Seizures reported with tramadol.
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Adverse Drug Reaction Reporting Systems↗
Biomedical subjects
L H Kahn
Publications and source records attributed to L H Kahn.
Over-the-counter naproxen sodium and esophageal injury.
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Anti-Inflammatory Agents, Non-Steroidal↗
Necrotizing soft tissue infections reported with nonsteroidal antiinflammatory drugs.
BACKGROUND: Recent reports of necrotizing fasciitis in children with varicella who received a nonsteroidal antiinflammatory drug (NSAID) recall earlier concerns regarding the possibility of relationships between infections and NSAIDs. We searched the Food and Drug Administration's Spontaneous Reporting System (SRS) for necrotizing soft tissue infections reported in conjunction with the use of NSAIDs, to identify common features. METHODS: A computer search of NSAID listings in the adverse event database recovered reports with codes for selected infection and necrosis-related diagnostic categories. From review of individual reports classified under these codes, cases were selected if the terms "necrotizing fasciitis," "necrotic," or "gangrenous" appeared in the adverse drug reaction description. Demographic, drug use, and disease course information were gathered. FINDINGS: Thirty-three cases were identified, of which 10 were fatal. Over two-thirds of the patients were younger than 40 years. Thirty (91%) had a possible portal of entry for infection. Most received NSAIDs for acute conditions including varicella, trauma, and postoperative or postpartum pain; 7 received an NSAID by intramuscular injection. Specific NSAIDs accounting for most reports were also among those likely to be most heavily used in the relevant populations. INTERPRETATION: Common features of these rare case reports of necrotizing soft tissue infections with NSAID use include characteristics such as age, portal of infection entry, indication for NSAID use, route of administration, and individual NSAIDs. The total number of SRS cases does not suggest that necrotizing infection is frequent with NSAIDs or likely without other risk factors. Controlled observational studies would help to define any causal contribution of these factors to the evolution of severe infection.
Adverse Drug Reaction Reporting Systems↗
The validity of hospital administrative data in monitoring variations in breast cancer surgery.
To assess the validity of using hospital administrative data to measure variations in surgery for early-stage breast cancer, ICD-9-CM coded information was compared with corresponding tumor registry data for 1293 breast cancer patients undergoing lumpectomy or mastectomy at a tertiary referral center from January 1989 to October 1993. Relative to "gold standard" tumor registry data, the administrative data proved 83.4% sensitive and 80.4% specific in identifying women with localized disease who would be potential candidates for lumpectomy. The proportion of women with localized disease undergoing lumpectomy in groups defined by race and insurance status was nearly identical, whichever data were used. Administrative data, which is often readily and publicly available, may be useful in studying variations in breast cancer treatment in key demographic groups.
Black or African American↗
Mumps outbreak in a highly vaccinated population.
From October 1988 to April 1989, a large mumps outbreak occurred in Douglas County, Kansas. Of the 269 cases, 208 (77.3%) occurred among primary and secondary school students, of whom 203 (97.6%) had documentation of mumps vaccination. Attack rates were highest for students attending junior high school (8.0%), followed by high school (2.0%) and elementary school (0.7%). A retrospective cohort study conducted at one junior high school with an attack rate of 12.9% did not find age at vaccination or type of vaccine received (single or combined antigen) to be risk factors for vaccine failure. Students vaccinated more than 4 years before the outbreak appeared to have a higher attack rate than those vaccinated more recently (relative risk (RR) = 4.3; 95% confidence interval (CI) = 0.6, 30.0); however, this association did not exist when risk was evaluated based on number of vaccine doses received. Students who had documentation of receiving only one dose of vaccine were at greater risk than those who had received two doses (RR = 5.2; 95% CI = 1.0, 206.2). Overall, vaccine effectiveness among Douglas County junior high school students was estimated to be 83% (95% CI = 57%, 94%). These data suggest that mumps vaccine failure and the failure to vaccinate have contributed to the relative resurgence of mumps observed in the United States since 1986. The recent change in immunization policy to recommend a two-dose schedule of measles-mumps-rubella vaccine should help reduce the occurrence of mumps outbreaks in highly vaccinated populations.
Age Factors↗
Protective effect of acetaminophen against aspirin- and ethanol-induced damage to the human gastric mucosa.
Aspirin and ethanol damage the gastric mucosa in humans, whereas acetaminophen does not. Acetaminophen increases prostacyclin activity in animals and thus may increase endogenous prostaglandin synthesis. The effect of acetaminophen was examined in five healthy subjects after intragastric aspirin or ethanol. Hydrogen and sodium ion fluxes were measured in the pylorus-occluded stomach that prevents duodenogastric reflux and gastric fluid losses. Studies were in random order and on 8 separate days. Potential difference was measured throughout and mucosal erosions were endoscopically quantitated (endoscopist masked, no premedication). The isoosmolar test solution (200 ml, 100 mM HC1, 54 mM mannitol, [14C]polyethylene glycol) was instilled into the stomach and removed 15 min later for four 15-min periods. Either aspirin (1300 mg) or ethanol (20% vol/vol) was added to the test solution only during the second 15 min. Acetaminophen (2600 mg) was given orally 1 h before aspirin or ethanol administration. To determine if the effect of acetaminophen was related to prostaglandin synthesis, prostaglandin production was inhibited with indomethacin (50 mg orally 12 h and 1 h before acetaminophen). Aspirin and ethanol alone each produced significant changes in net hydrogen and sodium fluxes, potential difference, and endoscopic changes. Acetaminophen significantly inhibited hydrogen ion flux, change in potential difference, and endoscopic damage; however, it did not totally abolish these changes. The protective effect of acetaminophen was abolished by pretreatment with indomethacin, suggesting that the effect of acetaminophen is likely to be prostaglandin-mediated. Indomethacin alone was without effect. These results demonstrate that oral acetaminophen protects the human gastric mucosa against the damaging effects of aspirin and ethanol.
Acetaminophen↗