The Legal Examiner Affiliate Network The Legal Examiner The Legal Examiner The Legal Examiner search feed instagram google-plus avvo phone envelope checkmark mail-reply spinner error close The Legal Examiner The Legal Examiner The Legal Examiner
Skip to main content

The U.S. Food and Drug Administration on May 15 approved for the treatment of “moderate to severe ulcerative colitis” a drug already approved to treat arthritis, Simponi (golimumab) injection. That means there is a new drug available to treat a condition that some, but not all, science has linked to the use of isotretinoin, once sold in the U.S. under the brand name Accutane.

The FDA approved Accutane in 1982 for the “treatment of severe, recalcitrant nodular acne that is unresponsive to conventional therapy, including antibiotics.” Inundated with Accutane lawsuits and generic competition, Accutane’s manufacturer, Hoffmann-La Roche, withdrew the medication from the domestic market in 2009. Hence, Accutane’s increased risks live on in the remaining isotretinoin-containing drugs, which are marketed under the FDA’s restricted-distribution program.

In addition to ulcerative colitis, which, along with Crohn’s disease, falls under the heading of inflammatory bowel disease, Accutane has been associated with an increased risk of birth defects.

Both birth defects and IBD were among Accutane’s labeled warnings.

In regard to IBD, a part of the labeling read, “In some instances, symptoms have been reported to persist after Accutane treatment has been stopped.”

A part of the birth defects warning read, “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.”

If many patients had known about the increased risks, as the manufacturer should have, then they might have been able to avert them, plaintiffs in Accutane lawsuits can claim.

Hoffmann-La Roche has been defending itself from thousands of U.S. pharmaceutical injury lawsuits, according to the manufacturer’s most recent annual report.

Referring to 7,830 Accutane actions that had been filed as of the end of 2012, the annual report explained, “The litigation alleges that Accutane caused certain serious conditions, including, but not limited to, inflammatory bowel disease, birth defects and psychiatric disorders … Most of the actions allege IBD as a result of Accutane use.”

Juries had awarded tens of millions of dollars in damages to the victims of Accutane side effects, according to HLR’s annual report.

# # #

The Accutane attorneys at Reich & Binstock ( want to help victims of the drug’s increased risks. For a free attorney consultation, one may call the law firm, no matter the state of residency, toll-free at 1-866-LAW-2400.

Comments are closed.