Black Box Warnings and Antidepressants

The Food and Drug Administration (FDA) requires boxed warning, or black box warnings, for prescription medications and products that carry a significant or life-threatening risk to the consumer’s health. Unfortunately, most black box warnings aren’t administered until numerous cases of adverse incidents prove it necessary. Boxed warnings are used to protect consumers through the provision of vital information. One of the most common black box warnings accompanies all antidepressants.

After the inception of their widespread popularity, antidepressants, or selective serotonin reuptake inhibitors (SSRIs), were given a boxed warning due to the reported increased risk of suicide and violent behavior. The market release of Prozac, the first well-known name brand SSRI, brought in numerous reports of some patients feeling suicidal and angry. Eli Lilly and Company, the manufacturer of Prozac, has paid out over $50 million in settlements to families that have been affected by the adverse effects of Prozac.

Though black box warnings are meant to protect patients, prescribers, and manufacturers, alike, some researchers question if the warnings will discourage people who need treatment from seeking the necessary help. Though SSRIs have been linked to suicidality in patients, it doesn’t affect a healthy majority of consumers. So, if a patient is too afraid to seek help, and a physician is too afraid to prescribe the medication because of potential risks, the outcome could be just as dangerous. For some patients, finding the most effective SSRI, can be a process. Waiting for the drug to take effect can take as long as six to eight weeks. Additionally, patients should pay attention to their mood especially if it worsens. If one SSRI causes a patient to feel suicidal, another medication usually works much better in alleviating feelings of depression.

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