Local Doctors OK Celebrex; The FDA is Wary About the Pain Medication After Studies Linked It to Heart Problems.
A few days after Celebrex suspended its television commercials, some local doctors and health care providers urged consumers not to panic about the drug’s safety.
The Food and Drug Administration has not recalled the popular drug often prescribed to treat arthritis.
On Dec. 17, the FDA announced that it had asked Pfizer to voluntarily stop direct marketing to consumers while the agency evaluated results of a new study.
A long-term cancer trial reported an increased risk of cardiovascular events in Celebrex users over the placebo group a finding contrary to past studies.
Patients in the clinical trial taking 400 milligram of Celebrex twice each day had 3.4 times greater the risk of a cardiovascular event compared with the placebo, according to the FDA. Those taking 200 milligrams twice daily had a risk that was 2.5 times greater.
Celebrex has been on the market for a few years and has a good safety record, said Dr. Robert Matylewicz of Susquehanna Trail Family Medicine.
“It was one study. It was a small study,” he said. Other studies have shown no problem, he said. Also, doses administered were higher than what is normally prescribed.
Matylewicz said the situation could confuse patients. He isn’t taking any patients off of Celebrex right now.
“In my opinion, at this point in time, there is no reason to stop taking it,” he said.
It seems the federal government is taking steps because of what happened with Vioxx, which was pulled from the market because of studies linking its long-term use to increased risk for cardiovascular events, he said.
In September, Merck & Co. voluntarily recalled Vioxx, after a long-term study showed twice the risk of heart attack for users compared with those in the placebo group.
Celebrex and Vioxx belong to a class of medications known as COX- 2 inhibitors. These drugs became popular among patients because they effectively relieved chronic arthritis pain. They didn’t have as many side effects as other edications, such as naproxen.
“It was the same way to get the same end result of pain relief,” Matylewicz said. “It didn’t aggravate the stomach.”
Then on Monday, the FDA announced that it was working with the National Institutes of Health to review available scientific information on naproxen, which also is used to treat arthritis in both prescription and over-the-counter forms. Over-the-counter naproxen in the form of Aleve can help relive ailments such as menstrual cramps and sprained ankles.
The Arthritis Foundation, Central Pennsylvania Chapter, is urging people to check with their doctors if they have concerns and not to immediately stop taking either medication.
The foundation has fielded many calls.
That state says York County is disproportionately burdened with people who have arthritis, said Catherine Penrod, chapter president and CEO.
About 145,000 adults are estimated to have arthritis in the county, based on data from the 2000 Census and Centers for Disease Control and Prevention, she said.
It’s not known exactly what causes arthritis or why it would be higher in York County, Penrod said. Some reasons could include the county’s manufacturing history, the age of the population and the prevalence of football and high-contact sports, she said.
Thomas Williams, manager of WellSpan Pharmacy, Dallastown, said patients will need to consult with their doctors to individually weigh their risks and benefits.
Doctors in the practice are leaving patients on Celebrex, unless the patient expresses that he or she feels unsafe, Williams said.
“We’re telling them to wait and see what happens,” he said. “When the drug gets pulled, there’s no question.”
Reach Jennifer Nejman at 771-2026 or jnejman@ydr.com.
