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Adverse drug reactions: report of the Australian Veterinary Association Adverse Drug Reaction Subcommittee, 1992.

Fifty-nine reports of suspected adverse drug reactions (ADRs) were received by the Adverse Drug Reaction Subcommittee of the Australian Veterinary Association from February 1991-March 1992 inclusive. The number of reports received/number of animals involved per species was: dogs (23/24); cats (20/30); horses (4/4); cattle (7/10); sheep (3/745); poultry (1/580); pigs (1/8). Of these, 38 (64%) were classified as definite ADRs and 9 (15%) as probable ADRs. In 10 (17%) reports an ADR could not be substantiated or there was insufficient information available to make a decision. Two reports involved veterinarians inadvertently overdosing animals. Eighteen reports involved apparent hypersensitivity reactions and 6 reports involved probable drug interactions. Four reports involved the use of drugs at appropriate doses but in inappropriate clinical situations, and 3 reports were associated with 'off-label' use.

Animals

Physician reporting of adverse drug reactions. Results of the Rhode Island Adverse Drug Reaction Reporting Project.

The Food and Drug Administration, Rockville, Md, contracted with the Rhode Island Department of Health, Providence, to conduct a project to increase reporting of suspected adverse drug reactions through physician education. Voluntary reporting, an important part of postmarketing surveillance that signals potential problems with marketed drugs, historically has been underused by physicians. After 2 years, there was a more than 17-fold increase in reports submitted directly from Rhode Island compared with the yearly average before initiation of the project. Increases in the total numbers of reports were paralleled by significant increases in the numbers of reports of severe reactions. Similar increases were not experienced nationally. Physicians in Rhode Island were surveyed before and 2 years after interventions began to determine changes in knowledge and attitudes about reporting of adverse drug reactions. Significant gains in knowledge and positive attitudes toward the reporting system occurred. We conclude that physicians can be stimulated to increase their reporting of suspected reactions, thereby improving the viability of the federal reporting system.

Attitude of Health Personnel

Epidemiologic approach to open-angle glaucoma: 2. Survival analysis of adverse drug reactions. Report of the Canadian Ocular Adverse Drug Reaction Registry Program. The Collaborative Glaucoma Study Group.

Medical treatment, intraocular pressure (IOP) and adverse drug reactions were recorded in a prospective multicentre study of 71 unselected, newly diagnosed cases of open-angle glaucoma. Eight ophthalmologists recorded standard information at five visits over a mean interval of 12.1 months. No limitations were imposed on the choice of drugs or interval between visits. The IOP was satisfactorily controlled throughout the follow-up period with the first drug prescribed in 36% of eyes. In an additional 10% to 13% the IOP was stabilized with alternative therapy, prescribed for approximately one-third of eyes per visit. A total of 27 patients reported 18 severe and 31 mild suspected adverse reactions during the follow-up period. Survival analysis showed that there was no significant difference between the proportions of patients continuing treatment with the first, second and third drug prescribed (half-life of treatment approximately 210 days in all three cases). However, when only changes for unsatisfactory pressure were considered, the half-life of treatment was significantly longer, 350 days (p = 0.02).

Acetazolamide

[The epidemiology of adverse reactions to nonsteroidal anti-inflammatory drugs. Nimesulide is tolerated by patients with adverse reactions to NSAIDs and modulates in man the skin response to histamine and codeine].

We evaluated the tolerance to NIM in patients with adverse reactions to NSAIDs, expressed by urticaria-angioedema, bronchial asthma or erythema polymorphous on 92 patients among which 32 atopics affected by asthma, rhinitis or contact dermatitis. Challenge test has been performed with increasing amounts of NIM per os every 2 hrs to a maximum of 100 mg/dose. The last dosage was repeated every 12 hrs for 4 times more. No reactions were observed in 86 patients (93.4%). Moreover we evaluated the efficacy of NIM in modulating pomphoid cutaneous reaction to histamine (HIS) and codeine (COD). Three subjects were prick tested with HIS and COD solutions at different concentrations (0.1 to 10 mg/ml), before and after a 5 days therapy with NIM at different dosages/kg/die. At NIM dosages of 3.7 and 2.7 mg/kg/die we observed a strong reduction of pomphoid activity of both HIS and COD. No clear effects were detected at 2.2 mg/kg/die dosage. We assume a dose-related in vivo inhibitory effect of NIM on cutaneous mast cells releasability or a direct anti-histaminic effect. We point out the possible therapeutic role of NIM in the treatment of allergic flogosis at steroid and cromon's side.

Adolescent

Mucopurulent cervicitis as a predictor of chlamydial infection and adverse pregnancy outcome. The Investigators of the Johns Hopkins Study of Cervicitis and Adverse Pregnancy Outcome.

The role of mucopurulent cervicitis in identifying pregnant women with Chlamydia trachomatis infection and poor pregnancy outcome was examined at the Johns Hopkins Hospital Obstetric Clinic in Baltimore, Maryland. The women studied were at high risk for chlamydial infection (14%), low birthweight (12%), and preterm delivery (13%). Yellow endocervical discharge on a cotton swab had a sensitivity of 23.9%, specificity of 89.4%, and positive predictive value of 28.6% for predicting chlamydial infection. The presence of greater than or equal to 30 polymorphonuclear cells per 1000 x field had a sensitivity of 25.0%, specificity of 87.6% and positive predictive value of 24.3%. Women with cervicitis defined by greater than or equal to 30 polymorphonuclear cells per 1000 x field were twice as likely to deliver a low-birthweight infant. Adjustment for potential confounding variables did not explain this association. The poor sensitivity, specificity, and positive predictive value of mucopurulent cervicitis suggests that this parameter is not a useful screening tool for chlamydial infection in pregnant women. However, mucopurulent cervicitis may be an indicator of increased risk for poor pregnancy outcome.

Adolescent