FDA Alerts

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 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 Drug Safety Communication: Methylene blue (UPDATE)
The U.S. Food and Drug Administration (FDA) has received reports of serious central nervous system (CNS) reactions when the drug methylene blue is given to patients taking psychiatric medications that work through the serotonin system of the brain ( serotonergic psychiatric medications).
Drug Safety Communication: Zyvox (UPDATE)
The FDA has received reports of serious central nervous system (CNS) reactions when the antibacterial drug linezolid (Zyvox) is given to patients taking psychiatric medications that work through the serotonin system of the brain (serotonergic psychiatric medications).
Risperdal (risperidone) and Risperidone Recall
Ortho-McNeil-Janssen Pharmaceuticals notified healthcare professionals and the public of a recall of specific lots of Risperdal ( risperidone ) 3mg tablets and risperidone 2mg tablets.
FDA Unveils Final Cigarette Warning Labels
The U.S. Food and Drug Administration (FDA) today unveiled the nine graphic health warnings required to appear on every pack of cigarettes sold in the United States and in every cigarette advertisement.
FDA: Chantix (varenicline) May Increase Cardiovascular Risk
The U.S. Food and Drug Administration (FDA) is notifying the public that the smoking cessation aid Chantix ( varenicline ) may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease.
Medication Errors Resulting From Name Confusion
The U.S. Food and Drug Administration (FDA) is alerting the public to medication error reports in which patients were given risperidone ( Risperdal ) instead of ropinirole ( Requip ) and vice versa. In some cases, patients who took the wrong medication needed to be hospitalized.
Motherhood is About to Make You a Little Crazier
FDA notified healthcare professionals that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated.
Tobacco Control
The FDA  announced that it issued its first warning letters to retailers for the illegal sale of tobacco products to minors in violation of the 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). Using state inspectors who have been commissioned by the agency, the FDA visited 493 different retail establishments in Mississippi over the past three months and issued 25 warnings. Mississippi was the first state to participate in the FDA’s State Enforcement Program, which got underway in the summer of 2010 and is designed to help enforce many provisions of t...