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Update on Drugs and Drug News: March 2010


Name/Company Approval Dates and Comments

Hyaluronic acid dermal filler + 0.3% lidocaine
JUVÉDERM® XC
Allergan, Inc.

The US FDA approved a new formulation of this hyaluronic acid dermal filler in February 2010 for the reduction of pain during treatment of moderate to severe facial wrinkles and folds (nasolabial folds). The addition of 0.3% preservative-free lidocaine my also shorten the treatment time by eliminating the need for an additional anesthetic.

Hyaluronic acid dermal filler + 0.3% lidocaine
RESTYLANE®-L
PERLANE®-L
Medicis Aesthetics

The US FDA approved additional formulations of these dermal fillers in February 2010 for the reduction of pain associated with the injectable correction of moderate to severe nasolabial folds. The approval provides the option of a single syringe containing a wrinkle filler with a local anesthetic. RESTYLANE®-L is approved for injection into the mid to deep dermis and PERLANE®-L is approved for implantation into the deep dermis to superficial subcutis.


Drug News

In December 2009, labeling changes regarding possible hepatic effects of diclofenac sodium topical gel 1% (Voltaren® Gel) was issued by the US FDA and Endo Pharmaceuticals/Novartis Consumer Health. This non-steroidal anti-inflammatory topical agent is indicated for the relief of pain associated with osteoarthritis of the joints (i.e., involving the knees and hands). Healthcare professionals were notified of revisions to the Hepatic Effects section of the prescribing information, which included new warnings and precautions about the potential for elevation in liver function tests during treatment with any product containing diclofenac sodium. In the first month of treatment with diclofenac, or anytime during therapy, cases of drug-induced hepatotoxicity have surfaced in postmarketing surveillance reports. The severe hepatic reactions include liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure, which in some cases have resulted in liver transplantation or even death. In patients receiving long-term therapy with diclofenac, treating physicians should measure transaminases periodically. Transaminases should be monitored within 4-8 weeks after initiating diclofenac treatment. The complete FDA warning, Dear Healthcare Professional Letter, and updated labeling can be found at: http://www.fda.gov/safety/medwatch/ safetyinformation/safetyalertsforhumanmedicalproducts/ucm193047.htm

Latanoprost, a prostaglandin analog, can stimulate eyelash growth (number, thickness, and darkness) in patients using ocular preparations for the treatment of glaucoma. In addition, topical prostaglandin analog studies using animal models suggest their benefits in promoting body and scalp hair growth. A recent study by Faghihi et al.* explored the efficacy of latanoprost as a treatment for alopecia areata (AA) of the eyebrows and eyelashes. Over a 4 month period, 26 patients with symmetrical eyelash and eyebrow AA were treated with topical latanoprost on 1 side and the other side was not treated with any drug. Through photographic comparisons, the investigators found that only 1 of the latanoprost-treated patients showed partial hair regrowth on the treated side. The relationship between hair regrowth and latanoprost application was not statistically significant (p=1). Based on these findings, topical latanoprost is not a promising drug candidate for the treatment of AA. However, investigators suggest further studies be undertaken with larger sample populations, longer study duration, and higher drug dosages.
*Faghihi G, et al. Eur J Dermatol 19(6):586-7 (2009 Nov-Dec).


In this issue:

  1. Does Diet Really Affect Acne?
  2. Current Concepts in Laser Tattoo Removal
  3. Update on Drugs and Drug News - March 2010