Question

Below are two articles that detail FDA recommended changes to a package insert. Indicate the data that led to this decision.

Please summarize below articles 150 words each no bullet points,

Article 1

actinic keratosis field treatment to undergo extensive label changes is imiquimod (3.75%), which under the brand name Zyclara® cream (Valeant Pharmaceuticals North America LLC), was originally approved in 2010 and indicated for actinic keratoses of the face and scalp. In 2011, the medication underwent three separate labeling changes. First, imiquimod was approved for the additional indication of external genital and perianal warts in patients 12 years and older, and as a result, a labeling change was initiated. Another labeling revision was submitted when the company created a new dosage of 2.5% for the treatment of actinic keratoses of the face or balding scalp. The drug company initiated these first two changes. However, similar to 5-fluorouracil, the final label revision was in response to an action letter from the FDA. This new drug label was released to include new data on the limitation of use of imiquimod in treating molluscum contagiosum in children. The newest label also made clear that imiquimod is not to be used for oral, ophthalmic, intra-anal, or intravaginal use. In the warnings section, users are warned that if imiquimod is placed on female external genitalia, it could lead to such a severe inflammatory reaction that the resultant swelling could lead to urinary retention.9

Article 2

The most recent of these drugs to undergo the process of label change is ingenol mebutate gel (Picato®, Leo Pharma Inc., Parsippany, New Jersey). In 2012, ingenol mebutate gel was approved in two concentrations for the treatment of actinic keratoses on the face and scalp (0.015%) and on the trunk and extremities (0.05%). In August 2015, the FDA issued a drug safety communication warning of severe adverse side effects, which mandated a label change. The communication cited reports of severe allergic reactions and herpes zoster associated with ingenol mebutate use. In addition, the communication mentioned that severe eye injuries and skin reactions were occurring because the ingenol mebutate was not being used as indicated on the label.10 As a result, similarly to previous actinic keratosis treatments, in October 2015, ingenol mebutate underwent a label revision, which specifically addressed the reported adverse events and the increased warnings about use in the periocular area.

Answer 1

Article 1

The Zyclara cream of Valeant Pharmaceuticals North America LLC was first approved in 2010 and its use to public for actinic keratosis on face and scalp in the a me year.This cream underwent an extent label change on imiquimoid (3.75%).In 2011 this medication underwent three different lable changes. The first labelling came to introduce the additional use of this drug to treat genital and perianal wart in 12 years and older patients.The second revision was done for dosing.A new dosage of 2.5% was introduced for treating cationic keratosis and balding scalp.The first two label changes were started by the drug company The third revision was in regards to the FDA action letter.This clearly described it is not used to treat mollascum contagiosum in children .It is not to be taken orally,intranal or intravaginal ,ophthalmic solution in to eyes.It a so specifies the warning of not using big in the female external genitaliacan cause swelling and urinary retention.

Article 2

The ingenol mebutate gel by Picato ,Leo Pharma Inc for the treatment of cationic keratosis is the recent change made in the drug name,In 2012 ,0.015% was used to tree at actinic keratosis on face and scalp and a concentration of0.05% for trunk and extremities. A drug safety warning was introduced in August 2015 and mandated a label change.The communication stares it causes severe allergic reactions and herpes zoster infection,severe eye injury and skin reactions if not used as indicated to a patient.In 2015 the lable consists of warning and adverse events .