FDA Warnings About Antidepressants (SSRI Medications)

Selective Serotonin Reuptake Inhibitors, also referred to as SSRIs, are the most commonly prescribed type of antidepressant today. They are used to treat depression, anxiety, obsessive compulsive disorder and panic attacks. Since Prozac – the first SSRI available – hit the U.S. market in 1988, serious side effects associated with SSRIs have been reported. Throughout their history, the FDA has made a number of label changes to reflect some of the more dangerous risks linked to this class of medications. The first FDA warnings appeared in 2004, and multiple safety alerts and additional warnings of SSRI side effects have been issued since that time.

SSRI black box warning issued for suicide risk

In October, 2004, a black box warning was ordered for the following SSRIs: Prozac, Paxil, Zoloft, Celexa and Lexapro, as well as some generic forms of the drugs. The FDA warning alerted healthcare providers and the general public about the association between use of SSRIs in adolescents and children and an increased incidence of suicidal thoughts and behaviors. The label change recommends that children or teens placed on an SSRI should be monitored closely for behavioral changes and/or suicidal ideation or tendencies. In 2006, the agency later extended this FDA warning concerning SSRIs and suicidal behavior to include young adults up to age 25.

What is a black box warning?

A black box is the most stringent type of FDA warning, which the agency reserves for drugs with serious or potentially fatal side effects. The warning is outlined by a black border designed to ensure that patients are alerted to possible risks prior to taking the drug. Over the past decade, there has been an increased use of black box warnings by the FDA, often in response to research that indicates an adverse drug reaction that is linked to a specific prescription drug or class of medications. Also known as a “boxed warning,” this cautionary text appears on a drug’s packaging in order to call attention to life-threatening risks.

The FDA issues black box warnings in cases where:

• The prescription medication can cause life-threatening or permanently disabling reactions, which must be weighed against the potential benefits of the drug.
• A serious side effect can be prevented, reduced in occurrence, or reduced in severity by proper use of the medication. For example, a drug may be safe for use in adults, but not in children, or the medicine may pose risks to pregnant women.

Other FDA warnings for SSRIs

In addition to the black box warning regarding SSRIs and suicide, the FDA has issued the following safety alerts and warnings involving SSRIs (including Celexa, Lexapro, Prozac, Paxil, Zoloft, Symbyax, and Fluvoxamine):

• SSRIs and Triptan drugs – In 2006, the FDA issued a separate warning regarding the interactions between SSRIs and Triptan medications, which are often used to treat migraines. The warning was issued after it was discovered that a combination of the two drugs could result in dangerous elevations of serotonin levels in the body that could lead to increased blood pressure and heart rate. The side effect was found to put some patients into shock and could lead to death if not promptly treated. The FDA warning applies to all of the SSRIs listed above.
• Birth defects – In 2006, federal regulators issued a warning regarding SSRIs and birth defects– including Paxil, Zoloft, Celexa, Lexapro, Prozac,  Symbyax, and Fluvoxamine – during pregnancy and an increased risk of a disorder known as Persistent Pulmonary Hypertension of the Newborn or PPHN. This condition occurs when the newborn is unable to adjust to breathing outside the uterus, resulting in loss of oxygen to vital body organs. The FDA warning is based on a study of approximately 1,200 women, which found that women who took SSRIs during pregnancy had a six-fold increased chance of having infants diagnosed with PPHN compared to women who did not take SSRIs.
• Birth defect warning revision – In 2011, the FDA issued an updated communication, stating the link between SSRIs and PPHN is still under investigation, due to conflicting findings in subsequent studies. Women are still advised to talk to their healthcare professionals about the benefits and potential risks of taking antidepressants during pregnancy, as reported SSRI side effects in newborns have included heart malformations and other birth defects such as spina bifida, club foot, cleft palate and omphalocele, among others.

Common SSRI side effects

In addition to the potential adverse drug reactions cited in FDA warnings, SSRI antidepressants are associated with the following more common side effects:

• Nausea and diarrhea
• Headache
• Rash
• Fatigue
• Dry mouth
• Insomnia
• Increased sweating
• Reduced sexual desire
• Weight gain or weight loss
• Agitation or nervousness

FDA warnings and SSRI lawsuits

FDA warnings are strong indicators of the potential risks and dangers associated with any class of medication, including Selective Serotonin Reuptake Inhibitors. In many cases the issuance of a black box warning or safety communication concerning a medication’s possible side effects triggers dangerous drug litigation as patients discover their injuries could be linked to a particular medication. If an individual took an SSRI prior to an FDA warning, they may argue that the drug manufacturer failed to adequately warn consumers about their product’s latent risks.