Urgent: Petition Calls for FDA Action on Dangerous Sleep Medication Side Effects
Frankfurt, June 11, 2025 – A non-profit organization has launched a petition urging the FDA to take immediate action against two widely prescribed sleep medications, Modafinil and Armodafinil, due to their potentially fatal side effects. The medications, commonly used to treat sleep disorders, have been linked to severe malformations in fetuses when taken during pregnancy.
Serious Health Risks for Pregnant Women
The petition, initiated by Public Citizen, calls for the FDA to discourage the use of these medications during pregnancy. Data from animal studies and a pregnancy register mandated by the FDA highlight the risks involved. Dr. Azza Abudagga from Public Citizen emphasizes the urgency, stating, “Measures by the FDA to protect U.S. babies from Modafinil and Armodafinil are long overdue.”
International Reactions and FDA Inaction
Other countries, including Australia, Canada, Ireland, and Great Britain, have already taken steps to advise against the use of these medications during pregnancy. However, the FDA has yet to implement comparable measures.
German Health Warnings
In Germany, the Federal Institute for Medicines and Medical Devices (BfArM) has also issued warnings. Modafinil is only approved for the treatment of adults with severe sleep disorders like narcolepsy. The BfArM advises against its use during pregnancy due to the risk of serious malformations.
Interactions with Hormonal Contraceptives
Additionally, both Modafinil and Armodafinil can affect the effectiveness of hormonal contraceptives. The BfArM recommends alternative or additional safe contraceptive methods. Non-pharmacological alternatives such as coping strategies and sleep hygiene are advised for pregnant women with sleep disorders.
Evergreen Context: The Risks of Medication During Pregnancy
Pregnancy is a critical period during which the fetus is highly susceptible to external influences. Medications, even seemingly benign ones, can have unforeseen consequences. It’s crucial for expectant mothers and healthcare providers to be aware of these risks and to consider non-pharmacological treatments whenever possible.
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