California Accutane Lawyers

What is Accutane?

Accutane is indicated for the treatment of severe recalcitrant nodular acne, but was originally developed as achemotherapy medication and is still used in that capacity because it kills rapidly dividing cells. Accutine is the chemical isotretinoin (also marketed as Amnesteem, Claravis, and Sotret.)

Because of Accutane's teratogenicity and to minimize fetal exposure, Accutane is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE™. Accutane must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Accutane must only be dispensed by a pharmacy registered and activated with iPLEDGE, and legally can only be dispensed to patients who are registered and meet all the requirements of iPLEDGE

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.

Accutane must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.

Birth defects which have been documented following Accutane exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported.

Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted.

If pregnancy does occur during treatment of a female patient who is taking Accutane, Accutane must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.

Accitame has been seen to show impairment of neuronal division in the murine hippocampus, and reductions in orbitofrontal brain metabolic rates in humans. This preclinical and neuroimaging data may suggest biological plausibility for the suspected psychiatric adverse events associated with isotretinoin.

• diffuse alopecia areata
• headache
• conjunctivitis
• hyperlipidaemia
• raised liver enzymes
• myalgia and/or arthralgia
• raised blood glucose level
• fatigue
• cataracts; optic neuritis
• optic neuritis
• inflammatory bowel disease
• pancreatitis
• hepatitis
• degenerative disc disease
• bone disease
• birth defects
• decreased frontal lobe function
• depression and suicidal behavior

• Tirado Sánchez A, León Dorantes G. Actas Urol Esp. 2005 Nov-Dec;29(10):974-6. Erectile dysfunction during isotretinoin therapy
  
• Kontaxakis VP, Skourides D, Ferentinos P, Havaki-Kontaxaki BJ, Papadimitriou GN. Ann Gen Psychiatry. 2009 Jan 20;8:2.Isotretinoin and psychopathology: a review.
  
• Lee SM, Kim HM, Lee JS, Yoon CS, Park MS, Park KI, Namgung R, Lee C. Yonsei Med J. 2009 Jun 30;50(3):445-7. Epub 2009 Jun 23.A case of suspected isotretinoin-induced malformation in a baby of a mother who became pregnant one month after discontinuation of the drug.
  
• Heckel S, Favre R, Weber P, Dellenbach P. J Gynecol Obstet Biol Reprod (Paris). 1993;22(1):43-7. Teratogenicity of retinoids
  
• Anick Bérard, Laurent Azoulay, Gideon Koren, Lucie Blais, Sylvie Perreault, and Driss Oraichi; Br J Clin Pharmacol. 2007 February; 63(2): 196–205. Published online 2007 January 3. doi: 10.1111/j.1365-2125.2006.02837.x.Isotretinoin, pregnancies, abortions and birth defects: a population-based perspective
  
• Gupta, Gupta, British Journal of Dermatology,Volume 139,Issue 5, Pages 846 - 850; 1998 British Association of DermatologistsDepression and suicidal ideation in dermatology patients with acne, alopecia areata, atopic dermatitis and psoriasis
  
• FDA Warns: FDA Warning: Don't Buy Accutane Over the Internet
  
• Isotretinoin-induced inflammatory bowel disease in an adolescent; Reniers and Howard Ann Pharmacother.2001; 35: 1214-1216 Isotretinoin-induced inflammatory bowel disease
  

If you were exposed to Accutane, and developed problems, lost a child, or if your child's life has been severely impacted by Accutane or another form of isotretinoin, you should seek a free consultation regarding your legal rights. Our Accutane lawyers have the experience and resources necessary to obtain compensation from pharmaceutical companies.

If you have experienced complications, you can act now. We can help you get the compensation you deserve.

Use the Free Evaluation form to tell us about your situation or call us today.

Back to Pharmaceutical Litigation.