"Many of the kids that look normal have learning-related problems," Dr Adams said.
She found that many of the children had trouble with "visual perception", such as drawing shapes, "spacial processing", such as piecing together a puzzle, and "organizing behavior".
The learning disabilities reportedly became more pronounced around the third or fourth grade. Classes such as geography, mathematics and writing often posed challenges, the study found, where children were required to read maps, count in their heads and organize paragraphs.
At the time, Dr Adams said that she hoped her study would change FDA rules and require drugs to be screened for their potential to cause learning disabilities.
A previous study by Dr Lammer, had influenced the FDA to require consent forms for women Accutane users as part of the Pregnancy Prevention Program (PPP), which required women to confirm a full understanding of risks associated with Accutane and pregnancy in writing.
In 1988, the FDA and Roche had developed the voluntary PPP, in attempt to prevent conception by women on Accutane. However, the consent forms, Dr Adams warned in 1997, had not been successful in stopping pregnancies.
"It's not working," she said, "people are still getting pregnant, they're just having abortions," she said.
Three years after Dr Adam's warnings, on January 21, 2000, the March of Dimes Birth Defects Foundation issued a warning alert on Accutane that said, "Americans must be more cautious with the prescription anti-acne drug Accutane (isotretinoin) and other retinoids, which can cause very serious birth defects when used during pregnancy," in response to a Boston University study published in the Morbidity and Mortality Weekly Report.
The Boston University Accutane Survey (BUAS) reported that 900 women became pregnant while taking the drug between 1989 and 1999, which averaged out to a rate of 3 pregnancies for each 1000 women treated with Accutane.
"Even a single pregnancy exposed to Accutane is one too many, given all we know about the severe harm this drug can do to fetuses," said Donald Mattison, MD, medical director of the March of Dimes. "We urge everyone, especially physicians, patients with acne, and pharmacists, to become better educated on the proper use of this drug and to follow the guidelines more carefully."
Dr Mattison also noted that the voluntary PPP was in place, but said it appeared that many physicians and patients were not participating in the program.
The PPP program was replaced in 2002 with the System to Manage Accutane Related Teratogenicity (SMART), which was meant to put more emphasis on contraception and pregnancy testing.
However, on February 25, 2004, the March of Dimes Foundation issued another warning that said, "Accutane Causing Miscarriages and Major Birth Defects, Tighter Controls Urgently Needed."
Major birth defects caused by exposure to Accutane and other brands of isotretinoin, continue to occur in the US each year because of the failure of voluntary safety measures meant to prevent them, the March of Dimes said.
At a January 26, 2004, FDA advisory committee meeting, the March of Dimes called on public health officials to immediately impose tougher restrictions on Accutane modeled after a system put in place for the drug, Thalidomide, when it was found to cause birth defects.
March of Dimes representative, Dr Nancy Green, MD, told the committee the voluntary measures had produced no substantial improvement in reported pregnancy exposures. "The tragic consequence for families," she said, "has been miscarriages, fetal loss, and major birth defects."
She found that many of the children had trouble with "visual perception", such as drawing shapes, "spacial processing", such as piecing together a puzzle, and "organizing behavior".
The learning disabilities reportedly became more pronounced around the third or fourth grade. Classes such as geography, mathematics and writing often posed challenges, the study found, where children were required to read maps, count in their heads and organize paragraphs.
At the time, Dr Adams said that she hoped her study would change FDA rules and require drugs to be screened for their potential to cause learning disabilities.
In 1988, the FDA and Roche had developed the voluntary PPP, in attempt to prevent conception by women on Accutane. However, the consent forms, Dr Adams warned in 1997, had not been successful in stopping pregnancies.
"It's not working," she said, "people are still getting pregnant, they're just having abortions," she said.
Three years after Dr Adam's warnings, on January 21, 2000, the March of Dimes Birth Defects Foundation issued a warning alert on Accutane that said, "Americans must be more cautious with the prescription anti-acne drug Accutane (isotretinoin) and other retinoids, which can cause very serious birth defects when used during pregnancy," in response to a Boston University study published in the Morbidity and Mortality Weekly Report.
The Boston University Accutane Survey (BUAS) reported that 900 women became pregnant while taking the drug between 1989 and 1999, which averaged out to a rate of 3 pregnancies for each 1000 women treated with Accutane.
"Even a single pregnancy exposed to Accutane is one too many, given all we know about the severe harm this drug can do to fetuses," said Donald Mattison, MD, medical director of the March of Dimes. "We urge everyone, especially physicians, patients with acne, and pharmacists, to become better educated on the proper use of this drug and to follow the guidelines more carefully."
Dr Mattison also noted that the voluntary PPP was in place, but said it appeared that many physicians and patients were not participating in the program.
The PPP program was replaced in 2002 with the System to Manage Accutane Related Teratogenicity (SMART), which was meant to put more emphasis on contraception and pregnancy testing.
However, on February 25, 2004, the March of Dimes Foundation issued another warning that said, "Accutane Causing Miscarriages and Major Birth Defects, Tighter Controls Urgently Needed."
Major birth defects caused by exposure to Accutane and other brands of isotretinoin, continue to occur in the US each year because of the failure of voluntary safety measures meant to prevent them, the March of Dimes said.
At a January 26, 2004, FDA advisory committee meeting, the March of Dimes called on public health officials to immediately impose tougher restrictions on Accutane modeled after a system put in place for the drug, Thalidomide, when it was found to cause birth defects.
March of Dimes representative, Dr Nancy Green, MD, told the committee the voluntary measures had produced no substantial improvement in reported pregnancy exposures. "The tragic consequence for families," she said, "has been miscarriages, fetal loss, and major birth defects."
(Note: You can view every article as one long page if you sign up as an Advocate Member, or higher).
