http://www.lawyercentral.com Food and Drug Administration Legal News en-us Copyright 2012 Sat, 26 May 2012 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=101#8 FDA monitors the way drug companies advertise and promote prescription drugs to help assure that the information is accurate and balanced. But it is difficult for the agency to check on these activities when they take place in doctors' offices, or i... Tue, 10 Aug 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=99#10 FDA is informing healthcare practitioners and patients that certain metered-dose inhalers used to treat asthma and chronic pulmonary obstructive disease will be gradually removed from the market because they use chlorofluorocarbons (CFCs) as propella... Tue, 08 Jun 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=99#9 Your patients can easily find them on the internet --- products advertised as "dietary supplements" to enhance sexual performance or treat erectile dysfunction. Many of these products are said to be "all natural" alternatives to prescription drugs, ... Tue, 08 Jun 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=99#8 A recent FDA article in the journal Nursing2010 describes a variety of problems associated with temporary pacing leads. Temporary pacing is used during emergency treatment of some bradyarrhythmias and tachyarrhythmias, and also used prophylactically... Tue, 08 Jun 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=99#7 Baxter Healthcare and Cangene Corporation are notifying healthcare professionals that intravascular hemolysis (IVH), which can be fatal, has occurred in patients with immune thrombocytopenic purpura treated with WinRho SDF, an intravenous immune glob... Tue, 08 Jun 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=99#6 Novartis Oncology has alerted healthcare professionals about a new boxed warning and other safety changes in the labeling for Exjade (deferasirox). Exjade is used to treat transfusional hemosiderosis, the chronic iron overload that can result from m... Tue, 08 Jun 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=99#5 FDA has told two drug companies to stop marketing sublingual nitroglycerin tablets that have not been approved as safe and effective by the FDA. Glenmark Generics and Konec Inc., have been selling unapproved nitroglycerin in 0.3, 0.4, and 0.6 mg dos... Tue, 08 Jun 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=99#4 FDA is informing healthcare professionals that a preliminary review of a large clinical trial shows an increased risk of muscle injury in patients taking the highest dose of the statin drug simvastatin. Simvastatin is sold as Zocor, and is also an i... Tue, 08 Jun 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=99#3 Through a new boxed warning, the FDA is alerting healthcare professionals about a subgroup of patients who cannot effectively metabolize the anti-platelet drug Plavix (clopidogrel). These patients, called "poor metabolizers," have little or no a... Tue, 08 Jun 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=99#2 FDA recently approved the first absorbable fibrin sealant patch to prevent bleeding from small blood vessels during cardiovascular surgery. The patch is called TachoSil and it is made by Nycomed. The patch provides an additional tool for surgeons t... Tue, 08 Jun 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=99#1 FDA has approved a new formulation of the controlled-release drug OxyContin that is designed to be more difficult to manipulate by someone trying to misuse or abuse the medication. OxyContin tablets contain the opioid analgesic oxycodone, which is r... Tue, 08 Jun 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=98#9 All liquid Maalox products are not the same. Maalox Total Relief, Maalox Advanced Regular Strength, and Maalox Advanced Maximum Strength may look similar but they are not interchangeable. In fact, using the wrong one could be harmful. FDA has ... Fri, 07 May 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=98#8 FDA is requiring that Erythropoiesis-Stimulating Agents (ESAs) be prescribed and used under a special risk management program. This program is designed to inform healthcare providers and their patients about the risks of these drugs and to ensure tha... Fri, 07 May 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=98#7 Here's an alert about the risk of overfill in patients being treated with Baxter's HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems. Overfill, or increased intraperitoneal volume, occurs when there's more fluid in the abdomen than... Fri, 07 May 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=98#6 FDA is reviewing clinical trial data suggesting that using Invirase (saquinavir) in combination with Norvir (ritonavir) may increase the risk of cardiac arrhythmias. Invirase and Norvir are protease inhibitors used in combination to treat HIV infect... Fri, 07 May 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=98#5 Beckman Coulter is alerting clinical laboratories about the importance of following twice-a-week maintenance procedures for the company's UniCel DxC clinical chemistry analyzers. The company has received reports of erroneous sodium results from ... Fri, 07 May 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=98#4 LifeScan is recalling certain lots of SureStep glucose test strips because they may provide falsely low results when glucose levels are above 400 mg/dL. If these results are used to adjust insulin doses, too little insulin could be administered. Th... Fri, 07 May 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=98#3 Arrow International is recalling the company's IV tubing sets and accessories, as well as certain other products, because they may not be sterile. The company discovered small holes in some of the products' sterile packaging. Using non-sterile prod... Fri, 07 May 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=98#2 FDA is warning healthcare professionals and medical facilities about counterfeit versions of polypropylene surgical mesh. These products are labeled with the C.R. Bard/Davol brand name, but they were not manufactured by Bard. FDA is investigatin... Fri, 07 May 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=98#1 FDA has approved a new pneumococcal vaccine that provides broader protection for infants and young children ages six weeks through five years. The new vaccine, called Prevnar 13, is effective against 13 serotypes of the bacterium Streptococcus pneum... Fri, 07 May 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=97#10 Turtles may look like cute pets, but they could be responsible for over 70,000 cases of salmonella infections every year in this country. Turtles commonly carry the Salmonella bacteria, and although the turtle doesn't get sick, people can become ver... Thu, 08 Apr 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=97#9 Nipro Medical Corporation has recalled the company's GlucoPro insulin syringes because the needle may detach from the syringe. If that happens, the needle could get stuck in the insulin vial, or get pushed back into the syringe, or even stay in the ... Thu, 08 Apr 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=97#8 FDA is notifying healthcare professionals about cases of a rare but serious complication, non-cirrhotic portal hypertension, in patients taking Videx (didanosine) or Videx EC, to treat HIV infection. Clinicians should monitor patients on Videx... Thu, 08 Apr 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=97#7 Hettich Instruments has recalled the plastic hematocrit rotors used with some of the company's centrifuges. These rotors may crack apart and explode through the centrifuge housing, which could be a safety hazard. There's been one report where a rot... Thu, 08 Apr 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=97#6 Wyeth is cautioning healthcare professionals about therapeutic drug monitoring for Rapamune (sirolimus). Rapamune is used to prevent organ rejection in certain renal transplant patients. The company points out that Rapamune blood concentrations... Thu, 08 Apr 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=97#5 Thomas Medical Products Inc. has recalled the SafeSheath Coronary Sinus Guide Introducer. This device is a hemostatic introducer system with an infusion side port that's used to insert various types of pacing or defibrillator leads. The company ... Thu, 08 Apr 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=97#4 FDA is alerting healthcare professionals that Meridia (sibutramine) is contraindicated in patients with a history of cardiovascular disease because the drug increases their risk of heart attack and stroke. Meridia is used to manage obesity. In ... Thu, 08 Apr 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=97#3 Here's an alert about certain lots of Q-Syte Luer access devices. These are split -septum needleless valves used with other infusion therapy products to administer IV fluids. The Q-Syte devices are sold by themselves and are also sometimes packaged ... Thu, 08 Apr 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=97#2 In February, Cardiac Science Corporation initiated a recall of several models of automated external defibrillators because manufacturing problems may make them susceptible to failure. If that happens, they might not be able to deliver therapy during... Thu, 08 Apr 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=97#1 The FDA is recommending that healthcare professionals use caution when considering Zyprexa (olanzapine) for treating adolescents 13 to 17 years old for schizophrenia and bipolar disorder. Physicians, patients and caregivers should understand tha... Thu, 08 Apr 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=96#8 You can easily find them on the internet - products sold as "dietary supplements" to enhance sexual performance or treat erectile dysfunction. Many of these products are said to be "all natural" alternatives to prescription drugs. That might make y... Thu, 04 Mar 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=96#7 An article by the Institute for Safe Medication Practices (ISMP) reminds healthcare practitioners how dangerous it can be to misread the letters and numbers on prescriptions, drug orders and medical records. Unfortunately, these mistakes are easy to... Thu, 04 Mar 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=96#6 FDA is warning the public about a potentially dangerous counterfeit version of the weight-loss drug Alli (orlistat). To date, all the counterfeits seem to have been sold on the internet. The genuine version of Alli, which is approved by FDA for ove... Thu, 04 Mar 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=96#5 Here's information about a recall of certain lots of Cleviprex injectable emulsion, an antihypertensive drug made by The Medicines Company. Vials in the recalled lots may contain particulate matter which has been found to be inert stainless ste... Thu, 04 Mar 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=96#4 To help clinicians weigh the benefits and risks of the diabetes drug Byetta (exenatide), FDA is requiring that information about the risk of renal impairment be added to the drug's labeling. From April 2005 to October 2008, FDA received 78... Thu, 04 Mar 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=96#3 FDA is reminding healthcare professionals and patients about an increased risk of birth defects in infants whose mothers took valproate sodium and related products during pregnancy. These drugs, which are used to treat epilepsy, bipolar disorder and... Thu, 04 Mar 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=96#2 The manufacturer Encompass Group is alerting healthcare professionals that Thermoflect products should not be used in an MRI environment. These products, such as blankets and apparel, are intended to prevent hypothermia by keeping patients warm usin... Thu, 04 Mar 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=96#1 FDA is alerting healthcare professionals about safety precautions to be used with Huber needles, and about a recall of one company's products. Huber needles are used to access ports implanted in chronically ill patients to withdraw blood and infuse ... Thu, 04 Mar 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#9 FDA is warning people not to use ear candles because they can cause serious injury. An ear candle is a hollow cone about 10 inches long made from a fabric tube soaked in beeswax or paraffin. They are promoted and sold in health food stores, health ... Fri, 19 Feb 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#8 The Institute for Safe Medication Practices (ISMP) has reported medication errors due to name confusion between Kapidex (dexlansoprazole) and Casodex (bicalutamide). Kapidex is used to treat erosive esophagitis and gastroesophageal reflux disease. ... Tue, 09 Feb 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#7 The FDA, the CDC and the Department of Veterans Affairs have issued a joint safety communication cautioning healthcare facilities about the risks to patients if endoscopes and their accessories are not processed properly between patients. The commun... Tue, 09 Feb 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#6 Sanofi-Aventis is notifying healthcare professionals about updated safety information for the antidepressant Norpramin (desipramine hydrochloride). The section on overdosage now notes that overdoses of this drug have resulted in a higher death rate ... Tue, 09 Feb 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#5 In September, the device company Synthes USA recalled the Synex II Vertebral Body Replacement device, a titanium implant used to replace an unstable or damaged vertebral body in the T1 to L5 portion of the spine. The devices were recalled after ... Tue, 09 Feb 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#4 FDA is notifying healthcare professionals about chondrolysis in patients receiving continuous intra-articular infusion of local anesthetics to treat post-surgical pain. FDA has received a number of reports of cartilage necrosis and destruction in th... Tue, 09 Feb 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#3 Update 02/02/10: FDA is extending to 18 months the total recommended time period for transitioning from Steris Corporation?s modified System 1 processor (SS1) to legally-marketed alternative devices. See "Additional Information" link below. FDA ha... Tue, 09 Feb 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#2 GlaxoSmithKline is notifying healthcare professionals that Lexiva (fosamprenavir calcium), a protease inhibitor, has been associated with an increased risk of myocardial infarction and dyslipidemia in HIV infected adults. The company's letter recomm... Tue, 09 Feb 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=95#1 FDA is alerting users of certain Powerheart and CardioVive automated external defibrillators that these devices may malfunction unexpectedly. This can cause a failure to deliver the electric shocks that are needed to treat sudden cardiac arrest or a... Tue, 09 Feb 2010 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=93#7 An important FDA program called "MedWatch" allows health care professionals and consumers to report serious problems that they believe may be associated with the medical products they prescribe, dispense, or use. These reports, along with follow-up i... Wed, 02 Dec 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=93#6 FDA is investigating a situation in which more than 200 patients undergoing CT brain perfusion scans at a single hospital received overdoses of radiation. In some cases the radiation doses were high enough to produce erythema and hair loss. While... Wed, 02 Dec 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=93#5 Medtronic Neuromodulation is alerting healthcare professionals and patients that the company's Sutureless Connector (SC) catheters and revision kits are not compatible with IsoMed implantable infusion pumps. The product labeling incorrectly stat... Wed, 02 Dec 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=93#4 FDA is notifying healthcare professionals and patients about a new USP monograph for heparin. Under the new monograph, the reference standard used to determine the potency of the drug will be changed in order to make it compatible with the WHO Inter... Wed, 02 Dec 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=93#3 The device company Unomedical Inc. is recalling some of its manual pulmonary resuscitators. A malfunction of these devices may make it difficult to generate enough positive pressure to resuscitate a patient properly, and that could lead to serious a... Wed, 02 Dec 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=93#2 Philips Healthcare is recalling certain HeartStart FR2+ automated external defibrillators. These AEDs are used by hospitals, fire departments and emergency medical services to treat sudden cardiac arrest. The recalled devices may have a memory chip... Wed, 02 Dec 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=93#1 FDA is requiring that promethazine hydrochloride injection products carry a boxed warning to communicate more strongly about the danger of giving the drug intravenously. The warning states that intra-arterial and subcutaneous administration of prome... Wed, 02 Dec 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#10 Emergency response help buttons are often worn by seniors to call for help in an emergency. The Philips Lifeline emergency button that is worn around the neck, may pose a choking hazard if the cord becomes accidentally entangled, and this can result... Tue, 03 Nov 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#9 Smiths Medical is recalling certain Portex uncuffed tracheal tubes in pediatric sizes. The recall affects several models of 2.5, 3.0 and 3.5 mm tubes manufactured before September 2009. The internal diameter of some of these tracheal tubes is sli... Tue, 03 Nov 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#8 FDA is requiring stronger warnings about an increased risk of lymphoma and other cancers in children and adolescents who are treated with drugs that block tumor necrosis factor. TNF blockers include Remicade (infliximab), Enbrel (etancercept), Humir... Tue, 03 Nov 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#7 The device company ConMed Linvatec is recalling certain surgical handpieces and cables. The handpieces are battery-powered devices used with drills, blades and other cutting devices during surgical procedures. This action affects certain model an... Tue, 03 Nov 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#6 Healthcare professionals have been notified by the manufacturers of CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid) that these drugs, in combination with other immunosuppressive agents, have been associated with cases of pure red ce... Tue, 03 Nov 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#5 Philips Healthcare has alerted healthcare professionals about the possibility of inaccurate fetal heart rate readings from the company's Avalon fetal monitors, which use ultrasound to measure fetal heart rate. Inaccurate readings could result in unn... Tue, 03 Nov 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#4 Boston Scientific has changed the name of the company's Liberté Bare-Metal coronary stent to VeriFLEX. The company took this action after reports that Liberté Bare-Metal stents were inadvertently implanted instead of TAXUS Liberté Drug-Eluting stent... Tue, 03 Nov 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#3 Tibotec Therapeutics is notifying healthcare professionals of severe and potentially life-threatening skin reactions from Intelence (etravirine), an antiretroviral drug used in HIV combination therapy. Intelence has been associated with cases of Ste... Tue, 03 Nov 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#2 Covidien is recalling certain lots of its End-Tidal CO2 Detectors, the Pedi-Cap and Pedi-Cap 6, because a modification made by the manufacturer may occlude the patient's airway. This could make it difficult to manually ventilate a patient, and lead ... Tue, 03 Nov 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=92#1 FDA has approved four vaccines for immunization against the 2009 H1N1 influenza virus. Three of them are inactivated virus vaccines for injection, manufactured by CSL Limited, Sanofi Pasteur, Inc, and Novartis Vaccines and Diagnostics Limited. The ... Tue, 03 Nov 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=91#7 FDA is warning the public not to use body-building products that claim to contain steroids or steroid-like substances, because they can cause serious health problems. These products, which are sold online and in retail stores, are promoted as altern... Tue, 06 Oct 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=91#6 Parents and other caregivers of small children should be aware that the company Luv N' Care Ltd. has recalled almost 20 styles of gel-filled teethers because they might be contaminated with bacteria. The gel inside these teethers may contain Baci... Tue, 06 Oct 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=91#5 Hospira, Inc. has issued an alert about a number of the company's medical devices that have defective AC power cords. These devices include infusion pumps, compounders, monitoring devices and printers. This action comes after reports of sparking,... Tue, 06 Oct 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=91#4 CareFusion is alerting healthcare professionals about a number of safety problems with several models of Alaris infusion systems. These problems could cause patients to be over or under-infused, which could lead to serious injury or death. Certai... Tue, 06 Oct 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=91#3 Teva Pharmaceuticals is recalling certain lots of Propofol Injectable Emulsion 10 mg/mL because some of the vials in these lots contain elevated endotoxin levels. The company says that it has received over 40 reports of patients treated with pro... Tue, 06 Oct 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=91#2 FDA is warning again that potentially fatal glucose monitoring errors can occur in patients who receive therapeutic products containing certain sugars other than glucose. These products include oral xylose, intravenous infusions that contain maltose ... Tue, 06 Oct 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=91#1 FDA has approved the first single-ingredient oral colchicine product. The drug, called Colcrys, is approved to treat acute gout flares and familial Mediterranean fever. Oral colchicine has been used to treat gout in the past, but until now it had n... Tue, 06 Oct 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=90#10 The Institute for Safe Medication Practices (ISMP) recently cited a report from the ISMP Canada Safety Bulletin about the death of a patient who was accidentally injected with topical epinephrine. The attending surgeon and nurse mistakenly thought t... Mon, 31 Aug 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=90#9 A recent FDA article in the publication "OR Nurse 2009" recommends several ways to prevent skin burns from surgical microscopes, which are used to illuminate and magnify internal structures during surgical procedures. The lights on these devices can... Mon, 31 Aug 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=90#8 FDA is updating healthcare professionals about its continuing review of safety data for cefepime, a broad-spectrum cephalosporin antibiotic sold as Maxipime and generics. In 2007, a meta-analysis published in the literature concluded that patients t... Mon, 31 Aug 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=90#7 FDA is investigating a situation in which pieces of tissue were found within certain arthroscopic shavers even after they were reportedly cleaned according to the manufacturer's instructions. Arthroscopic shavers are devices used in certain orthoped... Mon, 31 Aug 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=90#6 FDA is investigating the possibility that Lantus (insulin glargine) may be associated with an increased risk of cancer. Three of four observational studies published recently in the journal Diabetologia suggested an increased cancer risk associated ... Mon, 31 Aug 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=90#5 In July, Medtronic recalled certain infusion sets which are used with the company's Mini-Med Paradigm insulin pumps to deliver insulin to diabetic patients. Because of a manufacturing error, the vents on these sets may clog and then fail to equalize... Mon, 31 Aug 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=90#4 FDA is requiring that the labeling for several immunosuppressant drugs used to prevent organ rejection after transplants be updated with a warning that these drugs increase the risk of nephropathy associated with the BK virus, which can lead to trans... Mon, 31 Aug 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=90#3 FDA is requiring that two drugs used to help people stop smoking carry new warnings about the risk of serious neuropsychiatric effects. The drugs are Chantix (varenicline) and Zyban (bupropion). The same warnings will be required for other bupropio... Mon, 31 Aug 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=90#2 Hill-Rom Stabilet Infant Warmers were recalled in July because they might pose a fire risk. An infant lying under one of these devices in a hospital nursery suffered second and third degree burns when a fire occurred in the infant's bassinet. The i... Mon, 31 Aug 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=90#1 FDA is taking action to reduce the risk of fatal overdoses in patients taking the pain medication propoxyphene, an ingredient in drugs such as Darvon and Darvocet. Some European studies have indicated that propoxyphene may be more lethal than other ... Mon, 31 Aug 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=89#10 FDA has issued a warning that zinc-containing cold remedies administered directly into the nose have been associated with anosmia, which is a loss of the sense of smell. This warning is directed at several over-the-counter products marketed by Matri... Mon, 10 Aug 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=89#9 FDA is alerting the public that certain skin sanitizers and skin protectants made by Clarcon Biological Chemistry Laboratory are being recalled because they have been found to contain high levels of bacteria. Some of these bacteria could cause infec... Mon, 10 Aug 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=89#8 FDA is alerting healthcare professionals that stable liver transplant patients may have an increased risk of death if they are switched from an immunosuppressive regimen based on a calcineurin inhibitor (CNI) to sirolimus. Sirolimus, which is market... Mon, 10 Aug 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=89#7 FDA is alerting healthcare professionals that the labeling for antiepileptic drugs will now warn that patients taking these drugs have an increased risk of suicidal thoughts and actions. The warnings are based on FDA's analysis of placebo-contro... Mon, 10 Aug 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=89#6 Here's a reminder about the importance of keeping patients safe in hospital beds. These beds are not only found in hospitals, but also in outpatient care centers, long-term care facilities and even at home. FDA has received hundreds of reports of... Mon, 10 Aug 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=89#5 FDA is reminding healthcare professionals about the risk of serious fungal infections with TNF blockers, including Simponi (golimumab), which was recently approved. TNF blockers are immunosuppressants used to treat chronic inflammatory diseases, incl... Mon, 10 Aug 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=89#4 FDA is alerting the public that certain vials of the long-acting insulin Levemir were stolen and are being sold in the U.S. market. The stolen vials, which had come from three specific lots, may not have been stored or handled properly. Because of ... Mon, 10 Aug 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=89#3 Philips/Respironics is recalling some of the company's SmartMonitor 2 Infant Apnea Monitors. These devices are used to monitor infants' heart rate and respiration in the hospital or at home. The monitors are being recalled because they may fail to ... Mon, 10 Aug 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=89#2 FDA has asked the manufacturers of leukotriene-modifying drugs to include a precaution in their labeling about the potential for neuropsychiatric events with these medications. The drugs include Accolate (zafirlukast), Zyflo (zileuton) and Zyflo CR ... Mon, 10 Aug 2009 22:51:52 PST webmaster@lawyercentral.com (LawyerCentral.com) Food and Drug Administration http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript-rss.cfm?show=89#1 FDA is notifying healthcare professionals about the risk of serious and possibly fatal liver injury associated with propylthiouracil, an anti-thyroid drug used to treat Graves' disease. Propylthiouracil is generally considered second-line therapy in... Mon, 10 Aug 2009 22:51:52 PST