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FDA Actions

Required Label Changes Clarify New Safety Risks of Picato Gel

The FDA has warned about reports of severe allergic reactions and herpes zoster (shingles) associated with the use of Picato gel (ingenol mebutate). The agency has also received reports of cases involving severe eye injuries and skin reactions associated with the application of Picato gel, which is approved for the treatments of actinic keratoses. Some cases were associated with the product not being used according to the instructions for use on the label. Thus, the FDA is requiring changes to the label to warn about these new safety risks and to provide additional instructions on the safe and appropriate application of the product.

Consumer Update Issued Regarding Injectable Skin Lightening Products

Injectable skin lightening products are unapproved, untested drugs that could potentially cause harm, according to the FDA. “These products pose a potentially significant safety risk to consumers. You’re essentially injecting an unknown substance into your body—you don’t know what it contains or how it was made,” says pharmacist In Kim in a recent consumer update from the agency.

Allergan’s Teflaro Label Updated for Treatment of ABSSSI

The FDA approved Allergan’s supplemental new drug application (sNDA) to update the label for Teflaro (ceftaroline fosamil) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). The approved label contains new clinical data from two ABSSSI trials that included patients with baseline Staphylococcus aureus bacteremia. With the updated label, Teflaro also is now approved to be administered by intravenous (IV) infusion in five minutes to one hour in adult patients 18 years and older.

For more information on all of these stories, visit www.fda.gov.

DermTube Highlights Key Sessions from Summer AAD Meeting

Practical Dermatology® magazine and DermTube were on site in New York for the recent Summer Meeting of the American Academy of Dermatology to cover key presentations and data as they unfolded. Hosted by Seemal Desai, MD, DermTube’s video coverage featured key opinion leaders from across the specialty offering recaps of their presentations and insights on the latest in research and therapeutic innovations.

Jerry Bagel, MD discussed the vital role of phototherapy in the treatment of psoriasis, while Lawrence Eichenfield, MD addressed the increasingly urgent issue of antibiotic resistance in medicine. Additionally, Anneli R. Bowen, MD and Scott Robert Florell, MD offered pearls in diagnosing and treating dermatoses you’ve seen but may not have heard of.

Kanade Shinkai, MD, PhD recapped her popular session on improving patient management techniques. The session featured interactions with model patients. Kiran Godse, MD discussed strategies for managing urticaria.

In the cosmetic dermatology fold, Brooke Jackson, MD discussed the value of staying up to date with global aesthetic trends and also warned about counterfeit fillers and their potential impact on practice, while Hassan Galadari, MD shed light on the global filler market.

Popular presenter and cosmetic dermatology expert Susan Weinkle, MD discussed the importance of understanding facial anatomy, and Jason Emer, MD gave tips on assessing the aging face.

Whether you attended the Summer Meeting of the AAD last month or not, visit DermTube.com for expert insights on the most pressing topics in dermatology today.

Note: DermTube’s coverage of the 2015 Summer Academy Meeting of the AAD is not endorsed by or affiliated with the American Academy of Dermatology.

Valeant Partners with AstraZeneca on Brodalumab

AstraZeneca and Valeant Pharmaceuticals International, Inc. entered into a collaboration agreement under which AstraZeneca has granted Valeant an exclusive license to develop and commercialize the IL-17 receptor brodalumab. The monoclonal antibody is in development for patients with moderate-to-severe plaque psoriasis and psoriatic arthritis. Amgen, which developed brodalumab, ended its agreement with AstraZeneca for brodalumab in May following suicidal ideation and behavior events in the brodalumab program, which are expected to restrict labeling. Valeant will assume all development costs and hold exclusive rights to develop and commercialize brodalumab globally, except in Japan and certain other Asian countries. Regulatory submission in US and EU for brodalumab in moderate-to-severe psoriasis is planned for the fourth quarter of 2015.

Modernizing Medicine Reveals Telemedicine Component for its EMR

Modernizing Medicine, Inc. revealed a new telemedicine solution within its cloud-based EMA Dermatology® electronic medical record (EMR) system at this year’s American Academy of Dermatology (AAD) Summer Meeting in New York.

According to the company, the new solution will allow physicians to provide treatment, diagnosis and advice for their patients when a virtual visit is appropriate. Physicians can save time and add a new source of revenue by reviewing and responding quickly to a variety of cases such as rashes, minor burns, and bites, while freeing office time for more complex patient cases.

Additionally, Modernizing Medicine is debuting additional new features within EMA Dermatology. With the new Protocols, physicians can create their own master visits and customize their workflow to further enhance the intuitive adaptive learning that has helped EMA Dermatology capture approximately 30 percent of the dermatology market. With two clicks a physician can pull the master visit into the current visit to save time documenting while with a patient.

Genentech Initiates Phase III Trial of Rituximab in Pemphigus Vulgaris

A new Phase III trial is now underway to investigate the use of the biologic agent Rituxan (rituximab) for pemphigus vulgaris (PV). The aim of the study is to gauge the efficacy and safety of Rituxan as compared to mycophenolate mofetil in patients with moderate to severe disease. Patients in the Rituxan arm of the study will receive 1000mg rituximab given by intravenous infusion on Day 1 and 15, with repeat rituximab administration on Day 168 and 182 provided specific safety criteria have been met. According to Genentech, results of independent studies have shown that Rituxan may provide substantial improvement in PV remission rates and successful tapering and/or cessation of corticosteroid (CS) therapy.

New Survey Pinpoints Reasons for Consumer Delay on Cosmetic Procedures

Cost, fear of suboptimal results, and uncertainty over choosing a provider are the key concerns that may deter prospective patients from receiving cosmetic treatments, new findings from the 2015 American Society for Dermatologic Surgery Consumer Survey on Cosmetic Dermatologic Procedures show.

In response to the findings, ASDS President George J. Hruza, MD, MBA said those concerns can be successfully resolved. That contention is backed by high satisfaction rates expressed by those who have procedures. Several procedures frequently performed by ASDS members—including wrinkle-relaxing injections, soft-tissue fillers and laser/light-based procedures to improve skin tone—earned patient satisfaction ratings of 84 percent or higher. This marks the third straight year that survey respondents listed these three factors as the top reasons to hold off on pursuing a cosmetic procedure.

While acknowledging cost is always important to consumers, Dr. Hruza said patients receive tremendous value from cosmetic procedures performed by ASDS members considering their advanced level of training and expertise.

To see the full survey results visit www.asds.net

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