Posted on 02/19/2005 10:21:23 PM PST by neverdem
After a panel of medical experts gave a very cautious nod to the continued use of the painkillers Celebrex, Vioxx and Bextra on Friday, pain management experts said they expected to see the same caution transform the way the painkillers are prescribed from now on.
The drugs, which had been hugely popular for people with both short-term and chronic pain, will be prescribed much less readily, for a smaller group of patients, at lower doses and for shorter periods, the experts said.
"I am still very concerned about the cardiac risks of these medications," said Dr. David Campen, director of pharmacy services at Kaiser Permanente in Oakland, Calif., who led an effort to shift Kaiser patients off Celebrex and Vioxx and onto other painkillers. "If you can get away with a safer medication, you ought to."
But doctors expressed relief that they are likely to still have the drugs at their disposal.
"All of us have been reacting to the news as it comes forward, as to whether some of our tools will be taken off the market," said Dr. Raymond Gaeta, an anesthesiologist who directs Stanford's pain management clinic. "This is good news for patients over all. Clearly there are side effects with every medication, but it's really important to weigh the potential side effects versus the benefits for an individual patient."
On Friday the panel warned that all three drugs increased the risk of heart attack and strokes, although Celebrex is less hazardous than the other two, and recommended that the Food and Drug Administration place new warnings to that effect on their labels. But the experts also said the benefits to some patients outweighed the risks and concluded that the drugs should remain on the market. The agency usually follows the advice of its advisory panels.
While acknowledging the risks of the drugs, doctors pointed out that no drug was perfect for every patient. "As a physician, I like to have a choice of treatments, because people are different and some respond well to them," said Dr. James F. Fries, an arthritis specialist at Stanford University.
Dr. Sudhir Diwan, director of the division of pain medicine at New York-Presbyterian Hospital, said, "We all have found that these drugs can be very, very good in pain control and easy on the stomach," adding, "But it is true that we must do a better job of informing the public that these medications do have side effects."
Before prescribing any of the three drugs, doctors should carefully evaluate their patients' risk of heart problems, said Dr. Garret A. FitzGerald, a cardiologist at the University of Pennsylvania medical school, in Philadelphia, who was among those who spoke before the F.D.A. panel to warn of the drugs' risks. "Obviously one of the things to check is blood pressure," Dr. FitzGerald said. "And it's certainly wise to look at an echocardiogram to see if there is any impairment in cardiac performance." He said such drugs could help some patients with chronic pain who are prone to stomach irritation.
Anyone who has had a stroke or who has existing heart disease should be kept off the drugs, said Dr. Gaeta of Stanford, as should someone with obvious heart disease risk factors, like a diabetic smoker.
Unfortunately, many patients who are candidates for Celebrex, Vioxx and Bextra, because they are prone to stomach bleeding, are the same ones who are at risk for heart attack, said Dr. Campen of Kaiser Permanente. These patients tend to be older or have other health problems.
Doctors should also stick to low doses of the medications, said Dr. Fries, the Stanford arthritis specialist, noting that in the studies that have shown heart risks, patients took relatively large amounts.
Patients should take 10 milligrams of Bextra a day, rather than 20, he said, and 200 milligrams of Celebrex, rather than 400. And if Vioxx comes back on the market, it should be prescribed in 25-milligram doses rather than 50, Dr. Fries said.
(Merck withdrew Vioxx in September, after a study indicated it doubled the risks of heart attack and stroke, but an official told the F.D.A. panel that the company was now considering reintroducing it.)
Finally, doctors should avoid prescribing the three drugs for indefinite periods, said Dr. Diwan of New York-Presbyterian. Chronic pain typically ebbs and flows, he said, worsening when patients are very active or under stress. "When you are in pain for a few weeks, you take the drug, but when your pain is under control, you skip it for a few weeks, and then you lower your risk of problems," Dr. Diwan said.
Many patients can avoid taking Celebrex, Bextra or Vioxx altogether by switching to an older anti-inflammatory treatment like aspirin, ibuprofen (sold over the counter as Advil or Motrin, for example) or naproxen (available over the counter as Aleve). Some members of the F.D.A. panel were especially in favor of switching to naproxen, a drug that may help protect against heart attack and stroke, though not as much as aspirin does.
Celebrex, Vioxx and Bextra all belong to a class of drugs known as cox-2 inhibitors, which have come on the market since 1998. They block an enzyme called cyclooxygenase, or cox, as the older drugs do, but they block it selectively, leaving intact a form that helps protect the stomach lining. Thus, they are designed to ease pain and inflammation without irritating the stomach as readily as other anti-inflammatories do.
Research has indicated that Vioxx carries only half the risk of ulcers posed by older drugs. Theoretically, Celebrex and Bextra also protect the stomach, but no studies prove it.
At the height of the drugs' popularity, before their heart risks became widely known last fall, many people who were not prone to stomach distress took them.
Such people could switch to naproxen, ibuprofen or aspirin alone, doctors say. People who are vulnerable to stomach irritation or bleeding could take, in addition to anti-inflammatories, medications like Prilosec, Prevacid and Nexium, which block the production of stomach acids.
At Kaiser Permanente, many patients who in the past might have been given Vioxx or Celebrex are now prescribed anti-inflammatories that are somewhat gentler on the stomach than ibuprofen or naproxen - for example, nabumetone (marketed as Relafen) or etodolac (Lodine) - along with Prilosec, Dr. Campen said.
Some patients find that one drug works better for them, for reasons that doctors cannot necessarily determine. "Many people who took Vioxx were those for whom other medications had not worked," Dr. Diwan said.
One 71-year-old woman in East Brunswick, N.J., who has been taking Celebrex daily for five years, said it stopped the arthritis pain in her feet and ankles better than any other drug. The woman, who insisted that her name not be published, said she limited her daily dose to one 200-milligram pill, which limits the risk to her heart. "I don't overdo it," she said, "and I've never had any problems."
Cox-2 drugs are not thought to fight pain any better than aspirin, ibuprofen or naproxen do. Theoretically, the older anti-inflammatory treatments may even be somewhat more effective than cox-2 drugs because they are not as selective in the way they block cox, said Dr. FitzGerald of the University of Pennsylvania. But no study directly comparing the drugs' effectiveness has been done.
Nor has there been a large study comparing the safety of various painkillers. Dr. Robert Temple, director of the F.D.A.'s office of medical affairs, suggested to the advisory panel that such a study be done, to compare ibuprofen, naproxen, Tylenol, a cox-2 drug, diclofenac (another painkiller, sold as Voltaren) and perhaps also Tylenol with codeine, and aspirin.
"My main point is that there is really a very important need for more information about these drugs," Dr. Temple said.
The panel greeted Dr. Temple's proposal enthusiastically. One member, Dr. Thomas Fleming, a biostatistician at the University of Washington, calculated that such a study would need to include at least 10,000 patients on each drug and would need to follow them for three years in order to yield meaningful results.
But that would probably cost many millions of dollars. An executive from Pfizer, maker of Celebrex and Bextra, later said the company would like to participate in such a trial, but no one has yet offered to foot the bill.
Anahad O'Connor contributed reporting from New York for this article, and Gardiner Harris from Washington.
A study based on a review of V.A. patient records that was published last month in a medical journal, Gastroenterology, found that the rate of stomach bleeding caused by etodolac was substantially lower than that caused by naproxen and comparable to that of Vioxx.
You may want to ask your doc about etodolac, aka Lodine.
FReepmail me if you want on or off my health and science ping list.
Quick! Where can I get a bottle of this Caution stuff?
Too late!
Bumping...
What's too late, the Rx for caution? LOL!
The technical, hence expensive, book on the subject is Travell and Simons's Myofascial Pain and Dysfunction: The Trigger Point Manual. FWIW, Janet Travell was John F. Kennedy's doctor.
The practical manual (under $14 at Amazon) is Claire Davies's The Trigger Point Therapy Workbook: Your Self-Treatment Guide for Pain Relief.
You can do more good with this book and a firm tennis ball than a physician, a surgeon, and a chiropractor could do with your whole bank account. And you'll avoid the potentially fatal side-effects of pain-killing drugs.
Just roll your own ! hehehehehehehehehehehehehehe, no prescription needed.
These drugs are not for muscle pain. They are for chronic joint pain as well as the associated problems with other collagen diseases.
Frequent visits to the chiropractor and an occassional 15 mg MS Contin has been doing just fine for 10 years now.
Doctors of Osteopathy can do manipulations and be your regular physician. They have the initials D.O. after their name. Are any around you in Nevada?
IOW, the lame-ass doctors are gonna start prescribing the pills only in a manner consistent with their intended purpose. We need serious prescription reform:
Ban all the prescription-medicine television advertising. Doctors should prescribe a drug because it is their medical opinion that their patients need the drug, not because the patient saw an advertisement.
Ban instant prescriptions, such as over the internet or over the telephone, from doctors who have not previously met the patient in person.
Prohibit border crossing to obtain legal drugs.
Make the doctor, not the drug company, solely responsible for damages caused by the prescription of a drug in a manner inconsistent with the drug's labelling. (As in Phen-Fen, celebrex, Viagara, RU-486, estrogen, and other abuses.)
No, these aren't very libertarian. But it's nonsensical to have requirements for prescriptions and testing of drugs, and then these absurd Clinton-era medical practices going on.
That table is insufficient. Some of those drugs are very effective for some types of pain and not others. For instance, aspirin and tylenol were useless with a toothache which needed a root canal, but advil did work. Likewise, Advil was useless for fever-induced headaches, but Aspirin worked. And Tylenol works better for migraines than aspirin or advil.
Do you have references or is this anecdotal experience?
A number of other parents I have met swore by the efficacy of herbal "teething tablets". I bought some of these, then noticed that they were a homeopathic remedy. I do not see how homeopathic medicines can possibly work so I think all the people who noticed an effect of the tablets must be fooling themselves. The Amazing Randi has a $1 million dollar offer to anyone who can prove the efficacy of a homeopathic remedy. The money is unclaimed.
They should, but I doubt that banning advertising will pass muster. It used to be that physicians, lawyers, and pharmacies couldn't advertise (state laws). I believe those prohibitions were overturned on first amendment grounds. Of course, cigarettes and distilled liquor may be the analagous cases, in which case I would be wrong.
I quit using the terms "constitutional" and "unconstitutional" because they have no meaning, anymore, except to define what the unelected SC legislature allows and disallows, with only lip service paid to the Constitution for rationalization. But my thinking is that even banning advertisement of cigarettes and distilled liquor is antithetical to the Constitution, intellectual contortions like "public airways", etc. notwithstanding.
Where is this Randi? I'll collect the one mill. Use the homeopathics on your infant, you'll avoid a lot of problems later on. They work much better on children, who aren't as metabolically burdened as adults are.
I'd say that one of the few things the commerce clause DOES allow is for the Congress to regulate the trade of deadly substances. Hence, requiring perscriptions should be constitutional. And if a substance is in generally illegal to sell, that advertising its sale is generally illegal, except when religious or political issues (e.g., "Tell your congressman to legalize Xantax") make it protected speech outside of commerce.
Our Constitution is not libertarian, it merely requires that there be a valid state interest in restricting the lisence of the public.
>> Do you have references or is this anecdotal experience? <<
It's what I was told by my doctor, and the difference (particularly with the tooth problem) was no mere placebo effect; it was the difference between pounding my fist on the floor in agony and a good night's sleep.
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