Vioxx osteoarthritis pain

A lot to imagine

The advertisements for Vioxx encourage you to “imagine planning your day around your life, instead of your osteoarthritis pain.” For the millions of people who regularly suffer with that pain, it’s certainly an appealing thought. But according to a new report, at least five Vioxx users found themselves putting their lives on hold instead – because the drug caused a life-threatening side effect. In this week’s issue of the Archives of Internal Medicine, doctors from the Food and Drug Administration detail five cases of aseptic meningitis that are believed to be associated with the use of rofecoxib (Vioxx). The victims ranged in age from 16 to 67, all developed symptoms within as little as 12 days on the drug – and all ended up hospitalized with this life-threatening disease.
Dangerous NSAID side effect also applies to COX-2 inhibitors

When most people use the term “meningitis,” they actually mean bacterial meningitis. But in this case, we’re talking about aseptic meningitis, which is not caused by bacteria. Like the more common bacterial variety, aseptic meningitis is characterized by inflammation of the brain and spinal cord. It can be caused by a virus – and, according to the report, it’s a known rare side effect of other non-steroidal anti-inflammatory drugs (NSAIDs), like ibuprofen, tolmetin sodium (Tolectin), sulindac (Clinoril), and naproxen (Aleve, Naprosyn).

Vioxx (also known by its generic name rofecoxib) is one of a new class of NSAIDs called COX-2 inhibitors. They were designed to relieve pain without causing the gastrointestinal side effects that often accompany traditional NSAIDs. But they haven’t been without their problems. In the October 8, 2001 e-Alert we told you about how Vioxx might increase your risk of a heart attack. And in the January 2, 2002 e-Alert, we revealed how Vioxx and other COX-2 inhibitors like Celebrex can cause reduced kidney function in elderly patients and diabetics.

Although aseptic meningitis has been listed as a possible side effect on Vioxx’s product label and package insert since 2000, until recently, there were no cases documented in the medical literature. We should note that the FDA report doesn’t say that Vioxx directly caused these cases.

But I think the evidence speaks for itself. All of the patients in the report developed symptoms like headache, neck stiffness, eye pain, fever, confusion, and weakness within days of beginning Vioxx therapy. All were hospitalized, and all improved after being taken off a Vioxx. In one case, Vioxx was re-introduced twice after the initial recovery, and both times symptoms reappeared. The report also notes that there were two other cases that were not included because of complete information. And an Associated Press story reported that there are at least another six cases of meningitis that have been linked to Celebrex, another COX-2 inhibitor.
It’s a roll of the dice – no clear cut way to assess your risk

Granted, the numbers are small; Merck was quick to point out that 52 million prescriptions for Vioxx have been written since the drug was approved in 1999. But it’s important to note that the patients in this report didn’t share many similarities, other than their Vioxx use. Four of the five were women, and the report suggests that aseptic meningitis occurs more often in women. But aside from that, it’s impossible to say who might be more susceptible to this side effect than others.

If you take Vioxx or Celebrex, pay close attention to any unusual symptoms you may develop. If you get a severe headache, a stiff neck, an unexplained fever, or any of the other symptoms I detailed above, see your doctor immediately. Make sure that any health care professional who treats you knows the drugs that you take – and make sure they know about the possible connection.

And the March issue of your Members’ Alert told you about Nexrutine, a proprietary discovery from Next Pharmaceuticals, that was showing great promise in easing joint pain and other symptoms. To read the March article, follow this link: http://www.hsionline.com/hsi_0203_a.shtml

Everyone deserves the opportunity to live without arthritis pain. But none of us wants to trade that pain for another health problem – especially one that could land you in the hospital. Make sure you have all the facts before you decide how to treat your pain – and please be sure you report any usual changes to your doctor immediately.

Source: Archives of Internal Medicine 2002;162:713-715