We studied the incidence and type of side effects of minocycline in a doubleblind study. A total of 45 volunteers (18 men and 27 women) were given minocycline, and 44 volunteers (23 men and 21 women) were given placebo. The men in both the minocycline and placebo groups were significantly (P < 0.0001) larger than the women in the comparable groups. Minocycline dosage was 100 mg every 12 h for 5 days, and placebo was administered in an identical manner. Minocycline serum concentrations were determined in 12 volunteers at 1, 2, 4, and 6 h after the morning doses on days 1, 3, and 5 of the study. Side effects were recorded by volunteers in diaries and also through daily interviews and were evaluated by examination and electronystagmography. Peak minocycline serum concentrations were seen by day 3 and correlated with the peak onset of side effects. These concentrations were significantly higher in women than in men. Vestibular side effects occurred in 70.4% of the women on minocycline and significantly (P < 0.0001) exceeded the rate of the women on placebo (9.5%). Only loss of balance was significantly (P < 0.05) increased in the men taking minocycline as contrasted with men on placebo. Electronystagmography generally revealed no abnormalities. Side effects were usually not severe: four volunteers in the minocycline group and two in the placebo group discontinued their capsules because of side effects. It is concluded that women experience an unacceptably high incidence of side effects from minocycline, and this may be related to their higher serum concentrations, which in turn may relate to their smaller size.Minocycline has been shown to be an effective drug for meningococcal prophylaxis (8). Many recent reports, however, have indicated a high incidence of side effects from minocycline (3,6,10,15), and the Center for Disease Control now recommends rifampin for meningococcal prophylaxis (4). Recent studies showing a high incidence of side effects were, however, retrospective and not double blind. Therefore, this double-blind study was undertaken to document the frequency and character of side effects associated with minocycline. MATERIALS AND METHODS Volunteers. A total of 89 healthy volunteers were selected after history, physical examination, white blood count, differential, hematocrit, urinalysis, and a negative pregnancy test. The volunteers consisted of students and university and hospital employees. Hematological tests and urinalyses were repeated at the conclusion of the study. Persons allergic to tetracycline, those taking antacids, or those who had a past history of vertigo or light-headedness were excluded from the study. A full disclosure consent form outlining all the possible side I Present address: 100 Wendell Ave., Pittsfield, MA 01201.effects of the drug was signed by each volunteer. The study protocol and consent forms were reviewed and approved by the University of Vermont Human Experimentation Committee. Volunteers were randomly assigned into the placebo or the minocycline group in a double-blind...

Standardized rates of drug-attributed rises in blood urea nitrogen were 8.6%, 2.9%, and 9.3%, respectively, in patients receiving gentamicin alone, cephalothin alone, and both drugs together. These results provide evidence against a substantial synergism between the two drugs in the production of impaired renal function.Recently, case reports have appeared describing the development of impaired renal function in patients receiving both gentamicin and cephalothin, and it has been suggested that they may be synergistic in producing this effect (1,3,8,12). To evaluate this possibility, the data collected by the Boston Collaborative Drug Surveillance Program (BCDSP) were examined.(This paper was presented at the 15th Interscience Conference on Antimicrobial Agents and Chemotherapy in Washington, D.C., 24-26 September 1975.) PATIENTS AND METHODS The BCDSP has to date collected data on over 22,000 consecutive admissions to selected wards in nine hospitals. All patients were admitted to medical services, none had undergone surgery, and none had received anesthetic agents. The data routinely collected include detailed information on demographic characteristics, all drugs administered, and a record of any adverse events deemed by the attending physician to be related to the administration of any drug or combination of drugs. Thus, the event, rising blood urea nitrogen (BUN) attributed to a drug, was based on the attending physician's discovery and notation of this event during the clinical course of his patient. Further details of the program and its methods have been presented elsewhere (10).As a first step in the evaluation of the effect of the combination of gentamicin and cephalothin in producing impaired renal function, all patients receiving these drugs alone or in combination were identified. From this group, patients receiving other nephrotoxic agents (i.e., kanamycin, colistin sulfate, polymixin B, amphotericin B, cephaloridine, or tetracycline) were excluded from further study. For all of the remaining patients who had developed a drugattributed rising BUN, the records were studied in detail. For the purposes of the present evaluation, ' Address reprint requests to: Boston Collaborative Drug Surveillance Program, 400 Totten Pond Road, Waltham, Mas. 02154.rising BUN was ascribed to the relevant antibiotic under study in those instances where it occurred at least 24 h after treatment was begun and not more than 24 h after it was stopped.The following were evaluated as possible confounding factors: age, sex, hospital, admission BUN level, first discharge diagnosis, survival, drug dosage, route of drug administration, duration of antibiotic therapy, and concomitant administration of diuretics.A total of 1,073 patients met the criteria for inclusion. Among these, 18% were 40 years of age or less, 26% were between 41 and 60 years, and 56% were over 60 years of age. Fifty-six percent were male. The admission BUN was less than 25 mg/100 ml in 63% of the group, between 25 and 50 mg/100 ml in 22%, and over 50 mg/100 ...

No abstract

This report documents the occurrence of an Osler node, subungual hemorrhages, and Janeway lesions peripheral to an infected arterial catheter. A brief review of these dermatological manifestations of infection is given and the importance of surgical removal of the involved artery after poor response to medical therapy is stressed.

No abstract