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Background: The risk of gastrointestinal tract bleeding requiring hospitalization associated with naproxen sodium was compared with that with ibuprofen, using a prescription database to approximate over-the-counter dosing. Objective: To evaluate the safety of naproxen sodium. Methods: A claims database containing Ohio Medicaid data from January 1986 through February 1993 and Michigan Medicaid data from April 1983 through July 1993 was used to compare 101 318 patients dispensed naproxen sodium with 277 601 patients dispensed ibuprofen. Using a case-cohort design, all 59 patients from the full cohort who had been hospitalized with upper gastrointestinal tract bleeding (UGIB) that developed within 14 days after the first prescription for the study drugs were compared with a subcohort made up of a 10% random sample of subjects selected from the combined drug cohorts. Results: The incidence of UGIB occurring within 14 days after the first prescription in the naproxen sodium cohort was 26 (0.026%) of 101 318 (95% confidence interval [CI], 0.017%-0.038%), compared with 33 (0.012%) of 277 601 patients (95% CI, 0.008%-0.017%) in the ibuprofen cohort. Overall, the use of naproxen sodium vs ibuprofen was associated with an adjusted relative risk of 2.0 (95% CI, 1.1-3.8). Among people with multiple prescriptions, the crude relative risk for those receiving therapy in a dose typical of over-the-counter use was 4.1 (95% CI, 1.2-13.8). Conclusion: The overall incidence of UGIB is low with both drugs. There is little additional absolute risk posed by the use of low-dose naproxen sodium, compared with low-dose ibuprofen, despite an increased relative risk. However, given the widespread use of these drugs, a substantial number of additional cases of UGIB could result from use of naproxen sodium. This increased risk should be considered, especially for patients whose baseline risk of UGIB is elevated.

Acute ingestion of ibuprofen commonly results in no symptoms, or minor gastrointestinal or central nervous system manifestations. While most cases of ibuprofen overdose do well, serious toxicity may occur, and is difficult to predict. A case of ibuprofen overdose is presented in which the course was complicated by metabolic acidosis, adult respiratory distress syndrome, and renal failure necessitating prolonged dialysis. Key Words: anti-inflammatory agents, nonsteroidal; ibuprofen; nitroglycerin; poisoning, human; metabolic acidosis; adult respiratory distress syndrome; renal failure.), INTRODUCTION Ibuprofen, a propionic acid derivative, is a commonly prescribed nonsteroidal anti-inflammatory agent (NSAIA). This agent is also available over-the-counter, thus increasing its availability. It has generally been considered a [...]

Background: This study was developed to compare the incidence of endoscopically diagnosed ulcers in elderly patients taking nabumetone, ibuprofen, or concomitant ibuprofen/misoprostol. Further research is indicated to better establish the clinical relevance of these endoscopy findings. Methods: We conducted a prospective, multicenter, randomized, endoscopist-blinded, 12-week study involving 171 patients with osteoarthritis aged 60 years and older. Patients were randomized to receive nabumetone, 1000 mg (n=58); ibuprofen, 600 mg four times daily (n=53); or ibuprofen, 600 mg four times daily, administered concomitantly with misoprostol, 200 [mu]g four times daily (n=60). Endoscopy was performed at baseline and at weeks 2, 6, and 12. Endoscopy results were scored on a scale of 1 to 9. Significant ulcers were defined as breaks in the mucosa greater than 5 mm with appreciable depth. Results: Of the 171 randomized patients, 148 completed the study. There was no significant difference in the incidence of significant ulcers between the nabumetone group and the ibuprofen/misoprostol group (one vs zero). There were significantly fewer significant ulcers in the nabumetone and ibuprofen/misoprostol groups than in the ibuprofen monotherapy group (one and zero vs eight; P

The phenomenal growth of over-the-counter (OTC) analgesics and the increase in the number of people who take aspirin along with other drugs have consequently increased the risk of developing adverse reactions due to inappropriate aspirin-drug intake. A list of OTC analgesics and anti-inflammatories with their corresponding interactions when taken with other types of medications and other substances such as alcohol, and suggested caring techiques are discussed., The list of OTC analgesics--like the OTC market itself--has grown quite a bit since our earlier series. At that time, our guide to analgesics covered only acetaminophen and aspirin. Ibuprofen [...]

Children with cystic fibrosis (CF) have chronic lung infections. Inflammation, usually a protective response, may contribute to lung destruction in these children. Thus anti-inflammatory therapy may slow the loss of lung function in children with CF. Steroids are one type of anti-inflammatory medication that have aided pulmonary function, but they are associated with potentially severe side effects. Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID), which may be a safer alternative. The effects of 300 to 600 milligrams of ibuprofen were compared with placebo treatment in 19 children (10 female) with CF, who were 6 to 12 years old, to determine appropriate dosing and evaluate side effects. Eleven children completed the study. No significant changes in pulmonary status were observed over the course of the three-month study in either group. A relationship between ibuprofen levels and adverse effects was not found, although emotional lability and nosebleeds occurred. Studies of the rate at which ibuprofen was distributed through the body of children with CF indicated that the drug was cleared faster in those with CF than in healthy children; there also was a greater apparent body volume in which the drug was distributed in the patient group. These results are similar to the observed effects of other drugs in CF patients. Individualized adjustments of ibuprofen dosages will be necessary to obtain optimal blood levels of the drug when treating children with CF. (Consumer Summary produced by Reliance Medical Information, Inc.)

The use of the pain relievers known as nonsteroidal anti-inflammatory drugs has been associated with an increased risk of peptic ulcer disease and upper gastrointestinal bleeding. To study the specific degree of risk for ulcer disease and to determine what association might exist between drug dose, duration of use and peptic ulcer disease, 1,415 patients with known ulcers or gastrointestinal bleeding were compared with 7,063 control subjects without ulcer disease. The study patients were Medicaid recipients over the age of 65 who were hospitalized with documented peptic ulcer disease or bleeding, whose records were studied for evidence of nonsteroidal anti-inflammatory drug therapy. Current use of a nonsteroidal anti-inflammatory drug was found in 34 percent of patients with ulcer disease, compared with 13 percent of controls. The risk of peptic ulcer disease was found to be greater with increasing doses as well as with shorter duration of therapy (less than 30 days). When factors such as age, sex, race, and recent hospitalizations were considered, users of nonsteroidal anti-inflammatory drugs were shown to be at greater risk for peptic ulcer disease than control subjects. One drug, ibuprofen, carried a lower risk than several of the other anti-inflammatory drugs, but the dose of ibuprofen studied was less than that generally prescribed, so no conclusion about greater safety in the use of ibuprofen should be inferred. (Consumer Summary produced by Reliance Medical Information, Inc.)

Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit the synthesis of prostaglandins, which cause dilation of blood vessels. When patients with asymptomatic, mild but chronic renal failure are given NSAIDs, they are at risk for developing ischemia (inadequate blood supply) in the kidneys due to vascular constriction; this can lead to deterioration of the kidneys. The effects of the NSAIDs ibuprofen, piroxicam, and sulindac were evaluated in patients with asymptomatic, mild but chronic renal failure. It was found that the use of ibuprofen (Motrin) for a brief course, less than eight days, resulted in acute renal failure. This adverse effect occurred with large doses of ibuprofen, but it can also occur with doses that are obtainable without a prescription (over-the-counter). Patients with mild renal impairment, especially that which is undiagnosed, may develop kidney problems when taking over-the-counter ibuprofen. Patients given piroxicam and sulindac for 11 days showed no signs of renal problems. Further study is needed to evaluate the risks of taking piroxicam and sulindac for longer periods of time. These drugs may accumulate in the body. (Consumer Summary produced by Reliance Medical Information, Inc.)

Objective: To report a massive, 100 g ibuprofen ingestion in an adolescent, with survival. Case Report: The patient developed coma, metabolic acidosis, and mild thrombocytopenia, but improved rapidly with supportive care. Renal function remained normal and no gastrointestinal bleeding occurred. Conclusions: Massive ingestion of ibuprofen may result in a variable picture with some elements of significant toxicity, but supportive care usually results in survival without sequelae., INTRODUCTION Ibuprofen is usually considered of low toxicity.[1] Significant toxicity, however, may occur with large ingestions,[2-7] including coma,[2,3] seizures,[3] metabolic acidosis,[2,4] gastrointestinal (GI) bleeding,[2] shock,[3] acute renal failure, occasionally requiring [...]

ABSTRACT & COMMENTARY Synopsis: A case-control study found an association between ibuprofen use and the development of necrotizingfasciitis in children with varicella. Source: Zer DM, et al. A case-control study [...]

ABSTRACT & COMMENTARY Synopsis: This study suggests that high-dose rofecoxib may increase the risk of cardiovascular events. Source: Ray WA, et al. Lancet. 2002;360:1071-1073. THIS RETROSPECTIVE COHORT TRIAL ASSESSED THE [...]

Patients with congestive heart failure, cirrhosis of the liver, and renal insufficiency need to synthesize prostaglandins, which cause blood vessels to dilate and allow fluids to pass through the kidneys. Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit the synthesis of prostaglandins. When patients with these disorders are given NSAIDs, they are at risk for developing ischemia, or inadequate blood supply, in the kidneys due to vascular constriction; this can lead to kidney deterioration. Many clinicians think that the ischemic effects of NSAIDs take time to develop, and wait several weeks to test the renal function of patients who are at risk of kidney problems when taking NSAIDs. However, studies show that some NSAIDs, such as ibuprofen, are short-acting and may inhibit prostaglandin synthesis within 8 to 12 hours. The kidney function of patients who take short-acting NSAIDs should be monitored within days. Large doses of ibuprofen have been associated with negative renal effects, but doses of ibuprofen that can be obtained over-the-counter (without a prescription) can also cause renal ischemia. It has been suggested that over-the-counter ibuprofen should contain a warning that patients with serious conditions should consult their doctor before use. However, early monitoring of longer-acting NSAIDS, such as piroxicam and sulindac, is not sufficient; monitoring for these NSAIDS must be continued for longer periods of time. The costs of monitoring the renal functions of patients who are receiving NSAIDS could be staggering. Epidemiological studies are needed to determine the risks for developing kidney complications with NSAIDS. Guidelines are needed for clinicians to monitor certain patients taking NSAIDS. In addition, the public must be educated on the potential hazards of the use of NSAIDS if certain other medical conditions exist. (Consumer Summary produced by Reliance Medical Information, Inc.)

Another study suggests that ibuprofen blocks the cardioprotective effects of aspirin. In 2001, researchers showed that ibuprofen may block the COX-1 receptor on platelets, keeping aspirin from binding to the [...]

Background: Ibuprofen ingestion is rarely linked to deterioration in mental status. We report an adolescent who demonstrated progressive metabolic acidosis and deterioration of mental status after an isolated ibuprofen ingestion. Case report: A 17-year-old healthy female ingested approximately 14 grams of ibuprofen in a suicide attempt. She presented to the emergency department, unarousable, six hours post-ingestion. Her gag reflex was present, but her Glasgow coma scale (GCS) was consistently six (6). She was endotracheally intubated and placed on a ventilator for airway protection in the Pediatric Intensive Care Unit (PICU). Initial laboratory studies were significant for an anion gap-positive metabolic acidosis (venous pH: 7.19, anion gap: 31). Serum ibuprofen level on admission was 962.6 mg/L (therapeutic: 5-49 mg/L). A subsequent serum lactate level was elevated (33 mg/dL). Her acidosis worsened, requiring sodium bicarbonate administration. She was extubated on hospital day two, but her clinical course was complicated by high output renal failure (peak serum creatinine: 2.3 mg/dL on hospital day two). She recovered fully by three days post-ingestion. Workup and history were negative for coingestants. Conclusion: Massive ibuprofen ingestion may cause acute deterioration of mental status, and should be included in the differential diagnosis of altered consciousness after an unknown ingestion., K Wiger, DD Gummin. Departments of Pediatrics and Emergency Medicine, Medical College of Wisconsin, and the Children's Hospital of Wisconsin Poison Center, Milwaukee, [...]