8/18/2017 8:13:51 PM. Delay in shipping of the drug: 100 mg/10 mL single-dose vial (NDC 55150--324-25) Created Date. Safety, metabolism and excretion of the drug are also emphasized. Drug Safety and Availability > FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid... http://www.fda.gov/Drugs/DrugSafety/ucm446845.htm[5/15/2015 3:57:32 PM] patients. Please contact wholesaler for availability. Before sharing sensitive information, make sure you're on a federal government site. [12/3/2020] The U.S. Food and Drug Administration is alerting health care professionals about the risk of inadvertent intrathecal administration of tranexamic acid injection. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. ;�r�|�^B�E��j��ѕ{ut$�љ�ѭ��{s�½,����{{|vz���w�����O_��n���Ђwp^��`¹��ިҽ̬��`� Ⱦ�pW���k��&���fU���&��z}suu}qr|wqs����;9��/���?�]ج-�̟��P����� ��,��ͷ�|�bL$+�0�b��ͻ�,��.#LFT ����l�R|�'[ŐW8JMd"�C�V��n���������;]�ݬ�Noo�O�^}��U�a �YV^z:� Z��=��D+�R�b�g�v(�OEk���=�sЁ7��O����&|w�7���y=��4$L��;8�a�q��d����x:���c0ѐ�5A4���9���l�欅. Safety Announcement [04-26-2013] The U.S. Food and Drug Administration (FDA) is warning the public that the anti-seizure medication Potiga (ezogabine) can cause blue skin discoloration (See Photos) and eye abnormalities characterized by pigment changes in the retina. Intrathecal administration of tranexamic acid injection may result in serious life-threatening injuries, including seizures, cardiac arrhythmias, paraplegia, permanent neurological injury, and death. Utilize barcode scanning when stocking medication cabinets and preparing or administering the product. Drug Safety and Availability > FDA Drug Safety Communication: FDA approves label changes for antimalarial drug mefloquine hydrochloride due to risk of serious psychiatric and nerve side effects The Division of Drug Information (DDI) is CDER's focal point for public inquiries. %PDF-1.3 Store tranexamic acid injection vials separately from other drugs, in a way that makes the labels visible to avoid reliance on identifying drugs by the vial cap color. Drug Safety and Availability > FDA Drug Safety Communication: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks - Hallo friend FREE FROM DISEASE, In the article you read this time with the title Drug Safety and Availability > FDA Drug Safety Communication: FDA urges … Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA) 1 mg/mL, 10 mL vial, 10 count (NDC 63323-0411-10) Available Check wholesalers for inventory Demand increase for the drug: 1 mg/mL, 2 mL prefilled syringe, 24 count (NDC 76045-0001-20) Available A search of the FDA Adverse Event Reporting System (FAERS) database identified 20 cases of acidosis reported as … This use of the drug is off-label, which means that it is not an FDA-approved use of the drug. 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