ABSTRACT
Ranitidine was first marketed in 1981; since then many patients have been treated such that much experience has been accumulated on the safety of this histamine H2-receptor antagonist in the treatment of gastroduodenal disease. A wide array of ranitidine-associated side effects has been described, but infrequently. As so much information is now available, the aim of this review is to assess the weight of evidence for a causal link between ranitidine and the reported side effects. Overall, ranitidine is well tolerated. The incidence of general side effects at less than 2% is very similar to placebo. Headaches, tiredness, dizziness and mild gastrointestinal disturbance (e.g. diarrhoea, constipation and nausea) are among the most frequent complaints, but have very seldom resulted in stopping treatment. Cardiovascular side effects are extremely rare and unpredictable with the usual doses of oral ranitidine (at most 1 in 1 million patients). They mostly comprise sinusal bradycardia and atrioventricular blockade, especially after rapid intravenous administration, receding after cessation of the drug. Clinical studies, however, have not shown a significant pharmacological effect of ranitidine on the cardiovascular system via H2-receptors, even though individual sensitivities cannot be ruled out in a few isolated reports. Ranitidine is unlikely to be directly hepatotoxic: a transient change in liver function tests has been noted in only 1 in 100 to 1 in 1000 patients. Several cases of mixed hepatitis have been reported, but very few were fully documented. The incidence of ranitidine-associated acute hepatitis has been estimated to be less than 1 in 100,000 patients. Neuropsychiatric complications may be less common and clinically quite similar to those reported with cimetidine, i.e. confusion, disorientation, hallucinations, delirium. These side effects have occurred especially in critically ill and multiple-therapy patients, or patients with chronic renal or hepatic failure, so that the direct causal link with ranitidine treatment was often difficult to ascertain. Even though an H2-receptor-mediated effect is an attractive hypothesis (since similar complications were noted with other H2-receptor antagonists), other mechanisms have been suggested to play a role, e.g. cholinergic or histaminic effects. The overall incidence of neuropsychiatric complications is probably markedly less than 1%. White cell injury (i.e. agranulocytosis) appears to be the most frequent haematological complication, even though case reports are very few and poorly documented.(ABSTRACT TRUNCATED AT 400 WORDS)
Subject(s)
Ranitidine/adverse effects , Blood Cells/drug effects , Cardiovascular System/drug effects , Central Nervous System/drug effects , Drug Interactions , Endocrine Glands/drug effects , HumansABSTRACT
Law established a holding and a distribution, by the hospital pharmacist, of the clinical trial drugs. These operations can only be achieved with written procedures. Two sorts of procedures are required: general procedures for the whole of trials and special procedures for each of them. In that setting, a protocol for administration and distribution of drug involved in one study is established. It is intended for the three partners of the trial: sponsor, clinical investigator, and pharmaceutical department itself. It gives to these partners all the relevant informations so as to lead the operations and their chronology. This system has been acting in the hospital for a year. It appeared reliable for the three partners in about thirty trials. So, it can be considered as validated.
Subject(s)
Clinical Trials as Topic/methods , Medication Systems, Hospital/organization & administration , Pharmacy Service, Hospital/organization & administration , France , HumansABSTRACT
We describe five cases of vasculitis noted a few days after influenza vaccination. This complication has occurred in four women, and the mean age was 76 years. Although cutaneous biopsy has confirmed leucocytoclasic vasculitis in only one case, the clinical characteristics were evocative in the other cases. No systemic complication were noted. Spontaneous retrocession was noted in four patients and following corticosteroids once. To our knowledge only few cases of vasculitis has been previously reported after influenza vaccination. The mechanisms are unknown but preservatives may have some responsibilities.
