Analysis of Antineoplastics, Immunomodulators, Antibiotics and Analgesics Adverse Drug Reactions Reports Submitted to the Pharmacovigilance Database in Jordan

Mohammed Alsbou¹, Adel Batarseh², Nidda Bawaresh³, Jaber Jaber³, Gadeer Qawasmi ³ and Hayat Banat³

¹Department of Pharmacology, Faculty of Medicine, Mutah University, Jordan.

²Royal Medical Services, Jordan.

³Rational Drug Use and Pharmacovigilance Department, Jordan Food and Drug Administration, Jordan.

Corresponding Author E-mail: mohsb74@yahoo.com

DOI : http://dx.doi.org/10.13005/bbra/2477

ABSTRACT: A national pharmacovigilance database was created recently at the Rational Drug Use and Pharmacovigilance Department at Jordan Food and Drug Administration (JFDA). This study was based on the analysis of the adverse drug reactions (ADRs) reports submitted to the national pharmacovigilance (PV) database in Jordan from 2010 to 2014.The aims of this study were to identify the most frequently body system classes and the most common ADRs for the four major classes of dugs implicated in the PV database and include: antineoplastics, immunomodulators, antibiotics and analgesics. The most affected systems by ADRs in our study were the skin and the gastrointestinal (GI) systems. The skin ADRs associated with the use of antineoplastics were skin rash, hand and foot syndrome and acral erythema, and the most frequent GI ADRs were vomiting and diarrhea. The most affected system by the use of the immunomodulators was the blood system and the most common ADRs were anemia, thrombocytopenia and neutropenia. The most commonly ADRs following analgesics use were GI bleeding and duodenal ulcer and the skin reactions were rash, itching and flushing. Analysis of the national PV database provides close monitoring and more information about the safety of medicine in Jordan. All Health care provider should be aware of the importance of reporting of adverse reactions and should be encouraged to report suspected ADRs and be trained in detecting, diagnosing and treating patients with adverse effects of drugs.

KEYWORDS: adverse drug reactions;Jordan Pharmacovigilance database;

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