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Published on: August 30, 2018
[Pharmacovigilance and teratovigilance 2008].
Françoise Livio1, Anton Ivanyuk, Jérôme Biollaz
1Division de pharmacologie et toxicologie cliniques, Département de medecine, CHUV, 1011 Lausanne. francoise.livio@chuv.ch
Revue Medicale Suisse
|February 26, 2009
Summary
2008 pharmacovigilance alerts highlighted significant safety concerns for multiple drugs, including neuropsychiatric events with varenicline and rimonabant, and increased mortality risk with neuroleptics in elderly dementia patients.
Area of Science:
- Pharmacovigilance and Drug Safety
- Clinical Pharmacology
- Neuropsychopharmacology
Context:
- 2008 saw numerous pharmacovigilance signals and alerts regarding drug safety.
- Several medications raised concerns due to adverse events and potential risks.
Purpose:
- To summarize key drug safety issues and regulatory actions reported in 2008.
- To highlight emerging risks associated with various therapeutic agents.
Summary:
- Varenicline and rimonabant were associated with frequent neuropsychiatric adverse events; rimonabant's authorization was suspended.
- Ezetimibe/simvastatin raised cancer concerns, and neuroleptics (typical and atypical) increased mortality risk in elderly dementia patients.
- Biological drugs like rituximab, natalizumab, and efalizumab were linked to rare, fatal progressive multifocal leukoencephalopathy cases.
- Abacavir hypersensitivity risk necessitates HLA-B*5701 screening, and mycophenolate is identified as a human teratogen.
Impact:
- These findings underscore the importance of ongoing drug safety monitoring and regulatory vigilance.
- Recommendations include genetic screening before certain therapies and awareness of teratogenic potential.
- The suspension of rimonabant marketing authorization demonstrates regulatory response to significant safety signals.
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