June 19, 2006 – It’s not just Vioxx. Nearly all common painkillers may greatly — and quickly — increase the risk of death in heart attackheart attack survivors.
The drugs are the NSAIDs (nonsteroidal anti-inflammatory drugs) ibuprofen (Advil and Motrin) and diclofenac (contained in Arthrotec and Voltaren) and the Cox-2 inhibitors Vioxx and Celebrex. In a look-back study of more than 58,400 Danish first heart attack survivors, all of the drugs were linked to a significantly increased risk of death.
In 2004, concerns over heart risks led the drug company Merck to stop selling Vioxx.
Wake-Up Call for Doctors
The finding isn’t proof positive that these pain drugs are deadly. But it’s a wake-up call to doctors and patients that these drugs, previously thought to be safe, are linked to serious heart problems in vulnerable people.
Gunnar H. Gislason, MD, of the National Institute of Public Health in Copenhagen, and colleagues report the findings in the current issue of the journal Circulation.
“These drugs should be used with particular caution in patients with a prior [heart attack],” Gislason and colleagues warn. “Because studies in this field have revealed major safety concerns where none were thought present, the [heart] safety of not only the selective Cox-2 inhibitors but of all NSAIDs needs to be addressed further.”
In an editorial accompanying the study, NYU researchers Judith S. Hochman, MD, and Nirav R. Shah, MD, MPH, warn that common pain drugs may harm a disturbingly large number of high-risk patients.
“This latest estimate on the [heart] risk of NSAIDs is cause for concern,” they write. “If even short-term — that is, less than one month — use is associated with relatively large risk for death and [new heart attack] in those with prior [heart attack], then widespread use of such agents … may be resulting in substantial morbidity.”
Naproxen (Aleve and Naprosyn), a commonly prescribed NSAID, was not included in the Danish study.
While analysis of existing studies does not show increased heart risks for naproxen, Hochman and Shah warn that “the weight of overall evidence justifies substantial concern.”
Risk High for Heart Attack Patients
People who already have had a heart attack are at particularly high risk of another one. Such patients generally are left out of clinical trials of new drugs. But now it looks as though even older drugs may be a problem for these patients.
The Danish study showed little difference between Vioxx and Celebrex. Any use of Vioxx raised patients’ risk of death 2.8-fold, while those who ever used Celebrex had a 2.6-fold increase. High-dose Vioxx increased death risk 5.3-fold; high-dose Celebrex increased death risk 4.7-fold.
Any use of ibuprofen upped death risk by 1.5-fold; high doses (more than 1,200 milligrams per day) increased risk by 2.2-fold. Diclofenac increased death risk by 2.4-fold — and at high doses, 4.4-fold.
These risks are not tiny for heart attack survivors. One patient was harmed for every 13 patients who took Vioxx, for every 14 patients who took Celebrex, for every 24 patients who took diclofenac, and for every 45 patients who took ibuprofen.
It’s not at all clear what heart attack patients should do to relieve their pain. Even acetaminophen (Tylenol) may up the risk of heart diseaseheart disease.
Patients who have had a heart attack and also have “pain conditions relieved by these drugs should discuss carefully with their doctors the balance between benefits and risk of treatment,” Gislason and colleagues suggest.