Accutane and HS
Accutane is not advised for HS; if you choose to take this drug, please read below.
Accutane is an oral retinol treatment and should not be a treatment for HS as HS is not acne. This is typically a short term treatment and you cannot be on this type of treatment long term.
There are many side effects as this is an extremely harsh drug on the body with several side effects, some of which are dangerous, which is why they monitor the patient so closely. The monitoring is a huge commitment that comes with a lot of follow-up appointments, as well as a lot of blood work. Many patients end up with irreversible liver damage. Many reported that they developed diabetes and/or serious lifelong mental issues, along with other side effects which can last a lifetime.
Accutane is part of an “iPLEDGE program,” an FDA Risk Management program for “Pregnancy Prevention”. It is strongly cautioned that anyone who is thinking about getting pregnant in the future research and consider the long term impacts before beginning this drug. Further information on iPledge can be found HERE.
Information directly from their website:
Isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin in any amount, even for a short period of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. Because of this toxicity, isotretinoin can only be marketed under a special restricted distribution program. This program is called iPLEDGE®. Under this program, prescribers must be registered and activated with the iPLEDGE Program and can prescribe isotretinoin only to registered patients who meet all the requirements of iPLEDGE. Isotretinoin can be dispensed only by a pharmacy registered and activated with iPLEDGE. Registered and activated pharmacies can only receive isotretinoin from wholesalers registered with iPLEDGE.
Patients on isotretinoin have been known to become depressed or to develop other serious mental health problems. Some people have had thoughts of hurting themselves or putting an end to their own lives. Some people tried to end their own lives and some have ended their own lives. There have been reports that people on isotretinoin were aggressive or violent. No one knows if isotretinoin caused these problems or behaviors or if they would have happened even if the person did not take isotretinoin.
After suffering the side effects, it did nothing for my condition other than make times worse because it is not a treatment for HS. When I stopped taking it, my HS came back with a vengeance; this is one of the worst mistakes I have made with this disease.
If you have moderate-to-severe HS and are considering this drug, please be sure you explore all options for the most appropriate treatment for HS, including biologics, even if you are concerned about the side effects, biologics are a more appropriate treatment for HS.
In the US, Accutane was discontinued in 2009 due to lawsuits over serious side effects, however, it is now being prescribed under different names:
Most Common Side Effects:
Cracks in the corners of the mouth
Cracking or peeling skin
Inflammation of the whites of the eyes
Changes in your fingernails or toenails
Possible Long Term Side Effects:
Poor appetite leading to malnutrition
Numbness and tingling of hands and feet
Hair loss (thinning)
Sensitivity to light (see eye problems)
Decreased night vision, which may persist after treatment is stopped
Swelling of the feet or ankles
Low blood counts (white and red blood cells and platelets may temporarily decrease. This can put you at increased risk for infection, anemia and/or bleeding)
Abnormal blood tests: increased triglyceride, cholesterol and/or blood sugar levels
Increases in abnormal blood tests measuring liver function
Rare but Serious Side Effects of Accutane:
Blood clots: Blood clots rarely lead to pulmonary embolus or stroke, potentially life-threatening conditions.
Pancreatitis (inflammation of the pancreas): Mainly noted in blood tests that return to normal after therapy is discontinued. Symptoms of acute pancreatitis include pain in the upper abdomen that worsens with eating, swollen and tender abdomen, nausea, vomiting, fever, and rapid pulse. If these symptoms occur please notify your healthcare professional immediately.
APL differentiation syndrome: A very serious side effect that has been observed in patients that have taken medications similar to Accutane for treatment of leukemia, is called. This syndrome is a reaction between the drug and the leukemia. This syndrome produces fever, difficulty breathing, weight gain, lung and heart problems. It is generally treated with high-dose steroids. Be sure to let your health care professional know if you experience fever of 100.4F or 38C, difficulty breathing, or sudden weight gain.
Not all side effects will happen to everyone, but all side effects must be listed as required by the FDA.
History of Accutane from 1982 to Present by Naomi Mannino
1982 - The FDA approves Hoffmann-La Roche’s Accutane (isotretinoin), a prescription medication for use in treating severe acne that is unresponsive to conventional therapies. The FDA gives Accutane the Category X pregnancy rating, which means it’s contraindicated during pregnancy.
1984 - The FDA requires a “black box” warning for Accutane, citing the risk for fetal deformity.
1998 - Several medical studies cite a possible link between depression and Accutane use. The FDA issues a warning to physicians, and Accutane warning labels in the US are updated to include a possible risk of adverse psychiatric effects, including depression, psychosis, suicidal ideation and suicide.
1989 - The FDA mandates the implementation of the Accutane Pregnancy Prevention Program.
2000 - The FDA and Accutane manufacturer Hoffmann-La Roche agree to link a negative pregnancy test with each monthly prescription of Accutane.
2001 - A Medication Guide is approved to provide more plain language information about Accutane’s side effects. It is to be distributed by pharmacists to Accutane patients. The FDA also establishes an online Accutane Drug Information web page. Hoffmann-La Roche approves the use of the SMART (System to Manage Accutane Related Teratogenicity) program for pregnancy prevention. Key elements include patient-informed consent, pregnancy testing and contraception use.
2002 - The FDA becomes aware through the Adverse Event Reporting System of 173 reports of suicide associated with Accutane treatment worldwide. The FDA requires Hoffmann-La Roche to begin submitting quarterly summaries of side effects. By August 2002, the summaries include roughly 6,000 additional reports of psychiatric adverse events, such as depression and suicidal thoughts.
The FDA begins to collaborate with the National Institute of Mental Health to address the need for more independent research and holds a workshop to discuss basic scientific research into the effects of retinoids on the central nervous system. Hoffmann-La Roche starts including a Medication Guide in the Accutane blister pack. The guide will later become part of the iPLEDGE program.
Hoffmann-La Roche’s original patent for Accutane expires.
In the first 20 years of Accutane use, the FDA Adverse Event Reporting System contains almost 23,000 reports for Accutane, mostly from the US. The 5 most frequent reactions are alopecia (hair loss), depression, headache, dry skin and induced abortion to purposely end a pregnancy conceived while taking Accutane.
The FDA approves the first generic version of isotretinoin called Amnesteem.
2002 - 2003 - Generic isotretinoin versions of Amnesteem, Sotret and Claravis each propose a separate pregnancy-risk program to avoid pregnancy while taking the drug.
2003 - Hoffmann-La Roche and other isotretinoin drug manufacturers agree to work together on the need for a single pregnancy prevention program. Accutane use starts to decline from 284,925 (2000) to 128,936 (2003) for men and from 278,252 (2000) to 128,973 (2003) for women, according to a Hoffmann-La Roche presentation to the FDA Advisory Committee.
2004 - The FDA Joint Advisory Committee recommends a single, required, stronger risk management plan for all marketed isotretinoin products. The plan links isotretinoin prescriptions with pregnancy testing to reduce the chance of a pregnancy during treatment.
2005 - The FDA issues an alert for Accutane and all generic isotretinoin, advising doctors to monitor patients for suicidal thoughts or actions.
Wholesalers, pharmacies and prescribers begin registering for the iPLEDGE program in September 2005. Patients begin registering for the program on December 30, 2005.
2006 - In March, iPLEDGE pharmacies are required to obtain iPLEDGE system authorization before filling an Accutane or isotretinoin prescription. (Both patients and prescribers must prove they are registered with iPLEDGE.) Women of childbearing age are required to provide their doctors with a current negative pregnancy test result each month before receiving a prescription.
2007 - The FDA warns about purchasing Accutane or generic isotretinoin versions online.
The first case alleging that Accutane causes inflammatory bowel disease (IBD) results in a $2.6 million award. In October, a jury awards another plaintiff $7 million for a case involving IBD.
2008 - A New Jersey Superior Court jury awards $10.5 million in a case, one of 425 against Hoffmann-La Roche, alleging the drug causes IBD. (The judgment will be reversed in 2010.)
2009 - Hoffmann-La Roche voluntarily removes Accutane from the market, citing competition from generic isotretinoin versions.
2010 - The American Academy of Dermatology (AAD) issues an updated position statement on the use of isotretinoin. It claims that, according to published scientific studies, there is no direct causal relationship between isotretinoin and IBD and psychiatric disturbances. The AAD calls for the need for patient monitoring and more scientific testing on the topic.
In February, a jury awards Andrew McCarrell $25 million, the largest Accutane award to date. McCarrell claims he developed IBD years after taking Accutane. (This judgment will be upheld in 2011.)
2012 - In June, a New Jersey Superior Court orders Hoffmann-La Roche to pay $18 million in compensatory damages to 2 Accutane users who developed ulcerative colitis. The court found in Hoffmann-La Roche’s favor in 2 other cases.
2014 - Hoffmann-La Roche wins a reversal of a $2 million Accutane trial verdict. A former Accutane user had blamed the drug for her IBD — a condition she had years prior to taking Accutane. Hoffmann-La Roche continues to sell isotretinoin under the name Roaccutane in other countries. Other governments are still reviewing claims of psychiatric adverse events including suicide linked to Roaccutane use.
2015 - A New Jersey appeals court reversed Andrew McCarrell’s $25.2 million jury verdict against Roche (see above), ruling that McCarrell waited too long to bring the case. McCarrell will appeal, according to one of his lawyers.
Naomi Mannino is a Tampa, Florida-based freelance journalist who reports on health and medical news, research and technology. Follow her on Twitter @naomimannino.
Again, if you are considering or are being prescribed Accutane, please explore all options for HS management; biologics are much more suitable for this type of disease. Read more on biologics HERE.
Read The HS Treatment Journey: Your Options HERE
Content on this site is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay seeking treatment because of something you have read on this website.
Written by Denise Panter-Fixsen
Edited by Brindley Kons