Malpractice of Accutane: Is it malpractice for a dermatologist to not mention risk of chronic eye pain from Accutane?

A patient asked if it was malpractice for a dermatologist to not mention the risk of chronic eye pain with isotretinoin (Accutane) as a risk. My initial reaction was,  “I don’t think dermatologist know chronic eye pain is a risk.”

But after more research, I see the risk of meibomian gland loss from Accutane has been known since 1991. The article below, though, does not mention the devastation meibomian gland dysfunction causes in patients. 

We hope our upcoming paper on the role of screen use on MGD in kids in particular we hope to submit to the New England Journal of Medicine this week, will make an impact enough so the following letter I hope to send to all dermatologists will make a big impact on their prescription writing of Accutane. 

Dear Dermatologist, 

Please do not prescribe isotretinoin (Accutane) for any reason. It has a long history of many side effects which many are aware of, such as the many listed below. However, the risk of chronic debilitating eye pain because of meibomian gland dysfunction is often not mentioned and needs to be emphasized as a real, devastating risk. While future studies are needed to see who many who have used  isotretinoin (Accutane) have this side effect, eye surgeons are concerned the rate is very high and there remains no cure for this chronic condition.

Therefore, please cease prescribing isotretinoin (Accutane) as it has a great potential to do do great harm to patients. 

Noted Side effects of  isotretinoin (Accutane) do not mention meibomian gland loss which leads to a lifetime of chronic eye pain. 

  • depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself;
  • sudden numbness or weakness, especially on one side of the body;
  • blurred vision, sudden and severe headache or pain behind your eyes, sometimes with vomiting;
  • hearing problems, hearing loss, or ringing in your ears;
  • seizure (convulsions);
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • severe diarrhea, rectal bleeding, black, bloody, or tarry stools;
  • fever, chills, body aches, flu symptoms, purple spots under your skin, easy bruising or bleeding;
  • severe blistering, peeling, and red skin rash; or
  • joint stiffness, bone pain or fracture.
Less serious Accutane side effects may include:
  • joint pain, back pain;
  • feeling dizzy, drowsy, or nervous;
  • dryness of the lips, mouth, nose, or skin; or
  • cracking or peeling skin, itching, rash, changes in your fingernails or toenails.

Sandra Lora Cremers, MD, FACS

Meibomian gland morphology and tear osmolarity: Changes with accutane therapy

W. D. Mathers, W. J. Shields, M. S. Sachdev, W. M. Petroll, J. V. Jester
Research outputResearch – peer-review › Article
  • 80Citations


We evaluated the meibomian gland function of 11 patients before and during treatment with isotretinoin (Accutane) by assessing tear osmolarity, meibomian gland morphology, tear production, rose bengal staining, and meibomian gland excreta. We found, during Accutane use, that atrophic by meibography. Excreta thickness increased from 1.7 ± 0.9 to 3.1 ± 1.2 (p <0.005), and expressible excreta volume decreased from 1.52 ± 0.68 to 1.10 ± 0.3 (p <0.05) (scale 1-4). We also found a significant increase in tear osmolarity from 304.9 ± 11 to 316.3 ± 10 mosmol/L (p <0.005). There was no significant change in the Schirmer test during treatment. We suggest that the clinical symptoms of blepharitis during Accutane therapy are related to decreased meibomian gland function and consequent increased tear evaporation and tear osmolarity.


Acne drug tied to a doubled risk of eye problems

woman applying eyedroppes, close up

woman applying eyedroppes, close up  (iStock)
Prescription pills used to treat severe acne were linked to a two-fold risk of developing eye problems, such as pink eye, styes and dryness, in a large new study from Israel.
Isotretinoin, which goes by brand names including Roaccutane, Claravis and Amnesteem, is known to have serious side effects, such as bone growth delays in teenagers and miscarriages and birth defects when taken by pregnant women.
The medications are quite popular, however, for treating severe cases of acne in both teens and adults.
According to Roche, the maker of Roaccutane, formerly known as Accutane, 16 million people worldwide have used that brand alone since 1982.
Some eye problems are already more common in people with acne, but in the new study of nearly 15,000 Israeli adolescents and young adults, 14 percent of those taking isotretinoin were treated for eye conditions within a year of starting the drug.
That compared to seven percent of an acne-free comparison group and 9.6 percent of subjects with acne who had never taken isotretinoin.
“I would give parents the advice to (have their children) see an ophthalmologist before they take it, and every three months for the first year they take it, because if we catch things early we can fix them and not leave you with permanent side effects,” said Dr. Rick Fraunfelder, a professor at Oregon Health and Science University and an expert in eye problems related to medications.
Although eye problems have been documented among people taking the drugs, Fraunfelder, who was not involved in the new study, said past research has not detailed how common the issues are.
To get an idea of how often eye problems develop among patients on isotretinoin, researchers at the Tel Aviv Medical Center collected information on users and non-users from the records of a large managed-care organization.
Gabriel Chodick, a researcher at Tel Aviv University and one of the study authors, said that each year about one percent of adolescents in the Maccabi Healthcare Services system start isotretinoin treatment to clear up their acne.
In the study group, whose average age was 16, nearly 2,000 people developed inflammatory eye conditions — 991 who were taking isotretinoin, 446 with acne but not on the medication and 354 in the acne-free group.
The most common complaint was conjunctivitis, also called pink eye, which is inflammation or infection in the eye.
Four out of every 100 people on isotretinoin were diagnosed with conjunctivitis, while about two out of every 100 people not on any acne medication were treated for conjunctivitis, the researchers reported in Archives of Dermatology.
Chodick said one likely explanation for the increased risk of eye problems is that isotretinoin can disrupt the function of the meibomian glands on the eyelids.
These glands produce an oily substance that prevents the eyes from drying, and if the glands don’t work properly the eyes can become irritated or inflamed.
“In addition, the presence of isotretinoin and its metabolites in the tear film may have a direct irritating effect on the (eye’s) surface,” Chodick told Reuters Health in an email.
Roche would not comment on the study but a spokesperson pointed to possible side effects already listed in the medication’s packaging labels, including eye problems such as conjunctivitis, decreased night vision and visual disturbances.
Despite its potential hazards, the drug is still worth it for some patients, Chodick said.
“Several studies have shown that acne can diminish a person’s quality of life,” he said. “Many of the adverse effects of systemic isotretinoin can be avoided or minimized if proper measures are introduced with, or soon after, introducing the drug.”
He said that doctors who prescribe these acne drugs should do so along with eye lubricants to prevent drying and irritation.
“The beneficial preventive and therapeutic effects of using artificial tears should be discussed with the patients, especially for contact lens wearers,” Chodick said.
Fraunfelder urged people to seriously consider the side effects before starting isotretinoin treatment.
“It’s a relatively dangerous drug,” he said. “The best way to avoid these side effects is if you do not take the drug at all.”
If people do opt for the treatment, he added, they should make sure to talk with their doctor about ways to prevent damage to the eyes.
Shopping Cart