Drugs

Warnings Sought on Isotretinoin Sexual Effects

Three medical school professors have petitioned FDA to require addition of Warnings, Precautions, a Boxed Warning, and other language to the labeling for all isotretinoin products to inform users of sexual side effects. The 10/26 petition asks for the immediate revision of all isotretinoin labels to:

add Warnings, Precautions, highlights of prescribing information, and a Boxed Warning to inform that the use of and withdrawal from isotretinoin can result in erectile dysfunction, decreased libido, decreased vaginal lubrication, genital anesthesia, decreased orgasmic sensation, and anorgasmia; and
add Warnings, Precautions, highlights of prescribing information, and a Boxed Warning to inform that sexual side effects can sometimes persist indefinitely after discontinuation of the drug; they can emerge on treatment and remain afterwards, or emerge or worsen when the drug is stopped.

“Long-term changes to sexual function from the use of isotretinoin can be life-changing,” the petition concludes, “making it difficult or impossible to engage in normal intimate relationships. Current labeling does not adequately convey the breadth, severity, or potentially permanent nature of the adverse sexual effects from isotretinoin. Without appropriate warnings, patients are being deprived of informed consent. It is currently impossible for patients and healthcare professionals to weigh the benefits of treatment against the harms.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome