FDA Press Releases

1,067 Press Releases

Published on June 14, 2019 - 17:51 GMT

Fecal Microbiota for Transplantation: Safety Communication- Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug ...

[Posted 06/13/2019] AUDIENCE: Patient, Healthcare Professional ISSUE: The FDA is now aware of bacterial infections caused by multi-drug resistant organisms (MDROs) that have occurred due to transmission of a MDRO from use of investigational fecal …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 10, 2019 - 15:54 GMT

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Distribution channels: Healthcare & Pharmaceuticals Industry
Published on May 24, 2019 - 15:45 GMT

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The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on May 14, 2019 - 13:35 GMT

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The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on May 3, 2019 - 00:50 GMT

Certain Prescription Insomnia Medicines: New Boxed Warning - Due to Risk of Serious Injuries Caused by Sleepwalking, Sleep Driving ...

[Posted 04/30/2019] AUDIENCE: Patient, Health Professional, Pharmacy ISSUE: FDA is advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on April 4, 2019 - 14:25 GMT

E-cigarette: Safety Communication - Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults

[Posted 04/03/2019] AUDIENCE: Consumers, Emergency Medicine, Health Professionals ISSUE: The FDA has become aware that some people who use e-cigarettes have experienced seizures, with most reports involving youth or young adult users. Seizures or …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on February 25, 2019 - 21:38 GMT

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death ...

[Posted 02/25/2019] AUDIENCE: Patient, Health Professional, Pharmacy, Rheumatology ISSUE: FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib ( …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on December 20, 2018 - 19:55 GMT

Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain ...

[Posted 12/20/2018] AUDIENCE: Health Professional, Infectious Disease, Cardiology, Patient ISSUE: FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on November 21, 2018 - 07:08 GMT

Gilenya (fingolimod): Drug Safety Communication - Severe Worsening of Multiple Sclerosis After Stopping the Medicine

[Posted 11/20/2018] AUDIENCE: Patient, Health Professional, Neurology, Pharmacy ISSUE: FDA is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on November 15, 2018 - 05:21 GMT

Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration

[Posted 11/14/2018] AUDIENCE: Patient, Caregiver, Health Professional, Pain Management, Pharmacy, Neurology, Surgery ISSUE: The FDA is aware that patients undergoing treatment or management of pain are commonly given pain medicines in the spinal fluid ( …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on August 30, 2018 - 08:21 GMT

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious ...

[Posted 08/29/2018] AUDIENCE: Patient, Endocrinology, Health Professional, Pharmacy ISSUE: FDA is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on August 19, 2018 - 11:19 GMT

Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of ...

[Posted 08/17/2018] AUDIENCE: Transplantation, Surgery, Cardiology ISSUE: FDA has reviewed the final results from the post-approval study conducted by SynCardia Systems for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on August 8, 2018 - 18:11 GMT

Risks Associated with Use of Rupture of Membranes Tests - Letter to Health Care Providers

[Posted 08/08/2018] AUDIENCE: OBGYN, Risk Manager, Health Professional ISSUE: The FDA is reminding health care providers that tests to detect rupture of the amniotic membranes should not be used without other clinical assessments to make critical patient …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on August 3, 2018 - 14:00 GMT

Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant

[Posted 08/03/2018] AUDIENCE: Patient, Health Professional, Oncology ISSUE: The antibiotic Zithromax, Zmax (azithromycin) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on July 20, 2018 - 18:11 GMT

Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled Products

[Posted 07/19/2018] AUDIENCE: Consumer, Health Professional, Pharmacy ISSUE: The investigation into valsartan-containing products is ongoing and the following list may change. We will update this statement as we have more information. There are currently …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on July 10, 2018 - 22:30 GMT

Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects

[Posted 07/10/2018] AUDIENCE: Patient, Health Professional, Pharmacy ISSUE: FDA is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 22, 2018 - 15:00 GMT

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

[Posted 06/22/2018] AUDIENCE: Consumer, Health Professional ISSUE: The products have been found by the FDA via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 19, 2018 - 16:39 GMT

Various Aortic Endovascular Graft Systems: Letter to Health Care Providers - UPDATE on Type III Endoleaks

[Posted 06/19/2018] AUDIENCE: Risk Manager, Surgery, Patient, Cardiology ISSUE: The FDA continues to evaluate information from several sources and based on new information, the Endologix AFX with Strata device is at greater risk for a Type III endoleak …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 15, 2018 - 02:48 GMT

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health ...

[Posted 06/14/2018] AUDIENCE: Patient, Health Professional, Eye Care, Risk Manager ISSUE: At least 43 patients reported adverse events after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 6, 2018 - 19:51 GMT

CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope Corp.: Class I Recall - Due to Fluid Ingress that May Affect ...

[Posted 06/26/2018] AUDIENCE: Cardiology, Risk Management, Surgery ISSUE: Maquet Datascope Corp. is recalling the IABP due to a design issue that allows fluid (such as saline) to seep into the device. The fluid can cause corrosion of internal components …

Distribution channels: Healthcare & Pharmaceuticals Industry

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