• Contact Hill Dermaceuticals

May 3, 2011

Dear Patients, Consumers and Healthcare Professionals:

On December 3, 2010, Hill Dermaceuticals, Inc. received a Warning Letter from the U.S. Food and Drug Administration (FDA) regarding promotional messages on Hill Dermaceuticals' website, www.hillderm.com, for Derma-Smoothe/FS® (fluocinolone acetonide 0.01% topical oil) (Body Oil) that FDA believed were misleading. The FDA stated that certain messages for Derma-Smoothe/FS® (Body Oil) were misleading because the messages omitted and minimized the product's risks; suggested that the product was safer than other forms of atopic dermatitis therapy; overstated the efficacy of the product; suggested that the product was more efficacious than other forms of atopic dermatitis therapy; broadened the product's indication; and presented other misleading statements about the product.

To the extent patients, consumers, or healthcare professionals may have been misled by any information on its website, Hill Dermaceuticals is providing the following clarifying information about Derma-Smoothe/FS® (Body Oil).

I. Omission and Minimization of Risk Information

The FDA states the webpages minimized the risk of hypothalamic-pituitary-adrenal (HPA) axis suppression with Derma-Smoothe/FS® (Body Oil), a condition which can cause the adrenal glands to shut down if too much is passed through the skin. While HPA axis suppression was not seen in the open-label pediatric clinical trials for Derma-Smoothe/FS® (Body Oil), Hill Dermaceuticals wants you to know that topical corticosteroids, like Derma-Smoothe/FS® (Body Oil), can cause reversible HPA axis suppression with the potential for decreasing the supply of certain hormones (glucocorticosteroid) if too much is passed through the skin. In addition, the following can occur due to HPA axis suppression:

• an abnormal condition that is caused by too much corticosteroids in the body (Cushing's syndrome)
• abnormally high levels of sugar in the blood
• increased sugar in the urine

Hill Dermaceuticals would also like you to know the following information:

• Your healthcare professional may decide to do blood tests to check for adrenal gland function while you are using a corticosteroid product, like Derma-Smoothe/FS® (Body Oil).
• Examples which increase passing of drug through the skin include the use of stronger corticosteroids, use over large surface areas, use over a longer period of time, or if the treated skin area is bandaged or otherwise covered or wrapped.
• Because of a higher ratio of skin surface area to body mass, children are at a greater risk for adverse reactions throughout the body than are adults when treated with topical corticosteroids, like Derma-Smoothe/FS® (Body Oil).

The FDA also states that the webpages minimized the risk of Derma-Smoothe/FS® (Body Oil) use in peanut-sensitive individuals. While the peanut oil in Derma-Smoothe/FS® (Body Oil) is refined to a level below that likely to cause an allergic reaction in peanut-sensitive individuals, the FDA does not dismiss the possibility of peanut sensitive individuals having an allergic reaction when using the product. Hill Dermaceuticals wants you to know the following:

• Healthcare professionals should use caution in prescribing Derma-Smoothe/FS® (Body Oil) for peanut sensitive individuals. Should any signs of increased sensitivity or worsening of disease occur, Derma-Smoothe/FS® (Body Oil) should be immediately stopped and appropriate treatment by the healthcare professional should be started.

The FDA also states that the webpages did not contain the appropriate important risk information associated with the use of Derma-Smoothe/FS® (Body Oil). In addition to the risks of HPA axis suppression and use in peanut-sensitive individuals, Derma-Smoothe/FS® (Body Oil) is also associated with the following risks:

• Local side effects may occur with use of topical corticosteroids, like Derma-Smoothe/FS® (Body Oil), and may be more likely to occur when the treated skin area is bandaged or otherwise covered or wrapped, used for a longer period of time or with use of stronger corticosteroids. Some local side effects may be irreversible. Side effects may include skin thinning, stretch marks, tiny red lines or blood vessels showing through the skin, burning, itching, irritation, dryness, inflammation of a hair follicle, acne, change in skin color, a rash around the mouth, allergic skin reaction, infection occurring at the site of a pre-existing infection, and sweat problems.
• Skin infections occurring at the same time of treatment should be treated with an appropriate antimicrobial medication prescribed by a healthcare professional.
• Side effects most commonly observed in the clinical studies were cough, runny nose, fever, tiny red lines or blood vessels showing through the skin, sore throat, and change in skin color.

These are not all the risks associated with Derma-Smoothe/FS® (Body Oil). For a complete description, please see the accompanying full prescribing information (PI).

Furthermore, the FDA also stated that the webpages were misleading because they suggested that Derma-Smoothe/FS® (Body Oil) is the safest topical corticosteroid, and there are no safety concerns with its use. Derma-Smoothe/FS® (Body Oil) has not been compared to other treatments and therefore, has not been shown to be safer than other topical corticosteroids and there are serious risks that must be considered before using the product.

II. Overstatement of Efficacy

The FDA states that the webpages misleadingly suggested that a full course of treatment consisting of one to two bottles of Derma-Smoothe/FS® (Body Oil) will eliminate the symptoms of atopic dermatitis, a type of eczema. In addition, this presentation was misleading because it suggested that the drug was a more effective treatment of symptoms of atopic dermatitis than other treatment options. Hill Dermaceuticals would like for you to know that individual usage will vary depending on the severity and extent of disease and, as a result, more than one 4 ounce bottle may be necessary for some patients. Also, treatment consisting of one to two bottles of Derma-Smoothe/FS® (Body Oil) has not been proven to eliminate the symptoms of atopic dermatitis. In addition, Derma-Smoothe/FS® (Body Oil) has not been compared to other treatments and therefore, has not been shown to be more effective for treatment of symptoms of atopic dermatitis than other treatment options.

The FDA also states that the webpages misleadingly suggested that Derma-Smoothe/FS® (Body Oil) has been proven to repair skin barrier function, when the drug has not been proven to have this effect on skin.

Additionally, the FDA stated that the webpages misleadingly suggested that Derma-Smoothe/FS® (Body Oil) will keep a child's skin soft and normal looking for long periods of time and will help to prevent sudden appearance or worsening of the symptoms, when the drug has not been proven to have this effect on skin.

III. Broadening of Indication

The FDA found that certain statements regarding the use of Derma-Smoothe/FS® (Body Oil) in pediatric populations failed to adequately communicate the full indication of Derma-Smoothe/FS® (Body Oil). Hill Dermaceutical would like you to know that Derma-Smoothe/FS® (Body Oil) is "indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older, for up to four (4) weeks treatment. Safety and effectiveness in pediatric patients younger than 3 months of age has not been established."

The FDA also states the webpages misleadingly suggested that Derma-Smoothe/FS® (Body Oil) can be used all over the body. Hill Dermaceuticals wants you to know that Derma-Smoothe/FS® (Body Oil) should not be applied to the diaper area. Derma-Smoothe/FS® (Body Oil) should also not be used on the face, under arm or groin unless directed by a physician; and application to the folds of the skin near the affected area (intertriginous areas) should be avoided due to the increased risk of side effects.

IV. Other Misleading Statements

The FDA states that the webpages misleadingly suggested that patients can expect their skin to be soothed upon using Derma-Smoothe/FS® (Body Oil) and patients can reduce their chances of experiencing a burning sensation when using the drug product if they would only wet their skin before application. Hill Dermaceuticals would like for you to know that wetting the skin before application has not been proven to reduce this side effect of Derma-Smoothe/FS® (Body Oil).

If you have any questions about the corrective information in this letter, please contact Hill Dermaceuticals' Medical Affairs Department, Rosario Ramirez, M.D., at 407-323-1887. Please refer to the full prescribing information for Derma-Smoothe/FS® (Body Oil) included with this letter. As always, we request that you report any adverse events to Hill Dermaceuticals at 407-323-1887 or the FDA Med Watch Program at 1-800-FDA-1088 or www.fda.gov/medwatch.

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