2014 Drug Safety Communications
- FDA Drug Safety Communication: FDA reporting mental health drug ziprasidone (Geodon) associated with rare but potentially fatal skin reactions 12/11/2014
- FDA Drug Safety Communication: FDA warns about case of rare brain infection PML with MS drug Tecfidera (dimethyl fumarate) 11/25/2014
- FDA Drug Safety Communication: FDA reviews long-term antiplatelet therapy as preliminary trial data shows benefits but a higher risk of non-cardiovascular death 11/16/2014
- FDA Drug Safety Communication: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events 09/26/2014
- FDA Drug Safety Communication: FDA recommends not using lidocaine to treat teething pain and requires new Boxed Warning 06/26/2014
- FDA Drug Safety Communication: FDA warns of rare but serious hypersensitivity reactions with certain over-the-counter topical acne products 06/25/2014
- FDA Drug Safety Communication: FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required 06/24/2014
- FDA Drug Safety Communication: FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication after treatment 06/20/2014
- FDA warns of next-day impairment with sleep aid Lunesta (eszopiclone) and lowers recommended dose 05/15/2014
- FDA study of Medicare patients finds lower risk of stroke and death with Pradaxa (dabigatran) compared with warfarin 05/13/2014
- FDA requires label changes to warn of rare but serious neurologic problems after epidural corticosteroid injections for pain 04/23/2014
- FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial Hypertension 03/31/2014
- FDA approves label changes for antibacterial Doribax (doripenem) describing increased risk of death for ventilator patients with pneumonia 03/06/2014
- FDA Drug Safety Communication: FDA to review heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR) 02/11/2014
- FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products 01/31/2014
- FDA warns of possible harm from exceeding recommended dose of over-the-counter sodium phosphate products to treat constipation 01/08/2014