Roacutan: What is it? How does it work? Dosage, History, Side Effects and Warnings

The “Accutane” as it is known in some parts of the world, was discovered in 1979 when it was administered for the first time to patients with severe acne.

Most of them reacted with a clear, dramatic and permanent improvement in their acnesymptoms  .

It is a derivative of vitamin A (13-cis-retinoic acid) that is administered orally in pill form with a meal that contains an adequate amount of fat, usually for 15-20 weeks (3.5-4.5 months), although It is also sometimes prescribed in lower doses for up to six months or more.

It was originally recommended for people with severe acne who did not respond to other treatments, but has gained popularity in the last 25 years and is prescribed more frequently for less severe acne.

This practice is controversial because Roacutan is a systemic medication that affects all body systems and can cause lifelong side effects for the user. Roacutan does not need to be combined with other medications.

History

Gerald Peck and collaborators at the NIH (National Institute of Health) in Bethesda, Maryland, first studied isotretinoin in patients with skin cell disorders.

They accidentally discovered that it also worked in patients with severe acne . Isotretinoin was registered in 1979, was launched in the United States in 1982 as Accutane and was launched in Europe in 1985 as Roaccutane.

The Roche patent expired in 2002, and manufacturers began selling generic forms of the drug.

In June 2009, shortly after a jury awarded $ 33 million in damages to people who claimed that Accutane caused intestinal disease, Roche decided to suspend the sale of the brand, Accutane. The company cited decreasing sales as its reason.

How does roacutan or accutane work?

Exactly how roacutan works at a cellular level is unknown, but we know that it affects four ways in which acne develops.

It drastically reduces the size of the sebaceous glands of the skin (35% -58%) and reduces even more dramatically the amount of oil produced by these glands (around 80%).

The acne bacterium lives in the oil of the skin. Since the oil is drastically reduced, so is the amount of acne bacteria on the skin.

It decreases the speed with which the skin produces cells within the pore, which helps to prevent pores from clogging in the first place.

Although acne can get worse during the first month of Accutane use in approximately 30% of patients, the final results are usually dramatic.

Accutane works to achieve partial or complete clearance of acne in approximately 95% of people who complete a cycle, regardless of whether they have inflammatory or non-inflammatory acne.

Most people who take it experience a long-term remission of acne symptoms. Studies show relapse rates between 14.6% to 52%, with a true average of about 1/3 of people experiencing a relapse. In these cases, a second course is sometimes given.

This rate of relapse depends on the dose. Patients receiving a cumulative dose of 100-120 mg / kg obtain the best results and the lowest relapse rates. Patients who receive a lower dose relapse more frequently. The daily dosage depends on how much the patient weighs; 0.5mg-2mg / kg is typical.

Other factors that increase the chances of relapse are :

  • Male gender.
  • Severe acne
  • Do not take isotretinoin with an adequate amount of fat in your diet.
  • Hormonal imbalances such as polycystic ovary syndrome (PCOS) in women.

Dose

Low doses : Traditionally, most physicians prescribe high doses of at least 1 mg / kg / day for relatively short periods of time (15-20 weeks).

However, because many people develop serious roacutan side effects, more recently doctors began testing lower doses of roacutan administered over a longer period of time.

Initial data show that patients with mild to moderate acne can achieve long-term remission with significantly lower doses and, therefore, suffer fewer side effects 20-22, including a lower incidence of scarring.

For people with more severe acne, staying on a lower dose of Accutane for a longer period of time until reaching the full cumulative dose of 120 mg / kg may be a way to produce a long-term remission with significantly less side effects .

The current recommendation is based on this initial research is that the cumulative dose (the amount of roacutan that accumulates in the body) is the most important factor that determines the success of the treatment.

Intermittent dosing: intermittent administration (taking Accutane only one week per month) also produces fewer side effects but may not work as well. It has been studied twice.

In both studies, people who received an intermittent dose ended up receiving a lower cumulative dose, so we do not know if the poorer results are due to intermittent administration of the drug or the lowest cumulative dose. The first study compared an intermittent dose with a regular dose.

The researchers gave the patients in the intermittent dose group the same dose as the patients in the regular dose group, but only for one week of the month. This resulted in only ¼ of the cumulative dose after the end of the treatment.

This produced a slightly lower clearance of acne and more than three times the relapse rate compared to the regular dose group. The second study compared a similar intermittent dose for only one week of the month with a continuous low dose every day.

While the exact numbers were not reported, based on what we can deduce from the study, this resulted in approximately half the cumulative dose for the intermittent group compared to the continuous low dose group.

Both groups in this second study achieved a completely clear skin at the end of the treatment, but more people relapsed in the intermittent group21.

Side effects

Roacutan is a systemic medication that affects the entire body. Side effects are numerous and widespread, and affect almost all patients.

Side effects can be moderate and reversible, but in some cases they can be serious or long-term.

Some adverse effects:

  • Teratogenicity: Isotretinoin is associated with teratogenicity resulting in severe birth defects and spontaneous abortions.
  • Depression / Suicide: To date, a causal association between isotretinoin and depression / suicide has not been found.
  • Inflammatory bowel disease: To date, a causal association between isotretinoin and inflammatory bowel disease has not been found.
  • Celiac disease: To date, a causal association between isotretinoin and celiac disease has not been found.
  • Bone density: To date, a causal association between isotretinoin and bone density problems has not been found in young patients who use isotretinoin in the short term.

Clinical research shows an extremely high risk of birth defects if pregnant women take Roacutan.

Effects on the fetus:

The effects and risks of Accutane in the fetus are so severe that the FDA approved the iPledge program, which requires women of childbearing age to commit to using two forms of birth control while using roacutan.

However, despite warnings to women not to get pregnant while using roacutan, studies published in Canada, the Netherlands and the United Kingdom report a range of 11-24 per 1,000 women who become pregnant while taking roacutan.

This is lower than the pregnancy rate in the general population of these countries, which is about 50 per 1,000 women, but remains unacceptably high, leading to tragic results.

Another study conducted in California analyzed pregnancy rates before and after the implementation of the iPledge program. Fortunately, they found lower pregnancy rates among women who used Accutane in California, but found that the iPledge program had only modest results.

Before iPledge, 3.1 women in California for every 1000 who took the medication became pregnant, and after iPledge this number dropped to 2.7.

The researchers said they found that most women who take isotretinoin rely on contraceptive methods that require considerable adherence to be effective.

Unfortunately, our results suggest that this degree of adherence is not realistic for many women. Abstinence, condoms and the contraceptive pill were mentioned as areas of non-adherence.

The iPledge program began with a program called SMART (System for managing teratogenicity related to Accutane) in 2000, which became the iPledge program in March 2006.

Topical isotretinoin:

Topical isotretinoin exists, but it does not produce the results of oral isotretinoin. It is largely of historical importance in the treatment of acne.

Warnings

Do not buy Accutane or roacutan on the Internet!

According to the FDA:

“Buying (Accutane) through the Internet bypasses important procedures to ensure that patients can take this medication safely. When these procedures are ignored, isotretinoin can cause serious and harmful side effects. ”

You should NEVER buy Accutane (isotretinoin) without first consulting your healthcare professional.

You should NEVER take Accutane (isotretinoin) or any of the generic versions of Accutane if you are pregnant or trying to get pregnant or if you could become pregnant accidentally.

Some websites sell prescription drugs without a prescription. This is illegal and DANGEROUS.