FDA Alerts
FDA Approves Xalkori and Vysis ALK Break Apart FISH Probe Kit
The U.S. Food and Drug Administration today approved Xalkori ( crizotinib ) to treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers ( NSCLC ) who express the abnormal anaplastic lymphoma kinase ( ALK ) gene.
FDA approves Firazyr
The U.S. Food and Drug Administration today approved Firazyr ( icatibant ) Injection for the treatment of acute attacks of a rare condition called hereditary angioedema ( HAE ) in people ages 18 years and older.
FDA Drug Safety Communication: Celexa
The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and patients that the antidepressant Celexa ( citalopram hydrobromide ; also marketed as generics) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day.
FDA Hepatitis Update - Pegasys and Copegus
On August 22, 2011, the FDA approved the combination of Pegasys and Copegus for the treatment of chronic hepatitis C virus ( HCV ) infection in pediatric patients 5 through 17 years of age.
FDA Drug Safety Communication: Celexa
The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and patients that the antidepressant Celexa ( citalopram hydrobromide ; also marketed as generics) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day.
Previously, the citalopram drug label stated that certain patients may require a dose of 60 mg per day.
Facts about Celexa ( citalopram hydrobromide )
Is in a cla...
FDA approves Botox to treat specific form of urinary incontinence
The U.S. Food and Drug Administration today approved Botox ( onabotulinumtoxinA ) injection to treat urinary incontinence in people with neurologic conditions such as spinal cord injury and multiple sclerosis who have overactivity of the bladder.
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.
FDA Drug Safety Communication: Diflucan
The U.S. Food and Drug Administration (FDA) is informing the public that chronic, high doses (400-800 mg/day) of the antifungal drug Diflucan ( fluconazole ) may be associated with a rare and distinct set of birth defects in infants whose mothers were treated with the drug during the first trimester of pregnancy.
FDA: Unapproved Emergency Birth Control May Be Ineffective, Unsafe
The U.S. Food and Drug Administration (FDA) is warning U.S. consumers not to use the emergency birth control medicine labeled as Evital . These products may be counterfeit versions of the “morning after pill” and may not be safe or effective in preventing pregnancy.
Evital has not been approved by the FDA for use in the United States.
This potentially ineffective and suspect counterfeit emergency birth control may also be in distribution in some Hispanic communities in the United States.
The packaging label of the potentially ineffective and suspect counterfeit version says, ...
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.