Methemoglobin is a compound in the blood that does not combine with oxygen. Methemoglobinemia can therefore lead to a reduced ability to release oxygen to tissues and oxygen deprivation for affected individuals. Since FDA has not evaluated unapproved products for safety, efficacy, and quality, the relative safety and risk of these products is unknown. Sodium nitrite and sodium thiosulfate injection(s) can pose the serious risk of hypotension (low blood pressure). Sodium nitrite may cause methemoglobinemia, a disorder characterized by the presence of a higher than normal level of methemoglobin in the blood. No, this is not a recall. Previously manufactured unapproved products affected by this action may still be available for a short period of time until the inventory has been depleted or the product has expired, whichever occurs first.Ĥ) Is it safe to use the unapproved products? The unapproved products on the market compete with these approved products, and pose a direct challenge to the drug approval system.Ģ) When is the action going to take effect?įirms subject to this class action will have 90 days to cease manufacturing and 180 days to cease distribution of the unapproved drugs from the date of the Federal Register notice.ģ) Are the unapproved products being recalled? Sodium Nitrite Injection and Sodium Thiosulfate Injection are approved to be used sequentially: Sodium Nitrite is injected first, followed immediately by Sodium Thiosulfate, for the treatment of acute cyanide poisoning that is judged to be life-threatening. Additionally, in 2012, FDA approved NDAs for Sodium Nitrite Injection and Sodium Thiosulfate Injection, which are marketed in separate packaging.
In 2011, FDA approved a New Drug Application (NDA) for Nithiodote, a co-packaged Sodium Nitrite Injection and Sodium Thiosulfate Injection drug product, indicated for the treatment of acute cyanide poisoning that is judged to be life-threatening. This notification was published in the Federal Register on Novem( ).įDA is taking this action because there are now FDA-approved versions of these drug products on the market (Table 1). This is part of FDA’s on-going effort to ensure that all drugs marketed in the United States have the required FDA approval and are safe, effective, of good quality, and appropriately labeled. The FDA is notifying companies to cease manufacture or marketing of unapproved drug products containing sodium nitrite or sodium thiosulfate labeled for the treatment of known or suspected cyanide poisoning. 1) What action is FDA taking regarding unapproved drug products containing sodium nitrite or sodium thiosulfate labeled for the treatment of known or suspected cyanide poisoning?
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