December 22, 2004 in Nation/World

Painkiller studies foster patients’ confusion

Roni Rabin and Kathleen Kerr Newsday
 

With Vioxx off the market, a black box warning on Bextra, and new-generation Celebrex and old standby Aleve tied to possible heart risk, patients are confused. And there are no easy answers, doctors say.

The data from recent studies is preliminary and inconsistent, experts said, warning patients not to jump to conclusions, but to contact physicians for an individual assessment of risk.

“For physicians treating patients with arthritis pain, there’s no absolutely good drug and there’s no absolutely bad drug,” said Dr. Steven Carsons, chief of rheumatology, allergy and immunology at Winthrop University Hospital on Long Island. “Everything in medicine is a risk-versus-benefit equation, particularly in this area of arthritis and pain management.”

While some experts expressed skepticism about the findings of a greater incidence of heart attacks and strokes among long-term users of Aleve, or naproxen, in the latest suspended federal trial, Carsons said the study raises red flags about the whole class of non-steroidal anti-inflammatory drugs, or NSAIDs. NSAIDs, including COX-2 inhibitors such as Celebrex and over-the-counter drugs like ibuprofen, have long been known for vascular side effects in a minority of patients. “The whole class of drugs is going to come under scrutiny,” Carsons said.

Safety concerns about heart problems associated with Aleve may be addressed at a Food and Drug Administration meeting tentatively scheduled for February, which was originally to consider the safety of painkillers like Vioxx, FDA spokeswoman Cynthia Fitzgerald said Tuesday.

William O’Donnell, a spokesman for Bayer, which makes Aleve, said Tuesday the NIH study evaluated patients who used Aleve daily over three years “in sharp contrast to the approved shorter use of naproxen sodium (Aleve) for pain.”

“We are thoroughly investigating the matter, which would appear to contradict much of the available scientific knowledge … ,” O’Donnell said.

Many physicians were surprised by the findings. Dr. Mark Fendrick, a professor of internal medicine at the University of Michigan Medical School in Ann Arbor, said he is taking a wait-and-see position. He said it’s unlikely the problems revealed by the NIH and the FDA are caused by clotting because naproxen has a thinning effect on blood.

Dr. James Dillard, a pain specialist at Columbia University Medical Center, said he tells patients to take Aleve and its prescription counterpart for a maximum of five to 10 days.

“None of these medicines is likely to kill you with a few doses,” Dillard said.

The negative reports tying pain relievers to heart disease have been continuous in recent months.

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