Accutane - Another Case of Too Little Too Late

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SSRI-Research@

Mon, 24 Apr 2006 19:53:43 -0400

[sSRI-Research] Pringle - Accutane - Another Case of Too

Little Too Late

 

 

 

 

Accutane - Another Case of Too Little Too Late

 

http://www.lawyersandsettlements.com/articles/accutane.html

 

April 12, 2006. By Evelyn Pringle

 

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.

 

 

 

 

 

Drug-Free School Zone? Just Say NO to Prozac for Children.

[Guest guest]

I posted the info on Accutane to my blog at LiveJournal. Someone

I do not know posted a comment, which I am putting below in case

anyone cares to contact her.

 

Alobar

 

==================================================

 

I'm a freelancer writing about Accutane for a national women's

magazine. This article includes great information I hadn't already

seen -- specific studies of Accutane and birth defects.

 

Are there any women out there with stories they'd be willing to share

about their experiences on Accutane? If so, please contact me.

 

Stephanie May

mizmay at gmail.com

 

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On 4/24/06, califpacific <califpacific wrote:

> SSRI-Research@

> Mon, 24 Apr 2006 19:53:43 -0400

> [sSRI-Research] Pringle - Accutane - Another Case of Too

> Little Too Late

>

>

>

>

> Accutane - Another Case of Too Little Too Late

>

> http://www.lawyersandsettlements.com/articles/accutane.html

>

> April 12, 2006. By Evelyn Pringle

>