UPDATE ON DRUGS
|Approval Dates and Comments
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.
|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.
Control with SILCRYST™
|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.
0.25%, Zinc Oxide
15%, White Petroleum
|The US FDA approved this ointment in February 2006 for the
treatment of diaper dermatitis complicated by candidiasis.
|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.
|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).
|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).