Accutane and Suicide

Since 1985, Accutane's product label has warned that the acne medication may cause depression. However, over the past decade, stronger warnings have been added to Accutane's label and medication guide cautioning that the drug may cause more aggressive psychiatric problems in its users, such as violent behavior and suicide. The warnings gradually became more stringent after the U.S. Food & Drug Administration (FDA) received over a hundred reports of teenagers who commited suicide while taking Accutane.

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Studies suggest that Accutane has a direct causal link to depression

Accutane's manufacturer, Hoffmann-La Roche, has contended that suicides among Accutane users - specifically teenagers - is due to their increased likelihood of depression caused by social stigmas and insecurity that often result from having severe acne. A team of doctors at Emory University Hospital in Atlanta, however, believed Accutane has a more causal link to depression and performed a study to determine if such a link exists. Led by Dr. J. Douglas Bremner, the Emory University researchers administered positron emission tomography (PET) scans, which measure activity in regions of the brain, to a group of 28 people with acne. An assortment of psychological tests performed prior to the PET scans found no correlation between severity of the participants' acne and whether the participants felt depressed. The participants then received either Accutane or a course of oral antibiotics. At the end of four months, the researchers gave each participant a second PET scan. The researchers found that people who took Accutane showed decreased activity in the orbitofrontal cortex, the brain area thought to control mood and social interaction. On the other hand, participants who took antibiotics showed no change in any brain region between the first and second PET scans. Therefore, the results of the study confirmed the researchers' theory that Accutane may in fact cause psychiatric complications to its users.

Results of a more recent study were revealed in the August issue of the journal Neuropsychopharmacology. Scientists from Bath University in conjunction with the University of Texas in Austin conducted experiments on mice that showed that Accutane made the mice behave in ways comparable to depression in humans. The purpose of the study was to test the theory that continual administration of Accutane could lead to depression-related behaviors. Mice were given Accutane by daily injection for six weeks, which produced blood levels of Accutane similar to those reported in human patients who use the drug. The mice were then placed under stress- some were suspended by their tails, while others were put in water and forced to swim. Under such conditions, normal mice will swim or climb and thrash around in an attempt to escape, although they will have periods of immobility when they appear resigned. In contrast, a mouse that is depressed will spend a longer time in the immobile state than a normal mouse. In both the forced swim test and the tail suspension test, the researchers found that the mice treated with Accutane spent significantly more time immobile compared to the mice that were not injected with the drug. The results of the study therefore concluded that Accutane may indeed directly cause depression.

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Stronger warnings about suicide have been added to Accutane's label

Since its early days on the market, speculation has surrounded Accutane's psychiatric safety. Although a note on Accutane's potential to cause depression in its users was added to the label early on, it wasn't until the mid-1990's that the FDA began to take note of a potentially closer link between the drug and abnormal behaviors. Just after the FDA's MedWatch program took effect in 1996 allowing the FDA to track adverse reactions to approved pharmaceuticals, an FDA physician noted two reported cases of suicide associated with the Accutane. Subsequently, the FDA began a re-evaluation of the drug's ability to cause suicidal behavior in its users. As more reports of suicide among Accutane users rolled into the FDA, agency physicians noticed a consistent pattern of symptoms in patients with no previous history of suicidal tendencies or depression and no other identifiable reason for their occurrence. The reported cases apparently described symptoms that began during Accutane treatment and then disappeared soon after the medicine was stopped. In some cases, Accutane was restarted and the same psychiatric symptoms returned.

The following May, an FDA medical reviewer issued a memo to FDA officials recommending that depression should be added to the boxed warning for Accutane, stating that the overall impression "is that Accutane may precipitate serious psychiatric disturbance and suicide."

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In 1998, another FDA memo concluded "given all of the pieces of evidence available, it is difficult to avoid the conclusion that Accutane can adversely affect the adult human brain in clinically significant ways and that Accutane use is associated with severe psychiatric disease in some patients." It instructed Roche to strengthen the warnings on the drug and alert doctors as to the risk of "depression, psychosis and, rarely, suicidal ideation, suicide attempts and suicide."

In May 2001, Roche finally changed the warnings on the package label to include "...depression, and rarely suicidal thoughts, suicide attempts and suicide..." It was the first time the packaging contained the full psychiatric warning. Then, in November 2002, warnings about psychiatric problems displaying "aggression" and "violent behaviors" were added to the label warnings. The label also advises physicians that simply discontinuing the drug may not remedy any psychiatric problems and that further psychiatric evaluation may be necessary.

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Since February 2001, patients receiving prescriptions for Accutane have been required to review and sign an informed consent form that details the psychiatric issues associated with Accutane and explains that there have been numerous reports of depression and suicide in people who have taken the acne drug. Yet, as more and more reports of suicides among users of Accutane become publicized, the drug and its manufacturer haven't escaped blame and continuing controversy. Roche underwent a congressional hearing in 2002 over the safety of Accutane and faces numerous lawsuits claiming Accutane caused depression and suicide in its users.

If you or a relative experienced severe side effects while using Accutane and you would like to discuss your rights with a professional, please fill out this short form and an experienced member of Seeger Weiss's staff will contact you. Initial consultations are free of charge and do not create a legal relationship. Seeger Weiss LLP is located in New York and New Jersey and its attorneys are available to practice throughout the country.