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U.S. Food and Drug Administration (FDA) Advisories
U.S. Food and Drug Administration (FDA) Advisories
- December 3, 2013: Onfi (clobazam):
FDA is warning the public that the anti-seizure drug Onfi (clobazam)
can cause rare but serious skin reactions that can result in permanent
harm and death. FDA approved changes to the Onfi drug label and the
patient Medication Guide to describe the risk of these serious skin
reactions.
- November 25, 2013: Rosiglitazone-containing Diabetes Medicines:
FDA has determined that recent data for rosiglitazone-containing drugs,
such as Avandia, Avandamet, Avandaryl, and generics, do not show an
increased risk of heart attack compared to the standard type 2 diabetes
medicines metformin and sulfonylurea. As a result, FDA is requiring
removal of the prescribing and dispensing restrictions for rosiglitazone
medicines that were put in place in 2010. This decision is based on FDA
review of data from a large, long-term clinical trial and is supported
by a comprehensive, outside, expert re-evaluation of the data conducted
by the Duke Clinical Research Institute (DCRI).
- November 20, 2013: Lexiscan (regadenoson) and Adenoscan (adenosine):
The FDA is warning health care professionals of the rare but serious
risk of heart attack and death with use of the cardiac nuclear stress
test agents Lexiscan (regadenoson) and Adenoscan (adenosine). FDA has
approved changes to the drug labels to reflect these serious events and
updated recommendations for use of these agents. The Warnings &
Precautions section of the Lexiscan and Adenoscan labels previously
contained information about the possible risk of heart attack and death
with use of these drugs. However, recent reports of serious adverse
events in the FDA Adverse Event Reporting System (FAERS) database and
the medical literature prompted approval changes to the drug labels to
include updated recommendations for use.
- November 13, 2013: Over-the-Counter Topical Antiseptic Products:
FDA is requesting label and packaging changes to enhance the safe use
of certain over-the-counter (OTC) topical antiseptic products. The
request is the result of an ongoing evaluation of infrequent but
continuing reports of infections resulting from antiseptic products
labeled for preoperative or preinjection skin preparation. Health care
professionals and patients should follow all label directions to
decrease the chances of infection.
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