Sedative-hypnotic drug products are a class of drugs used to induce and/or maintain sleep. FDA Drug Safety Communications: Prescription Insomnia Drugs (UPDATED) For prescribing information, please […]

The FDA has issued new information about this safety issue, see the FDA Drug Safety Communication issued on 12-12-2016. [8-4-2011] The U.S. Food and Drug Administration […]

[ 4-27-2017 ] The U.S. Food and Drug Administration (FDA) is notifying the public that we have approved previously announced label changes regarding the use of […]

[08-03-2018] The U.S. Food and Drug Administration (FDA) is warning that the antibiotic azithromycin (Zithromax, Zmax) should not be given long-term to prevent a certain inflammatory […]

[07-10-2018 ] The Food and Drug Administration (FDA) is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar […]

[ 05-23-2018 ] The U.S. Food and Drug Administration (FDA) is warning that over-the-counter (OTC) oral drug products containing benzocaine should not be used to treat […]

The U.S. Food and Drug Administration (FDA) is advising caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased […]

9/20/2019 UpdateTo help address loperamide abuse and misuse, FDA approved changes to the packaging for tablet and capsule forms of the brand-name over-the-counter (OTC) anti-diarrheal medicines […]

Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States WARNING LETTER Date:   June 26, 2020 TO:  [email protected] –Kent New and Jennifer Sawyer […]