FDA MedWatch

04/21/2010 - FDA has added a Boxed Warning to the label for propylthiouracil, to include information about reports of severe liver injury and acute liver failure, some of which have been fatal, in adult and pediatric patients using this medication. More>>>

03/04/2010 - FDA and Baxter notified healthcare professionals of a Class I recall of the HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems, which are prescription medical devices used to treat pediatric and adult patients with kidney failure. Reports of serious injuries and at least one death have been associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity. More>>>

02/05/2010 - FDA notified healthcare professionals and patients that the risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of Tysabri infusions received. This new safety information, based on reports of 31 confirmed cases of PML received by the FDA as of January 21, 2010, will now be included in the Tysabri drug label and patient Medication Guide. More>>>

01/20/2010 - FDA notified consumers and healthcare professionals about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit). The counterfeit version contained the controlled substance sibutramine and did not contain orlistat, the active ingredient. More>>>

12/29/2009 - McNeil Consumer Healthcare and FDA notified consumers that it is expanding a voluntary recall to include all available product lots of TYLENOL Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP (Full list of lot numbers provided in press release at link below). In November 2009, 5 lots of this product were recalled due to consumer reports of an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. More>>>

12/03/2009 - The FDA notified health care professionals and patients about the increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies exposed to valproate sodium and related products (valproic acid and divalproex sodium) during pregnancy. More>>>

11/23/2009 - FDA notified healthcare professionals and patients that it is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients using a placebo (sugar pill). Sibutramine is marketed as Meridia, a prescription drug, in the United States. More>>>

11/16/2009 - FDA notified healthcare professionals of a Preliminary Public Health Notification describing deaths and serious complications associated with the use of Negative Pressure Wound Therapy (NPWT) systems. FDA has received reports of six deaths and 77 injuries associated with NPWT systems over the past two years. More>>>

11/04/2009 - Bodybuilding.com and FDA notified healthcare professionals and patients of a nationwide and international recall of all lots and expiration dates of 65 dietary supplement products that were sold through the Company's website, www.bodybuilding.com. More>>>

11/02/2009 - FDA notified healthcare professionals of revisions to the prescribing information for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency. More>>>

10/28/2009 - Qualitest Pharmaceuticals and FDA notified healthcare professionals of a nationwide recall of Accusure Insulin Syringes. All syringes, regardless of lot number, are subject to this recall. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots may have needles which detach from the syringe. More>>>

10/23/2009 - Genentech and FDA notified healthcare professionals about a third case of progressive multifocal leukoencephalopathy [PML], the first case of PML in a patient with rheumatoid arthritis [RA] treated with Rituxan who has not previously received treatment with a TNF antagonist. More>>>

10/20/2009 - FDA is investigating whether certain types of power cords used with medical devices may be defective. Two medical device manufacturers (Hospira, Inc. and Abbott Nutrition) have sent FDA 122 reports of sparking, charring, and fires from the power cords used with their devices. More>>>

10/16/2009 - American Regent and FDA notified healthcare professionals that anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. The Boxed Warning has been modified to recommend administering a test dose prior to the first therapeutic dose and observing for signs or symptoms of anaphylactic-type reactions during administration of Dexferrum. More>>>

10/09/2009 - GlaxoSmithKline (GSK) and FDA notified healthcare professionals of a report of the death of a patient with influenza who received Relenza (zanamivir) Inhalation Powder which was solubilized and administered by mechanical ventilation. Relenza (zanamivir) Inhalation Powder is not intended to be reconstituted in any liquid formulation and is not recommended for use in any nebulizer or mechanical ventilator. More>>>

10/06/2009 - Philips and FDA notified healthcare professionals of the recall of 5,400 HeartStart FR2+ automated external defibrillators (AED) due to reports of a memory chip failure which could render the AED inoperable and prevent it from delivering therapy when indicated. More>>>

10/01/2009 - Penumbra and FDA notified healthcare professionals about a voluntary field removal of the original version of Neuron 6F 070 Delivery Catheter due to reports that the catheter could kink or ovalize in certain anatomical situations, lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter. More>>>

09/25/2009 - FDA notified healthcare professionals of the Class 1 recall of Medtronic SC Catheters and Revision Kit Models: 8709SC, 8731SC, 8578, and 8596SC when paired with the Medtronic IsoMed Pump Model 8472, due to a design incompatibility resulting in a physical interference between the SC catheter connector and the IsoMed pump. More>>>

09/25/2009 - McNeil Consumer Healthcare and FDA notified consumers of a nationwide recall of certain Tylenol products as a precautionary measure because of potential manufacturing problems. The company initiated a recall of certain oral suspension products distributed between March 2008 and May 2008 due to the potential of bacteria in raw materials used to manufacture the finished product. More>>>

09/22/2009 - FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri. Tysabri was approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS) in November 2004 and for moderately to severely active Crohn’s disease in January 2008. From July 2006, (when Tysabri marketing resumed) to September 8, 2009, 13 reported cases of Tysabri-related PML were confirmed worldwide in patients being treated for MS with Tysabri monotherapy. More>>>

09/16/2009 - FDA notified healthcare professionals of a Class I recall of certain LIFEPAK CR Plus Automated External Defibrillators (AED) manufactured and distributed from July 9, 2008 through August 19, 2008. An extremely humid environment may cause the affected devices to improperly analyze the heart rhythm and may cause the device to delay or fail to deliver therapy. More>>>

09/09/2009 - Penumbra and FDA notified healthcare professionals of the Class 1 recall of the Neuron 5F Select Catheter, used to remove blood clots or foreign objects from blood vessels. Due to a manufacturing error, the catheters may contain pin holes and exposed wire braids which may result in a brain clot or a blood vessel puncture, and this may lead to possible death. The device was distributed from May 5, 2009 through June 12, 2009. More>>>

09/05/2009 - FDA issued a Dear Healthcare Provider Letter to notify healthcare professionals and facilities of a number of complaints of inaccurate readings when using the Philips Avalon Fetal Monitors, Models FM20, FM30, FM40, and FM50 with the ultrasound transducer. On September 4, 2009, Philips issued an Important Device Safety Alert. Inaccurate output readings, if not properly addressed, may lead to unnecessary interventions, failure to identify the need for interventions, and failure to identify fetal distress. More>>>

09/01/2009 - FDA notified healthcare professionals that it has completed its analysis of tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. This new safety information is now being added to the Boxed Warning for these products. More>>>

08/27/2009 - Tibotec Therapeutics and FDA notified healthcare professionals of revisions to the WARNINGS AND PRECAUTIONS section of the prescribing information for Intelence (etravirine). There have been postmarketing reports of cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme, as well as hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure. More>>>

08/24/2009 - FDA notified healthcare professionals and patients that it is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat. Orlistat is marketed in the United States as a prescription product, Xenical, and as an over-the-counter (OTC) product, Alli. More>>>

08/24/2009 - Qualitest Pharmaceuticals and FDA notified patients and healthcare professionals of a voluntary nationwide recall of two lots of Accusure Insulin Syringes that have needles which can detach from the syringe. More>>>

08/21/2009 - FDA informed consumers and healthcare professionals of its intent to take action against eight companies that market unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen. More>>>

08/14/2009 - Barr Laboratories, Inc. issued a voluntary recall of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate. More>>>

08/13/2009 - FDA notified healthcare professionals of the possibility of falsely elevated blood glucose results when using GDH-PQQ glucose test strips on patients who are receiving therapeutic products containing certain non-glucose sugars. These sugars can falsely elevate glucose results, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death. More>>>

08/06/2009 - FDA notified healthcare professionals of the Class 1 recall of various modules of Cardinal Health’s Alaris System, electronic infusion pumps that deliver controlled amounts of medications or other fluids to patients through an intravenous, intra-arterial, epidural, and other routes of administration. More>>>

08/04/2009 - FDA notified healthcare professionals of changes to the established drug names for Botox/Botox Cosmetic, Dysport and Myobloc to reinforce individual potencies and prevent medication errors. More>>>

08/04/2009 - FDA notified healthcare professionals that it has completed its analysis of tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. More>>>

07/30/2009 - Abbott and FDA notified healthcare professionals of the national Class 1 recall of three lots of POWERSAIL Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints that the distal shaft of the catheter exhibited damage. More>>>

07/28/2009 - FDA notified both healthcare professionals and their patients about new safety information concerning products marketed for body building and increasing muscle mass, frequently marketed as alternatives to anabolic steroids for increasing muscle mass and strength and sold both online and in retail stores. These products are promoted to athletes to improve sports performance and to aid in recovery from training and sporting events. More>>>

07/22/2009 - FDA notified healthcare professionals and patients that a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze. More>>>

07/17/2009 - Young You Corporation and FDA notified healthcare professionals and consumers that four weight loss dietary supplements sold and marketed by the firm (Slimbionic, One Weight Loss Pill, SlimDemand Capsules, Botanical Weight Loss) contain an undeclared drug ingredient, Sibutramine More>>>

07/16/2009 - FDA is evaluating interim safety findings from an ongoing study of Xolair (omalizumab) titled Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma. More>>>

07/07/2009 - FDA notified healthcare professionals that it is taking several actions to reduce the risk of overdose in patients using pain medications that contain propoxyphene because of data linking propoxyphene and fatal overdoses. More>>>

07/01/2009 - FDA notified healthcare professionals and patients that it has required the manufacturers of the smoking cessation aids varenicline (Chantix) and bupropion (Zyban and generics) to add new Boxed Warnings and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms in patients using these products. More>>>

06/22/2009 - FDA and the CDC are warning consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness). More>>>

06/16/2009 - FDA notified consumers and healthcare professionals to discontinue use of three Zicam Nasal Gel/Nasal Swab products sold over-the-counter as cold remedies because they are associated with the loss of sense of smell that may be long-lasting or permanent. More>>>

06/15/2009 - FDA is continuing its review of the strengths and limitations of this and other epidemiological studies that evaluate the risks of stimulant medications used to treat ADHD in children. More>>>

06/13/2009 - FDA notified patients and healthcare professionals that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. are being sold in the U.S. market, may not have been stored and handled properly, and may be dangerous for patients to use. More>>>

06/11/2009 - FDA notified healthcare professionals of clinical trial data that suggest increased mortality in stable liver transplant patients after conversion from a calcineurin inhibitor (CNI)-based immunosuppressive regimen to sirolimus (Rapamune). More>>>

06/03/2009 - FDA notified healthcare professionals of the risk of serious liver injury, including liver failure and death, with the use of propylthiouracil (PTU) in adult and pediatric patients. Reports to FDA’s Adverse Event Reporting System (AERS) suggest there is an increased risk of hepatotoxicity with PTU when compared to methimazole (MMI). More>>>

05/28/2009 - Centocor Ortho Biotech and FDA reminded healthcare professionals of the risk of serious fungal infections associated with TNF-αlpha blockers, including Simponi [golimumab]. More>>>

05/12/2009 - AS Medication Solutions, LLC, a drug repackage company, announced today that all tablets of Caraco brand Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of August, 2011, are being voluntarily recalled to the consumer level. More>>>

05/07/2009 - FDA notified healthcare professionals that it will require two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products’ labels after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products. More>>>

04/30/2009 - FDA notified healthcare professionals that after an ongoing safety review initiated in February 2008, the manufacturers of licensed botulinum toxin products will be required by FDA to strengthen warnings in product labeling and add a boxed warning regarding the risk of adverse events when the effects of the toxin spread beyond the site where it was injected. More>>>

04/22/2009 - ABC Beauty Supply and FDA notified consumers and healthcare professionals of a recall of 34 dietary supplement products. FDA lab analyses identified undeclared sibutramine, an FDA-approved drug, used as an appetite suppressant for weight loss. More>>>

04/09/2009 - ZOLL Medical Corporation and FDA notified healthcare professionals of a Class 1 recall of ZOLL AED Plus Defibrillators distributed from May, 2004 through February 9, 2009. The recall was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient during treatment of sudden cardiac arrest. More>>>

04/07/2009 - The March 2009 posting includes 38 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE. More>>>

04/03/2009 - Tri-State Hospital Supply Corporation and FDA notified healthcare professionals of a class 1 recall of multiple types of Centurion brand disposable trays and kits used for insertion of tubes, catheters and ports, due to package sealing that may effect the sterility of the devices. More>>>

03/27/2009 - Medtronic and FDA notified healthcare professionals about a Class I recall of the Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide due to the possibility that the ventricular catheter may become detached from the snap base assembly after implantation and may require emergency corrective surgery. More>>>

03/25/2009 - FDA and Watson Pharmaceuticals notified healthcare professionals and patients of a recall of Propafenone HCL 225 mg tablets, a drug product used to treat cardiac arrhythmias. The drug is being recalled because some tablets may contain slightly higher levels of the active ingredient than specified. More>>>

03/16/09 - FDA and Welch Allen notified healthcare professionals and consumers of a nationwide Class I recall of 14,054 AED 10 and MRL JumpStart external defibrillators manufactured between October 3, 2002 and January 25, 2007. More>>>

03/05/2009- FDA notified healthcare professionals and patients that certain transdermal patches (medicated patches applied to the skin), containing aluminum or other metals in the backing of the patches, can overheat during an MRI scan and cause skin burns in the immediate area of the patch. More>>>

02/23/2009- FDA notified healthcare professionals that updated clinical data has determined that treatment with zonisamide, indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy, can cause metabolic acidosis in some patients. More>>>

02/04/2009- FDA is aware of a recently published study, a retrospective medical record review of 73 patients who receive Drotrecogin alfa (activated), marketed as Xigris, indicated for the reduction of mortality in adult patients with severe sepsis who have a high risk of death (Gentry et al.; Crit Care Med 2009).The study reported an increased risk of serious bleeding events and of death in patients with sepsis and baseline bleeding risk factors who received this product. More>>>

02/04/2009- ETHEX Corporation, a subsidiary of KV Pharmaceutical Company is issuing a voluntary nationwide recall of the products identified below (all lots within their expiration dates) at a wholesale level. The Company is taking this action as a precautionary measure, because the products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practice (cGMP). More>>>

02/04/2009- ETHEX Corporation, a subsidiary of KV Pharmaceutical Company (NYSE: KVa/KVb), is issuing a voluntary expansion to the retail level of a previously announced recall on certain products. The recall on the products listed below had previously been issued to the wholesale level, but is now being expanded to the retail level. More>>>

01/27/2009- FDA notified consumers not to take Venom HYPERDRIVE 3.0, a product sold as a dietary supplement but containing sibutramine, an undeclared drug product and a controlled substance with risks for abuse or addiction. More>>>

01/19/2009- FDA issued a public health advisory to remind patients, healthcare professionals, and caregivers about potentially serious hazards of using skin numbing products, also known as topical anesthetics, for relieving pain from mammography and other medical tests and conditions. More>>>

01/13/2009- FDA provided updated information to its March 2008 Early Communication. FDA is continuing to review clinical trial data to assess other neuropsychiatric events, (mood and behavioral adverse events) related to drugs that act through the leukotriene pathway (montelukast, zafirlukast, zileuton). More>>>

12/31/2008- 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 with renal insufficiency. More>>>

12/26/2008- 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>>>

12/22/2008- 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>>>

12/11/2008- FDA has become aware of reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products (OSP) for bowel cleansing prior to colonoscopy or other procedures. More>>>

12/11/2008- Advanced Medical Optics (AMO), Inc. and FDA notified healthcare professionals of a recall of Healon D Ophthalmic Viscosurgical Device, Lot Number UD30654, 30 mg/mL fill size syringes. Some of the tested OVD syringes had endotoxin levels above the required limit. More>>>

12/10/2008- Hospira, Inc. notified healthcare professionals of a recall of one lot (lot number 65-620-FW, expiration date May 1, 2010, NDC 0409-7902-09) of 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP in 1000 mL flexible plastic containers. A small number of the containers may be incorrectly labeled with a bar code for 5% Dextrose Injection, USP (NDC 0409-7922-09). More>>>

12/08/2008- Terumo Cardiovascular Systems (Terumo CVS) is issuing an urgent, nationwide/worldwide recall of its Tenderflow™ Pediatric Arterial Cannulae involving 21 lot codes. Terumo received five reports of difficulty retracting the introducer from the cannula. When the introducer cannot be retracted from the cannula, the cannula must be removed and replaced, a process that may lead to aortic damage, blood loss and/or death. More>>>

11/25/2008- Animas Corporation and FDA informed consumers and healthcare professionals of a nationwide recall of battery caps used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump. More>>>

11/24/2008- FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy in Asian patients positive for human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including Han Chinese, Filipinos, Malaysians, South Asian Indians, and Thais. More>>>

10/09/2008- FDA notified healthcare professionals and consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying the product labels for consumers of over the counter (OTC) cough and cold medicines to state "do not use" in children under 4 years of age. More>>>

10/07/2008- FDA informed healthcare professionals that FDA has reviewed preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium), a large, 4-year, placebo controlled clinical trial with Spiriva HandiHaler in approximately 6000 patients with chronic obstructive pulmonary disease. More>>>

10/03/2008- FDA notified healthcare professionals of a Class I Recall of the Nebion HLX-8 Magnetic Resonance Device. The manufacturer of the device made unsupported claims that the product could be used to treat many different medical conditions and diseases. More>>>

10/02/2008- Medtronic and FDA notified healthcare professionals of the Class I Recall of several Medtronic intrathecal catheters and intrathecal catheter revision kits used with the implanted Medtronic SyncroMed II, SynchroMed EL, and IsoMed infusion pumps that store and deliver parenteral drugs to the intrathecal space. More>>>

10/01/2008- FDA has asked that a boxed warning be added to the prescribing information for fluoroquinolone antibiotics. The warning will remind healthcare professionals that patients taking these drugs may experience an increased risk of tendinitis and tendon rupture. More>>>

09/30/2008- An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." More>>>

09/26/2008- FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke. More>>>

09/23/2008- OSI and Genentech notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. More>>>

09/23/2008- Ucyclyd Pharma, Inc. informed healthcare professionals of the detection of particulate matter in the Ammonul Injection product. This particulate matter may impact the safe use of Ammonul. More>>>

09/18/2008- Covidien and Mallinckrodt Inc. informed healthcare professionals of important new safety information in prescribing Phosphocol P 32. Phosphocol P 32 is approved for the intracavitary instillation for the treatment of peritoneal or pleural effusions caused by metastatic disease. Phosphocol P 32 may increase the risk for leukemia in certain situations. More>>>

09/18/2008- The Drug Safety Newsletter is a FDA publication for healthcare professionals and the medical community. The newsletter provides information on the findings of selected postmarketing drug safety reviews from FDA's Center for Drug Evaluation and Research. More>>>

09/12/2008- FDA issued a Health Information Advisory to consumers and healthcare professionals regarding milk-based infant formula manufactured in China. The Chinese manufactured infant formula may be contaminated with melamine. More>>>

09/11/2008- LifePak CR Plus Automated External Defibrillators- Class I Recall Because The Shock Button Is Not Visible Which Impedes Responder's Ability To Provide Shock Therapy. More>>>

09/11/2008- Physio Control, Inc., issued a recall of LifePak CR Plus Automated External Defibrillators (AED), used by emergency or medical personnel to treat adults in cardiopulmonary arrest. More>>>

09/08/2008- FDA notified healthcare professionals about the potential for sparks, fires, toxic fumes, and explosions when disposable battery operated lavage systems’ (BOLS) cables are cut. More>>>

09/04/2008- FDA notified healthcare professionals that pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-α blockers (TNF blockers). This has resulted in delays in appropriate treatment, sometimes resulting in death. More>>>

08/28/2008- Pacific Consolidated Industries, LLC, and FDA notified healthcare professionals of the Class I Recall of the Mobile Oxygen Storage Tank manufactured and distributed between January - March 2007, because the device's pressure gauge may rupture and may catch fire as a result of hydraulic fluid present in the pressure gauge tubing. More>>>

08/25/2008- The FDA informed healthcare professionals of two new cases of progressive multifocal leukoencephalopathy (PML) in European patients receiving Tysabri monotherapy for multiple sclerosis for more than one year. More>>>

08/21/2008- FDA informed healthcare professionals that the Agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of Vytorin and a potentially increased incidence of cancer. More>>>

08/18/2008- Since issuing Information for Healthcare Professionals in October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta More>>>

08/14/2008- Boston Scientific and FDA informed healthcare professionals and patients of the Class I Recall of NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System, distributed from June 19, 2007, through May 5, 2008. More>>>

08/12/2008- FDA informed healthcare professionals of the risk of adverse injection site reactions in patients receiving naltrexone. Naltrexone is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment. More>>>

08/09/2008- FDA notified healthcare professionals of the risk of muscle injury, rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone. More>>>

08/01/2008- Levitronix and FDA notified healthcare professionals of a Class 1 recall of the Levitronix CentriMag Extracorporeal Blood Pumping System and Primary & Backup Consoles manufactured by Levitronix, GmbH, Zurich, Switzerland and distributed from January, 2001 through March, 2008. More>>>

07/29/2008 -  FDA reminded health care professionals who treat patients with mitoxantrone about recommendations that left ventricular ejection fraction (LVEF) be evaluated before initiating treatment and prior to administering each dose of mitoxantrone. More>>>

07/25/2008 -  FDA informed healthcare professionals that serious and sometimes fatal hypersensitivity reactions (HSR) caused by abacavir therapy are significantly more common in patients with a particular human leukocyte antigen. More>>>

07/18/2008 -  FDA is updating healthcare professionals about recent changes made to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information for micro-bubble contrast agents, a sterile suspension of perflutren gas microspheres, indicated for use in certain patients with suboptimal echocardiograms. More>>>

07/16/2008 - Roxane Laboratories, Inc. informed healthcare professionals of the recall of two lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; lot 856396A Exp April 2010, and lot 856693A Exp May 2010), a product used to treat hyperkalemia. More>>>

07/16/2008 - FDA informed healthcare professionals of the possibility that x-rays used during CT examinations may cause some implanted and external electronic medical devices to malfunction. More>>>

07/15/2008 - Genentech, Inc. informed healthcare professionals of reports of several cases of microangiopathic hemolytic anemia (MAHA) in patients with solid tumors receiving Avastin in combination with sunitinib malate. More>>>

07/10/2008 - Genentech informed healthcare professionals that an increased number of complaints were received regarding damaged and broken vials of Herceptin 440 mg and BWFI (bacteriostatic water for injection) diluent. More>>>

07/08/2008 -  FDA notified healthcare professionals that a BOXED WARNING and Medication Guide are to be added to the prescribing information to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use. More>>>

07/02/2008 -  Jack Distribution, LLC issued a voluntary nationwide recall of selected lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, marketed as dietary supplements. More>>>

07/02/2008 -  FDA informed healthcare professionals of reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein (rhBMP) when used in the cervical spine. The safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use. More>>>

07/01/2008 -  Sage Products informed healthcare professionals of the voluntary recall of limited lots of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation product. More>>>

06/30/2008 - Roche Laboratories informed healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the CellCept prescribing information. More>>>

06/17/2008 -  FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis.  More>>>

06/10/2008 -  ETHEX Corporation notified healthcare professionals of a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. More>>>

06/05/2008 -  FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating a 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>>>

06/02/2008 -  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>>>

06/02/2008 -  Abbott notified consumers and healthcare professionals of the recall of two lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron powder, a low-calcium and Vitamin D-free infant formula specifically designed for the nutritional support of infants and children with hypercalcemia.More>>>

05/30/2008 -  International Pharmaceuticals, Ltd. and FDA notified consumers and healthcare professionals that the company is recalling all supplement products sold under the brand name of Viril-ity Power (VIP) Tablets. More>>>

05/29/2008 -  FDA informed consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. More>>>

05/27/2008 -  FDA alerted consumers and healthcare professionals not to buy or use Xiadafil VIP Tablets sold in bottles of 8 tablets (Lot #6K029) or blister cards of 2 tablets (Lot# 6K029-SEI). More>>>

05/20/2008 - Medicis and FDA notified healthcare professionals of the recall of lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of Solodyn Extended Release Tablets. More>>>

05/16/2008 - 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>>>

05/15/2008 - Following publication of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study in the May 14, 2008 online issue of The New England Journal of Medicine, Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. More>>>

05/06/2008 -  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>>>

05/06/2008 -  Hydrox Labs issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash because the product was found to contain Burkholderia cepacia (B. cepacia). More>>>

05/02/2008 -  Amgen and Wyeth Pharmaceuticals informed healthcare professionals of revisions to prescribing information for Enbrel. The revisions include a BOXED WARNING about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with Enbrel. Infections have included bacterial sepsis and tuberculosis. More>>>

04/28/2008 -  Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. More>>>

04/24/2008 -  The January 2008 posting includes 41 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES. More>>>

04/14/2008 -  Herbal Science International, Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers. More>>>

04/10/2008 -  The FDA notified healthcare professionals and patients that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula." More>>>

04/10/2008 -  FDA informed healthcare professionals that the Agency is investigating a potential association between the use of CellCept and Myfortic, medicines used to prevent organ rejection, and the development of progressive multifocal leukoencephalopathy (PML), a life-threatening disease. More>>>

04/10/2008 -  Schwarz Pharma informed healthcare professionals and patients of the recall of Neupro, a transdermal delivery system worn on the skin and used to treat early stage Parkinson’s disease. More>>>

04/10/2008 -  Pfizer informed healthcare professionals and patients of updated safety information in the WARNINGS section of prescribing information for Exubera, a short-acting insulin you breathe in through your mouth using the Exubera inhaler that helps to control high blood sugar in adults with diabetes. More>>>

04/09/2008 -  Cubist Pharmaceuticals, Inc. informed healthcare professionals that a potentially significant impurity, 2-mercaptobenzothiazole (MBT), has been isolated from reconstituted Cubicin stored in with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc. More>>>

04/02/2008 -  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 who are receiving neuraminidase inhibitors, including Relenza. More>>>

04/02/2008 -  Covidien notified healthcare professionals of a voluntary recall of certain lots of Heparin Sodium USP because two lots of the product acquired by Covidien had a heparin-like contaminant. More>>>

04/01/2008 -  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>>>

03/28/2008 -  The FDA notified consumers of a recall of, and advised them not to purchase or consume, the liquid dietary supplement products, Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. More>>>

03/27/2008 -  The 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>>>

03/27/2008 - The 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>>>

03/27/2008 -  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>>>

03/26/2008 -  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>>>

03/24/2008 -  The December 2007 posting includes 43 drug products with safety labeling changes to the following sections:  BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES. More>>>

03/21/2008 -  B. Braun Medical Inc. was notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). More>>>

03/21/2008 -  FDA and Medtronic notified healthcare professionals of the Class 1 recall of Medtronic Neuromodulation Implantable Infusion Pumps, implantable devices for administering drugs to a specific site in the body to treat pain, spasticity and cancer. More>>>

03/18/2008 -  Boehringer Ingelheim and FDA notified healthcare professionals that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take Spiriva. More>>>

03/18/2008 - FDA issued a Public Health Notification to inform healthcare professionals of an update to earlier FDA safety information on this product. The notification re-emphasizes the need for continued surveillance of patients treated with endovascular grafts, and provides updated information on the mortality risks associated with the use of the AneuRx Stent Graft More>>>

03/12/2008 -  Amgen and FDA notified healthcare professionals of changes to the Boxed Warnings/WARNINGS: Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT labeling. More>>>

03/12/2008 -  FDA and Tibotec Therapeutics notified healthcare professionals of changes to the WARNINGS section of the prescribing information for Prezista (darunavir) tablets regarding the risk of hepatotoxicity. More>>>

03/07/2008 -  FDA advised healthcare professionals and consumers that the Agency issued Warning Letters to six U.S. companies and one foreign individual for marketing unapproved and misbranded drugs over the internet to U.S. consumers for the prevention and treatment of sexually transmitted diseases (STDs). More>>>

03/04/2008 -  Roche and FDA informed healthcare professionals of neuropsychiatric events associated with the use of Tamiflu, in patients with influenza. More>>>

02/29/2008 -  FDA informed healthcare professionals and consumers of the correct way to use Spiriva and Foradil inhalation powder capsules. FDA and the National Poison Control Center have received many reports of patients swallowing Spiriva and Foradil capsules rather than placing the capsules in the inhalation devices. More>>>

02/29/2008 - UPDATE - Baxter Healthcare and FDA informed healthcare professionals of a voluntary recall of all Heparin multi-dose and single-use vials, and Heparin lock flush solutions. More>>>

02/28/2008 -  Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. More>>>

02/26/2008 -  FDA and GlaxoSmithKline notified pharmacists and physicians of a new Medication Guide for Avandia (rosiglitazone maleate). More>>>

02/26/2008 -  FDA notified dental healthcare professionals and patients of the risk of serious allergic reactions in users of denture cleansers. More>>>

02/19/2008 -  Actavis Inc. announced a nationwide recall of certain lots of Fentanyl transdermal system CII Patches sold in the United States and labeled with an Abrika or Actavis label. More>>>

02/15/2008 -  PriCara and Sandoz Inc. announced a nationwide recall of all lots of 25 mcg/hr Duragesic Patches sold in the United States. More>>>

02/11/2008 - FDA informed healthcare professionals of important warnings and instructions for Heparin Sodium Injection use. There have been reports of serious adverse events. More>>>

02/11/2008 -  Chattem, Inc. and FDA informed consumers and healthcare professionals of a voluntary nationwide recall of its Icy Hot Heat Therapy products, including consumer "samples" that were included on a limited promotional basis in cartons of its 3 oz Aspercreme product. More>>>

02/08/2008 -  FDA issued an early communication about an ongoing safety review regarding Botox and Botox Cosmetic. FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses. More>>>

02/06/2008 -  FDA announced its intention to take enforcement action against companies marketing unapproved, injectable colchicine, a drug used to treat gout. More>>>

02/04/2006 - 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>>>