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Biomedical subjects

H Jick

Publications and source records attributed to H Jick.

287 records · Page 16Linked to original sources
PubMedDate not supplied

Certain nonsteroidal antiinflammatory drugs and hospitalization for upper gastrointestinal bleeding.

In this follow-up study we attempted to estimate the risk of hospitalization for upper gastrointestinal bleeding (exclusive of bleeding from duodenal ulcer) caused by taking certain nonsteroidal antiinflammatory drugs (NSAIDs) in people below the age of 65 years. The final figures represent our best estimate, taking into account all of the available information, and suggest that NSAIDs (excluding aspirin) rarely cause gastrointestinal bleeding from the stomach that requires hospitalization in this age group. A formal analysis of the data according to classic techniques was not feasible since numerous important confounding factors could not be controlled. Indeed, the results indicated that such formal analysis is unnecessary. The data as they stand are of considerable value in providing a reasonable estimate of attributable risk for the drugs studied.

Adult↗
PubMedDate not supplied

Adverse reactions to quinidine in hospitalized patients: findings based on data from the Boston Collaborative Drug Surveillance Program.

This study systematically analyzed the incidence and variety of adverse reactions to quinidine sulfate in 652 consecutively monitored hospitalized patients. Fourteen percent of the patients sustained adverse reactions of sufficient severity to warrant discontinuation of the drug. These reactions include GI intolerance, cardiac arrhythmias, fever with and without associated hepatic dysfunction or leukopenia, cinchonism, and hemolytic anemia. Cardiac arrhythmias were infrequent and, when present, generally occurred within 3 days of institution of quinidine therapy. There were no quinidine-related fatalities in this study group.

Adult↗
PubMedDate not supplied

Acute toxicity of aspirin in hospitalized medical patients.

Among 2,391 recipients of plain aspirin tablets, 121 (5.1%) were reported to have adverse reactions. Minor gastrointestinal disturbances, particularly heartburn and nausea, were most common (2.1%). Central nervous system effects were second (1.2%). Among these, tinnitus was reported most often (0.8%); deafness occurred in eight patients (0.3%). Gastrointestinal bleeding, the third major category of adverse reactions, occurred in 1.0% of recipients; it was not considered serious in any of the patients with reactions judged "definitely" or "probably" related to aspirin. The frequency of all adverse reactions increased as the unit dose, daily dose and total dose became larger. Deafness occurred only at high doses. Reactions were more common in females.

Aspirin↗
PubMedDate not supplied

Adverse reactions to co-trimoxazole in hospitalized medical patients.

Of 29,524 hospitalized medical patients monitored in a drug surveillance program, 649 (2.2%) received the fixed dose combination of trimethoprim-sulfamethoxazole, co-trimoxazole. Adverse effects of this drug occurred in 8% of recipients, the most frequent being skin rashes which occurred in 23 patients (3.5%) and upper gastrointestinal upsets which occurred in 22 (3.4%). Reactions frequently occurred within 72 hours of starting the drug and promptly resolved on stopping it. No patient experienced severe or life-threatening adverse effects. Adverse effects were unrelated to age, weight, duration of hospitalization or presenting blood urea nitrogen concentration, but were significantly commoner in female recipients.

Adult↗
PubMedDate not supplied

A large population-based follow-up study of trimethoprim-sulfamethoxazole, trimethoprim, and cephalexin for uncommon serious drug toxicity.

We conducted a population-based 45-day follow-up study of 232,390 people who were prescribed trimethoprim-sulfamethoxazole (TMP-SMZ), 266,951 prescribed trimethoprim alone, and 196,397 prescribed cephalexin, to estimate the risk of serious liver, blood, skin, and renal disorders resulting in referral or hospitalization associated with these drugs. The results were based on information recorded on office computers by selected general practitioners in the United Kingdom, together with a review of clinical records. The risk of clinically important idiopathic liver disease was similar for persons prescribed TMP-SMZ (5.2/100,000) and those prescribed trimethoprim alone (3.8/100,000). The risk for those prescribed cephalexin was somewhat lower (2.0/100,000). Only five patients experienced blood disorders, one of whom was exposed to TMP-SMZ; of seven with erythema multiforme and Stevens-Johnson syndrome, four were exposed to TMP-SMZ. The one case of toxic epidermal necrolysis occurred in a patient who took cephalexin. Finally, only five cases of acute parenchymal renal disease occurred, none likely to be caused by a study drug. We conclude that the risk of the serious diseases studied is small for the three agents, and compares reasonably with the risk for many other antibiotics.

Adult↗
PubMedDate not supplied

The risk of sulfasalazine- and mesalazine-associated blood disorders.

Sulfasalazine (SASP) has often been reported to cause serious blood disorders, particularly agranulocytosis; however, little quantitative information is available to estimate the risk or to identify possible modifiers of the risk. We used comprehensive clinical information recorded on office computers by selected general practitioners in Britain to conduct a follow-up study of some 10,000 users of SASP and some 4000 users of mesalazine to estimate the risk of blood disorders associated with these drugs. Overall, the frequency of blood disorders attributable to SASP was 27/10,332 (2.6/1000 users). The risk for SASP users who were treated for arthritic disorders (6.1/1000 users) was some 10 times higher than that for users who were treated for inflammatory bowel disease (0.6/1000 users). There were no cases of blood disorders in users of mesalazine.

Adolescent↗
PubMedDate not supplied

A follow-up safety study of ciprofloxacin users.

We followed 37,233 outpatients for 45 days after receiving a prescription for ciprofloxacin to identify any newly diagnosed, important illnesses that might have been caused by the drug. For 29 users the role of ciprofloxacin in the etiology of the illness could not be confidently ruled out (7.79/10,000 persons; 95% CI 5.42-11.18). In only seven was a causal relation to ciprofloxacin considered likely: three skin reactions and one case each of thrombocytopenia, "headache, nausea, and shakes," hallucinations, and palpitations. No fatal illnesses occurred, and all patients recovered after discontinuing the drug. In addition, few cases of photosensitivity were associated with the agent. We conclude that important adverse reactions attributable to ciprofloxacin are uncommon.

Central Nervous System Diseases↗
PubMedDate not supplied

Nonsteroidal antiinflammatory drugs and certain rare, serious adverse events: a cohort study.

We performed a population-based study of over 100,000 users of diclofenac, naproxen, or piroxicam to identify cases of important blood, skin, central nervous system, kidney, pancreas, or pulmonary disorders caused by these drugs. In three cases a causal relation seemed likely; one of hemolytic anemia attributed to diclofenac, one of neutropenia attributed to naproxen, and one of pancreatitis attributed to piroxicam. In 13 additional cases a causal connection seemed unlikely but could not be fully ruled out. We conclude that such illnesses are uncommonly caused by the three agents studied.

Adult↗
PubMedDate not supplied

Liver disorders in patients receiving chlorpromazine or isoniazid.

Based on information derived from computers and clinical records obtained from general practitioners in the United Kingdom, we estimated the frequency of liver toxicity associated with two known hepatotoxins, chlorpromazine and isoniazid. Among the cohort of 10,502 users of chlorpromazine, 14 had illnesses compatible with drug-induced liver disease, a frequency of 1.3/1000 users (95% Cl 0.8, 2.2). Four presumed cases of the disorder occurred among 921 users of isoniazid, for a frequency of 4/1000 users (95% Cl 1.7, 11.1). This study provides population-based quantification of the frequency of liver disorders associated with the use of these two agents.

Adult↗
PubMedDate not supplied

The risk of myocardial infarction associated with antihypertensive drug treatment in persons with uncomplicated essential hypertension.

We conducted a case-control study based on computer-recorded information accrued in the United Kingdom General Practice Research Database to assess and compare the relation between different antihypertensive drug therapies and myocardial infarction in patients with no known clinical or laboratory risk factors for myocardial infarction other than hypertension. Cases were treated hypertensive patients with no other known risk factors who developed a first acute myocardial infarction between January 1, 1993, and October 31, 1994. They were ascertained from a review of the clinical record together with a questionnaire filled out by the attending general practitioner. Controls were matched to each case for age, sex, general practice, and index date. Antihypertensive therapy was derived from the computerized patient record. The study consisted of 210 cases and 793 controls. Compared with users of beta-blockers alone, the adjusted relative risk (RR) estimates for all other treatment regimens were close to 1.0. A comparison of users of calcium channel blockers alone with users of beta-blockers alone yielded a RR estimate of 0.9 (95% CI 0.5, 1.7). We conclude that the risk of acute myocardial infarction in otherwise healthy, treated hypertensive patients is not materially associated with the particular drug they receive.

Adult↗
PubMedDate not supplied

A review of epidemiologic research on drug-induced acute liver injury using the general practice research data base in the United Kingdom.

Drug hepatotoxicities have been evaluated in case histories, surveys based on retrospective record reviews, and spontaneous adverse drug reactions reported to national pharmacovigilance systems, but in relatively few epidemiologic studies. To identify and quantify the risk of acute liver injury associated with individual drugs, we reviewed and integrated all the published epidemiologic research on the subject. The source population for the eight studies was general population registered on a single large general practice-based computerized data base. All were retrospective cohort studies, but some had a case-control design nested within the source cohort. Participants were selected according to their use of selected agents (nonsteroidal antiinflammatory drugs [NSAIDs], antibiotics, acid-suppressing drugs, other drugs suspected of being hepatotoxic) during the study period. Among the agents, we found a group of important hepatotoxic drugs with an associated incidence rate of acute liver injury greater than 100/100,000 users, including chlorpromazine and isoniazid. Agents with less risk but greater than 10/100,000 users were amoxicillin-clavulanic acid and cimetidine. A third group of drugs had an associated incidence rate of acute liver injury of less than 10/100,000 users. Our results provide evidence of relative safety for commonly administered agents such as NSAIDs, amoxicillin, omeprazole, and ranitidine. We also quantified important suspected liver toxicity, providing a reasonable precise risk estimate of clinical liver injury associated with chlorpromazine, isoniazid, and amoxicillin-clavulanic acid.

Adverse Drug Reaction Reporting Systems↗
PubMedDate not supplied

The risk of seizures associated with tramadol.

We conducted a study of the risk of idiopathic incident seizures among users of tramadol derived from data present in the General Practice Research Database based in the United Kingdom for 1994-1996. We used a nested case-control study design, comparing risks of idiopathic incident seizures during exposed and unexposed times among patients who had ever taken tramadol using a 90-day follow-up. Among the 10,916 subjects, we identified 17 cases of idiopathic seizures, 11 of which were definite and 6 possible. None of the patients was exposed to tramadol alone in the prior 90 days. Eight patients were exposed to opiates, five to both tramadol and opiates, three to other analgesics, and one to no analgesics. We found no increased risk of idiopathic incident seizures associated with exposure to tramadol alone. Thus seizures seem rarely attributable to the agent.

Adolescent↗