MCTAfter the five long hours of labor, the baby finally arrived. She was a healthy weight of seven pounds eight ounces – but something was horribly wrong.
The baby was born with severe birth defects. Her legs were crippled and eye positions displaced.
She would have been born with strong, able legs and round, sparkling eyes if it hadn’t been for her mother’s acne medication.
Dr. Johann Peikert, a physician in the dermatology department at Luther Midlefort, 533 Spring St., said a good 50 percent of babies whose mothers have taken the acne drug, Accutane, had birth defects.
Around 120 women a year, Peikert said, still have been getting pregnant while on the drug, and the drug has been on the market for nearly 30 years.
Birth defects, along with depression and suicide, have made the prescribed drug heavily regulated while on the market. Its success rate of clearing extreme acne cases however keeps it at the top of the list.
Accutane, also known in its generic form as Isotretinoin, is a vitamin A-based drug that decreases the amount of oil developed from the oil glands of the skin, dermatologist, Dr. Nyles Eskritt M.D., 3508 E Maria Dr., Stevens Point, said.
“It’s used to treat severe nodular acne regions that do not respond to topical medication or oral antibiotics,” Eskritt said.
Only after everything else has failed first, Peikert said, can the prescription be given out.
The regulations for obtaining Accutane specified by the Federal Drug Administration are extensive, however the results it delivers make it a “great medicine,” Peikert said, where “virtually everyone is cleared (referencing to the patient’s acne) when they finish using it.”
When an individual has tried all possible forms of treatment and has the consent of their dermatologist or physician, the first step in the Accutane process is the iPLEDGE program.
The iPLEDGE is a computer-based risk management program that requires all patients meet qualification criteria and monthly program requirements.
Types of questions, Eskritt said, that would be asked on the questionnaires include whether or not the patient understands the serious side effects of the drug, whether they agreed to tell their doctor about depression systems, whether a family member has had a history of depression and whether they agreed to stop taking the medication if signs of depression were seen. Patients must agree not to donate blood while taking Accutane.
After the questionnaire and counseling session, female patients must then verify they are not pregnant or using primary and secondary forms of birth control.
“Women have to go through counseling, get pregnancy tests and if not on birth control, need to start it and then get tested again for pregnancy,” Peikert said.
Because the iPLEDGE program is computer based, patient information must be entered into the system.
“I can’t just write a prescription for everyone,” Peikert said. “The pharmacist has to see it by computer.”
Bruce Bergmann, the pharmacy manager at Marshfield Clinic Eau Claire Center’s pharmacy, 2116 Craig Rd., said Accutane runs in the range of $500 per month when two capsules are taken per day. Less extreme oral prescriptions, like amoxicillin and tetracycline, run under $20 a month, he said.
Some of the minor side effects individuals may experience on Accutane, Eskritt said, include dryness of the face, allergies where breathing difficulties develop and hives, vision problems involving night vision, muscles and joint aches, increased heart rate, blood clots, back pain, a decrease in red and white blood counts and sensitivity to the sun.
While on Accutane, Peikert said sun protection is important because Accutane increases the skin’s sensitivity to the sun.
Since Accutane’s release, Peikert said the numbers have gone down in use, mainly because of the iPLEDGE program.
“Some doctors don’t prescribe it . and more of a drop occurred when there was a discussion of depression and suicide became hot topic issues,” he said.
Eskritt is among some of the dermatologists who won’t prescribe the drug. He said too few of his patients request it and the iPLEDGE program is restrictive.
Luckily, many cases of acne don’t require such extreme prescriptions, and there are many successful options available that work well.
“Accutane is a great drug,” Peikert said. “Physicians just need to be very selective on who should take it,” adding the majority of his patients who take Accutane aren’t depressed, but “smiley.”
