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Accutane, Pregnancy & Birth Defects

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Evelyn Pringle is a columnist for Independent Media TV and an investigative journalist focused on exposing corruption in government. She has just posted a well-researched article on Accutane and its trail of misery, particularly for pregnant women. 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.

Evelyn Pringle is a columnist for Independent Media TV and an investigative journalist focused on exposing corruption in government. She has just posted a well-researched article on Accutane and its trail of misery, particularly for pregnant women.

Accutane – Another Case of Too Little Too Late

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.

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.

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.

The shameful delays in alerting and protecting the public are outlined in the remainder of this powerful article.

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.

“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.”

…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.”

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.