FDA Alerts
FDA Discovers Autoimmune Mechanism for Drug Reactions
A team of researchers led by the U.S. Food and Drug Administration has discovered a new mechanism for identifying and understanding drug-related autoimmune reactions.
FDA Widens FilmArray Respiratory Panel Use
The U.S. Food and Drug Administration today expanded the use for the FilmArray Respiratory Panel, the first test that can simultaneously detect both viral and bacterial causes of respiratory infection from a single sample.
Levaquin Approved for Treatment of the Plague
The U.S. Food and Drug Administration (FDA) today approved Levaquin ( levofloxacin ) to treat patients with plague, a rare and potentially deadly bacterial infection.
Victrelis and HIV Drug Interactions
The U.S. Food and Drug Administration (FDA) is notifying the public that co-administration of Victrelis ( boceprevir ), a hepatitis C virus ( HCV ) protease inhibitor, along with certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors, is not recommended at this time.
Because of the possibility of reducing the effectiveness of the medicines, permitting the amount of HCV or HIV virus in the blood (viral load) to increase. Ritonavir-boosted HIV protease inhibitors include ritonavir-boosted Reyataz ( atazanavir ), ritonavir-boosted Prezista ( darunavir ), and Kal...
FDA Issues Second Warning to Physicians about Certain Compounded Drugs
FDA has received additional reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G ( BBG ) during eye surgery since the FDA Warning to Physicians was posted on March 19, 2012.
FDA Issues Second Warning to Physicians about Certain Compounded Drugs
FDA has received additional reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G ( BBG ) during eye surgery since the FDA Warning to Physicians was posted on March 19, 2012.
FDA Approves New Viral Blood Test
Avioq HTLV-I /II Microelisa System, a test designed to detect antibodies to viruses in donors of human blood and blood components that are associated with several diseases, including some forms of leukemia and neurologic diseases, was approved by the Food and Drug Administration.
FDA Proposes Lower Risk Classification for Tuberculosis Testing
The Food and Drug Administration issued a proposed rule that would encourage the development of a type of test used to detect cases of tuberculosis (TB).
This rule would lower the current risk classification for nucleic acid-based tests allowing manufacturers to utilize the faster, more streamlined clearance pathway for medical devices.
Nucleic acid-based tuberculosis tests can detect the presence of copies of tuberculosis bacterium genetic materials (RNA or DNA) in a mucus (sputum) sample obtained from the patient. This allows timely identification of TB disease.
Currently, the...
Novel Vaccine to Prevent Seasonal Influenza Approved
FluMist Quadrivalent , a vaccine to prevent seasonal influenza in people ages 2 years through 49 years, has been approved by the U.S. Food and Drug Administration.
Hepatitis C and HIV Drug Interactions
The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals and patients that drug interactions between the hepatitis C virus ( HCV ) protease inhibitor Victrelis ( boceprevir ) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors ( atazanavir , lopinavir , darunavir ) can potentially reduce the effectiveness of these medicines when they are used together.