Update on Drugs and Drug News: February 2011

Human papillomavirus
quadrivalent (Types 6, 11, 16,
and 18) recombinant vaccine

Gardasil®
Merck & Co., Inc.

The US FDA granted an additional indication to this
human papillomavirus (HPV) recombinant vaccine
in December 2010 for the prevention of anal cancer
caused by HPV types 16 and 18 and for the prevention
of anal intraepithelial neoplasia (AIN) grades 1, 2 and
3 (anal dysplasias and precancerous lesions) caused
by HPV types 6, 11, 16 and 18, in males and females
9 to 26 years of age.

Daptomycin for injection
Cubicin®
Cubist Pharmaceuticals, Inc.

The US FDA approved this currently-marketed
antibiotic for once-a-day dosing as a 2-minute
intravenous (IV) injection in December 2010 for the
treatment of methicillin-resistant Staphylococcus
aureus (MRSA) complicated skin infections and
bacteremia. In addition to 2-minute IV injection,
several other changes to the drug’s label were
incorporated. These include changes and reformatting
of the Warnings and Precautions in the label, updates
to the Post Marketing Experience section of the label,
and re-formatting of the label to be compliant with
the FDA’s Physician Labeling Rule (PLR).

The American Academy of Dermatology and AAD Association recently released their
updated position statement on isotretinoin, which continues to support physicianmonitored
use of the drug for the treatment of severe acne. The AAD’s stance affirms
patient safety is the primary concern and its commitment to the safe and responsible use
of isotretinoin, generally considered by dermatologists to be the most effective treatment
for severe recalcitrant nodular acne. This most recent amendment dated November 13,
2010 includes the following revisions:

• The AAD advocates compliance with the manufacturer-sponsored and US FDAapproved risk management program for prescribing isotretinoin (iPLEDGE). The Association opposes on-line Internet dispensing, sharing, or use without physician supervision, because these activities do not provide for sufficient patient education about isotretinoin risks and do not require participation in the iPLEDGE* program.
• A correlation between isotretinoin use and depression/anxiety symptoms has been suggested, but an evidence-based causal relationship has not been established. Other studies give evidence that treatment of acne with isotretinoin was accompanied by improvement of both depressive and anxiety symptoms, as well as improved quality of life of patients with acne.
• Current evidence is insufficient to prove either an association or a causal relationship between isotretinoin use and inflammatory bowel disease (IBD) in the general population. While some recent studies have suggested such a relationship, further studies are required to conclusively determine if an association or causal relationship exists and/or whether IBD risk may be linked to the presence of severe acne itself.

The position statement concludes that the prescription of isotretinoin for severe nodular
acne continues to be appropriate as long as prescribing physicians are aware of the risks
and concerns related to isotretinoin use and that their patients are monitored for any
signs of IBD and psychiatric disturbances. Education by treating physicians to encourage
patient vigilance in recognizing and reporting signs of IBD and depressive symptoms is
also endorsed.

The complete AAD position statement on isotretinoin is available at: http://www.aad.org/forms/policies/Uploads/PS/PS-Isotretinoin.pdf
*Information on the iPLEDGE program is available at: https://www.ipledgeprogram.com/