Esther Salgueiro

Hepatotoxicity Induced by Antiandrogens: A Review of the Literature

Introduction: Hepatotoxicity is a serious adverse reaction potentially induced by all antiandrogens. We have reviewed here the published cases of hepatotoxicity induced by steroidal and nonsteroidal antiandrogens, and compared the type and characteristics of liver damage. Methods: Using two different databases: MEDLINE and IDIS (Iowa Drug Information Service), we searched for published cases of liver injury induced by antiandrogens. Analysis was made of the type of hepatotoxicity, therapeutic indication, other pharmacological treatments and evolution. Mean values of latency and recovery periods of the adverse reactions and liver function tests were also evaluated. Results: Hepatitis was the most common type of hepatotoxicity reported, and was associated with all antiandrogens. This adverse reaction does not seem to be dependent on the patients age, therapeutic indication or the dose prescribed. Hepatitis showed a longer latency period for cyproterone acetate than for flutamide. Some transaminase levels were significantly higher for flutamide than for cyproterone acetate, although the evolution was no worse in the cases reported for flutamide. We also found occasional reports of hepatocellular carcinoma and hepatic cirrhosis suspected of being induced by cyproterone acetate. Conclusion: Although there are differences in the clinical features of hepatotoxicity induced by steroidal and nonsteroidal antiandrogens, these do not predict which patients will develop hepatotoxicity during treatment or evolution. Serial liver function tests are required for early detection of liver damage.

Safety profile of proton pump inhibitors according to the spontaneous reports of suspected adverse reactions.

OBJECTIVE [corrected] To evaluate similarities and differences in safety among proton pump inhibitors (PPIs) under the usual conditions of prescription. METHODS A search of spontaneous reports on adverse reactions associated with these drugs and registered between January 1, 2004 and December 31, 2004 was undertaken in the Spanish Pharmacovigilance System Database. We compared the frequency of reports with the consumption of PPIs, and analyzed the organ and system distribution for each PPI. Of the organ and system groups more commonly affected, diarrhea, myalgia, abnormal vision and hepatitis were selected for further analysis. RESULTS Nearly 8 times more reports for omeprazole compared to other drugs were found but a similar difference was observed in their consumption. Skin and appendage disorders were more frequently reported for omeprazole and rabeprazole, the urinary, female reproductive and endocrine systems for lansoprazole, musculoskeletal for omeprazole and esomeprazole, vision for pantoprazole, rabeprazole and esomeprazole, gastrointestinal tract for omeprazole and lansoprazole and liver and biliary systems for omeprazole, lansoprazole and pantoprazole. Myalgia appears more often in younger patients than diarrhea, abnormal vision or hepatitis and shows longer periods of latency and recovery. The four adverse reactions analyzed were mainly reversible. CONCLUSION A direct relationship was found between consumption and the number of reports. Some organ and system groups were affected by more than one PPI and this showed a specific pattern of group toxicity to these pharmacological agents. Some reports involved only lansoprazole and these require further analysis.

Post-marketing safety of antineoplasic monoclonal antibodies: rituximab and trastuzumab†

The aim of this study was to analyse the suspected adverse reactions associated with rituximab or trastuzumab reported to the Spanish Pharmacovigilance System.

Los criterios STOPP/START más frecuentes en España. Una revisión de la literatura

OBJECTIVE To analyse STOPP/START criteria found most frequently in the studies carried out in Spain, in order to identify the main areas of potentially inappropriate prescribing. METHODS A literature review was carried out on the original studies performed in Spain that applied the original version of the STOPP/START criteria and that described the most common STOPP and/or START criteria found. In each study, a weighted analysis was performed on the criteria found, by assigning 5 points to the criterion in first position, 4 points to the criterion in second position, and so on to fifth criterion. The total points of each analysed criterion were then obtained. RESULTS A total of 19 original studies analysing STOPP criteria were selected, 14 of them also studying all START criteria. From the total of studies, 11 were developed in out-of-hospital care, and 8 in hospital care. The STOPP criterion with the highest weighted assessment was B7 (long-term, long-acting benzodiazepines), followed by J (any duplicate drug class prescription). The START criterion with the highest weighted assessment was F4 (statin therapy in diabetes mellitus if coexisting major cardiovascular risk factors present), followed by E3 (calcium and vitamin D supplement in patients with known osteoporosis: previous fragility fracture, acquired dorsal kyphosis). CONCLUSIONS The most common areas of potentially inappropriate prescribing are well defined, and suggest a particular intervention in some specific therapeutic points.

What can we learn from the public's understanding of drug information and safety? A population survey

The aim of our study was to analyse the perceptions of the public on medicine information and safety and on consumer reporting of suspected adverse drug reactions (ADR).