Without an understanding of what causes severe post-injection reactions with Endo Pharmaceuticals Solutions Inc.’s long-acting injectable testosterone Aveed, risk management interventions like the proposed Risk Evaluation and Mitigation Strategy will not be able to sufficiently address the safety issue, FDA’s Reproductive Health Drugs and Drug Safety and Risk Management advisory committees said April 18.
REMS Can’t Help Endo’s Aveed – Won’t Address Unpredictable Safety Events, FDA Advisors Say
Without predictive factors to determine who is likely to get a severe post-injection reaction, FDA advisory committees say Endo’s proposed REMS for its long-acting testosterone is unlikely to allay safety concerns.