News Briefs http://lecom.edu/cdir/news-briefs.php en-us MutualGravity WebContent Angel v3 Potential Safety Signal Update http://lecom.edu/cdir/news-briefs.php/potential-safety-signal-update/240/0/3100/21669 Last quarter, the CDIR Newsletter gave a brief introduction to the Adverse Event Reporting System (AERS) database.  This will be the first quarter that we will be highlighting important potential safety signals from the Food and Drug Administration’s (FDA).   Although it is... Tue, 13 Sep 2011 0:00:00 EDT http://lecom.edu/cdir/news-briefs.php/potential-safety-signal-update/240/0/3100/21669 New topical strengths now available http://lecom.edu/cdir/news-briefs.php/new-topical-strengths-now-available/240/0/3100/21456 On April 29, 2011, Abbott received approval for Androgel (testosterone) 1.62%.  Androgel 1% has been available since February of 2000.  Both strengths are approved to restore testosterone in hypogonadal males.  The purpose of the Androgel 1.62% is to produce the same results with... Tue, 9 Aug 2011 0:00:00 EDT http://lecom.edu/cdir/news-briefs.php/new-topical-strengths-now-available/240/0/3100/21456 Daliresp Approved by FDA for COPD Treatment http://lecom.edu/cdir/news-briefs.php/daliresp-approved-by-fda-for-copd-treatment/240/0/3100/20790 New PDE-4 inhibitor approved for treatment of severe COPD  Sun, 3 Apr 2011 0:00:00 EDT http://lecom.edu/cdir/news-briefs.php/daliresp-approved-by-fda-for-copd-treatment/240/0/3100/20790 FDA: Gardasil approved to prevent anal cancer http://lecom.edu/cdir/news-briefs.php/fda-gardasil-approved-to-prevent-anal-cancer/240/0/3100/20342 The U.S. Food and Drug Administration today approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years. Gardasil is already approved for the same age population for... Fri, 4 Feb 2011 0:00:00 EST http://lecom.edu/cdir/news-briefs.php/fda-gardasil-approved-to-prevent-anal-cancer/240/0/3100/20342 FDA approves Makena to reduce risk of preterm birth in at-risk pregnant women http://lecom.edu/cdir/news-briefs.php/fda-approves-makena-to-reduce-risk-of-preterm-birth-in-at-risk-pregnant-women/240/0/3100/20341 The U.S. Food and Drug Administration today approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm delivery before 37 weeks of pregnancy, in pregnant women with a history of at least one spontaneous preterm birth. The drug is not intended for use in women with a... Fri, 4 Feb 2011 0:00:00 EST http://lecom.edu/cdir/news-briefs.php/fda-approves-makena-to-reduce-risk-of-preterm-birth-in-at-risk-pregnant-women/240/0/3100/20341 Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) between July - September 2010 http://lecom.edu/cdir/news-briefs.php/potential-signals-of-serious-risks%2Fnew-safety-information-identified-by-the-adverse-event-reporting-system-aers-between-july-september-2010/240/0/3100/20335 FDA has posted the names of products and potential signals of serious risks/new safety information that were identified for these products during the period July - September 2010 in the AERS database. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the... Thu, 3 Feb 2011 0:00:00 EST http://lecom.edu/cdir/news-briefs.php/potential-signals-of-serious-risks%2Fnew-safety-information-identified-by-the-adverse-event-reporting-system-aers-between-july-september-2010/240/0/3100/20335 Avandia (rosiglitazone) labels now contain updated information about cardiovascular risks and use in certain patients http://lecom.edu/cdir/news-briefs.php/avandia-rosiglitazone-labels-now-contain-updated-information-about-cardiovascular-risks-and-use-in-certain-patients/240/0/3100/20334 The U.S. Food and Drug Administration (FDA) is notifying the public that information on the cardiovascular risks (including heart attack) of the diabetes drug rosiglitazone has been added to the physician labeling and patient Medication Guide. This information was first announced by FDA on September... Thu, 3 Feb 2011 0:00:00 EST http://lecom.edu/cdir/news-briefs.php/avandia-rosiglitazone-labels-now-contain-updated-information-about-cardiovascular-risks-and-use-in-certain-patients/240/0/3100/20334 FDA approves Viibryd to treat major depressive disorder http://lecom.edu/cdir/news-briefs.php/fda-approves-viibryd-to-treat-major-depressive-disorder/240/0/3100/20300 The U.S. Food and Drug Administration today approved Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults. Major depressive disorder, also called major depression, is characterized by symptoms that interfere with a person's ability to work, sleep, study, eat, and... Wed, 26 Jan 2011 0:00:00 EST http://lecom.edu/cdir/news-briefs.php/fda-approves-viibryd-to-treat-major-depressive-disorder/240/0/3100/20300 FDA Approves Head Lice Treatment for Children and Adults http://lecom.edu/cdir/news-briefs.php/fda-approves-head-lice-treatment-for-children-and-adults/240/0/3100/20301 The U.S. Food and Drug Administration today approved Natroba (spinosad) Topical Suspension 0.9% for the treatment of head lice infestation in patients ages 4 years and older. Head lice are parasitic insects found on people’s head, eyebrows, and eyelashes. They feed on human blood several... Wed, 26 Jan 2011 0:00:00 EST http://lecom.edu/cdir/news-briefs.php/fda-approves-head-lice-treatment-for-children-and-adults/240/0/3100/20301 Safety Communication: Severe liver injury associated with the use of dronedarone (marketed as Multaq) 01-14-2011 http://lecom.edu/cdir/news-briefs.php/safety-communication-severe-liver-injury-associated-with-the-use-of-dronedarone-marketed-as-multaq-01-14-2011/240/0/3100/20222 The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with the heart medication dronedarone (Multaq). Dronedarone is a... Fri, 14 Jan 2011 0:00:00 EST http://lecom.edu/cdir/news-briefs.php/safety-communication-severe-liver-injury-associated-with-the-use-of-dronedarone-marketed-as-multaq-01-14-2011/240/0/3100/20222 FDA limits acetaminophen in prescription combination products; requires liver toxicity warnings 01-13-2011 http://lecom.edu/cdir/news-briefs.php/fda-limits-acetaminophen-in-prescription-combination-products-requires-liver-toxicity-warnings-01-13-2011/240/0/3100/20220 The U.S. Food and Drug Administration is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule. The FDA also is requiring manufacturers to update labels of all... Thu, 13 Jan 2011 0:00:00 EST http://lecom.edu/cdir/news-briefs.php/fda-limits-acetaminophen-in-prescription-combination-products-requires-liver-toxicity-warnings-01-13-2011/240/0/3100/20220 Update to ongoing safety review of Lantus (insulin glargine) and possible risk of cancer 01-13-2011 http://lecom.edu/cdir/news-briefs.php/update-to-ongoing-safety-review-of-lantus-insulin-glargine-and-possible-risk-of-cancer-01-13-2011/240/0/3100/20219 The U.S. Food and Drug Administration (FDA) is updating the public about its ongoing safety review of Lantus (insulin glargine) and a possible increased risk of cancer. Lantus is a long-acting modified version of human insulin (insulin analog) used to control blood sugar in patients with Type 1 and... Thu, 13 Jan 2011 0:00:00 EST http://lecom.edu/cdir/news-briefs.php/update-to-ongoing-safety-review-of-lantus-insulin-glargine-and-possible-risk-of-cancer-01-13-2011/240/0/3100/20219