FDA May Strengthen Chantix Label

FAA bans pilots and air controllers from using Chantix after report

(NEWSER) - Pfizer smoking-cessation drug Chantix has been linked to nearly a thousand serious incidents in the last quarter of 2007, the Wall Street Journal reports. A report from a drug safety group found that some users of the drug—already linked to depression and suicide—suffered heart trouble, diabetes, or accidents caused by dizziness and confusion. More»

Smokers with mental illnesses should avoid them, agency says

(NEWSER) - The Food and Drug Administration is warning smokers about serious mental-illness risks of two smoking-cessation drugs, as reported suicides among their users increase. Chantix and Zyban must now carry the agency’s strongest warning label, the New York Times reports. The FDA isn’t trying to scare patients, an official says: “You should just be careful.” More»

Big pharma uses tricks, distractions to veil harmful side-effects

(NEWSER) - Drug ads are multiplying on TV, and manufacturers are starting to advertise medical equipment used in invasive procedures, so now might be a good time to wonder what the spots are telling us. Not as much as they should, Time reports. An independent researcher has found drug companies are using distractions, fast-talking, and tricks gleaned from neuroscience to downplay negative side-effects. More»

FDA-approved medications pass clinical trials, but the real world uncovers more

(NEWSER) - Despite rigorous testing, some drugs have side effects that only rear their ugly heads when introduced to the general population. Forbes catalogs some of the weirdest:

1. Anti-smoking drug Chantix can cause insomnia and nightmares.
2. Diet drug Alli can have unforeseen gastrointestinal side-effects; these can be counteracted by eating a low-fat diet, of all things.
3. Mirapex, prescribed for Parkinson's and restless-leg-syndrome patients, can lead to compulsive-eating and gambling urges.

'Off-label' use under scrutiny after fatalities, severe reactions

(NEWSER) - The FDA is investigating the safety of Botox and a competing medication after learning that the drug might have caused death and breathing problems in children being treated for cerebral palsy, Reuters reports. That's not an approved use for the cosmetic drug; docs administer it because it can block nerve impulses and relax spasmodic muscles. No adult deaths were reported, according to the Wall Street Journal. More»