FDA Alerts
FDA Investigating Two Deaths Following Injection of Zyprexa Relprevv
The US Food and Drug Administration (FDA) is investigating two unexplained deaths in patients who received an intramuscular injection of the antipsychotic drug Zyprexa Relprevv (olanzapine pamoate).
Nicotine Replacement Therapy Labels May Change
When nicotine replacement therapy (NRT) products were first marketed almost 30 years ago to help people stop smoking, there wasn't a lot of data available on how long consumers could safely use them, and whether they could be used in combination with other NRTs or with continued smoking.
FDA Drug Safety Communication: Chantix Heart Risk
The US 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.
FDA Warning: Counterfeit Adderall
The U.S. Food and Drug Administration is warning consumers and health care professionals about a counterfeit version of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets that is being purchased on the Internet.
Celexa and Risk of Arrhythmia
The U.S. Food and Drug Administration (FDA) is clarifying dosing and warning recommendations for the antidepressant Celexa ( citalopram hydrobromide ; also available in generic form).
Generic Lexapro Approved
The U.S. Food and Drug Administration approved the first generic Lexapro ( escitalopram tablets) to treat both depression and generalized anxiety disorder in adults.
Drug Safety Communication: SSRI use during pregnancy
The U.S. Food and Drug Administration (FDA) is updating the public on the use of selective serotonin reuptake inhibitor ( SSRI ) antidepressants by women during pregnancy and the potential risk of a rare heart and lung condition known as persistent pulmonary hypertension of the newborn ( PPHN ).
FDA Safety Communication: Chantix
The U.S. Food and Drug Administration (FDA) has reviewed the results from two FDA-sponsored epidemiological studies that evaluated the risk of neuropsychiatric adverse events associated with the smoking cessation drug Chantix ( varenicline ).
FDA Approves First Generic Olanzapine
The U.S. Food and Drug Administration today approved the first generic versions of Zyprexa ( olanzapine tablets) and Zyprexa Zydus ( olanzapine orally disintegrating tablets) to treat schizophrenia and bipolar disorder.
FDA Drug Safety Communication: Saphris
The U.S. Food and Drug Administration (FDA) is warning the public that serious allergic reactions have been reported with the use of the antipsychotic medication Saphris ( asenapine maleate ).