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FDA Will Strengthen Warnings on Arthritis and Pain Drugs

There's greater stroke and heart attack risk with use of ibuprofen

My favorite home remedy for treating arthritis pain is raisins soaked in gin and honey. And I don’t even like raisins. Or gin, for that matter.

But when Americans get joint pain or headaches, we often turn to a class of medications referred to as NSAIDs: non-steroidal anti-inflammatory drugs. This includes drugs like ibuprofen (Motrin, Advil) and naproxen (Aleve, Naprosyn); it does not include acetaminophen (Tylenol).

This week, the Food and Drug Administration (FDA) announced it will be strengthening and broadening previous warnings about the side effects of NSAIDs, in particular, the drugs’ propensity for raising the risk of heart attack or stroke. This increased cardiovascular risk isn’t a new finding, and you can read about it on the label as you work to remove the child-and-nearly-adult-proof lid off the bottle.

But when an FDA advisory committee met in February 2014 to review the most recent data, its members agreed that current labeling, which focused primarily on NSAID users with known cardiovascular disease and those who were taking an NSAID on a long-term basis, was too narrow.

New labeling will reflect the following conclusions: The more and the longer you take it, the higher the risk. But a stroke or a heart attack can occur with even casual use, and even in people not known to have atherosclerosis — the scarring of the inside of the blood vessels that is the hallmark of cardiovascular disease.

Why the Risk?

The new warnings beg the same old question:“Why would a pain medication give you a heart attack?”

A stroke or a heart attack can occur with even casual use, and even in people not known to have atherosclerosis.

NSAIDs work by inhibiting an enzyme called cyclooxygenase. It comes in two basic forms —COX-1 and COX-2. In the old days, it was pretty simple: the pain and inflammation relief came from blocking the COX-2 enzyme and the side effects (heart attacks and strokes, stomach ulcers, kidney problems) all came from blocking the COX-1 enzyme.

The trouble is, all NSAIDs block the COX-1 enzyme to varying degrees, so the downsides were hard to avoid.

But when a new class of NSAIDS, the “selective COX-2 inhibitors” like Vioxx and Celebrex, arrived a few years back, we thought we had it made: all of the good COX-2 blocking effects without the bad COX-1 side effects.

But apparently it’s not that simple.

Unanticipated Effects

It turns out there are COX-2 enzymes in the lining of our arteries, not just in our joints. And when those enzymes get blocked, the arterial lining can get “stickier.” That’s when the trouble starts.

When you cut your finger with a paring knife because you’re loaded up on gin-soaked-raisins, platelets stick to the damaged blood vessels and plug the hole by forming a clot. In the case of a stroke or heart attack, atherosclerotic damage “tricks” the platelets into forming a clot, and a blood vessel that should be open for business is now closed. So Vioxx got the ax, Celebrex got a black box warning and NSAIDs got a warning label.

A cardiologist I saw on the CBS morning show used the word “dangerous” to describe NSAIDs, but that’s a little strong. People choke to death on olives: Are olives “dangerous?” People fall and injure themselves while walking: Is walking “dangerous” and is crawling a more reasonable, safer option? And wouldn’t that be bad for the knees?

It turns out that nothing is safe, and everything is a matter of risk.

How Worried Should We Be?

How risky are NSAIDs? Estimations vary, but Dr. Daniel Solomon, a rheumatologist at Harvard Medical School, said in a Medscape interview that he tells his patients NSAID use may increase their risk for a heart attack from 5 per 1,000 per year to 6 or 7 per 1,000 per year.

Solomon is also on the executive committee of the PRECISION Trial, a placebo-controlled study comparing Celebrex, naproxen and ibuprofen. The results are due about a year from now and will hopefully bring more clarity to this subject.

The trial does not, as you may have guessed, include a gin-soaked-in-raisins-and-honey group. But Dr. Oz gave the remedy a thumbs up.

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