Patient Heart Attacks Inspire More Prominent Avandia Warning
The
Food and Drug Administration (FDA) has strict regulations relating to
the information that is displayed on drug packaging, and in the
patient information provided with the prescription. Regulations
designate certain types of labels based on several risk factors,
including the severity of the adverse reactions, and the percentage
of people that have actually exhibited those same symptoms. Recently,
GlaxoSmithKline was required to adjust the Avandia warning that
accompanies their brand name rosiglitazone medication.
Each
level of patient alert requires manufacturers to prominently display
complete descriptions of issues that may arise. In the most extreme
cases of life-threatening problems, the FDA requires what is called
“black box” labeling, which is the most extreme alert that can
accompany a legal drug. Unfortunately, in 2007, two studies were
published that forced the FDA to reevaluate the Avandia warning that
came with prescription information, and require GlaxoSmithKline to
provide more information about the life-threatening dangers of using
the popular diabetes therapy. The
most prominent study was published in The
New England Journal of Medicine
and concluded that patients taking the drug had a dramatic increase
in the likelihood that they would experience a heart attack. In fact,
their chances increased by as much as 43%. While the FDA mandated
that GlaxoSmithKline conduct more studies, and change their Avandia
warning, Canadian officials said that the therapy could only be used
with other drugs that help control the risks. They also warned that
previous heart failure victims should not use it. The
fact that the medication may cause heart attacks and heart failure is
especially troubling, considering that it is a prescription typically
prescribed to treat patients of type II diabetes. While most people
know that this malady does require a lifetime of maintenance and
possibly insulin injections, many people do not know that, due to the
complications of their disease, diabetics are already at an increased
risk of heart problems. If
you are a type II diabetic patient that is currently taking this
medicine, pay close attention to the following issues, even if they
are mild, but especially if they are severe or last for several days,
as they may be a sign of future heart attack or failure. Shortness
of breath (dyspnea), breathlessness at any time, but especially
while resting or lying flat Coughing
and wheezing, particularly if it produces white or pink mucus Edema,
or the unusual buildup of fluid under the skin or other tissues Fatigue
or tiredness Lack
of appetite due to nausea Confusion
and impaired thinking Drastically
increased heart rate
If
you have ever taken any of GlaxoSmithKline’s rosiglitazone drugs,
and are feeling ill, contact your health care professional for more
Avandia
information
immediately. If your doctor or physician diagnoses you with any of
the problems outlined above, they may have been caused by the
medications, and you may be eligible to start or join an existing
lawsuit, or pursue one of your own. To determine the recompense that
you may be owed, contact one of our top attorneys immediately.
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