These ratios are defined as the ratio of exposure odds among reported arrhythmia cases to the exposure odds of all other ADRs. In the Netherlands lots of attention to antihistamine-induced arrhythmias was raised at the beginning of 1998 when the Dutch government in accordance with many other countries decided that, for safety reasons, the former over-the-counter drugs terfenadine and astemizole could no longer be obtained without a prescription.įor the comparison of exposed and nonexposed patients with respect to the risk of developing cardiac arrhythmias, ADR reporting odds ratios were calculated. However, also attention in the media may result in selective reporting of certain adverse events. So far most concern has been expressed in relation to the persistent feature of underreporting. The validity of the method has, however, been criticised because the fact that reports on adverse reactions on a voluntary basis can be biased. In other words, the drug is associated to the specific adverse reaction. A large odds ratio indicates that the studied drug represents a disproportionate share of the reports of the adverse reaction of interest compared with the share of reports of other adverse reactions. This method includes the calculation of an adverse drug reaction reporting odds ratio, which is used as an estimate of the risk of developing a certain event for patients using the index drug(s) relative to patients using reference drug(s). One of the available strategies to identify rare adverse events is to evaluate spontaneous reports of adverse drug reactions (ADRs) using the concept of ‘reaction proportion signalling’ described firstly by Finney and consequently applied by several others. The absolute risk of developing ventricular arrhythmias as a result of the use of these drugs is found to be very low: approximately 0 prescriptions. The use of nonsedating antihistamines, widely used to treat allergies, has been associated with arrhythmias in various case reports. Therefore prevention of drug-induced QTc-prolongation is of utmost importance. ![]() Prolongation of the QTc interval may lead to fatal ventricular arrhythmias, like torsades de pointes and is associated with increased mortality. Cardiac arrhythmia, notably associated with QTc interval prolongation, has been one of the most important adverse drug reactions leading to regulatory action in recent years.
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