Accutane is the brand name for a drug known as isotretinion made by Hoffmann-LaRoche Inc. It is often used to treat severe acne. However, it has been linked to various severe side effects, including bowel disease and birth defects. Interestingly, as an acne treatment, it is incredibly effective and was often hailed as a miracle drug after its 1982 FDA approval. However, the side effects are significant, including Crohn’s disease. As is often the case with prescription drugs that turn out to be dangerous, it wasn’t until doctors started to notice an increased number of patients presenting with strange illnesses that the link between these illnesses and Accutane became clear.

Once it did, however, the FDA immediately issued a black box warning. By 2009, Roche ceased manufacturing the drug altogether. However, Sotret, Claravis and Amnesteen, all brand names with the same ingredients, continue to be available.

Doctor Warnings

Accutane was first prescribed in 1982. One year later, the first report of a baby born with birth defects after the mother used Accutane was listed. This led to two separate Dear Doctor Letters.

“Letters issued to veterinary medicine professionals by drug manufacturers alerting the professionals to important safety information.”

Essentially, these letters are required by the FDA from drug manufacturers if it is felt that they are presenting a drug with an incomplete label. These letters list such things as more severe than expected side effects and other elements. If a Dear Doctor letter is sent out, physicians know that the possibility of birth defects exists. Between 1984 and 1988, a further seven Dear Doctor letters were sent out in relation to Accutane.

The FDA took notice, and so did others. Dr. Frank Yoder was one of the scientists who actually discovered Accutane. In 1983, he wrote to the Journal of American Medicine to express his concerns about the drug he had essentially discovered himself.

“I wish to express my concern and anxiety over the potential tragedy that might arise from abuse and misuse of Accutane…. The potential toxicity of this drug has been seriously under-emphasized.”

Through his letter, he basically told the general public that Roche was not being entirely forthcoming with just how toxic Accutane actually is.

Besides these two, Public Citizen, a nonprofit group for health advocacy, sent a petition to the FDA. In it, they requested that Accutane labels should contain warnings about potential birth defects. This also happened in 1983. Yet it wasn’t until 1985 that the black box warning was issued by the FDA.

“It appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks.”

In 1988, there was a full pregnancy prevention program in place. The goal of this program was to lower the number of women who took Accutane and fell pregnant. It took some time for this program to be truly effective, but it did work. Eventually, the number of women who became pregnant while taking Accutane was halved, from 4 to 2 women per 1,000. Worryingly, however, the number of prescriptions grew.

It seems this country was slightly behind in terms of accepting the seriousness of Accutane for pregnant woman. In the United Kingdom, and woman who wanted to be prescribed the drug would have to sign a waiver stating that they would abort their pregnancy if they conceived during treatment. No figures are known about how many women actually did have an abortion.

One of the key players in making sure that people knew about the dangers of Accutane was the Centers for Disease Control and Prevention (CDC), which continue to this day to provide reports on whether babies are still born with Isotretinoin-related birth defects.

“The continuing reports of severely malformed infants born to mothers inadvertently exposed to isotretinoin emphasize the need to repeat the warnings of teratogenicity. Any woman taking isotretinoin who becomes pregnant should receive informed counseling about the risks to her fetus. To define the teratogenic risks of isotretinoin more accurately, further information about inadvertently exposed fetuses and infants is needed. This information is most valuable when an exposed, pregnant woman is reported before the outcome is determined.”

It is very important, according to the CDC therefore, that people know what to do if they believe they have been affected by it.

By June 2009, the FDA had received so many warnings and so many reports of problems that Roche felt the need to stop manufacturing the drug altogether. They also faced several lawsuits and the company felt that it was in their best economic interest to no longer manufacture the drug. It was also recalled in 11 different countries.

Mild Accutane Side Effects

One of the big issues with Accutane is that it not only leads to birth defects. It also brings about various other side effects. These include severe bowel disease and more. It is vital, therefore, that those who take a type of isotretinoin are properly monitored by their physician.

Accutane Birth Defects

Accutane has an X pregnancy rating. This means the chance of fetal abnormalities is so high that it should not be taken during pregnancy at all. According to the FDA, the birth defects of babies born to mothers who took Accutane during pregnancy are both internal and external. These include missing ears, cleft palate, central nervous system malformations, and facial dysmorphism. Now that extensive research has been completed into the drug, it is known that birth defects happen in 42% of all pregnancies in mothers who took Accutane, which is almost half.

Not only is there a significant chance of deformities, many women also suffered from miscarriages, spontaneous abortions and still births. As a result, the FDA started working closely with Roche in order to find ways to prevent women from falling pregnant if they took the drug. The first of these programs was the System to Manage Accutane Related Teratogenicity (SMART) program.

“SMART may have lead to a decrease in isotretinoin prescriptions. Further research is needed to determine whether the reduced number of isotretinoin prescriptions reflects appropriate use or inhibited use resulting in loss of access to the product’s benefits.”

SMART was successful, but not successful enough. This is why, by 2006, the i-PLEDGE program replaced it.

“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.”

It is believed that this program made a great difference in the prevention of birth defects as a result of Accutane. Unfortunately, to this day, birth defects continue to exist due to isotretinoin, marketed under different brand names.