The Bitter Pill

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Accutane – Another Case of Too Little Too Late

Evelyn Pringle April 12, 2006

Accutane is prescribed to treat a type of severe acne called nodular acne which causes red, swollen, tender lumps to form under the skin. Accutane is supposed to be used only when all other treatments, including antibiotics, have failed.

The treatment usually lasts 4 or 5 months, at a cost of about $3000, including lab tests and doctor’s visits. The drug is manufactured by Roche Pharmaceuticals and is also marketed under the generic names Amnesteem, Claravis, Isotretinoin, and Sotret. The FDA estimates that about 100,000 prescriptions for the drug are written in the US each month.

Accutane has many side effects. Patients have been known to develop serious mental health problems and the FDA has acknowledged reports of suicide or suicide attempts associated with use of the drug.

In July 2005, the FDA posted an Action Alert on its web site that said, all patients treated with the drug should be observed closely for symptoms of depression or suicidal thoughts, such as sad mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating, or for mood disturbance, psychosis, or aggression.

The FDA advised patients to stop taking the drug and contact their healthcare provider right away if they experiences any of the symptoms mentioned in the alert.

Accutane has been marketed in Canada since 1983. As of December 31, 2005, Health Canada had received 29 reports of vascular disorders or myocardial infarction suspected of being associated with the use of the drug.

The drug has also been linked to a condition caused by increased pressure on the brain which can lead to permanent loss of eyesight and, in some cases, death. The drug’s side effects also include headaches, joint pains, and upset stomach.

But most importantly, the drug should not be used by women who are pregnant, or who may become pregnant. There is an extremely high risk that serious birth defects will occur if mothers-to-be take Accutane in any amount, even for a brief period of time. Any fetus exposed to Accutane can be affected and there is no way to determine whether or not a fetus has been harmed.

According to the March of Dimes Foundation, birth defects known to be associated with Accutane include: hydrocephaly (enlargement of the fluid-filled spaces in the brain); microcephaly (small head and brain); mental retardation; heart defects; ear and eye abnormalities; cleft lip and palate; and other facial abnormalities.

Accutane can cause these birth defects in the early weeks after conception, a time when a woman often doesn’t know she’s pregnant, the March of Dimes warns.

Accutane came on the market in 1982, which means Roche and the FDA had more than 20 years to eliminate its use by pregnant women and they failed in that mission miserably.

Between 1982 and 2000, Roche has documented reports of 1,995 pregnancy exposures and 383 live births. Of those births, 162 infants were born with birth defects. And between April 1, 2001, and August 15, 2003, the FDA has reports of 325 known pregnancies in women taking the drug.

So its not as if Roche and the FDA were not aware of the on-going problem. Researchers have also been sounding the alarm for years.

Back in 1997, University of Massachusetts, Dr Jane Adams, associate professor of psychology, and Dr Edward Lammer of Standford University, published the results of a study that followed nearly 50 children who were exposed to Accutane in the womb.

The researchers found that about 25% of the babies had physical abnormalities such as ear and jaw malformations, asymmetric faces, and brain abnormalities.

And although physical abnormalities seemed to miss some children, the study found about half of the children suffered from learning disabilities.

“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.”

If such a system was not put into place, the Doctor warned, the March of Dimes would consider calling for a complete ban on all forms of Accutane.

Shortly after the hearing, the FDA began examining ways of designing a new program with stricter requirements and in August 2005, a new plan, called iPLEDGE, was announced.

Since March 2006, new regulations require doctors and patients to register in an electronic database before Accutane can be dispensed. The plan also requires two pregnancy tests. And during treatment, women must take 2 approved forms of birth control and have a pregnancy test each month.

The drug can now only be dispensed by a pharmacy registered with iPLEDGE, and pharmacies can only purchase Accutane from wholesalers who are registered with the program.

Although this iPLEDGE program sounds good and well, it should have been in place 20 years ago. This is just another example of the profit-driven, greedy drug makers and our compromised public health officials who reside in their back pocket, once again doing too little too late.

Filed under: 2006, Accutane, Birth Defects, FDA, Roche, suicide

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