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    ABSTRACT: The WHO Programme for International Drug Monitoring, maintained by the Uppsala Monitoring Centre (UMC), has more than 90 member countries contributing individual case safety reports (ICSRs) from their existing national pharmacovigilance systems; these reports are stored in the WHO global ICSR database, VigiBase. A continuous increase of ICSRs of alopecia in suspected connection to lamotrigine use has been observed in VigiBase; however, only limited information has been published on this topic. Objective: To examine in greater detail the association between lamotrigine and alopecia by outlining the characteristics of the accumulated reports in VigiBase. An analysis of all reports in VigiBase, up to 1 April 2009, where lamotrigine was suspected of having caused alopecia. Lamotrigine was suspected of being involved in the development of alopecia in 337 patients, reported from 19 countries. The age of the patients ranged between 5 months and 84 years (mean 36 years), with a predominance (58%) of patients <40 years of age. 272 patients were female. In 291 reports, lamotrigine was the only drug suspected by the reporter, and in 112 reports, lamotrigine was the sole reported drug. Commonly co-reported drugs were other antiepileptic drugs. For 217 patients, alopecia was reported as the single event. In 11 patients, the reaction abated on cessation of lamotrigine. One patient was reported to have had a recurrence of alopecia on re-administration of lamotrigine. The UMC continues to receive reports of alopecia associated with the use of lamotrigine. Although alopecia may not be regarded as serious from a regulatory perspective, this adverse reaction has the potential to affect compliance, resulting in decreased efficacy of the treatment regimen and detrimental effects on patient health outcomes.
    Drug Safety 08/2010; 33(8):653-8. DOI:10.2165/11536190-000000000-00000 · 2.62 Impact Factor
  • Epilepsy & Behavior 08/2013; 29(1). DOI:10.1016/j.yebeh.2013.06.032 · 2.06 Impact Factor
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    ABSTRACT: Side effects are among the most frequent reasons preventing patients from taking their medication. Although the management of side effects is an important issue in clinical practice, particularly in patients with physical comorbidities, research on clinical management of side effects is rather scattered. The aim of this article was to provide an overview on the prevalence and management of various side effects of mood-stabilizing drugs. In December 2012, we carried out a PubMed search for publications reporting side effects in patients with bipolar disorder. Naturalistic studies describing the prevalence of side effects in treatment with mood stabilizers are sparse. We describe the prevalence of neurological, gastrointestinal, metabolic, thyroid, dermatological, nephrogenic, cognitive, sexual, hematological, hepatogenic, and teratogenic side effects of lithium, valproate, carbamazepine, and lamotrigine and discuss their clinical management. There are specific strategies that aim at reducing side effects, but, to date, studies on the efficacy of these interventions are lacking. With age, the renal elimination and hepatic metabolism of drugs reduce and comedication and somatic comorbidity increase, making elderly patients particularly susceptible to side effects. Most side effects can be managed by striving for the lowest possible dose without losing efficacy by lowering the dose below the therapeutic window. Specific measurements to limit certain side effects are available and may ameliorate treatment adherence.
    International clinical psychopharmacology 07/2013; 28(6). DOI:10.1097/YIC.0b013e32836435e2 · 3.10 Impact Factor

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