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Accutane (isotretinoin) is a pharmaceutical drug prescribed to treat severe acne. Generally, Accutane was only prescribed to patients that did not respond to other conventional acne therapies. The drug was first approved by the U.S. Food and Drug Administration (FDA) in 1982. Originally manufactured by Roche Pharmaceuticals, Accutane was prescribed to more than 13 million people since its introduction to the market.

Common side effects associated with Accutane include:

  • Nosebleeds
  • Dry skin
  • Bone or joint pain
  • Skin infections
  • Inflammation of the lips or eyes
  • Peeling skin
  • Dizziness
  • Drowsiness

Since its inception, Accutane has been mired in controversy due to several severe and potentially catastrophic side effects. In 2009, the acne medication was withdrawn from the market by Roche Pharmaceuticals partly due to the increasing cost of lawsuits, according to the company.


When Accutane was approved by the FDA in 1982, several published articles and studies had already linked the acne medication to severe birth defects.

One year later, the FDA required a warning label on the medication, warning women of Accutane’s danger to unborn children. The warning would soon be changed to the FDA’s strictest safety warning — a black box or boxed warning. In 1988, the FDA reported that approximately 1,000 children were born with defects, 1,000 were miscarried, and upwards of 7,000 women had abortions after taking Accutane.

Miraculously, the drug remained on the market for more than 20 years after the report. Instead of issuing a recall on the dangerous drug, the FDA implemented a program that would require women to sign consent forms, take regular pregnancy tests, and receive education while taking Accutane. Other safeguards were put in place, such as requiring women to use extra contraceptive protection while on the medication and only administering a 30-day supply of the drug.

Five pages worth of warnings and precautions regarding the risk of birth defects in women taking Accutane were put in the patient medication guide. Despite the certainty of causing birth defects in pregnant women, Accutane remained on the market.

Birth defects caused by Accutane usage during pregnancy include:

  • Skull abnormalities
  • Ear abnormalities
  • Eye abnormalities
  • Facial dysmorphia
  • Cleft palate
  • Brain abnormalities
  • Cardiovascular abnormalities

If your unborn child or newborn baby was affected while you underwent Accutane treatment, contact Thomas J. Henry. Our team of experienced dangerous drug lawyers are available to evaluate your claim and see if you could be entitled to compensation for your child’s injuries.


Accutane has been linked to an increased risk of developing serious gastrointestinal disorders, such as inflammatory bowel disease. Instances of inflammatory bowel disease has been reported in patients without any prior intestinal issues. In addition, some symptoms of this disorder have been reported even after Accutane treatment has ceased.

Inflammatory bowel disease symptoms may include:

  • Abdominal pain
  • Rectal bleeding
  • Severe diarrhea
  • Fever
  • Fatigue
  • Reduced appetite
  • Weight loss

In 2005, the FDA required a label change on Accutane to reflect the risk of developing depression and suicidal thoughts. Among isotretinoin users in the United States, there were nearly 5,000 reports of psychiatric disturbances between 1982 and 2004, including 190 suicides. Although no causal association can be established, the agency recommends that patients taking Accutane be monitored for any changes in mood or behavior that could signal new or worsening depression or suicidal thoughts.

Signs and symptoms of depression may include:

  • Feelings of sadness
  • Crying spells
  • Sleeping too much or having trouble sleeping
  • Irritability, anger, aggressiveness
  • Change in appetite and body weight
  • Withdrawn from family and friends
  • Thoughts of self-harm or suicide

Patients who suffer these symptoms while taking Accutane should contact their healthcare provider immediately. If you have taken Accutane for acne treatment and you developed a serious gastrointestinal disease or depression, you may be entitled to compensation. Roche Pharmaceuticals was required to pay a man $25 million after the man claimed Accutane use in 2003 caused him to have his colon and rectum removed. The man alleged that Roche failed to provide proper warning about the health risks associated with the dangerous acne medication.


If you or a loved one have been injured after taking the dangerous acne drug Accutane or another isotretinoin generic medication, contact Thomas J. Henry. Our experienced pharmaceutical drug litigation attorneys are available 24/7, nights and weekends to hear your case and determine if you may be entitled for compensation for the damages you have incurred. Pharmaceutical companies continue to put profit before safety. Thomas J. Henry has the legal and financial resources necessary to take on the pharmaceutical giants and bring them to justice. Call today for a free legal consultation.


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