Accutane may be buried but the generic form, isotretinoin, is alive and may be hurting. Roche Holding pulled Accutane off the market in June 2009, about 15 years too late for countless victims of Accutane injury. Since its approval in 1984, the drug had been linked to psychological changes, suicidal behavior, auto-immune disease, central nervous system problems, birth defects and most notably, inflammatory bowel disease (IBD).
But Roche didn’t discontinue manufacturing its blockbuster drug for safety reasons. Instead it had to do with legal and economic issues: generic competitors reduced the drug’s market share to less than 3 percent — Accutane’s departure leaves Claravis (Teva/Barr) with 54.8 percent of the isotretinoin market, followed by Amnesteem (Mylan/GenPharm) and Sotret (Ranbaxy), each with 22.8 percent. And Roche has paid out plenty in personal injury lawsuits. (To date, juries have awarded more than $33 million to patients who blame Accutane for their IBD.)
So the pharmaceutical industry spawns other generic forms of Accutane, called isotretinoin, priced from 10 percent to 65 percent (Sotret) less than Accutane. That may be good news for some lawyers–one attorney has filed more than 100 similar cases against makers of generic isotretinoin–but bad news for teens and young adults who (might) weigh the odds and decide they would rather develop IBD than suffer with acne and hey, the medication is now so much more affordable. Granted, acne can be debilitating emotionally. It can cause high levels of anxiety or depression during teen years, reason enough to disregard more dangerous side effects such as IBD.
The dermatology jury isn’t out on isotretinoin, yet. One dermatologist says that pharmacists mistakenly believe all isotretinoin products are therapeutically equivalent and they prescribe the generic brand because their patients wanted a cheaper product. “Dermatologists were essentially forced by patients to abandon [Accutane],” says Dr. Taub, who believes that “bioavailability from patient to patient differs so much more with generic isotretinoin than with Accutane.” Dermatologist Ty Owen Hanson says Claravis didn’t seem to work for his patients. “It was almost like patients were taking a placebo.”
Another dermatologist, Dr Webester, says Accutane and its generics possess identical pharmacokinetic curves. Dr. Feldman says he sees no difference between Accutane and its generics and doesn’t know which generics his patients get. Generally dermatologists stopped prescribing Accutane when the Roche reps stopped coming by with free samples, about the same time the generic isotretinoin debuted. More than two decades after Accutane’s introduction, it still cost up to $1,200 monthly, versus $600 to $900 for generics.
So the end of Roche’s blockbuster drug paves the way for other drug companies to cash in. But will generic manufacturers remain in the marketplace if they begin to get slapped with personal injury lawsuits? After all, there’s only one way to spell isotretinoin…