FDA Makes Plans to Correct Cancer-Drug Shortages in the U.S.

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Emergency efforts will keep the flow of lifesaving drugs to American doctors.

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Drug shortages in the U.S. have been an ongoing concern over the last couple of years, and have come to a head in recent months. Two cancer drugs in particular, Doxil (doxorubicin hydrochloride liposome injection) and the life-saving methotrexate are in short supply, but the FDA has made plans they say should swiftly reverse the situation.

Shortages of the medications worsened when a major manufacturing plant, Ben Venue Laboratories, shut down production due to safety concerns. To make up for the deficit, the FDA has decided to allow imports of a Doxil substitute, called Lipodox (doxorubicin hydrochloride liposome injection), which will apparently meet demand over the coming weeks. To address the methotrexate shortage, the Agency has approved another manufacturer to import a preservative-free generic version of the cancer drug to boost supplies.

Doxil is used to treat several forms of cancer, including ovarian cancer when other methods have failed. Methotrexate is also used for multiple cancer types as well as other diseases like psoriasis and rheumatoid arthritis.

Last October, President Obama issued an Executive Order to address the dwindling drug supply, immediately followed by the FDA's own letter to drug manufacturers, urging them to notify the government of possible shortages early on. Since that time, 114 shortages have been prevented, which is a large portion of the 195 shortages prevented over the entire year.

Doxil is used to treat several forms of cancer, including ovarian cancer when other methods have failed. Methotrexate is also used for multiple cancer types as well as other diseases like psoriasis and rheumatoid arthritis. The FDA says that the preservative-free form of the drug is required for injections into the fluid around the brain and spinal cord, and to treat osteosarcoma, a serious form of bone cancer.

"Through the collaborative work of FDA, industry, and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need," said FDA Commissioner Margaret A. Hamburg.


This article originally appeared on TheDoctorWillSeeYouNow.com, an Atlantic partner site.

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Alice G. Walton, PhD, is a health journalist and an editor at The Doctor Will See You Now.

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