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Acetaminophen's safety called into question by FDA (7/1/09)
Examiner.com - USA
The reason for the government's interest in this common, popular analgesic is because of the numerous reports of liver damage it has caused. Routinely used for pain and fever reduction, acetaminophen overdose or misuse has been pinpointed in at least 56,000 emergency room cases, more
Ezetimibe/Simvastatin - Update of Safety Review (1/9/09)
FDA MedWatch
The FDA has completed its review of the final clinical study report of ENHANCE and issued an update. more
January/February 2009 FDA Patient Safety News is now available (1/8/09)
FDA MedWatch
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. more
Innohep (tinzaparin sodium) Dear Healthcare Professional Letter issued re: increased risk of death in renal impaired elderly (12/31/08)
FDA MedWatch
Celgene has issued a Dear Healthcare Professional letter describing a controlled clinical study suggesting that Innohep may increase the risk for death, compared to unfractionated heparin when used to treat elderly patients... more
Stryker Custom Cranial Implant Kits: Class 1 recall due to lack of assurance of sterility and risk on infection (12/24/08)
FDA MedWatch
Stryker Leibinger USA and FDA notified healthcare professionals of a Class 1 recall of all sizes of the cranial implant kit distributed from November 5, 2007 through October 23, 2008. The company is recalling these products because sterility cannot be assured. more
Hydromorphone tablets [ETHEX] recalled due to oversided tablets and potential for over dosage (12/24/08)
FDA MedWatch
ETHEX and FDA notified heathcare professionals of a nationwide recall of a single lot of Hydromorphone HCl 2 mg Tablets due to potential for oversized tablets. Hydromorphone is a drug used for pain management. more
Weight Loss Pills contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk (12/22/08)
FDA MedWatch
FDA alerted consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk. more
SunMed Greenline/D MacIntosh No. 3 Laryngoscope Blades recalled due to potential to break during use (12/19/08)
FDA MedWatch
A piece of the acrylic light tube that runs along the laryngoscope blade may break off during the procedure. more
October 2008 Drug Safety Labeling Changes for 61 Drugs Now Available on Web (12/19/08)
FDA MedWatch
The October 2008 posting includes 61 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERTS, and MEDICATION GUIDES... more
FDA, Terumo Cardiovascular Systems Tenderflow Pediatric Arterial Cannulae Recall (12/8/08)
FDA MedWatch
Terumo received five reports of difficulty retracting the introducer from the cannula... a process that may lead to aortic damage, blood loss and/or death... more
Ethex Corp and FDA Recall of Five Generic Products (11/10/08)
FDA MedWatch
Propafenone HCl, Isosorbide Mononitrate Extended Release, Morphine Sulfate Immediate and Extended Release, Dextroamphetamine Sulfate: The products may contain oversized tablets that may contain more than the intended levels of the active drug ingredient that could result in patients receiving as much as twice the expected dosage... more
WalMart "ReliOn" insulin syringe recall due to potential for serious overdose (11/6/08)
FDA MedWatch
Covidien and FDA notified patients and healthcare professionals of a recall of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles. The mislabeled syringe may result in patients receiving an overdose... more
September 2008 Drug Safety-Related Labeling Changes for 36 Drugs Now Available on Web (11/4/08)
FDA MedWatch
The September 2008 posting includes 36 drug products with safety labeling changes... more
Judge Gives Class Action Status to Zyprexa Cases (9/10/08)
InjuryBoard.com - Tampa,FL,USA
Zyprexa, Eli Lilly's schizophrenia drug, has come under fire for adverse effects including weight gain and diabetes. more
FDA BOLS Notice (9/8/08)
FDA MedWAtch
Disposable Battery Operated Lavage System (BOLS): risk of explosion and harm to patients and staff when BOLS cables are cut... more
The September 2008 FDA Patient Safety News is now available... (8/30/08)
FDA MedWAtch
It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. more
Nursing Home Abuse News and Updates (8/29/08)
Compiled by Bee Becker
Spokesperson for SafetyForum Nursing Home Abuse Action Group (NHAAG) More...
FDA, EG Labs, LLC, Viapro Recall (7/31/08)
FDA MedWatch
Viapro 375mg Capsules: voluntary recall because the product was found to contain a potentially harmful analog of Sildenafil... more
FDA Notice: Erythropoiesis Stimulating Agents (7/31/08)
FDA MedWatch
Procrit, Epogen, and Aranesp - FDA clarifies approved conditions for use of ESAs in patients with cancer and revises dosing directions... more
FDA Warning: Herceptin 440mg Vials & BWFI Diluent (7/10/08)
FDA MedWatch
Complaints of damaged and broken vials that may lead to a loss of sterility... more
FDA, Ethex Corp Morphine Sulfate Tablet Recall (6/10/08)
FDA MedWatch
A single lot of Morphine Sulfate 60 mg Extended Release Tablets is recalled due to a report of a tablet with twice the appropriate thickness... more
FDA Early Communication: Remicade, Enbrel, Humira and Cimzia (6/4/08)
FDA MedWatch
FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. more
FDA, Abbott Calcilo Recall (6/2/08)
FDA MedWatch
Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula With Iron Powder recalled because of oxidation... more
The June 2008 FDA Patient Safety News is Now Available (6/2/08)
FDA MedWatch
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. more
FDA, International Pharmaceuticals, Ltd. Viril-ity Power (VIP) Tablets Recall (5/30/08)
FDA MedWatch
Supplement contains potentially harmful undeclared ingredient... more
FDA Mommy's Bliss Nipple Cream Warning (5/29/08)
FDA MedWatch
Mommy's Bliss Nipple Cream contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants... more
FDA Xiadafil VIP Tablets Warning (5/27/08)
FDA MedWatch
Xiadafil VIP Tablets contains potentially harmful, undeclared ingredient that may cause life-threatening side effects... more
FDA Opens Public Comment for Safety of Mercury in Dentistry (5/24/08)
Natural News.com - Phoenix,AZ,USA
Under intensifying consumer group pressure, the FDA has announced that it will open public comment regarding its proposed ruling on the classification of dental mercury amalgam materials. more
FDA, Medicis Recall Solodyn (5/19/08)
FDA MedWatch
Solodyn Extended Release Tablets: One of the bottles contained Azasan (azathioprine tablets) instead of Solodyn Tablets. more
FDA Mycophenolate Mofetil (CellCept) and Mycophenolic Acid (Myfortic) (5/16/08)
FDA MedWatch
FDA is aware of reports of infants born with serious congenital anomalies, including microtia and cleft lip and palate, following exposure to mycophenolate mofetil (MMF) during pregnancy. more
FDA, Bayer PharmaceuticalsTrasylol Notice (5/14/08)
FDA MedWatch
Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. Under a limited use agreement, access to Trasylol is limited to investigational use of the drug... for certain patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy. more
FDA, Hydrox Labs Recall Cardinal Health Mouthwash (5/6/08)
FDA MedWatch
Cardinal Health Alcohol-Free Mouthwas Product Recalled Because Of the Presence Of Burkholderia Cepacia... more
The May 2008 FDA Patient Safety News Is Now Available (5/6/08)
FDA MedWatch
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. more
FDA, Amgen and Wyeth Pharmaceuticals Enbrel Warning (5/1/08)
FDA MedWatch
Enbrel (etanercept)-Prescribing Information Revised To Include A Boxed Warning Regarding The Risk Of Infection, Including Tuberculosis... more
FDA, Actavis Totowa LLC Digitek Recall (4/28/08)
FDA MedWatch
Digitek (digoxin tablets)-Class I Recall Because Tablets May Contain Twice The Approved Level Of Active Ingredient... more
January 2008 Drug Safety Labeling Changes for 41 drugs now available on web (4/24/08)
FDA MedWatch
The January 2008 posting includes 41 drug products with safety labeling changes... more
FDA, Herbal Science International, Inc. Dietary Herbal Supplements Recall (4/14/08)
FDA MedWatch
FDA and Herbal Science International, Inc. recalls twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers. more
FDA "Total Body Formula" Notice (4/10/08)
FDA MedWatch
FDA alerts consumers to stop taking "Total Body Formula" and "Total Body Mega Formula." Hazardous levels of selenium in samples of certain flavors of the dietary supplement were found. more
FDA CellCept and Myfortic Investigation (4/10/08)
FDA MedWatch
FDA investigates a potential association between the use of CellCept (mycophenolate mofetil) and Myfortic (mycophenolate acid), medicines used to prevent organ rejection, and the development of progressive multifocal leukoencephalopathy (PML), a life-threatening disease. more
FDA, Schwarz Pharma Neupro Patch Recall (4/9/08)
FDA MedWatch
Neupro Patch (rotigotine transdermal system) - recalled due to the formation of rotigotine crystals in the patches which affects efficacy... more
FDA, Pfizer Exubera Warning (4/9/08)
FDA MedWatch
Prescribing informatin for Exubera (insulin human rDNA origin) inhalation powder has been updated to include information about primary lung malignancies in patients in clinical trials... more
FDA, Cubist Pharmaceuticals, Inc. ReadyMed Notice (4/9/08)
FDA MedWatch
Healthcare professionals are advised to discontinue using ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc., with Cubicin due to possible MBT leaching... more
FDA, GlaxoSmithKline Relenza Warning (4/2/08)
FDA MedWatch
GlaxoSmithKline informed healthcare professionals of changes to the WARNINGS AND PRECAUTIONS sections of prescribing information for Relenza regarding information from postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury in patients with influenza... more
FDA Investigates Safety Of Asthma Drug Singulair (3/29/08)
Medical News Today - UK
(FDA) is reviewing the safety of Merck & Co's anti-asthma drug Singulair (montelukast) following reports querying a potential link between the drug's use and changes to behaviour and mood, suicide, and suicidal thinking and behaviour. more
FDA Recalls Total Body Formula Liquid Dietary Supplements (3/28/08)
FDA MedWatch
Recall of Total Body Formula dietary supplements due to reports of hair loss, muscle cramps, diarrhea, joint pain and fatigue... more
FDA Ziagen and Videx Study (3/27/08)
FDA MedWatch
FDA issued an Early Communication about recent findings of The Data Collection on Adverse Events of Anti-HIV Drugs Study. Data analyses from this study indicate a higher risk of heart attack in patients infected with HIV-1 who were taking Ziagen (abacavir) or Videx (didanosine) as part of their drug therapy. more
FDA Regranex Gel Study (3/27/08)
FDA MedWatch
FDA is conducting a safety review based on study data suggesting there may be an increased risk of death from cancer in diabetic patients using Regranex (becaplermin) Gel, a skin product used to heal leg and foot ulcers. more
FDA Investigates Singulair (3/27/08)
FDA MedWatch
FDA informed healthcare professionals and patients of the Agency's investigation of the possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. more
Blue Steel and Hero dietary supplements may cause severe lowering of blood pressure (3/25/08)
FDA MedWatch
The U.S. Food and Drug Administration is advising consumers not to purchase or use "Blue Steel" or "Hero" products, marketed nationally as dietary supplements, because these products contain undeclared ingredients, which may dangerously affect a person’s blood pressure level. more
Why Drug Lawsuits are Necessary: FDA “isn’t capable of policing” drug safety, says Alaska Judge (3/25/08)
Tort Deform - New York,NY,USA
Without lawsuits like the one the State of Alaska brought against Lilly, claims that drugs cause health problems “might well go unaddressed,” Anchorage Superior Court Judge Mark Rindner said from the bench this week. more
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