Category Archives: FDA media releases

FDA video: interaction of IV ceftriaxone with calcium-containing products

The FDA updated the full prescribing information of ceftriaxone (Rocephin and generics). This is an update to a previous ( september 2007) alert on the risk of interaction between ceftriaxone and calcium-containing IV products, the 2007 alert was based on reported fatal cases in neonates.Continue Reading

FDA: potential risk of HIV and hepatitis transmission when insulin pens and cartridges are shared

An excerpt of FDA’s press release issued  19th March 2009: The U.S. Food and Drug Administration today issued an alert to health care professionals reminding them that single-patient insulin pens and insulin cartridges should not be used to administer medication to multiple patients due to the potential risk of transmitting blood-borne pathogens such as HIV…

Metoclopramide and tardive dyskinesia: FDA adds boxed warning

The FDA issued a press release (dated February 26, 2009) in which they announce that the agency will require Metoclopramide (Maxolon, Reglan, Degan, Maxeran, Primperan, and Pylomid) manufacturers to include a boxed warning about the risk of long term or high dose use: The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide,…

Zonisamide (Zonegran): FDA warns about risk of metabolic acidosis and issues recommendations

The FDA issued an alert (February 23, 2009) about the risk of metabolic acidosis in patients treated with zonisamide (Zonegran). An excerpt from the alert on this anticonvulsant adverse effect: Following a review of updated clinical data,  the FDA has determined that treatment with zonisamide can cause metabolic acidosis in some patients.  Zonisamide is indicated…

FDA approves ATryn (recombinant human antithrombin) for the treatment of hereditary antithrombin deficiency

The FDA issued a press release (February 6th, 2009) announcing the approval of the first biological product produced by genetically engineered animals: recombinant human antithrombin. Some excerpts from the press release: The U.S. Food and Drug Administration today issued its first approval for a biological product produced by genetically engineered (GE) animals. The approval is…

Are you a visual learner interested in learning psychopharmacology? Click here to get our videos