Data Based Medicine Americas Ltd. The undersigned submits this petition to request the Commissioner of Food and Drugs to immediately require the addition of boxed warnings, warnings, precautions, and highlights of prescribing information to the product label for all selective serotonin reuptake inhibitor SSRI and serotonin-norepinephrine reuptake inhibitor SNRI products, including branded and generic formulations.
Sexual dysfunctions such as low libido, anorgasmia, genital anesthesia, and erectile dysfunction are very common in patients taking selective serotonin reuptake inhibitors SSRIs. It has been assumed that these side effects always resolve after discontinuing treatment, but recently, four cases were presented in which sexual function did not return to baseline.
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