Food and Drug Adminstration (FDA): Patient Safety News |
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| Thu, 01 May 2008 04:00:00 GMT: New Medical Products: FDA Licenses New Hemophilia TreatmentFDA recently licensed a new treatment for hemophilia A called Xyntha. Xyntha, which is made by Wyeth Pharmaceuticals, is a genetically engineered version of factor VIII, a protein essential for blood clotting that is decreased or absent in patients ... |
| Thu, 01 May 2008 04:00:00 GMT: Recalls and Safety Alerts: Unsafe Use of Extended-Release Tussionex SuspensionFDA is cautioning healthcare professionals, patients and caregivers about the unsafe use of Tussionex Pennkinetic Extended-Release Suspension. This product is a long-acting cough suppressant containing hydrocodone, a narcotic antitussive, and chlorp... |
| Thu, 01 May 2008 04:00:00 GMT: Recalls and Safety Alerts: Liver Injury with TysabriBiogen Idec and Elan Pharmaceuticals are warning healthcare professionals about reports of clinically significant liver injury in patients taking Tysabri (natalizumab). Tysabri is a monoclonal antibody used to treat certain patients with relapsing f... |
| Thu, 01 May 2008 04:00:00 GMT: Recalls and Safety Alerts: Updated Labeling Changes for Tamiflu and RelenzaRoche Laboratories has updated information on neuropsychiatric events for Tamiflu (oseltamivir phosphate), a drug that's used to treat or prevent influenza in patients 1 year and older. The revised labeling reminds practitioners that some patients... |
| Thu, 01 May 2008 04:00:00 GMT: Recalls and Safety Alerts: New Instructions for Using Talecris IG SyringesTalecris Biotherapeutics has revised the directions for administering some of the company's immune globulin products -- ones that come in uncalibrated prefilled 2 mL syringes with fixed needles. The products are HyperRAB? S/D , which is an anti-rabi... |
| Thu, 01 May 2008 04:00:00 GMT: Recalls and Safety Alerts: Hepatotoxicity with PrezistaFDA and Tibotec Therapeutics are alerting healthcare professionals about the risk of hepatotoxicity associated with the antiretroviral drug Prezista (darunavir). Prezista, co-administered with ritonavir and other antiretroviral agents, is used to tr... |
| Thu, 01 May 2008 04:00:00 GMT: Recalls and Safety Alerts: Information on Mortality Rates with the AneuRx® Stent Graft SystemIn a recent Public Health Notification, FDA informed healthcare professionals about new data on mortality rates associated with the AneuRx® Stent Graft System. This endovascular graft, made by Medtronic, is used as an alternative to open surgery in ... |
| Thu, 01 May 2008 04:00:00 GMT: Preventing Medical Errors: Mistakenly Swallowing Inhaler CapsulesFDA has issued an advisory about the danger of mistakenly swallowing Spiriva (tiotropium bromide inhalation powder) and Foradil (formoterol fumarate inhalation powder) inhalation capsules. These capsules are intended to be used with inhalation devic... |
| Thu, 01 May 2008 04:00:00 GMT: Patients Are Asking: Choosing the Correct Test Strip for a Blood Glucose MeterFDA is aware of cases where patients have used LifeScan OneTouch Ultra test strips with their Abbott Precision Xtra blood glucose meters. As a result, the meters recorded lower-than-expected blood glucose levels, which can have serious clinical ... |