FDA Issues Warning About the Risk of Byetta Kidney Failure
The Food and Drug Administration (FDA)
recently issued a warning about the risk of Byetta kidney failure for
those who are taking the drug to help control type 2 diabetes. The
agency is requiring changes to the label that will provide more
information about the potential for this dangerous side effect.
Also known as exenatide, the medication
is intended to aid in the control of blood glucose levels in those
suffering from diabetes. It is administered with an injection under
the skin and works by helping the pancreas produce insulin more
efficiently. Though the drug has been linked to
severe cases of pancreatitis, some of the common Byetta side effects
may seem less serious and indeed commonplace among prescription
medications. These include: Loss of appetite
Weight loss Heartburn Nausea Vomiting Dizziness Headache Feeling jittery Diarrhea
However, these less severe symptoms
could be warning signs of something more serious – for example,
nausea. Doctors believe that the major cause of this is the effect
that the drug has on the stomach. If a patient begins vomiting, the
volume of fluid in their body decreases – and if this volume
becomes low enough, kidney damage can occur. Therefore, for those
taking Byetta kidney failure can be a troubling concern. Of the 78 cases of renal problems
related to the medication that were reported to the FDA between 2005
and 2008, 91% of the patients were hospitalized, 18 required
dialysis, 2 required transplants, and 4 died. Half of the patients
who subsequently discontinued use of the medicine showed improvement
afterwards.
The labeling changes required by the
FDA include: Information about post-market
reports of acute renal failure, highlighting that patients with
severe renal impairment should not use the drug Recommendations to doctors that
they should be cautious about initiating or increasing doses in
patients with moderate renal impairment Recommendations that doctors
carefully monitor patients for the signs of kidney failure Information about renal damage in
the patient Medication Guide that will help people understand the
associated risks
Diabetes is a life-altering condition,
and those who suffer from it should have all of the available
information about the potential risks and benefits of different
treatments. Diabetes renal failure is only one of a number of
potential complications. Both patients and their doctors should
be on the lookout for any of these renal failure symptoms during a
course of this medication: Changes in frequency of urination Dark urine Dull ache in the mid to lower back Swelling of the hands or feet Increased blood pressure Changes in appetite Changes in digestion Lethargy
In addition to remaining alert in
watching for these symptoms, there are also a number of precautions
that patients should keep in mind after receiving a prescription for
an exenatide injection:
Use it exactly as prescribed,
following the directions on the label Do not use in larger amounts or
for a longer time period than recommended Do not administer immediately
after eating a meal Never share the pen with another
person Check your blood sugar levels
regularly Use for no more than 30 days, and
then discard Avoid drinking alcohol while
taking this medicine Inform your doctor of all other
drugs that you are using, including over-the-counter vitamins or
minerals
If you are using this drug, you should
alert a medical professional if you notice any of these symptoms of
kidney damage, and should always consult with a doctor before
discontinuing a medication. However, if you have been diagnosed with
any of the conditions detailed here, you may want to seek legal
advice as well. There are already lawsuits pending against the
manufacturers, claiming that they failed to adequately warn about
these potential risks. A qualified attorney can assist anyone
interested in seeking compensation for the costs associated with
healthcare, lost wages, and general pain and suffering.
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