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Two Studies Link Over-the-Counter Painkillers with Increased Risk of Developing Ulcers, Perforations, and GI Bleeding

Thu, 03 Nov 2005 00:00:00 -0800

Two new studies document the dangers of taking over-the-counter (OTC) non-steroidal anti-inflammatory drugs (NSAIDs); including ibuprofen, the pain reliever in Advil and Motrin; and naproxen, the active ingredient in Aleve.

All of these medications were found to increase the risk of gastrointestinal (GI) bleeding especially when taken with aspirin or when taken in high doses.

One study, done at the University of Utah College of Pharmacy in Salt Lake City, showed that patients, who took aspirin and OTC NSAIDs together, were two to three times more likely to develop stomach ulcers, perforations and bleeding compared to individuals who took the NSAIDs alone.

The findings were presented yesterday at the American College of Gastroenterology annual meeting in Honolulu.

Another study, conducted by Dr. Barry Bowen of McMaster University in Hamilton, Ontario and published in the November issue of Clinical Gastroenterology and Hepatology, reports that those on an ibuprofen regimen suffered four times as much blood loss from stomach ulcers and gastro intestinal problems than those individuals not taking the medication.

The researchers conducted an analysis of two random studies that considered 68 healthy subjects who were given either four weeks of an ibuprofen regimen at 800 mg, three times daily for 28 days (twice the daily recommended dosage) or a placebo.

Healthy individuals, who took the ibuprofen, had blood loss that was 3.64-fold greater than the placebo group. The bleeding started as little as three days into the study and lasted for the entire course of treatment in many individuals.

Joe Biskupiak, study author at the University of Utah College of Pharmacy, stated that the risks documented in the recent studies were not unexpected: "We know that the prescription NSAIDs increase risk. Over-the-counter NSAIDs are a little harder to pin down because it's harder to get data on patients using them. Everybody suspected it, but there hasn't been a lot out there."

He also remarked that both doctors and patients need to be educated about the gastrointestinal problems associated with the drugs. Recent findings suggest that most of the people taking pain relievers, who were at risk for bleeding, were not taking medication to prevent it. Many were also unaware of the possible negative side effects.

Several other experts also regard the new studies as “confirmatory” of the link between high-dosage, frequent, and multiple NSAID use and gastrointestinal problems. In addition, regulating OTC NSAID use “remains the most substantial modifiable risk factor to reduce gastrointestinal complications from NSAIDs," according to Dr. Mark Fendrick, professor of internal medicine at the University of Michigan School of Medicine at Ann Arbor.

The NSAID family of drugs includes Cox-2 inhibitors such as Vioxx and Bextra (now off the market) and Celebrex (still available). Those versions of NSAIDs were successful because of their less serious GI effects.

Since Cox-2 inhibitors have now been associated with an increased risk of serious cardiovascular problems, however, many patients have returned to the “non-specific” OTC NSAIDs for relief thereby significantly increasing the number of people exposed to the GI problems associated with either high-dosage, frequent, or multiple OTC NSAID use.

As Biskupiak put it: “Just because it’s over-the-counter doesn’t mean it’s devoid of risk.”

New Study Links Common Painkillers with Heart-Attack Risk

Thu, 09 Jun 2005 00:00:00 -0700

Ibuprofen and other non-steroidal anti-inflammatory drugs (NSAIDS) may increase the risk of heart attack, according to research published in this week's BMJ.

Patients should not stop taking the drugs involved, the authors caution, but further investigation into these treatments is needed, they say.

In the biggest study of its kind to date, researchers identified 9,218 patients across England, Scotland and Wales who suffered a heart attack for the first time over a four-year period. Patients ranged in age from 25 to 100.

The investigators looked at the prescribing patterns for these patients, tracking whether and when they had been prescribed NSAIDS. This class of medications, which commonly are prescribed to relieve inflammation and pain, includes ibuprofen, diclofenac (Advil, Motrin, etc.), naproxen (Aleve, Nuprin, etc.), celecoxib (Celebrex) and rofecoxib (Vioxx) plus a host of other less commonly prescribed anti-inflammatories.

Rofecoxib is no longer commercially available, having been withdrawn from the market in 2004. NSAIDS Increased Risk

The findings were adjusted to allow for several other heart-attack risk factors including age, obesity and smoking habits. Importantly, the researchers also adjusted for whether patientd already suffered from heart disease or were prescribed aspirin.

For those who were prescribed NSAIDS in the three months just before the heart attack, the risk increased compared with those who had not taken these drugs in the previous three years, the researchers found. For ibuprofen, the risk increased by almost a quarter (24%) and for diclofenac, it rose by over a half (55%).

The newer generation of anti-inflammatories known as COX-2 inhibitors also were associated with increased rates of first-time heart attack. Those patients who were prescribed the drugs in the preceeding three months were at 21% higher risk of heart attack if taking celecoxib (Celebrex) and 32% increased risk if taking rofecoxib (Vioxx).

'Considerable Implications for Public Health'

Since this study was concluded, rofecoxib was withdrawn due to concerns over heart-attack risk. That makes the impact of this study on patients even more important, say the authors, since those previously taking rofecoxib will have turned to the other anti-inflammatories in greater numbers.

The most significant findings were for the drugs ibuprofen, diclofenac and rofecoxib, say the authors. In terms of "numbers needed to harm" in the 65 and over age group, for those taking diclofenac, one extra patient for every 521 patients was likely to suffer a first-time heart attack.

For rofecoxib, the figure was one patient for every 695 patients; and for ibuprofen, one patient for every 1,005 patients was at risk.

"Given the high prevalence of the use of these drugs in elderly people and the increased risk of myocardial infarction [heart attack] with age, the relatively large number of patients needed to harm could have considerable implications for public health," say the authors.

The nature of this report, an observational study may make it prone to other explanations for the findings, say the authors. "However, enough concerns exist to warrant a reconsideration of the cardiovascular safety of all NSAIDS," they conclude.

Childrens Advil Stevens Johnson Sydrome Side Effects

Thu, 09 Jun 2005 00:00:00 -0700

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Injured by Advil?

Children’s Advil is a commonly used painkiller that is designed for children aged two to eleven years, and is available over the counter (OTC). Children’s Advil was introduces in the late 1990s. Children’s Advil has been linked to two often-deadly skin diseases: Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).

Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are two forms of the skin disease that can cause rash, skin peeling, and sores on the mucous membranes. Stevens Johnson Syndrome is an immune-complex–mediated hypersensitivity disorder that may be caused by many drugs, viral infections, and malignancies.

Often, the drugs causing the onset of Stevens Johnson Syndrome and Toxic Epidermal Necrolysis, such as Children’s Advil, did not have warnings placed on their labels until recently. Patients unknowingly took these drugs and many developed the potentially fatal Stevens Johnson Syndrome.

If you or a loved one took Children's Advil and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.