Whether a medication guide provided by Roche for its Accutane acne drug adequately warned of inflammatory bowel disease will have to be decided by a jury in litigation brought against the drugmaker by 84 people in a New Jersey state court,Mealey's Emerging Drugs & Devices reports.
The plaintiffs allege Accutane caused them to develop IBD and Roche sought a summary judgement to dismiss the litigation, arguing that a patient medication guide adopted in January 2001 made warnings about IBD adequate, according to Mealey's. But Superior Court Judge Carol Higbee agreed with the plaintiffs that the language of the med guide does not mention IBD.
"In fact, the new language refers generally to ‘the liver, pancreas, and bowel,’ ” she wrote. "It is so general it could be found to weaken the information in the label, not strengthen it. There is no direct reference to IBD.” She added the guide also states symptoms “may not get better” after Accutane is stopped. “It is not disputed,” she wrote, “that if you have IBD, you will not get ‘better,’ in the sense you will ever be cured.”
Other language in the medication guide that Accutane “could lead” to serious health problems that “may not” clear up is “ambiguous,” Higbee continued. Noting that four juries have found that Accutane causes IBD (back story), Judge Higbee said, " 'could lead’ and ‘may not’ are just not direct enough to render the warning adequate as a matter of law even if they directly discussed IBD which they did not. Again, it may be adequate, but it clearly is a jury question.”
The judge rejected Roche’s argument that the guide and existing package insert form an adequate warning. Higbee already denied summary judgment on the package insert warnings and said the guide is not “sufficiently forceful to render the warning adequate as a matter of law.” And so she decided the question of whether inserts after May 2002 and the January 2001 medication guide are adequate warnings are questions best left to a jury.
4 Comments
I took two courses of Accutane in the early 80's and not only did it clear up the acute cystic acne that I had all over my face and torso, but I never had any of the side effect problems that have evolved over the years. The only side effect I can recall was the cost which was $200 per month for 5 months - extremely expensive at the time, luckily I had good insurance. Not sure I'd be running to my derm to get a scrip today, however...
My daughter was 16 when she was on Accutane for 5 months. She started experiencing GI issues about a year later and now at the age of 23 has full blown Crohns. In conversation with the GI spec, the occurance of GI/IBD issues among young women is on the upswing. The dermatologist scares you death with precautionary measure to prevent pregnancy, but never mentions any GI/IBD issues as being a risk.
I wish I had never heard of accutane. It haunts me every single day. I ask myself - why did i make that fateful and unnecessary decision to take accutane. Clearly at the time, I had no idea that I would suffer a lifetime of complications and surgeries from ulcerative colitis. I have had my bowel removed and a pouch surgically formed which is constantly afflicted with inflammation. Anyways, i thought the worst thing to expect was dry skin and temporary hair loss.
I will let you all know how she makes out with the treatment.
swhe didn't do well with anything else.