“In addition to our ongoing concerns related to IV saline products, we also are particularly focused on the shortage of amino acids for injection,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
To address the shortage of intravenous saline, the FDA has been working with the supplier Baxter to help restore production in its local facilities and has also approved IV saline products from Fresenius Kabi and Laboratorios Grifols, which have stepped up production to help meet the need. The IV saline shortage is expected to improve by the end of 2017, Dr. Gottlieb said.The shortage of amino acids for injection predates Hurricane Maria, but the hurricane’s impact worsened the situation by disrupting Baxter’s ability to manufacture amino acids in Puerto Rico. The FDA has worked with Baxter to temporarily import pediatric and adult amino acid injections from the United Kingdom and Italy, as well as working with other amino acid manufacturers to increase supplies.
“We continue to work closely with federal and Puerto Rican authorities to address the needs of manufacturers on the island for power and other resources. These efforts have been focused on the needs of patients – to prevent potential shortages of medically important products where possible, and help ensure that any shortages that do occur are mitigated as quickly as possible,” Dr. Gottlieb said.
Read the full statement on the FDA website.