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Study: Ibuprofen Doubles Risk of Ulcers

February 15, 1991

PHILADELPHIA (AP) _ The widely used pain reliever ibuprofen doubles the risk of ulcers, according to Vanderbilt University researchers, and some experts say people taking it may want to consider lower doses or alternatives.

But for those suffering chronic pain and inflammation, researchers said ibuprofen may be the best choice, as it has the lowest ulcer risk among the drugs studied. Those drugs belong to a prescription class called non-steroidal anti-inflammatory drugs or NSAIDs.

″Occasional low-dose users should not be concerned about the increased risk,″ said the study’s lead author, Dr. Marie Griffin. ″It is unlikely that taking one or 2 ibuprofen (pills) several times a month poses any significant risk.″

The researchers did not study aspirin, which is also an NSAID, but said that aspirin is ″at least″ as risky as ibuprofen. Acetaminophen, used in the pain reliever Tylenol, is not an NSAID and is not associated with ulcers.

The Vanderbilt study confirms the increased risk of ulcers in people who used the prescription NSAIDs studied, and also found that the overall risk increased with higher doses and was greatest in the first month of use.

Ibuprofen, available without a prescription since 1985, is sold under such brand names as Advil, Medipren, Motrin and Nuprin. It has captured about 20 percent of the $2.5 billion non-prescription pain-reliever market. As the prescription drug Motrin, it has annual sales of $46 million.

The study, published in Friday’s Annals of Internal Medicine, involved 1,415 Tennessee Medicaid enrollees hospitalized for ulcers from 1984 to 1986 and 7,063 control patients.

At recommended dosages for treating rheumatoid arthritis, NSAIDs on average quadrupled the risk for ulcers. But of the dozen drugs studied, ibuprofen showed the lowest risk, at 2.3 times, while meclofenamate increased the risk 8.7 times.

The biggest-selling NSAID, naproxen, quadrupled the risk. Under the brand name Naprosyn, it has annual sales of $395 million, according to the National Disease and Therapeutic Index.

Ibuprofen is the only one of that group available in over-the-counter strength. Aspirin is also an NSAID but was not included in the study because it is not a prescription drug.

Ibuprofen was included because, at the beginning of the study, it was still a prescription drug and was available free under Medicaid. While ibuprofen is now available without a prescription, the Vanderbilt researchers based the risk on an average dose of 1,600 milligrams daily.

The highest recommended over-the-counter dose is 1,200 milligrams a day, while the highest recommended prescription dose is 3,200 milligrams.

But even at the 1,200 milligram dose, ibuprofen probably would double a person’s risk of ulcers, said Griffin. One of the earliest investigators of the link between NSAIDs and ulcers, Dr. Sanford Roth of the Arthritis Center in Phoenix, called the Vanderbilt study ″an important paper″ that ″corroborates that lower doses do make a difference.″

″These drugs should not be regarded casually,″ said Roth, who served as a consultant to the U.S. Food and Drug Administration during its decision to allow ibuprofen to be sold without a prescription.

Of those patients hospitalized with ulcers, 34 percent were taking NSAIDs compared with 13 percent of the control group. The researchers found that 29 percent of the hospitalizations were due to the NSAIDs.

″These drugs do have side effects,″ said the study’s lead author, Dr. Marie Griffin.

Griffin said higher risk for short-term use of NSAIDs may occur because people who develop ulcers do so quickly and stop taking the drug. Another possible reason is that the stomach begins to provide protection against the drug’s side effects, she said.

NSAIDs work by interfering with the body’s production of prostaglandin, substances that affect a number of processes in the body, including pain and protection of the stomach lining. The drugs often are recommended to treat arthritis, back pain, headaches and menstrual cramps.

Side effects include fluid retention, rashes, problems with kidney function and disorientation in the elderly, Griffin said.

UCLA gastroenterologist Dr. Andrew Soll, who moderated a conference paper published with the Annals study, said Griffin’s work ″is an extremely well- done study that further underlines the risk″ of ulcers.

Roth said the study’s strength was its demonstration of the increased risk with increased dosage, and the more controversial finding that short-term regular use is riskier than long-term regular use.

The researchers said people using NSAIDs even occasionally should reassess what kind of pain they suffer and their use of NSAIDs, including ibuprofen.

″People who have pain without inflammation may want to choose″ an analgesic other than ibuprofen, Griffin said. ″But for people with severe chronic arthritis, there may not be a safer alternative. Consumers need to know about the risks.″

Dr. Bernie Schachtel, medical director for the New York-based Advil manufacturer Whitehall Laboratories Inc., said the research’s message was ″the low doses are the safer ones″ of NSAIDs.

An advisory panel of the FDA met in February 1990 to consider the warning labels on nonprescription ibuprofen, but has not yet made any recommendations, said FDA spokeswoman Bonnie Aikman.

The companies making ibuprofen are phasing in a highlighted portion of the warning label, as the FDA requested, Ms. Aikman said.

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