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Retinoid Shortage Begins, Prompting FDA Intervention


January 19, 2017

A manufacturing issue has led to the shortage of Panretin gel 60 Gram Tube (Eisai Medical Affairs), an important topical treatment of cutaneous lesions in patients with AIDS-related Kaposi’s sarcoma, according to the US Food and Drug Administration.

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However, in order to alleviate the shortage of Panretin gel 60 Gram Tube (NDC 62856-601-22) in the United States, the FDA is allowing the sale of Panretin gel tubes approved for use in the European market.

In a letter to health care providers, Avinash Desai, MD, vice president of medical affairs at Eisai, says that allowing providers to use the EU-approved product should help to ensure that patient needs are being met while she and her company work closely with the FDA to address manufacturing issues related to the US product. She also notes that there are differences in the labels of Panretin gel tubes for US use and EU use which providers should be aware of.

“A copy of the FDA-approved prescribing information is being distributed with the European Panretin gel,” Dr Desai writes. “Please refer only to the US-approved package insert for full prescribing information.”

There is currently no timetable for when the US shortage will end.—Sean McGuire.

References

FDA Drug Shortages. US Food and Drug Administration Website. http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Alitretinoin+%28Panretin%29+Gel&st=c&tab=tabs-4&panels=0. Published January 17, 2017. Accessed January 19, 2017.

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