FDA Alerts
Azithromycin (Zithromax or Zmax) and the Risk of Potentially Fatal Heart Rhythms
The US Food and Drug Administration (FDA) is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm.
FDA approves new seasonal influenza vaccine made using novel technology
The US Food and Drug Administration today announced that it has approved Flublok , the first trivalent influenza vaccine made using an insect virus ( baculovirus ) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age.
FDA Proposes New Food Safety Standards
The US Food and Drug Administration today proposed two new food safety rules that will help prevent foodborne illness. The proposed rules implement the landmark, bipartisan FDA Food Safety Modernization Act ( FSMA ) and are available for public comment for the next 120 days. The FDA encourages Americans to review and comment on these important proposed rules.
FDA Approves First Anti-Diarrheal Drug for HIV/AIDS Patients
The US Food and Drug Administration today approved Fulyzaq ( crofelemer ) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection.
Diarrhea is experienced by many HIV/AIDS patients and is a common reason why patients discontinue or switch their antiretroviral therapies. Fulyzaq is intended to be used in HIV/AIDS patients whose diarrhea is not caused by an infection from a virus, bacteria, or parasite.
Patients take Fulyzaq two times a day to manage watery diarrhea due to the secretion of electrolytes ...
FDA Approves Sirturo as Tuberculosis Option
On Dec. 28, the US Food and Drug Administration approved Sirturo ( bedaquiline ) as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available.
FDA Approves Varizig for Reducing Chickenpox Symptoms
The US Food and Drug Administration has approved Varizig for reducing the severity of chickenpox ( varicella zoster virus) infections in high risk individuals when given within four days after exposure.
FDA expands Tamiflu’s use to treat children younger than 1 year
The US Food and Drug Administration today expanded the approved use of Tamiflu (oseltamivir) to treat children as young as 2 weeks old who have shown symptoms of flu for no longer than two days.
FDA Approves Raxibacumab to Treat Inhalational Anthrax
The US Food and Drug Administration today approved raxibacumab injection to treat inhalational anthrax, a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis.
FDA approves first seasonal influenza vaccine manufactured using cell culture technology
The US Food and Drug Administration announced today the approval of Flucelvax, the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs.
FDA Warns Tennessee Company that Online Product Claims Violate Federal Law
The US Food and Drug Administration today issued a Warning Letter to The Avalon Effect Inc., a company based in Franklin, Tenn., for its marketing of a light therapy product that claims to cure or treat symptoms of fungal meningitis, methicillin-resistant Staphylococcus aureus (MRSA), concussions, Lyme disease, and other diseases.