Pregnant Women's Use of Accutane Results In Severe Birth DefectsApr 29, 2004 | The BYU Newsnet
Jennifer Morton chose abstinence as her form of birth control in order to start her prescription for Accutane. However, the drug's depressive side effects hit Morton (not her real name) hard, and after a few weeks of daily pills and crying spells, Morton fell to her lowest point.
"Everything went wrong that could have gone wrong with me, all in one little package," the 33-year-old mother said. "I had so many horrible Accutane side effects. It started with severe headaches, day and night nausea, but I'm thinking, this will go away, stick it out."
Then, in the midst of her depression, her old high school boyfriend convinced her to get back together. Morton said she was in too much of a mess to make any rational decisions and they hooked up.
Now Morton lovingly talks about her 7-year-old son David.
David has brain damage, seizures, speech problems, hand tremors, some autistic behavior, sensory impairment, chronic constipation and lack of muscle control. However, Morton said the hardest everyday task is worrying about David's feeding tube. The tube is needed because he can't work his muscles enough to even swallow water. David suffers from all of these problems because he is an Accutane-baby.
"It's just so hard," Morton said. "Everything is so hard. Some of the physical things he's caught up on, but he's so far behind."
Morton began taking Accutane when she was 24, and according to the FDA's Review of Pregnancy Reports, was right on target, as the largest group of Accutane patients, 27 percent, are women in the age range of 20-24.
Julia Robertson is the coordinator of the Utah Pregnancy Risk Line, a group interested in the increased number of Accutane-exposed pregnancies in Utah. In 2000, 13 pregnancies were exposed to Accutane, a drastic increase from the previous 15 years, where the average had been two or three. And despite the low number of pregnancies in 2003 -- five --it is still five too many for Robertson.
"We haven't seen a decrease in our numbers," she said. "We just got another patient this week. I don't know how to gauge that."
Robertson said in 2003, close to 200 Accutane-exposed pregnancies in the United States were reported to the FDA.
"That's too high," she said. "Our goal is in Utah to not have any pregnancies exposed."
Accutane, or the generic term, isotretinoin, is the strongest acne medicine on the market. It falls in the categories of teratogens, which have the potential to cause major deformities in a developing fetus. The drug is to be used only as a last resort after other acne treatments have failed.
Lynn Martinez, coordinator for the Birth Defects & Genetics Program in Utah worries that because Accutane is becoming a first-choice treatment, many patients are uneducated and don't understand how powerful the drug really is.
"The thing about Accutane that I think most folks don't know, is that it's the strongest known inducer of birth defects," she said. "It's the worst, not just in terms of medicines, but in terms of anything. It carries the highest risks for the worst conditions."
No longer just a teenage wonder drug, Accutane is becoming a hot commodity among women of childbearing age. Those who want to get rid of acne often use it as a quick fix, which shouldn't be happening, according to Roche, the company that created Accutane.
Before beginning the drug, patients should be examined by a family physician or a dermatologist to see if they have severe, scarring acne. Doctors should also explain the numerous possible side effects, and stress the importance of two forms of birth control for the duration of the prescription. Females must also take a pregnancy test before starting medication.
System to Manage Accutane Related Tertogenicity, or SMART, is Roche's educational system designed to prevent pregnancy by requiring participation for women who take Accutane and doctors who prescribe it. As part of the education, Gail Safian, a public affairs consultant for Roche, said the company distributes a spiral-bound book, not just a pamphlet, to help educate doctors and patients.
"We have a very major program actually," Safian said. "We've always had educational materials for the physicians and their patients."
Dermatologists and physicians are required to read this book and sign a letter saying they understand how to prescribe the drug. After this training, they are enrolled and receive special stickers that are placed on prescriptions to signify validity.
After patients review this booklet, they are given a three-page consent form that again specifies Accutane should only be used only as a last resort. It also reminds patients of the drug's numerous side effects, such as depression, tiredness, loss of appetite and possible suicidal thoughts. The form also requires the patient to tell doctors of any past or current symptoms of depression. There are 12 places for patients to initial their understanding, and multiple spaces for signatures from health care providers.
Robertson is aware of this program, but wonders about its efficacy, as it is impossible to know how much time doctors are setting aside to go over everything.
"If you look at the manufacturer's program, it's substantial," Robertson said. "But what we don't know is if health care providers are using it."
For Morton, the SMART program wasn't even around when she started taking the drug. She said she remembered the birth control issue as a quick question with little follow-up.
"She [the dermatologist] said, 'What form of birth control would you like to use?' and I chose abstinence," Morton said. "That was the end of our conversation on that. That was it-it was about a sentence long." The entire Accutane-acquiring process was just as forgettable.
"I did get a brochure," Morton said, "Nothing I kept. But basically I signed a consent form, but it was just 'Here, sign this, go.' It wasn't anything that I really knew at the time, or knew what I was getting myself into."
At a recent February conference in Maryland, the FDA, Roche and the Drug and Safety Advisory Committee met to discuss the SMART program and its failings. The FDA demanded that Roche put in place a mandatory registration for Accutane users that would put more pressure on doctors to record who is taking the drug and how they are doing. However, Robertson said it might take more than action on Roche's part to truly effect a change.
"If health care providers and their clients work together and follow those recommendations that are in the drug insert, we shouldn't have any pregnancies," she said. "But we're not following those, and until they are mandatory requirements, I don't think anybody will follow them. Roche can say, this is what you have to do, but Roche really doesn't have a lot of power to do that. The FDA has to come through and say it's a must."
Increased awareness may have helped Morton, as well as better education about side effects. She described her experience as horrible, as the side effects of Accutane took over her life. She said she thinks it might not have been so bad had she been more carefully monitored.
Besides the constant nausea and headaches, Morton later developed hypersomnia, a sleep disorder, and because she was so weak, forgetful and depressed, she was forced to quit school and her two jobs. She also developed suicidal thoughts and was taken to a psychiatrist.
BYU junior Derrick Allred, a biology major from Richfield, said he took Accutane for three months. His brothers and his mom also took the acne medication.
"There are definitely a lot of mood changes, attitude changes," he said. "My mom took it for the full six months, and it was six months of heck."
The Allreds may not have experienced psychiatric effects as severe as Morton's, but the occurrence of such symptoms is not unusual, nor surprising. In the 30-plus page Accutane manual, Roche lists side effects occurring in areas such as cardiovascular, endocrine, gastrointestinal, musculo-skeletal, neurological, psychiatric and respiratory, with side effects ranging from headache and insomnia to depression and stroke.
Morton said her biggest complaint is with the psychiatric influence of the drug. She points out that Roche warns about the psychiatric, as well as the terotegenic side effects, but said she thinks for safety reasons, the two effects shouldn't be together in one medication.
"You shouldn't be giving a teratogen to someone who could be in a severely depressed mental state, then requiring that they use two forms of birth control," Morton said. "[They're] underestimating what a responsibility that is. Throw in depression and suicidal thoughts, and you're just asking for it."
Accutane affected Morton to the point where she could no longer make rational decisions. Getting pregnant would have never happened if she hadn't been on Accutane, she said.
"It happened, and it was a mistake," she said. "At first I thought it was my fault and I was such a horrible person. How could I have ever let something like this happen? I learned later that the psychiatric side effects of Accutane were doing something to me that was out of my control."
For Morton, Accutane is no longer a simple aesthetic oral treatment, but a strong drug that is misunderstood and under-regulated. Morton said she wants in-depth pre-screening, more monitoring and better follow-up if Accutane is going to continue to be prescribed to women of childbearing age. She warned that even if someone is mentally healthy starting the drug, they still need to be followed by a psychiatrist, and if side effects like hers occur, they need to get professional help and stop the treatment before pregnancy becomes an issue.
"I believe there's an increased risk of unplanned pregnancies when a patient is exposed to psychiatric side effects," Morton said. "There's a huge increased risk."
The FDA conference was a big step in helping to address an issue that has forever changed Morton and David's life. Talking about her son is another step.
"It takes me a lot of guts to tell my story because I know people can really attack me and judge me," she said. "I know there are other girls going through this, so I want to say something because my child has birth defects. I don't think it's worth it to keep quiet. I really want to warn people, so it doesn't happen to them."