16th ISoP Annual Meeting ''Pharmacovigilance for Safer Tomorrow'' Agra, India 16–19 October, 2016

<span title="">2016</span> <i title="Springer Nature"> <a target="_blank" rel="noopener" href="https://fatcat.wiki/container/gwjfiddrarc4zhvrdexu2pibom" style="color: black;">Drug Safety</a> </i> &nbsp;
Adverse drug reactions (ADRs) associated with psychotropic drugs leads to noncompliance, increased morbidity and higher economic burden. There is growing concern to assess the ADRs which is a hindrance in achieving successful remission. Aim: To analyze the pattern, causality, preventability, severity and predictability of occurrence of ADRs. Method: This observational study was carried out from 2012 to 2016 to analyze the ADRs reported spontaneously from the Department of Psychiatry at Victoria
more &raquo; ... Hospital to the ADR monitoring Centre. Patient demographics, clinical and drug data, details of ADR, onset time, causal drug details, outcome and severity were collected as per CDSCO-ADR reporting form. Causality was assessed by WHO-ADR probability scale, preventability by Modified Schumock and Thornton scale and Severity by Hartwig and Siegel Scale. Results: A total of 81 ADRs were reported in 5 years. 40.7 % of the ADRs were observed among 31-40 years. Majority of ADRs were noted among patients with depression (34.5 %), followed by schizophrenia (28.3 %). Central nervous system (58 %) was affected predominantly. Headache (12.3) was the most common ADR, followed by dystonia (11.1 %) and drowsiness (9.9 %). Dystonia was seven times more common in patients with conventional antipsychotics. Antidepressants (48 %) and antipsychotics (37 %) caused higher frequency of ADRs. Patients with antipsychotics encountered 1.8 times more ophthalmic ADRs than antidepressants. Fluoxetine (17 %) accounted for most of the ADRs, followed by risperidone (12.3 %). Occurrence of diarrhea was two times more frequent with fluoxetine than amitriptyline. 85 % of the ADRs were of 'probable' causality and 5 % were unpredictable. Two unpredictable ADRs: amitriptyline induced desquamative erythematous rash and escitalopram induced arthralgia. 9 % of the ADRs were severe: haloperidol induced dystonia, chlorpromazine induced neuroleptic malignant syndrome, amitriptyline induced desquamative erythematous rash and isoniazid induced psychosis. Serious ADRs were noted 1.9 times more among the patients prescribed with conventional antipsychotics over newer antipsychotics. Majority (74 %) of the ADRs were probably preventable. 44 % of the ADRs required additional medical treatment, while causative drug was withdrawn in 36 %. 96.3 % of the patients recovered completely. Conclusions: A wide spectrum of ADRs affecting the CNS, gastrointestinal, cardiovascular, metabolic and hematopoietic system were reported. Rare adverse events like Clozapine induced thrombocytopenia, escitalopram induced arthralgia and risperidone induced perioral tremor were observed. Conventional antipsychotics lead to serious ADRs 1.9 times more. Antipsychotics caused 1.8 times more ophthalmic ADRs than antidepressants. Though 5 % of ADRs were serious, no mortality was noted which highlights the appropriate management of ADRs at our Centre.
<span class="external-identifiers"> <a target="_blank" rel="external noopener noreferrer" href="https://doi.org/10.1007/s40264-016-0445-6">doi:10.1007/s40264-016-0445-6</a> <a target="_blank" rel="external noopener" href="https://www.ncbi.nlm.nih.gov/pubmed/27612845">pmid:27612845</a> <a target="_blank" rel="external noopener" href="https://fatcat.wiki/release/6tev4gmnyfcjpc5pfsa6ljt434">fatcat:6tev4gmnyfcjpc5pfsa6ljt434</a> </span>
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