Unsafe
Drugs
In recent years, several drugs and dietary supplements have been
linked to serious health problems, clearling outweighing their potential
benefits. According to the Journal of the American Association,
adverse drug reactions resulting from correctly administered Federal
Food and Drug Administration (FDA)-approved prescription drugs are
responsible for over 100,000 deaths per year in the United States
making it the fourth leading cause of death in the United States.
There are also
typically over 2.2 million annual occurrences of non-fatal, but
serious, reactions, and millions of complications and disabilities
related to the unexpected effects of drugs and a variety of products.
Drug
Recalls, Warnings & Alerts
The Food and Drug Administration (FDA) is responsible for ensuring
the safety of a variety of products, including drugs, medical devices
and foods. A RECALL is an action taken to remove a product from
the market. Recalls are conducted by FDA request or on the initiative
of the manufacturer. In many recall situations (Class I Recall)
there may be a reasonable probability that the use of or exposure
to a product will cause serious injury or death. A Class II Recall
is a situation where use or exposure to a product may cause temporary
or medically reversible injury. The recall of a defective or harmful
consumer product is sometimes publicized in newspapers and in news
broadcasts. This may be especially true when a recall involves drugs,
medical devices, foods or other products regulated by the FDA. The
FDA seeks publicity about a recall only when it believes the public
needs to be alerted about a serious hazard.
The
FDA expects companies to take full responsibility for product recalls,
including follow-up checks to assure that recalls are successful.
FDA guidelines call on manufacturers to develop contingency plans
for product recalls. After a recall is completed, the FDA makes
sure that the product is destroyed or suitably reconditioned and
investigates why the product was defective.
A SAFETY ALERT
is issued in situations where a medical device or product may present
an unreasonable risk of substantial harm. In some cases, these situations
are also considered recalls.
RecalledDrugs.com is a law firm produced newsletter about product safety and product liability. This is not a government, manufacturer, or medical website. Information may not be complete or current.
Some products on this website may not be subject of a warning or recall. You should not stop medication without first consulting your doctor.
If you have a medical question or concern you should consult a qualified physician. |
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