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How Reporting of Adverse Drug Reactions Can Improve the Safety Profile of Medicines

Goal of Pharmacovigilance. Rational and safe use of medicinesThe findings:Influence physicians, pharmacists and patients in their choice of medicines and the precautions to be takenInformation produced by PV may change the position of a drug. ADR reports will alert a signal/early detection.Furth

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How Reporting of Adverse Drug Reactions Can Improve the Safety Profile of Medicines

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    1. How Reporting of Adverse Drug Reactions Can Improve the Safety Profile of Medicines Fuziah Abdul Rashid Ketua Penolong Pengarah Biro Pengawalan Farmaseutikal Kebangsaan

    2. Goal of Pharmacovigilance Rational and safe use of medicines The findings: Influence physicians, pharmacists and patients in their choice of medicines and the precautions to be taken Information produced by PV may change the position of a drug

    3. ADR reports will alert a signal/early detection. Further study is usually needed to test the hypothesis.

    4. ACTIVE INGREDIENTS WITHDRAWN THALIDOMIDE (1961) Congenital limb defects BENOXAPROFEN (1982) Hepatotoxicity PHENFORMIN (1982) Lactic acidosis FENFLURAMINE (1997) Heart-valve abnormalities ASTEMIZOLE (1999) Many drug interactions PHENYLPROPANOLAMINE(2000) Haemorragic stroke KAVA KAVA Liver abnormalities CERIVASTATIN (2001) Rhabdomyolysis CISAPRIDE (2000) Cardiac arrythmias ROFECOXIB (2004) Cardiovascular events VALDECOXIB (2005) Cardiovascular events, serious skin reactions COMFREY, SENECIO Nephrotoxicity TEGASEROD (2007) Cardiovascular events CLOBUTINOL (2007) Cardiac arrhythmia

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