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Accutane®

Do not discontinue taking any medications without first consulting your physician.

Update: FDA ALERT [7/2005]: Suicidal Thoughts or Actions: In addition to the strengthened risk management program, FDA continues to assess reports of suicide or suicide attempts associated with the use of isotretinoin. All patients treated with isotretinoin 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.   Patients should stop isotretinoin and they or their caregiver should contact their healthcare professional right away if the patient has any of the previously mentioned symptoms. Discontinuation of treatment may be insufficient and further evaluation may be necessary. [Action taken 08/12/05 Labeling revision]

Accutane, or isotretinoin [eye-so-TRET’n-o-in], is an oral drug prescribed for severe nodular acne, the emotionally scarring type that causes pus-filled lesions and pitted scars. Since the early 1980s, Accutane has been considered the biggest breakthrough drug to permanently clear severe acne that was unresponsive to other treatments. However, since its approval, Accutane’s growing list of side effects has come under close scrutiny by the FDA. From the beginning, users were warned against possible birth defects associated with Accutane use. Later, severe depression was added to the list of possible serious side effects. Others include seizures, stroke and permanent loss of sight.

How does Accutane work?
Accutane is a member of the retinoid drug family, a synthetic form of vitamin A, which helps to combat infections. The drug works to regulate the amount of oil (sebum) the sebaceous glands produce which helps to unclog infected pores. Accutane was developed by Roche Laboratories in 1982 and is used as a last resort treatment for severe acne that is unresponsive to other antibiotic treatments.

What are the biggest dangers associated with Accutane?
Before its approval, studies showed that Accutane could cause fetal abnormalities in lab animals and, once it was approved, the FDA warned users of potential birth defects with Accutane use. According to The New York Times, since 1982, 25 to 35 percent of babies whose mothers took Accutane during their pregnancy suffered malformations of the head, face and heart. Many more developed learning disabilities and other problems not obvious at birth. More recently, numerous reports of severe depression and suicide attempts have been linked to Accutane users.

What serious side effects are associated with Accutane?
In Accutane’s Medication Guide, which is given to every prescribed user, the FDA lists the possible serious side effects known to be associated with Accutane use:

Birth defects
deformities, miscarriage, premature birth or death of the baby

Mental problems
depression, sleeping disorders or suicidal thoughts and attempts

Brain problems
severe headaches, seizures or stroke

Stomach problems
abdominal pains, rectal bleeding or dark urine

Bone and muscle problems
back and joint pain

Hearing problems
hearing loss or constant ringing

Vision problems
loss of sight, blurred vision or painful dryness

Lipid problems
high levels of cholesterol and other fats

Allergic reactions
fever, rash or red patches and/or bruises on legs

Others
including trouble breathing, convulsions, slurred speech and blood sugar problems

How many people have been injured as a result of taking Accutane?
Accutane has been prescribed to over 12 million people worldwide, including 5 million in the United States. According to the Associated Press, between 1982 and 2001, the FDA was notified of 2,181 women who became pregnant while on Accutane. Those pregnancies resulted in 1,310 elective abortions, 242 spontaneous abortions, 192 normal babies born, and 166 reports of babies born with abnormalities. As of January 2002, the New York Times says the FDA has received 140 reports of suicide among Accutane users worldwide (94 in the U.S.). Another 257 were hospitalized with extreme depression or for attempted suicide.

What is being done to protect consumers?
The FDA has been working with Roche over the last two decades to properly warn consumers of Accutane’s possible side effects. Presently, FDA officials say there is no proof that Accutane directly causes depression, but there have been enough reports to properly warn consumers. After Roche made the appropriate label changes, each user now has to sign a consent form, acknowledging the possible serious side effects, including psychological, associated with Accutane.

Because of the high rate of birth defects, female users are now required to have two negative pregnancy tests before their first prescription and a monthly pregnancy test before they can be refilled. They are also required to use two forms of birth control while taking Accutane and a month after they stop taking it.

What should I do if I am taking Accutane?
The FDA lists numerous possible side effects associated with Accutane on its Medication Guide, which is given to every prescribed user. If you experience any of these side effects, speak with your doctor or dermatologist immediately and discuss alternative acne treatments. If you feel you have been injured as a result of using Accutane, contact us for a free consultation.


Do not discontinue taking any medications without first consulting your physician. This article is for informational purposes only. It is not intended to constitute medical advice and should not be viewed as such. For medical advice, you should always consult with your physician.

Accutane® is a registered trademark of Hoffman-La Roche. The reference to the registered trademarks of Hoffman-La Roche is used here only for the purpose of identifying the product in question.

This law firm is not affiliated with, sponsored by or associated with Hoffman-La Roche, the FDA, the New York Times, or the Associated Press.

 

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