Chantix/Champix To Get Suicide Warning In Australia

OK, this is weird. There are hundreds of reports of suicide, suicidality and depression connected to the stop smoking drug Chantix (Champix elsewhere) among people who've taken the drug in the US. They've been reported to the FDA, which presumably will act upon them once it's gotten off its butt and its lawyers and Pfizer's lawyers have had nice little go-round, or however it is the game actually works when a newish drug is under a safety review. Meanwhile, Australia's Therapeutic Goods Administration (their FDA) has already acted before Chantix even goes on the market in Oz next month. According to this press account, the TGA is using the same reports that were submitted to the FDA. So far, the FDA isn't doing much to safeguard the American public and, to be honest, neither is the media in this country (outside of some smart coverage in the Dallas area).

The TGA will require Pfizer to add a warning to the drug's packaging advising of links to suicidality in users of the drug. It's also making the company send a Dear Doctor letter out as well. That's something that needs to be done in this country, as I noted last week. Or does the FDA want another Zyprexa situation where in 2002 the Japanese government required Lilly to 'fess up about diabetes and hyperglycemia and the FDA sat on its thumbs for another two years? Has the FDA learned from that experience? I'm beginning to think not. Apparently, the FDA thinks it's OK for Americans to die so that Aussies can be properly warned, as opposed to using the evidence to address the need where it's greatest--you know, in America.

As for Pfizer, one wonders when they are going to get smart and get ahead of the game by addressing the drug's problems now instead of later. I'm still waiting for some answers.