FDA Alerts
FDA Recommends Against Prolonged Use of Magnesium Sulfate to Stop Pre-term Labor
The US Food and Drug Administration (FDA) is advising healthcare professionals against using magnesium sulfate injection for more than 5-7 days to stop pre-term labor in pregnant women.
New FDA Boxed Warning for Codeine
The US Food and Drug Administration (FDA) is updating the public about new actions being taken to address a known safety concern with codeine use in certain children after tonsillectomy and/or adenoidectomy (surgery to remove the tonsils and/or adenoids). Deaths have occurred post-operatively in children with obstructive sleep apnea who received codeine for pain relief following a tonsillectomy and/or adenoidectomy. Codeine is converted to morphine by the liver. These children had evidence of being ultra-rapid metabolizers of codeine, which is an inherited (genetic) ability that causes the ...
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 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 Warning: Serious Adverse Events From Eye Drops and Nasal Sprays Ingestion
The US Food and Drug Administration (FDA) is warning the public that accidental ingestion (swallowing) by children of over-the-counter (OTC; available without a prescription) eye drops used to relieve redness and nasal decongestant sprays can result in serious harm.
FDA Approves Children's Brain Tumor Drug
The US Food and Drug Administration today approved Afinitor Disperz (everolimus tablets for oral suspension), a new pediatric dosage form of the anti-cancer drug Afinitor (everolimus) used to treat a rare brain tumor called subependymal giant cell astrocytoma (SEGA).
FDA Approves New Vaccine for Children
Today the US Food and Drug Administration approved Menhibrix , a combination vaccine for infants and children ages 6 weeks through 18 months, for prevention of invasive disease caused by Neisseria meningitidis serogroups C and Yand Haemophilus influenzae type b.
FDA Approves New Drug For Premature Babies
The U.S. Food and Drug Administration approved Surfaxin ( lucinactant ) for the prevention of respiratory distress syndrome ( RDS ), a breathing disorder that affects premature infants.
The lungs of premature infants are not able to make enough surfactant, a liquid that coats the inside of the lungs and helps to keep them open. Without enough surfactant, the lungs collapse and the infant has difficulty breathing. Most babies who develop RDS show signs of breathing problems and a lack of oxygen at birth or within the first few hours after birth.
Surfaxin is the fifth drug approved i...
Reducing Fever in Children: Safe Use of Acetaminophen
You’re in the drug store, looking for a fever-reducing medicine for your children. They range in age from 6 months to 7 years, and you want to buy one product you can use for all of them.
Statement from Surgeon General Dr. Regina M. Benjamin on World Breastfeeding Week
World Breastfeeding Week provides an opportunity to highlight the benefits of breastfeeding and to encourage everyone to support mothers who want to breastfeed.