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FDA Warns: Stop Using GenStrip™ Blood Glucose Test Strips
The Food and Drug Administration (FDA) is advising people with diabetes to stop using GenStrip™ Blood Glucose Test Strips because the strips may report incorrect blood glucose levels. GenStrip™ Blood Glucose Test Strips are "third-party" blood glucose monitoring test strips sold by Shasta Technologies LLC. Shasta’s GenStrip™ test strips are advertised for use with the LifeScan OneTouch® family of glucose meters, including the models Ultra®, Ultra® 2, and UltraMini®. During a recent inspection of Shasta Technologies LLC, the FDA found that Shasta Technologies did not have in place many of the requirements of a quality system. Without assurance of an adequate quality system, the FDA believes that the strips could report incorrect blood glucose levels. The affected test strips have been manufactured and distributed since March 2013 and are available through online retailers and retail pharmacies. The blood glucose test strips are used in the home and in healthcare facilities to measure blood glucose levels in diabetes care and management. People with diabetes carefully monitor their blood glucose levels and require urgent treatment for low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia). An inaccurate blood glucose reading could lead to inappropriate or delayed treatment that could significantly harm a patient. For more information and to view a photo of the GenStrip™ packaging, please visit: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm395180.htm
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FDA Clarifies Warning About Use of Revatio for Pulmonary Arterial Hypertension in Children
The US Food and Drug Administration (FDA) has clarified its previous recommendation related to prescribing Revatio (sildenafil) for children with pulmonary arterial hypertension (PAH). PAH is a condition in which the blood pressure in the lungs is elevated. The FDA revised the Revatio prescribing information in August 2012, adding a warning stating that “use of Revatio, particularly chronic use, is not recommended in children.” This recommendation was based on results from a clinical research study in children with PAH that showed 1) children prescribed higher doses of Revatio for PAH were at a higher risk of dying than those prescribed lower doses and 2) the low doses of Revatio were not effective in improving exercise ability in children with PAH. The FDA also issued a Drug Safety Communication at that time. The purpose of the FDA’s recommendation was to raise awareness of the clinical trial results. The recommendation was not intended to suggest that Revatio should never be used in children. Revatio contains the active ingredient sildenafil. Sildenafil is also marketed in the prescription product Viagra®, a drug for men with erectile dysfunction (inability to get or maintain an erection). The FDA does not believe that this safety concern applies to the use of Viagra. For more information, please visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm391152.htm
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Date Published Title Drug Source
2014-05-01 FDA Warns: Stop Using GenStrip™ Blood Glucose Test Strips Tolazamide FDA
2014-04-01 FDA Clarifies Warning About Use of Revatio for Pulmonary Arterial Hypertension in Children Sildenafil FDA
2014-03-31 GlaxoSmithKline Reports Product Tampering With alli® Orlistat Manufacturer
2014-03-07 Pfizer Recalls Some Lots of Antidepressant Effexor Venlafaxine Manufacturer
2014-02-20 Manufacturer Recalls Specific Lots of L-Citrulline After Reports of Adverse Events Citrulline FDA
2014-02-20 Ben Venue Laboratories, Inc. Recalls Single Lot of Acetylcysteine Solution 10%, 30 mL Vial Acetylcysteine FDA
2014-02-12 FDA Reviewing Saxagliptin (Onglyza or Kombiglyze XR) Trial Data for Possible Heart Failure Risk Saxagliptin FDA
2014-02-04 NewMarket Health Products, LLC Recalls Single Lots of NorthStar Arthritis Relief Cream Menthol FDA
2014-02-04 Greenstone LLC Recalls Single Lot of Nifedipine, Extended-Release 90 mg Tablets Nifedipine FDA
2014-02-03 FDA to Evaluate Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products Methyltestosterone FDA
2014-01-17 Some Over-the-Counter Wart Removers Are Flammable Dimethyl Ether and Propane FDA
2014-01-15 Tandem Diabetes Care Issues Recall for Insulin Cartridges Used with t:slim Insulin Pump Insulin FDA
2014-01-15 Merck Recalls All Lots of Liptruzet Atorvastatin and Ezetimibe Manufacturer
2014-01-15 New FDA Recommendations Aimed at Cutting Risks from Acetaminophen FDA
2014-01-10 Nipro Recalls TRUEtrack and TRUEbalance Glucose Meters Insulin Aspart FDA
2014-01-08 FDA Warns of Possible Harm From Exceeding Dose of Over-the-Counter Enemas and Oral Solutions Used to Treat Constipation FDA
2014-01-02 FDA Requires New Safety Measures for Iclusig (Ponatinib) Before It Can Return to Market Ponatinib FDA
2013-12-17 FDA Warns of Rare Risk of Priapism Associated with Methylphenidate Products Dexmethylphenidate FDA
2013-12-03 FDA Warns of Risk of Serious Skin Reactions with Onfi (Clobazam) Clobazam FDA
2013-11-27 FDA Removes Some Prescribing and Dispensing Restrictions For Rosiglitazone-Containing Medicines, Including Avandia, Avandamet, and Avandaryl Glimepiride and Rosiglitazone FDA
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