What is a REMS risk for Addyi?

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What is a REMS risk for Addyi?

Addyi has a REMS because it can cause serious drops in blood pressure leading to fainting, and this risk is especially tied to alcohol use with the medication. When flibanserin is taken with alcohol, the combination can markedly lower blood pressure, increasing the chance of syncope. The REMS program exists to ensure patients are educated about this risk and to restrict prescribing and dispensing to settings that can properly manage it. While headaches, dizziness, and nausea can occur with Addyi, they are not the REMS risk being described. So the REMS risk described here is hypotension and syncope due to alcohol interaction.

Addyi has a REMS because it can cause serious drops in blood pressure leading to fainting, and this risk is especially tied to alcohol use with the medication. When flibanserin is taken with alcohol, the combination can markedly lower blood pressure, increasing the chance of syncope. The REMS program exists to ensure patients are educated about this risk and to restrict prescribing and dispensing to settings that can properly manage it. While headaches, dizziness, and nausea can occur with Addyi, they are not the REMS risk being described. So the REMS risk described here is hypotension and syncope due to alcohol interaction.

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