FDA media releases
Articles filed under FDA media releases.
FDA video: tramadol and suicide risk
FDA video: tramadol and suicide risk
Caution on olanzapine in adolescents
Caution on olanzapine in adolescents
FDA: Hepatotoxicity with propylthiouracil
FDA video about the risks of hepatotoxicity with propylthiouracil.
Golimumab (Simponi) side effects: risk of serious fungal infections
Centocor Ortho Biotech and FDA reminded prescribers of the risk of serious fungal infections associated with TNF-α blockers, this includes the newer Simponi (golimumab).
TNF blockers and lymphoma: FDA adds boxed warning
FDA: TNF blockers increase the risk of lymphoma and other malignancies in children and adolescents. Drugs included: etanercept –Enbrel-, infliximab –Remicade- and adalimumab –HUMIRA-
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.
FDA video on erlotinib (Tarceva) adverse effects
FDA video warning on gastrointestinal dermatologic and ophthalmic side effects of erlotinib (Tarceva).
FDA approves bevacizumab (Avastin) for glioblastoma multiforme
Prescribing information, mechanism of action, approved indications and videos on Avastin (bevacizumab) for glioblastoma multiforme.
FDA video warning on metoclopramide and tardive dyskinesia
Video: patient safety warning on chronic use of metoclopramide and the risk of developing tardive dyskinesia.
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
Efalizumab (Raptiva) for plaque psoriasis. EMEA recommends withdrawal of its marketing authorization, FDA issues public health advisory
Raptiva and progressive multifocal leukoencephalopathy : EMEA recommends withdrawal of marketing authorization and FDA recommends monitoring patients.
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
Xigris (Drotrecogin alfa activated): concerns of serious bleeding and increased death trigger FDA safety review
On February 4th, 2009 the FDA announced an ongoing safety review of Xigris (Drotrecogin alfa [activated]). An introduction from Wikipedia: Drotrecogin alfa (activated) (Xigris, marketed by Eli Lilly and Company) is a recombinant form of human activated protein C ( rhAPC) that has anti-thrombotic, anti-inflammatory, and profibrinolytic properties. Drotrecogin alpha (activated) belongs to the class