risk of serious cardiovascular events, increase the risk of heart failure and increase the risk of dying in the first year after suffering a heart attack.  And what about the conclusion that the NSAIDs that work only work at their maximum dose? The FDA say that these risks increases with higher doses or longer use (FDA Safety Announcement 7-9- 2015).

According to a meta-analysis of 24 controlled studies, even low dose Aspirin causes gastrointestinal bleeding (BMJ 2000;321:1183-7). 28% of people who take low dose aspirin to prevent heart disease develop an ulcer (Ailementary Pharmacology & Therapeutics 2005;22:795-801).

Lancet 2016;387:2093-2105

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