FDA Boxed Warning for Tygacil
The FDA is warning that an analysis shows an increased risk of
death when intravenous (IV) Tygacil (tigecycline) is used for FDAapproved
uses as well as for non-approved uses. As a result, the
FDA approved a new Boxed Warning about this risk to be added
to the Tygacil drug label and updated the Warnings and Precautions
and the Adverse Reactions sections. A Boxed Warning is the
strongest warning given to a drug. These changes to the Tygacil
label are based on an additional analysis that was conducted for
FDA-approved uses after issuing a Drug Safety Communication
(DSC) about this safety concern in September 2010.
Health care professionals should reserve Tygacil for use in situations
when alternative treatments are not suitable. Tygacil is
FDA-approved to treat complicated skin and skin structure infections
(cSSSI), complicated intra-abdominal infections (cIAI), and
community-acquired bacterial pneumonia (CABP). Tygacil is not
indicated for treatment of diabetic foot infection or for hospitalacquired
or ventilator-associated pneumonia. Patients and their
caregivers should talk with their health care professionals if they
have any questions or concerns about Tygacil.
In the 2010 DSC, the FDA informed the public that a combined
analysis, or meta-analysis, of 13 Phase 3 and 4 trials showed a
higher risk of death among patients receiving Tygacil compared
to other antibacterial drugs: 4.0% (150/3788) vs. 3.0% (110/3646)
respectively. The adjusted risk difference for death was 0.6%
with corresponding 95% confidence interval (0.1, 1.2). The increased
risk was greatest in patients treated with Tygacil for
ventilator-associated pneumonia, a use for which the FDA has
not approved the drug.
Since issuing the 2010 DSC, the FDA analyzed data from 10 clinical
trials conducted only for FDA-approved uses (cSSSI, cIAI, CABP),
including trials conducted after the drug was approved. This analysis
showed a higher risk of death among patients receiving Tygacil
compared to other antibacterial drugs: 2.5% (66/2640) vs. 1.8%
(48/2628), respectively. The adjusted risk difference for death was
0.6% with corresponding 95% confidence interval (0.0%, 1.2%). In
general, the deaths resulted from worsening infections, complications
of infection, or other underlying medical conditions.
FDA Clears Nu Skin Facial Spa Device for Market
Nu Skin Enterprises, Inc. has announced that it has received FDA
clearance to market a facial spa device for over-the-counter cosmetic
use. The company's 510(k) application was filed approximately
one year ago. The company estimates that the facial spa will become
available for sale some time during the first half of 2014.
FDA Approves Botox Cosmetic for Crow’s Feet
The FDA has approved a new use for Botox Cosmetic (onabotulinumtoxinA)
for the temporary improvement in the appearance
of moderate to severe lateral canthal lines, known as crow’s feet,
in adults. Botox Cosmetic is the only FDA approved drug treatment
option for lateral canthal lines.
The FDA approved Botox Cosmetic in 2002 for the temporary improvement
of glabellar lines in adults. Botox Cosmetic’s safety and
effectiveness for treating lateral canthal lines were established in
two clinical efficacy and safety studies. The studies enrolled 833
adult participants with moderate to severe lateral canthal lines
who were randomly assigned to receive Botox or placebo. Results
showed that those treated with Botox had greater improvement
compared to placebo in the appearance of lateral canthal lines.
The most common adverse reaction associated with the use of
Botox Cosmetic for treatment of lateral canthal lines is eyelid
edema, a condition in which the eyelids are swollen and contain
excessive fluid.
OnabotulinumtoxinA is marketed as Botox and Botox Cosmetic.
The FDA approved Botox for the treatment of chronic
migraine, severe underarm sweating, blepharospasm (eyelid
spasm) and strabismus (misalignment of the eyes when one or
both eyes turn inward or outward). Botox and Botox Cosmetic
have a boxed warning that says the effects of the botulinum
toxin may spread from the area of injection to other areas of the
body, causing symptoms similar to those of botulism. Those
symptoms include swallowing and breathing difficulties that
can be life-threatening. There has not been a confirmed serious
case of toxin spread when Botox or Botox Cosmetic has been
used at the recommended dose for the approved indications.
FDA Approves Generic Hydrocortisone Butyrate Cream
Glenmark Generics has received abbreviated new drug approval
(ANDA) from the FDA for hydrocortisone butyrate cream USP,
0.1 per cent, a generic version of Locoid Lipocream. Glenmark
is entitled to 180 days of exclusivity with respect to its hydrocortisone
butyrate cream, as it is the first generic company to
file an ANDA for the product. Hydrocortisone butyrate cream is
indicated for the relief of the inflammatory and pruritic manifestations
of corticosteroid-responsive dermatoses in adults and
the treatment of mild to moderate atopic dermatitis in patients
three months to 18 years of age.
