FDA Faults Next-Gen Olympus Duodenoscopes After demanding single-use devices, agency finds they have their own problems Mar 27, 2023
FDA Warns on Use of Hospira Drug in Kids Due to 'Unsafe' Aluminum Levels Agency cites risk for aluminum toxicity in infants Feb 10, 2023
CDC Sounds Alarm on Eye Drops Linked With Drug-Resistant Infection Permanent vision loss, death due to possible contamination leads to product recall Feb 02, 2023
Legal Loophole Lets Faulty Devices Maintain Their Legacy Harlan Krumholz on how devices subject to Class I recalls are used as predicates for new devices Jan 11, 2023 video
Abbott Formula Plant Was 'Unacceptably Insanitary,' FDA Chief Tells Lawmakers Abbott official says the company is "deeply, deeply sorry" about the formula shortage May 26, 2022
More Medical Device Deaths Than We Previously Thought? Study finds many reports of patient deaths that were not classified as a death in FDA database Jul 27, 2021
FDA Warns Doctors, Consumers on Contaminated Chantix Latest drug found with cancer-causing nitrosamines Jul 20, 2021
Bad Day Sunshine: Benzene Found in Many Sun Care Products Valisure also detected the carcinogen in hand sanitizers earlier this year May 26, 2021
Common Hospital PCR Test Affected by Viral Variant Cepheid Xpert joins three other tests for which B.1.1.7 can be problematic Apr 05, 2021
FDA: Arrhythmia Risk With Lamotrigine May Be Class Effect Agency updates warning for people with cardiac disease taking sodium channel blockers Apr 01, 2021
Benzene Found in Multiple Hand Sanitizer Brands Known human carcinogen can be absorbed through the skin Mar 25, 2021
JAK Inhibitor Misses Endpoint in Safety Study. Now What? Major blow to popular class of oral rheumatology drugs Jan 27, 2021
Metformin Recalls Ballooned in 2020 Last addition to the list in November brought number to 254 products recalled Dec 29, 2020
Virtual Heart Failure Care No Substitute for the Face-to-Face Visit? Reduced GDMT titration suggests a dip in quality of care Oct 05, 2020
FDA Drops Boxed Warning From Invokana Label Amputation risk "lower than previously described" Aug 27, 2020
HCQ No Longer Approved Even a Little for COVID-19 Study after study showed no benefit, and now the FDA has had enough Jun 15, 2020
NDMA Prompts Metformin Recall FDA finds certain products with excessive levels of potential carcinogen May 29, 2020
Montelukast Warning Upgraded Existing risk information not prominent enough and needs a black box, FDA decides Mar 04, 2020
FDA Loosens Alcohol Warning for Addyi But refuses drugmaker's demand to remove black box Apr 11, 2019
FDA Issues 'Clean' List for Sartan Drugs Nitrosamine-free ARBs do exist, agency stresses Apr 04, 2019
Potentially Fatal Immune Reactions to Lamotrigine Draw FDA Warning Eight serious events including one death since drug was approved in 1994 Apr 25, 2018
Device May Ease Fistula Creation Catheter-based, ultrasound-guided device had good long-term patency Nov 08, 2017
Largest AED Maker to Halt Most Operations as FDA Cites Problems Quality controls have not been up to FDA standards Nov 01, 2017
FDA Warns on MRI in Patients with Implantable Pumps Medication, mechanical issues may follow exposure Jan 11, 2017
FDA Warns on Cardiac Surgery Heater-Cooler Device Cites mycobacterial contamination risk Oct 13, 2016
FDA Warns of Heart Risk with Imodium Permanent and fatal arrhythmias tied to misuse of loperamide Jun 07, 2016
Use of Expired Auto-Injectors OK'd by FDA WASHINGTON -- The FDA cautioned emergency medical staff to retain recently expired auto-injectors by Meridian Medical Technologies and to use them in emergencies if no other product is available. Nov 29, 2013
FDA Adds GI Warning to Benicar Label WASHINGTON -- The FDA ordered the maker of the blood pressure drug olmesartan (Benicar) to add a warning about risk of the intestinal condition known as sprue-like enteropathy to the drug's label. Jul 03, 2013
CDC: Cut Back on Doxycycline Use A continuing shortage of doxycycline means the drug should be used only for conditions that have no alternative treatments, the CDC advised this week. Jun 14, 2013
NuPathe's Patch for Migraine Wins FDA Approval WASHINGTON -- Adults with migraine will soon have a new treatment option -- Zecuity, a transdermal, battery-powered sumatriptan patch. Jan 18, 2013
'Rugby' Iron Pills Pulled Due to Drug Mix-Up 锘縒ASHINGTON -- The manufacturer of an iron supplement has recalled one lot of the product due to bottles of the affected lot potentially containing anti-nausea tablets instead. Jan 18, 2013
FDA: Booze and Xyrem Are Dangerous Mix WASHINGTON -- The FDA is warning healthcare professionals that patients taking the muscle weakness and narcolepsy drug sodium oxybate (Xyrem) should not consume alcohol or use central nervous system depressants. Dec 17, 2012
Suboxone Maker Pulls Pills in Favor of Film The buprenorphine-naloxone combination product (Suboxone) in sublingual tablet form will soon be pulled from the U.S. market because its child-resistant packaging isn't effective enough. Sep 25, 2012
Brain-Eating Amoeba Came From Faucet The recent cases of primary amoebic meningoencephalitis represent the first reported instances of U.S. tap water harboring the amoeba that causes the fatal disease, according to CDC researchers. Aug 23, 2012
Oxygen Devices Recalled WASHINGTON -- The FDA has issued a class I recall of several models of oxygen concentrators because of a potential fire hazard. Jun 20, 2012
New Drug for ED Wins FDA Approval WASHINGTON -- The PDE-5 inhibitor class of drugs for erectile dysfunction gained its first new member in a decade with the FDA approval of avanafil (Stendra). Apr 27, 2012
FDA Warns of Clot Risk with Yaz, Other OCs Labels for oral contraceptives that contain drospirenone will now note that studies have shown up to a threefold increased risk of blood clots compared with other birth control pills. Apr 10, 2012
