Merck Vioxx News and Press Releases

By Barbara Anderson / The Fresno Bee

Pain sufferers may feel the Grinch stole their Christmas.

December 25, 2004 - With painkillers Celebrex and Aleve possibly increasing the risk of heart attacks and stroke — and the withdrawal of Vioxx from the market this fall — those living with chronic pain certainly have fewer choices for relief.

The federal Food and Drug Administration advised doctors Wednesday to limit prescriptions for the nonsteroidal anti-inflammatory drugs Celebrex and Bextra, and for consumers to strictly follow label directions for over-the-counter Aleve and consult a doctor if taking it for longer than 10 days. But doctors say the pharmaceutical stocking isn't empty. Replacement drugs exist for alleviating pain. And nontraditional treatments, such as acupuncture, can help people with arthritis, sore backs, sprained ankles and pinched nerves.

"Don't panic," says Dr. David Campen, a rheumatologist and the medical director of pharmacy operations at Kaiser Permanente in California. "There are many safe alternatives out there to help control pain." Patients should consult their doctors about the best treatment and base their decisions on facts as opposed to anxieties, he says.

If people want to switch from Celebrex or Aleve and continue taking a nonsteroidal anti-inflammatory to reduce swelling and pain, several drugs are on the market. Over-the-counter ibuprofen, such as Motrin, works for many people. And doctors can prescribe Relafen and Lodine, two among several prescription pain relievers that have been around for a while. "These are affordable alternatives that people can use," Campen says.

One of the side effects of these older drugs, however, is bleeding ulcers. Celebrex and Vioxx are less caustic to the stomach, and when they came on the market in the 1990s, doctors offered them to patients with histories of bleeding ulcers and other gastrointestinal problems. It's estimated that more than 16,000 people die a year of bleeding ulcers from taking painkillers, says Dr. Kevin Wingert, a Fresno family physician. "That is more than those who die from AIDS each year."

For those who want to take the older, nonsteroidal anti-inflammatory drugs but have had problems tolerating them, doctors can prescribe drugs to reduce the risk of ulcers, Wingert says. But there's another choice: acetaminophen, sold as Tylenol. Taken on a regular basis, Tylenol gives a lot of relief from pain associated with arthritis. And the drug doesn't cause stomach problems. Tylenol can damage the liver if taken in too high of a dose. All over-the-counter pain relievers should be taken at recommended doses, and label instructions should be followed to be safe, Wingert says.

Dr. Berj Kalamkarian, a Fresno pain specialist, says his telephone has been ringing nonstop since reports were issued this month about the potential heart attack and stroke risks of taking high doses of Celebrex and Aleve. He's not writing Celebrex prescriptions until he gets confirmation they're safe, he says. Data suggest an increased risk of cardiovascular problems for patients taking Celebrex at doses of 400 milligrams to 800 milligrams a day. Kalamkarian is advising some of his patients, who don't have gastrointestinal problems, to go back to ibuprofen. For others, he's suggesting Tylenol. In extreme cases, he's prescribing narcotic painkillers, such as Vicodin and Codeine.

Wingert won't prescribe Celebrex in daily doses higher than 200 milligrams. And he's also prescribing more narcotics, which don't cause ulcers and are safe if used properly, he says. He's also offering acupuncture. Acupuncture can help reduce pain to manageable levels, he says.

Nancy Magyar, 56, of Fresno tried almost every type of painkiller, from Vioxx to Vicodin, for her aching lower back. But her discomfort worsened. About a year ago, a nurse practitioner at Wingert's office suggested that she try acupuncture. After a few sessions, the procedure eased her pain. Today, she only occasionally needs painkillers in between acupuncture treatments she receives once every 10 weeks.

Heart attack and stroke risks associated with Vioxx, and the possibility of similar concerns with Celebrex and Aleve make her more relieved she no longer needs painkillers. "It's so great not to have to take pain pills," she says. Magyar, a kindergarten teacher, is lucky. Her insurance through the Fresno Unified School District covers the costs of acupuncture treatments. Not all insurance companies pay the $85 per-treatment charge. Acupuncture won't solve everyone's pain problems, Wingert says. But the less medication someone can take, the better.

Campen says pain sufferers need to evaluate their options. While reports about risks associated with Celebrex and Aleve are reason for concern, the risks are lower than those with Vioxx, he says. Naproxen, sold over-the-counter as Aleve, showed signs of elevating heart risks and strokes in a study designed to prevent Alzheimer's disease.

But other studies, including one by Kaiser, showed the drug having little or no effect on the heart, Campen says. "I think clearly we need to have more study about this," he says. "I think to respond by saying we ought to convert people off of this would be rash and would not really serve the best interests of our patients." Wingert concurs. "You don't stop something on just the basis of one study." No drug is without risk, he says. Even aspirin upsets stomachs and causes bleeding ulcers.

People should weigh the potential benefits versus the potential side effects and costs, he says. "People want perfection out of medications, and unfortunately, we're never going to get that."

The reporter can be reached at banderson@fresnobee.com or (559) 441-6310.

Users say Vioxx triggered trouble for them

Vicki Buffolino
KENS 5 Eyewitness News

It was perhaps the biggest medical story last year — a widely used arthritis drug was pulled off the market and its maker was put on the hot seat.

Did Vioxx really cause heart attacks and stroke? That depends on whom you ask. "He was a very loving, giving person," Alicia Gomez said of her husband Joe Gomez. Joe, who was 50 when he retired from the Marines, was looking for a career change back in 2003. In fact, he had just passed the physical to become a police officer. "Push ups, sit ups, the sprints, the runs and he was excited that he passed it all," Alicia said.

But what happened just hours later would change everything. "It changed all of our lives," Alicia said. It was suppose to be a routine trip to the dentist — that's what it was supposed to be.

Alicia knew something very wrong when she got several messages on her answering machine from the Veterans Affairs hospital. They told her to come to the hospital and don't come alone. "When they took us into this room, the doctor said 'I'm sorry.' I said 'sorry for what?" He said 'He passed away,' " Alicia said. The Bexar County Medical Examiner ruled Joe Gomez died of cardiovascular disease and cardiomyopathy — an inflamed heart.

When the prescription pain reliever Vioxx was pulled from the shelves in September of 2004. The Gomez family says they made a connection. They claim the pill Joe was on for shoulder pain caused his sudden and untimely death. "It was a massive hit to the medical community," Dr. Salvatore Barbaro, a San Antonio heart surgeon, said. "He, like so many others, believed Vioxx was okay."

"You have to have faith in something, that's all you can do," Barbaro said. "I'm hoping when they say a drug is okay, they've done everything according to today's standards to make a drug safe." "I woke up in the middle of the night and my jaw hurt, really bad. It was like a toothache but it was my whole jaw," John Stout said. The pain, according to Stout, turned out to be a heart attack. "They couldn't find any blockages, any abnormalities. They couldn't figure out why it happened," Stout said.

That is until he heard the news about Vioxx. He, too, believes there's a connection to the drug he was taking for arthritis pain and his heart attack. "It's just not a fun thing to go through and I don't think it should happen to anyone else," Eileen Stout, John's wife, said.

The makers of Vioxx, Merck & Co., announced when they pulled the drug, that patients who took it 18 months or longer may have had double the risk of heart attack and stroke. Joe Gomez had been on it of about three months before his death. John Stout had been on it seven months before his heart attack. Now facing hundreds of lawsuits over Vioxx, a company spokesman told KENS 5 Eyewitness News that "Merck intends to vigorously defend these case on an individual basis. Each one has a different set of facts, which is why we expect to be trying them for many years."

Over at the Food and Drug Administration, the organization that sets the standards, questions remain about the approval of the drug in the first place. Even though they're now suing Merck, the Stouts feel lucky. "We don't take each other for granted," Eileen Stout said. Alicia is also suing, along with hundred of families across the country who believe Vioxx took away more than the pain. "I know he's not coming back and I have to learn to accept that. But there's no closure yet," Alicia said.

Beginning Wednesday morning, the FDA starts public meetings on the future of the two other drugs in the same class as Vioxx — Celebrex and Bextra. They will weight the benefits and the risks of taking these popular and widely prescribed medications.

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