Amid a safety crisis, you need an expert with a cool head
Despite best efforts to describe risks and benefits of medications before market introduction, some rare or very rare risks may be too small to describe or predict with certainty. An unexpected serious adverse event or death may generate a safety signal requiring additional pharmacovigilance or pharmacoepidemiological studies in response to a safety alert. Even medicines used for decades may suddenly face unexpected adverse reactions, potentially leading to withdrawal from the market and liability litigation.
ZEG Berlin can assist you during a safety crisis, providing expert advice and opinion on how best to clarify the safety concern and determine if further action is required. In collaboration with your pharmacovigilance and epidemiological teams, we can develop targeted studies to quickly and effectively address stakeholder concerns. Some examples of work we have previously undertaken in this area include:
- Cyproterone acetate (CPA) and increased risk of liver cancer
- Combined oral contraceptives and risk of thromboembolism (“pill-crisis”)
- Simple analgesics and risk of end-stage renal failure