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FDA Warnings for Antidepressants


The FDA warns that antidepressants like Zoloft, Paxil and Prozac can increase the risk of suicidal thoughts in children, and result in birth defects when taken during pregnancy.

Although antidepressants known as selective serotonin reuptake inhibitors (SSRIs) are the most popular drugs used to treat depression and other mental illnesses worldwide, they are not without life-changing risks. The U.S. Food and Drug Administration (FDA) has warned consumers time and again with new alerts about the consequences of taking such drugs with so many potentially serious complications.

Prozac, Zoloft and Paxil are part of the antidepressant SSRI family of drugs, and all come with risks.

Suicide Warning for Zoloft, Paxil & Prozac

Prozac is one of the only antidepressants that has been approved for youths who suffer from depression. Unfortunately, it is not a simple solution to a complicated illness.

In October 2004, after many studies linked these antidepressants to increased suicidal thoughts and behavior in children, the FDA coordinated a multi-faceted strategy to inform the public of such dangers. Manufacturers of all antidepressant medications were required to add a black-box warning to their drugs that they may increase suicidality in children and adolescents.

Two years later, the FDA expanded its public health advisory to include anyone 24 or younger. In 2007, the FDA took a stronger stance, requiring manufacturers of SSRI antidepressants to update the black-box warnings about the higher risks of suicidal thoughts and behavior during the first one to two months of treatment. Black-box warnings are the FDA's most stringent warning a drug can carry before it is pulled from the shelves.

Serotonin Syndrome

In 2006, the FDA warned health care providers to be vigilant about the use of antidepressants in combination with Triptan medications, which treat migraine headaches. Used together, the drugs can cause an overdose of the mood elevator serotonin in the brain, leading to serotonin syndrome. The onset of this severe reaction can happen within minutes, producing high blood pressure, hyperthermia, high body temperature and increased heart rate that can lead to shock. It is often fatal.

Antidepressants and PPHN

Also in 2006, the FDA issued a public health advisory linking antidepressants with a very serious birth defect called persistent pulmonary hypertension of the newborn (PPHN). This is a problem that affects a newborn's heart and lungs. Some scientists say taking an antidepressant during the second half of pregnancy can lead to this condition, while other researchers link PPHN to ingesting an antidepressant during the first trimester.

PPHN develops when a baby does not adjust to breathing outside of the womb. Babies with this condition may require a ventilator to help them breathe. If PPHN is severe, organ damage -- including brain damage -- can result.

A National Institutes of Health (NIH) study found that taking an antidepressant during pregnancy leads to a risk of having a baby with PPHN. However, about 99 percent of women who take SSRIs give birth to a baby who never develops PPHN.

The agency stated in December 2011 that the extent of the connection between antidepressants and PPHN is still being determined.