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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 Approves Generic Singulair

The U.S. Food and Drug Administration approved the first generic versions of Singulair (montelukast sodium) for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies.

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...

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).