Clindamycin-induced acute generalised exanthematous pustulosis: five cases and a review of the literature.

Acute generalised exanthematous pustulosis (AGEP) is a rare but serious cutaneous adverse drug reaction, often related to antibiotics such as beta-lactams or macrolides. However, it is rarely associated with clindamycin which belongs to the lincosamide antibiotics. The Netherlands Pharmacovigilance Centre Lareb received five reports of AGEP associated with the use of clindamycin. We present these five cases and provide support for this association from the Lareb database, the database of the WHO Collaborating Centre for International Drug Monitoring (Vigibase™), the database of the European Medicine Agency (Eudravigilance), and from a mini review of the literature.

Drug-induced cerebellar ataxia: a systematic review.

BACKGROUND AND OBJECTIVES: Cerebellar ataxia can be induced by a large number of drugs. We here conducted a systemic review of the drugs that can lead to cerebellar ataxia as an adverse drug reaction (ADR). METHODS: We performed a systematic literature search in Pubmed (1966 to January 2014) and EMBASE (1988 to January 2014) to identify all of the drugs that can have ataxia as an ADR and to assess the frequency of drug-induced ataxia for individual drugs. Furthermore, we collected reports of drug-induced ataxia over the past 20 years in the Netherlands by querying a national register of ADRs. RESULTS: Drug-induced ataxia was reported in association with 93 individual drugs (57 from the literature, 36 from the Dutch registry). The most common groups were antiepileptic drugs, benzodiazepines, and antineoplastics. For some, the number needed to harm was below 10. Ataxia was commonly reversible, but persistent symptoms were described with lithium and certain antineoplastics. CONCLUSIONS: It is important to be aware of the possibility that ataxia might be drug-induced, and for some drugs the relative frequency of this particular ADR is high. In most patients, symptoms occur within days or weeks after the introduction of a new drug or an increase in dose. In general, ataxia tends to disappear after discontinuation of the drug, but chronic ataxia has been described for some drugs.

Pharmacovigilance: methods, recent developments and future perspectives.

BACKGROUND: Pharmacovigilance, defined by the World Health Organisation as 'the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem' plays a key role in ensuring that patients receive safe drugs. Our knowledge of a drug's adverse reactions can be increased by various means, including spontaneous reporting, intensive monitoring and database studies. New processes, both at a regulatory and a scientific level, are being developed with the aim of strengthening pharmacovigilance. On a regulatory level, these include conditional approval and risk management plans; on a scientific level, transparency and increased patient involvement are two important elements. OBJECTIVE: To review and discuss various aspects of pharmacovigilance, including new methodological developments.