Hospital Pharmacy - June 2018 - 134

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HPXXXX10.1177/0018578718763852Hospital Pharmacy

Current FDA-Related Drug Information

Summaries of Safety Labeling Changes
Approved By FDA- Boxed Warnings
Highlights October-December 20171

The FDA's MedWatch program safety labeling changes for
boxed warnings are compiled quarterly for drugs and therapeutic biologics where important changes have been made
to the safety information. These and other label changes are
searchable in the Drug Safety Labeling Changes (SLC)
database2, where data are available to the public in downloadable and searchable formats. Boxed warnings are ordinarily used to highlight either: adverse reactions so serious

Hospital Pharmacy
2018, Vol. 53(3) 134-135
© The Author(s) 2018
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https://doi.org/10.1177/0018578718763852
DOI: 10.1177/0018578718763852
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in proportion to the potential benefit from the drug that it is
essential that it be considered in assessing the risks and
benefits of using the drug; OR serious adverse reactions
that can be prevented/reduced in frequency or severity by
appropriate use of the drug; OR FDA approved the drug
with restrictions to ensure safe use because FDA concluded
that the drug can be safely used only if distribution or use is
restricted.

LEVO-T (NDA- 021342) (LEVOTHYROXINE SODIUM)
Edited Boxed Warning
PLR conversion; newly added information:
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
Thyroid hormones, including Levo-T, either alone or with other therapeutic agents, should not be used for the treatment of obesity or
for weight loss.
In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction.
Larger doses may produce serious or even life threatening manifestations of toxicity, particularly when given in association with
sympathomimetic amines such as those used for their anorectic effects.

Avastin (BLA-125085) (BEVACIZUMAB)
Edited Boxed Warning
Additions and/or revisions underlined:
WARNING: GASTROINTESTINAL PERFORATIONS, SURGERY AND WOUND HEALING COMPLICATIONS, and HEMORRHAGE
Gastrointestinal Perforations: The incidence of gastrointestinal perforation, some fatal, in patients receiving Avastin ranges from 0.3% to
3%. Discontinue Avastin in patients who develop gastrointestinal perforation Surgery and Wound Healing Complications: The incidence
of wound healing and surgical complications, including serious and fatal complications, is increased in patients receiving Avastin.
Discontinue Avastin in patients who develop wound healing complications that require medical intervention. Withhold Avastin at least
28 days prior to elective surgery. Do not administer Avastin for at least 28 days after surgery, and until the wound is fully healed.
Hemorrhages: Severe or fatal hemorrhage, including hemoptysis, gastrointestinal bleeding, hematemesis, CNS hemorrhage, epistaxis, and
vaginal bleeding occur up to 5-fold more frequently in patients receiving Avastin. Do not administer Avastin to patients with a recent
history of hemoptysis. Discontinue in patients who develop Grade 3-4 hemorrhage.

LO/OVRAL FE (NDA-018206) (ETHINYL ESTRADIOL; LEVONORGESTREL; FERROUS FUMARATE)
Edited Boxed Warning
(Additions and/or revisions are underlined)
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk
increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs
should not be used by women who are over 35 years of age and smoke.
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