Most people know that prescription drugs must be approved by the Food and
Drug Administration before they can legally be sold in the United States.
But many people don’t realize that the decision to approve or reject
a drug is rarely easy or straightforward. The benefits of a given drug
must be weighed against known side effects, which can be serious or even
fatal in some cases.
Unfortunately, some side effects may not become clear until after the drug
is approved and comes into widespread use. At this point, the FDA may
decide to change warning labels on
dangerous drugsto better reflect hazards to consumers.
A good example is what happened with the smoking cessation drug Chantix,
which is manufactured by Pfizer. The drug was originally approved by the
FDA in 2006, and it achieved almost instantaneous popularity because it
was shown to be highly effective at helping smokers kick the habit.
Within a few years, however, the FDA had received numerous reports of "neuropsychiatric"
side effects, including suicidal thoughts, depression, agitation and hostility.
The families of some Chantix users even brought legal action against Pfizer,
claiming that the drug caused their loved ones to attempt or complete
suicide. The FDA eventually required Chantix to carry a "black box"
warning label, which is the strongest warning the FDA issues.
Recently, the FDA issued yet another Chantix warning. It relates to dangerous
side effects that can occur when some Chantix users drink alcohol while
on the drug. There have been numerous reports of patients experiencing
blackouts, increased aggressive behavior and even seizures. The FDA cautioned
that "until patients know how Chantix affects their ability to tolerate
alcohol, they should decrease the amount of alcohol they drink."
It is an unfortunate reality that all of a drug's risks and side effects
often cannot be known before the drug is approved. If pharmaceutical companies
make a good-faith effort to do their research and warn of new threats
as they become known, most problems can be resolved with little harm.
But when companies cover up known problems and avoid warning consumers,
they may be held liable for the harm they cause to patients.
Source: HNGN.com, "
FDA Warns Of Seizures And Alcohol Intolerance With Chantix," Kelsey Breunig, March 11, 2015