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Prescription Drug Promotion Essay

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The Office of Prescription Drug Promotion (OPDP) of the U.S Food and Drug Administration (FDA) has reviewed a print advertisement for the approved product LATISSE® (Bimatoprost Opthalmic Solution 0.03%) in various pharmaceutical journals and magazines. This print advertisement was found to have inadequate balance of benefit and risk information. As a result, LATISSE® print advertisement was found to violate PhRMA Guiding Principles on Direct to Consumer Advertisements About Prescription Medicines. It specifically violates the guideline principle # 2, 10,11, 13, 14, 16. This print advertisement is concerning from a public health perspective because it creates a misleading and misinformed impression about the safety and approved indication for LATISSE® .
Background
Below are the indication and summary of the most serious and most common risks associated with the use of LATISSE®.
According to its FDA-approved product labeling :
LATISSE® is a prostaglandin analog, indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.
Important limitations of Use:
Use in pediatric patients below the age of 16 years is
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LATISSE® solution should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated is required to be mentioned in the print advertisement. Also, the direction that it is important to apply LATISSE® only to the skin of the upper eyelid margin at the base of the eyelashes using the accompanying sterile applicators should have been mentioned to inform the patients about the proper usage of the product. Such statements raise considerable public health concerns and are particularly alarming when not informed in the
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