Accutane, a popular acne medication used by teenagers and adults, has been involved in a number of lawsuits in the past 10 years, the most recent of which was in February 2010 when Alabama resident Andrew McCarrell won $25 million in damages from the pharmaceutical company Hoffmann-La Roche, Inc. after he was forced to have his colon removed due to side effects of the drug.
According to a Hoffmann-La Roche, Inc.’s annual 2009 finance report, the pharmaceutical company no longer sells the drug because of the high cost to defend lawsuits against medical problems that Accutane has been linked to, such as ulcerative colitis, Crohn’s disease and inflammatory bowel disease—what McCarrell suffered from. A recall for Accutane was issued in 2009, after which it was rereleased as general Isotretinoin. There are currently 1,000 lawsuits pending against Isotretinoin in federal and state courts.

“The common side effects of Isotretinoin [Accutane] are dry skin, nose bleeding and chapped lips,” Bethesda dermatologist Jay Barnett said. “There has been some concern over a link to depression and to inflammatory bowel disease, but these have not been proven.”
While Isotretinoin has been associated with these adverse side effects, it has also been recommended by doctors as the most effective acne medication.
According to a Nov. 22 statement issued by the American Academy of Dermatology Association (AADA), Isotretinoin prescriptions must be monitored carefully by physicians for possible side effects, but have proven in numerous clinical studies to treat severe acne more effectively than other medications.
“Isotretinoin is extremely successful in the right kind of patient,” Barnett said. “[More than] 80 percent [of my patients] who complete the five-month course are now free of acne forever, without additional treatment.”
According to Barnett, he normally recommends the drug to teens and prescribes it frequently. He does, however, only recommend it as a last resort for teenagers who have tried other treatments.
“It’s the strongest medicine, [and] I wanted something that would really work,” said sophomore Christine, who asked that her real name not be used. “I was aware of the [possible] effects, but I only had chapped lips. I would recommend it.”
Other possible side effects linked to Isotretinoin include depression, psychiatric disturbance and, for pregnant women, birth defects, which is why routine blood work and testing is necessary for people who want to go on the medication.
“If a woman gets pregnant while on isotretinoin, there is a high likelihood of having a child with birth defects,” Barnett said. “The drug doesn’t affect her fertility or future pregnancies, only developing fetal tissue. This is why we are very careful to be sure that women are not pregnant and will not become pregnant while on isotretinoin, or for one month after discontinuing it.”
According to Accutane Class Action Lawsuit Center, the lawsuits that have reached court involving Isotretinoin and the pharmaceutical drug companies all involve people who were misinformed of the risks and then suffered from different diseases which severely affected the bowel regions of their body. McCarrell won against Hoffmann-La Roche, Inc. primarily because he proved he had not been warned of the possible effects.
“I think that the current lawsuits have no merit,” Barnett said. “The drug has been prescribed for about 40 years, and its side effects are well known by dermatologists. At any given time, I have ten [to] 30 teenagers on it.”
Accutane, a popular acne medication used by teenagers and adults, has been involved in a number of lawsuits in the past 10 years, the most recent of which was in February 2010 when Alabama resident Andrew McCarrell won $25 million in damages from the pharmaceutical company Hoffmann-La Roche, Inc. after he was forced to have his colon removed due to side effects of the drug.
According to a Hoffmann-La Roche, Inc.’s annual 2009 finance report, the pharmaceutical company no longer sells the drug because of the high cost to defend lawsuits against medical problems that Accutane has been linked to, such as ulcerative colitis, Crohn’s disease and inflammatory bowel disease—what McCarrell suffered from. A recall for Accutane was issued in 2009, after which it was rereleased as general Isotretinoin. There are currently 1,000 lawsuits pending against Isotretinoin in federal and state courts.
“The common side effects of Isotretinoin [Accutane] are dry skin, nose bleeding and chapped lips,” Bethesda dermatologist Jay Barnett said. “There has been some concern over a link to depression and to inflammatory bowel disease, but these have not been proven.”
While Isotretinoin has been associated with these adverse side effects, it has also been recommended by doctors as the most effective acne medication.
According to a Nov. 22 statement issued by the American Academy of Dermatology Association (AADA), Isotretinoin prescriptions must be monitored carefully by physicians for possible side effects, but have proven in numerous clinical studies to treat severe acne more effectively than other medications.
“Isotretinoin is extremely successful in the right kind of patient,” Barnett said. “[More than] 80 percent [of my patients] who complete the five-month course are now free of acne forever, without additional treatment.”
According to Barnett, he normally recommends the drug to teens and prescribes it frequently. He does, however, only recommend it as a last resort for teenagers who have tried other treatments.
“It’s the strongest medicine, [and] I wanted something that would really work,” said sophomore Christine, who asked that her real name not be used. “I was aware of the [possible] effects, but I only had chapped lips. I would recommend it.”
Other possible side effects linked to Isotretinoin include depression, psychiatric disturbance and, for pregnant women, birth defects, which is why routine blood work and testing is necessary for people who want to go on the medication.
“If a woman gets pregnant while on isotretinoin, there is a high likelihood of having a child with birth defects,” Barnett said. “The drug doesn’t affect her fertility or future pregnancies, only developing fetal tissue. This is why we are very careful to be sure that women are not pregnant and will not become pregnant while on isotretinoin, or for one month after discontinuing it.”
According to Accutane Class Action Lawsuit Center, the lawsuits that have reached court involving Isotretinoin and the pharmaceutical drug companies all involve people who were misinformed of the risks and then suffered from different diseases which severely affected the bowel regions of their body. McCarrell won against Hoffmann-La Roche, Inc. primarily because he proved he had not been warned of the possible effects.
“I think that the current lawsuits have no merit,” Barnett said. “The drug has been prescribed for about 40 years, and its side effects are well known by dermatologists. At any given time, I have ten [to] 30 teenagers on it.”
According to Sage Advice, a skin care website, 85 percent of teenagers suffer from acne, and only 11 percent of them seek medication. While Isotretinoin is associated with risks, it could also offer a solution.
“In the more than 20 years I have been a dermatologist, I would not be surprised if I had prescribed it to 5,000 people or more,” Barnett said. “If it is used properly and patients are counseled properly, [they] typically do very well. It is truly life changing for teens with bad acne.”

According to Sage Advice, a skin care website, 85 percent of teenagers suffer from acne, and only 11 percent of them seek medication. While Isotretinoin is associated with risks, it could also offer a solution.
“In the more than 20 years I have been a dermatologist, I would not be surprised if I had prescribed it to 5,000 people or more,” Barnett said. “If it is used properly and patients are counseled properly, [they] typically do very well. It is truly life changing for teens with bad acne.”