Accutane rules concern doctors
By DEANNA FLEISCHMANN, Journal Staff Writer
MARQUETTE - The Food and Drug Administration is watching those who prescribe, distribute or consume the acne drug Accutane but not closely enough, according to U.S. Rep. Bart Stupak.
The FDA in November decided that doctors prescribing, pharmacists dispensing and patients taking Accutane, known chemically as isotretinoin, will be registered in a central database. The FDA made the move after Accutane was listed among five drugs that remain on the market despite safety concerns.
Stupak, D-Menominee, has a personal connection to the drug's side effects.
"My son died on Accutane," Stupak said.
Bart Stupak Jr., known to friends as B.J., died in May 2000 from a self-inflicted gunshot wound. Stupak believes that Accutane increases the chance of depression and that families aren't being protected.
"I was in Washington November 15, 16 and 17 and I talked with three other families about their sons who died on Acctuane," Stupak said.
Under the FDA's new management plan, women of childbearing age must prove they're not pregnant before a pharmacy can dispense the drug. Stupak's main concern is the number of pregnancies exposed to Accutane.
"You're supposed to have two negative pregnancy tests before you get the drug, yet there are about 2,000 babies exposed to Accutane each year," Stupak said.
This is not the first time Accutane has been restricted. In April of 2002, the drug's manufacturer, Hoffmann-LaRoche, implemented the System to Manage Accutane Related Teratogenicity. SMART was designed to link a negative pregnancy test with each prescription. Physicians were required to affix a qualification sticker with the date of the test to the prescription. Patients were instructed to use two forms of contraception and pharmacists must fill the prescription within seven days.
Marquette dermatologist Dr. Dennis Herzog said pregnancy education should be stressed, rather than more restrictions put on the drug.
"I think education is the big thing because there are already these restrictions, so how else are we supposed to get less exposures?" Herzog said.
Herzog added that heavier restrictions on the drug will force more doctors to stop prescribing it.
"You know, we already have to follow all these procedures, it takes up to four visits before I can put someone on the drug there's so many hoops to jump through and that's just more costly for them (patients)," Herzog said. "If they restrict it more I might just stop using it, which is sad because it's without a doubt the most effective drug that I have used in dermatology. There are side effects but there are side effects for any acne drug."
Dr. Milton Soderberg, another dermatologist in Marquette, agreed with Herzog.
"We're all upset by the Stupak tragedy and I explain it to my patients on Accutane, but at the same time it is a miracle drug," Soderberg said. "We've (dermatologists) been using it for 20 years and most of us feel we'd be strapped without it." A congressional hearing to discuss future restrictions on Accutane is expected to be held in January.