An acne medication thought to cause suicidal thoughts or depression has been determined to cause negligible risk to an individual’s mental well-being and, in fact, may reduce thoughts of suicide, according to a new study.
A study published in JAMA Dermatology involving over 1.6 million participants found that the risk of suicide attempts or suicidal ideation while using isotretinoin to treat severe acne was less than 0.5 percent, while the risk of developing depression was 3.83 percent.
The study’s findings contradict years of reports that the drug, sold under the brand names Absorica, Amnesteem, Claravis, Myorisan, Zenatane, and, for a while, Accutane, has been associated with suicide and a wide range of psychiatric disorders, including depression and anxiety. The associations with these disorders led the U.S. Food and Drug Administration (FDA) to issue a warning about the drug in 2005.
Isotretinoin was first approved for acne use in the 1980s and has been used without issue by millions of people worldwide whose acne has been unresponsive to other medications. Treatment typically lasts four to five months.
However, over the years, it is estimated that between 1 in 1,000 and 1 in 10,000 people taking isotretinoin experienced changes to their mental well-being, such as low mood, anxiety, and agitation. More severe side effects have been reported, too, including depression, signs of psychosis, losing contact with reality or hearing voices, having suicidal thoughts, harming oneself, or attempted suicide.
Indeed, as recently as May 2019, a 15-year-old girl from Ripon, North Yorkshire in England died by suicide after taking the medication for just six months, as reported by The Telegraph.
Conflicting Research Leads to Uncertain Safety Risks
Previous research indicates the use of isotretinoin may alter levels of neurotransmitters involved in mood regulation, including dopamine, serotonin, and norepinephrine, suggesting a link between the acne drug and mood alteration. However, not all past research indicates a link between isotretinoin and suicide and psychiatric disorders.
“Given the widespread use of isotretinoin and the potential deleterious outcomes for mental health, it is important to clarify the association between isotretinoin and psychiatric disorders,” researchers wrote in the JAMA Dermatology article.
The study analyzed 24 observational studies and identified that, along with a minor risk for completed suicide, suicide attempt, or suicide ideation, the moods of those who took the drug actually improved as their acne improved.
Researchers did find slightly increased risks for other psychiatric disorders, including depression (3.83 percent), mood disorder (2.32 percent), and anxiety (6.67 percent). Their conclusions led them to suggest that isotretinoin should be considered safe at a population level.
As Parker Magin and Shaun Prentice wrote in an editorial accompanying the study, “It seems clear that patients with severe or markedly problematic acne … can be offered isotretinoin as a treatment option for this distressing condition.”
However, Mr. Magin and Mr. Prentice noted that the drug could still have “markedly adverse, idiosyncratic psychiatric effects in a small minority of individual patients.” Because of this, dermatologists should continue to practice caution when prescribing isotretinoin.
According to the American Academy of Dermatology (AAD), anyone prescribed isotretinoin will be monitored for mental health risks. Dermatologists will discuss and share educational materials with patients to help them decide whether to take the medication. The AAD notes that dermatologists are trained to spot warning signs that a patient could be depressed and screen patients carefully for possible signs of depression and thoughts of suicide, empowering them to determine if isotretinoin is the right medication for an individual.
As of 2018, the AAD supports the use of isotretinoin and does not recognize an evidence-based causal relationship between depression or anxiety and the use of the medication. The organization’s position statement notes that studies provide ample evidence that the treatment improves the quality of life of patients with acne.