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Update on Drugs and Drug News - April 2006




Approval Dates and Comments

Antipsoriatic Agent

Calcipotriene/ Betamethasone Dipropionate
Taclonex® Ointment
Warner Chilcott/ LEO Pharma

The US FDA approved this topical ointment in January 2006 as a once-daily treatment of psoriasis in adults. Taclonex is sold as Dovobet® or Daivobet® outside the US.

Antibacterial Agent


The US FDA began its review process in January 2006 for this investigational antibacterial drug. Retapamulin belongs to a new class of antibiotics being developed as a topical treatment for uncomplicated skin and skin structure infections due to susceptible strains of Staphylococcus aureus and Streptococcus pyogenes.

Wound Care

Antimicrobial Barrier Dressing
Acticoat™ Moisture Control with SILCRYST™ Nanocrystals
NUCRYST Pharmaceuticals

The EMEA approved this foam dressing in February 2006 for the treatment of wounds with light-to-moderate exudate for up to 7 days. It was approved by the US FDA and TPD Canada in 2005.

Diaper Dermatitis

Miconazole Nitrate 0.25%, Zinc Oxide 15%, White Petroleum 81.35%
Vusion® Ointment
Barrier Therapeutics

The US FDA approved this ointment in February 2006 for the treatment of diaper dermatitis complicated by candidiasis.

Drug News

Drug Warning

The US FDA sent out a warning in December 2005 advising consumers not to use Miracle II Neutralizer and Miracle II Neutralizer Gel products manufactured by Tedco, Inc. because the products are bacterially contaminated and have not been proven to be safe and effective. These products have not been approved by the FDA. Unapproved uses include the treatment of diaper rash, dermatitis, hives, psoriasis, and skin cancer. Use of these products could pose a risk of serious adverse events such as infections, particularly in children, the elderly, and individuals with weakened immune systems, who are particularly susceptible to illness.

Drug Warning

According to a Canadian study being published in the New England Journal of Medicine*, elderly people who took gatifloxacin (Tequin®, Bristol Myers Squibb) were 17 times more likely to develop serious diabetes than if they took another antibiotic, and were four times more likely to be hospitalized for low blood sugar. Gatifloxacin is a fluoroquinolone antibiotic indicated for the treatment of skin and skin structure infections, pneumonia, urinary tract infections, and certain sexually transmitted diseases. The investigators further reported that this drug does not permanently damage the body’s ability to control blood sugar; however, it could be deadly if a person’s blood sugar falls too low. Doctors were urged to stop prescribing it.

*Park-Wyllie LY, et al. N Engl J Med (2006 Mar 1). Available from URL: content/abstract/NEJMca055191v1.

Systemic Lupus Erythematosus

A study recently published in the New England Journal of Medicine* reported that women with either inactive or stable systemic lupus erythematosus were able to take oral contraceptives without increased risk of flares. Subjects who took triphasic 35ìg ethinylestradiol/0.5-1mg norethindrone for twelve 28-day cycles had no statistically significant difference in the occurrence of flares than those taking placebo. Severe flares occurred in about 7% of the women regardless of whether they received oral contraceptives or placebo.

*Petri M, et al. N Engl J Med 353(24):2550-8 (2005 Dec 15).

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