Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Wednesday, July 1, 2009

Fourth Time's the Charm for Chantix?


More bad news for drugmakers today. Chantix, the prescription smoking-cessation aid from Pfizer, will now require a black box warning, the FDA said today. Reports that the drug may increase suicidality as well as seriously altered behavior aren't being taken lightly by regulators. 

Forbes.com mentioned something significant about this decision that many other media outlets didn't: This is the fourth (!) label change for the drug. Zyban, from GlaxoSmithKline, will also require the black box label. That pill is better known as Wellbutrin--the name used when it's sold as an antidepressant. But the FDA's edict will affect Pfizer more, as it's struggled to find another market blockbuster like Viagra. Chantix has been a big money maker for Pfizer in the past, but sales have plummeted as warning after warning has been slapped on the pills. 

While of course this decision was made to protect lives, MediaNewser worries it may mean higher prices for other Pfizer products across the board--and another hit to health consumers' already stressed wallets. 

Photo courtesy of FreeFoto.com.

Tuesday, June 30, 2009

Is the Next Tylenol Scare Upon Us?



Tylenol and other analgesics are under scrutiny this week by the FDA, due to reports of liver damage--some patients required liver transplants, and some have even died--from accidental overdoses of Tylenol. Back in May, the FDA recommended the packages of Tylenol have stronger warnings added

The FDA is also recommending the maximum adult dose be reduced to 650 mg...that's significantly less than the 1,000 mg most adults take when they pop two of the extra-strength kind. 

What I find interesting is that there are two spots on the Tylenol.com web site that hint about health issues related to Tylenol. But they're teeny tiny--and I mean teeny tiny (see above). Sorry, have to get my glasses to see that! 

Advil.com, on the other hand, which is also facing potential labeling changes, has a very in-your-face message on their homepage about 10 times bigger than the one on Tylenol's site. Not that I expect the average consumer to head to these companies' sites before taking their pills, but I'd expect traffic to these sites will likely increase when the FDA meeting concludes today and press coverage sees a boost. Advil's being much more transparent; Tylenol seems to be acting like a company that has something to hide.

The medical community's concerns about Tylenol go back years; University of Washington researchers have studied liver damage that occurs when acetaminophen is taken along with caffeine, and of of course combining the drug with alcohol also increases the potential for irreversible liver damage. 

Next time I have a headache, I'm pulling a grandma and will use an old-fashioned ice pack.