FDA Alerts
FDA Limits Duration and Usage of Samsca
The US Food and Drug Administration (FDA) has determined that the drug Samsca (tolvaptan) should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can cause liver injury, potentially requiring liver transplant or death.
FDA Approves Diclegis
The US Food and Drug Administration today approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) to treat pregnant women experiencing nausea and vomiting.
Ravicti for the Management of Urea Cycle Disorders Approved
The US Food and Drug Administration today approved Ravicti (glycerol phenylbutyrate) for the chronic management of some urea cycle disorders (UCDs) in patients ages 2 years and older.
Andy Capp’s Hot Fries Recalled Due To Undeclared Soy Allergen
Today, ConAgra Foods, Omaha, Neb., in cooperation with the US Food and Drug Administration (FDA) is voluntarily recalling a limited number of packages of its Andy Capp’s Hot Fries flavor product that may contain the Andy Capp’s Cheddar Fries flavor, and, therefore, an undeclared allergen—soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products. There have been no illnesses reported to date in connection with this product.
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 Gattex to Treat Short Bowel Syndrome
The US Food and Drug Administration today approved Gattex (teduglutide) to treat adults with short bowel syndrome (SBS) who need additional nutrition from intravenous feeding (parenteral nutrition).
FDA Approves Humira to Treat Ulcerative Colitis
The U.S. Food and Drug Administration today expanded the approved use of Humira ( adalimumab ) to include treatment of moderate-to-severe ulcerative colitis in adults.
FDA issues Safety Alert on Intestinomicina
The US Food and Drug Administration is warning consumers not to use Intestinomicina, a drug product manufactured in El Salvador and marketed as a treatment for infectious diarrhea and acute gastrointestinal infections.
FDA Safety Alert on Intestinomicina
The US Food and Drug Administration is warning consumers not to use Intestinomicina, a drug product manufactured in El Salvador and marketed as a treatment for infectious diarrhea and acute gastrointestinal infections.
Drug Approved for Gaucher Disease
The U.S. Food and Drug Administration approved Elelyso ( taliglucerase alfa ) for long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder.