By now, consumers have heard the names Fen-Phen
and Baycol and many know regulators recalled both drugs after finding
they can have serious, sometimes deadly side effects. But most
of us would likely be shocked to discover that each year, authorities
recall an average of 15 drugs because of similar life-threatening
problems. It’s important then to understand what a drug recall
entails, how often one occurs and where you can find the most up-to-date
recall information.
Both the U.S. Food and Drug Administration and
drug manufacturers have the ability to initiate a recall. There
are three levels of product recall. The most serious of these,
known as a Class I recall, occurs when there is a reasonable probability
that the use of or exposure to the recalled product will result
in serious adverse health consequences or death. The Fen-Phen and
Baycol® recalls were both of the Class I variety.
A Class II recall occurs when the use of or exposure
to the recalled product may cause temporary or medically reversible
adverse health consequences or where the probability of serious
adverse health consequences is remote. For example, the maker of
Nasonex® allergy dispensers temporarily recalled the drug because
it came out in a spray instead of a thin mist, delivering too much
medication per dose. In the U.S., there are about 250 Class II
recalls annually.
A Class III recall occurs when the use of or exposure
to the recalled product is not likely to cause adverse health consequences.
For example, Aventis Pharmaceuticals recalled two lots of the antihistamine
Allegra® because the labels indicated that the boxes contained
capsules when they actually contained tablets. Annually, there’s
an average of 125 Class III recalls in the U.S.
To find the latest information on drug recalls,
you could go to the FDA’s
Website, Class I recalls appear on the site’s homepage.
The remainder of recalls is buried deeper in the site. An easier
option for consumers is safetyalert.com. This site takes its information
directly from FDA reports, but makes it easier for the average
consumer to read and understand.
As with any aspect of your health, it’s
critical that you be a vigilant, active participant. Educate yourself
about the risks of any drugs you are prescribed and keep up with
the status of those drugs.
By law, drug manufacturers can be held liable
for injuries caused by a defective or unreasonably Dangerous
Drug Product, even if the manufacturer was unaware of the danger.
At The Rasansky Law Firm, we work to help victims who sought to
improve their health, but instead were injured by the very drugs
they relied on for relief.
If you or a loved one has suffered due to the
effects of a Dangerous Drug or
an Over The Counter Drug,
please contact the Rasansky Law Firm to look into your potential
claim.
