A huge increase in opioid consumption has occurred during the time period covered by this study, with fentanyl consumption accounting for most of that increase. Although oral morphine is the first-choice drug among strong opioids, fentanyl is currently the most consumed.
Several non-steroidal anti-inflammatory drugs (NSAIDs) have been associated with liver damage. The aim of this study was to compare proportions of hepatic adverse drug reaction reports associated with NSAIDs in France and Spain. Information from the Spanish and French pharmacovigilance databases were used from 1982 to 2001. To assess the risk of liver injury, the case/non-case methodology was applied, 'cases' being reports of liver damage and 'non-cases' or controls, all other reports. Exposure was considered as the presence of at least one NSAID. Liver injury risk was estimated for each drug in the two databases by calculation of reporting odds ratio in cases and non-cases, with its 95% confidence interval. Out of 62 456 reports from the Spanish database, 2114 (3.38%) were identified as liver injuries, whereas there were 27 372 liver injuries out of 200 046 (13.68%) in the French database. In Spain, there was a significant association between liver injuries and droxicam, sulindac, and nimesulide. The risk was also slightly above 1 for aceclofenac. In France, the risk was very high with clometacin, followed by sulindac, and was slightly above 1 for naproxen, diclofenac, piroxicam, and tenoxicam. This study shows that some NSAIDs are associated with reports of hepatic injuries when compared with other drugs, and most of those have been withdrawn from the market for this reason. However, the frequency of drug-related hepatic injuries reported differed in the French and Spanish databases, and some drugs did not show the same risk level in the two countries. These discrepancies could be explained in part not only by reporting rates, but also by difference in drug use patterns and/or by genetic or environmental factors.
The reported incidence of hepatic adverse reactions to nefazodone seems to be higher than that estimated so far. Given the high prevalence of depression and the widespread use of antidepressants, physicians should be alert to the possibility that these medications cause hepatitis and consider early discontinuation of an antidepressant if the condition is suspected.
There has been an increase of anti-ulcer drug consumption in Spain. A high proportion of this consumption may be due to the use of those drugs as gastroprotective agents when co-prescribed with nonsteroidal anti-inflammatory drugs (NSAIDs). The aim of this study was to learn how these treatments are being used: the prevalence of use, the type of drug and the main features of patients. A sample of patients going to pharmacies with a NSAID prescription, with or without a gastroprotective agent, was obtained. A survey questionnaire was distributed to learn clinical and demographic data of the patients. Of the 942 patients interviewed, 41.6% were co-treated with a gastroprotective agent in addition to the NSAID. Most of these patients received proton-pump inhibitors and, to a lesser extent, histamine-2-receptor antagonists, antacids and prostaglandin analogues. The use of gastroprotective agents increased with age, treatment duration and illness chronicity; specialists prescribed a higher proportion of those co-treatments than did general practitioners. There was a high prescription rate of gastroprotective agents; in general, these were used according to recommendations. However, the type of gastroprotective agents being used does not seem to be justified by the current guidelines: histamine-2-receptor antagonists and antacid drugs have not proved their efficacy in this indication. The fact that one in four treatments with gastroprotective drugs was issued to patients without associated risk factors identifies a possible problem where an intervention could be appropriate.
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