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Looking for a job in 2018? Apply for a job at the Department of Health and Human Services (HHS). With positions available around the country in many fields including health care, technology, and more, HHS might just be your perfect next move.  Play the Mars Rover Game Download the free app and play NASA's Mars Rover game! Search for water, avoid craters, and simulate how the real Mars rovers explore the planet.  Understanding Civil Rights Through Rosa Parks Help your students better understand Rosa Parks' role in the Civil Rights Movement with the Library of Congress. Use lesson plans, discussion questions, and primary source documents to deepen the insights into this American icon. What is the Winter Solstice?   December 21 marks this year's Winter Solstice. This astronomical phenomenon marks the shortest day and longest night of the year, but why is this so? Learn more of the history and science behind this yearly occurance!   MedWatch - The FDA Safety Information and Adverse Event Reporting Program Long-Acting Beta Agonists (LABAs) and Inhaled Corticosteroids (ICS): Drug Safety Communication - Boxed Warning About Asthma-Related Death Removed AUDIENCE: Pharmacy, Pulmonology, Internal Medicine, Family Practice ISSUE: FDA's most prominent warning, the Boxed Warning, about asthma-related death has been removed from the drug labels of medicines that contain both an ICS and LABA. A FDA review of four large clinical safety trials shows that treating asthma with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) does not result in significantly more serious asthma-related side effects than treatment with ICS alone. A description of the four trials is now also included in the Warnings and Precautions section of the drug labels. These trials showed that LABAs, when used with ICS, did not significantly increase the risk of asthma-related hospitalizations, the need to insert a breathing tube known as intubation, or asthma-related deaths, compared to ICS alone.   BACKGROUND: In 2011, FDA required the drug companies manufacturing fixed-dose combination drugs containing an ICS and LABA (GlaxoSmithKline, Merck, Astra Zeneca) to conduct several large, 26-week, randomized, double-blind, active-controlled clinical safety trials to evaluate the risk of serious asthma-related events when long-acting beta agonists (LABAs) were used in fixed-dose combination with an inhaled corticosteroid (ICS) compared to ICS alone in patients with asthma. FDA reviewed the results of four trials involving 41,297 patients. The results demonstrate that the use of ICS/LABA in fixed-dose combination does not result in a significant increase in the risk of serious asthma-related events compared to ICS alone. The results of subgroup analyses for gender, adolescents 12-18 years, and African Americans are consistent with the primary endpoint results.  The four trials also assessed efficacy of the ICS/LABA products. The primary efficacy endpoint was asthma exacerbation, defined as a deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days, or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. The results showed that the ICS/LABA combination reduced asthma exacerbations compared to ICS alone, noting that the majority of these exacerbations were those that required at least 3 days of systemic corticosteroids. This efficacy information has been added to the Clinical Studies section of the ICS/LABA drug labels. RECOMMENDATION: Health care professionals should refer to the most recently approved drug labels for recommendations on using ICS/LABA medicines (see links in Table 1 of the Drug Safety Communication). Patients and parents/caregivers should talk to your health care professional if you have any questions or concerns. Do not stop taking your asthma medicines without first talking to your health care professional. Also read the patient information leaflet that comes with every prescription. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm590001.htm Pantoprazole Sodium for Injection 40 Mg Per Vial: Recall - Presence of Glass Particles AUDIENCE: Pharmacy, Gastroenterology ISSUE: AuroMedics Pharma LLC is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial, to the hospital level. The product was found to contain glass particles in the vial. This problem was discovered as a result of a product complaint in which the contents of one vial from one batch was found to contain a piece of glass. The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening. The affected Pantoprazole Sodium for Injection lot being recalled is CPO170035, EXP. May 2019.  AuroMedics commenced shipping the product to customers on August 7, 2017 and was distributed to wholesalers and/or hospitals nationwide. See the press release for product photo. BACKGROUND: Pantoprazole Sodium for Injection 40 mg per vial, is used for short term treatment of gastroesophageal reflux disease associated with a history of erosive esophagitis and pathological hypersecretion including zollinger-ellison syndrome and is packaged in a carton containing 10 vials, NDC: 55150-202-10. RECOMMENDATION: AuroMedics Pharma LLC is notifying its distributors and customers by recall letters and is arranging for return/replacement etc. of all recalled product. Consumers/distributors/retailers that have the product lot which is being recalled should immediately stop using and return to place of purchase/contact their doctor as appropriate. Consumers with questions regarding this recall can contact Aurobindo Customer Service weekdays 9:00AM to 5:00PM EST at 866-850-2876 Option 1.  If you need assistance in returning your product or have questions about the recall process, contact Inmar at 800-967-5952 weekdays Monday through Friday 8:30 AM to 5:00 PM EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 Read the MedWatch Safety Alert, including a link to the press release, at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm589946.htm Gel Spice Company, Inc. Issues Allergy Alert On Undeclared Soy And Wheat In Beef Flavored Bouillon Cube Products. Gel Spice Company, Inc. is voluntarily recalling certain Spice Time and Spice Supreme Beef Flavored Bouillon Cube products (identified below) because they contain undeclared soy and wheat. People who have an allergy or severe sensitivity to soy and/or wheat run the risk of serious or life-threatening allergic reaction(s) if they consume these products. The beef flavored bouillon cube products identified above were distributed by Gel Spice throughout the United States to retail locations and distribution centers located in: Alabama; California; Connecticut; Florida; Georgia; Illinois; Indiana; Iowa; Maryland; Michigan; Minnesota; Montana; New Hampshire; New Jersey; New York; North Carolina; Ohio; Pennsylvania; South Carolina; South Dakota; Texas; Virginia; and Washington. Springfield Smoked Fish Expands their Recall of Smoked Salmon Because of Possible Health Risk Springfield Smoked Fish of Springfield, MA is expanding their voluntary recall of smoked fish products because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeriainfection can cause miscarriages and stillbirths among pregnant women. Recalled products were distributed and sold at retail stores and wholesale establishments in Massachusetts, Connecticut, New York, Rhode Island, Colorado, Ohio, Pennsylvania from May 2017 through December 2017. Product was also sold nationwide through online sales. FTC Challenges Consummated Merger of Companies That Make Microprocessor Prosthetic Knees Agency alleges that Otto Bock’s acquisition of Freedom Innovations has harmed competition that benefits amputees The Federal Trade Commission has issued an administrative complaint challenging the merger of two prosthetics manufacturers that are top sellers of prosthetic knees equipped with microprocessors. According to the FTC’s complaint (which will be available on the Commission’s website soon), Otto Bock’s recent acquisition of FIH Group Holdings (owner of Freedom Innovations) harmed competition in the U.S. market for microprocessor prosthetic knees by eliminating head-to-head competition between the two companies, removing a significant and disruptive competitor, and entrenching Otto Bock’s position as the dominant supplier. Since closing the acquisition on September 22, 2017, Otto Bock has taken steps to integrate the Freedom Innovations’ business, including personnel, intellectual property, know-how, and other critical assets. To preserve the viability of the business, including assets and personnel pending resolution of this action, the company has agreed to a Hold Separate and Asset Maintenance Agreement under which Otto Bock will take steps to ensure the preservation and health of the former Freedom Innovations business. Microprocessor knees, which use microprocessors to adjust the stiffness and positioning of the joint in response to variations in walking rhythm and ground conditions, provide a stable platform for amputees. Prosthetists and doctors typically prescribe microprocessor knees to patients with above-the-knee amputations who have a relatively high degree of mobility. Compared to other products, microprocessor prosthetic knees reduce the risk of falling, cause less pain, and promote the health and function of the sound limb. New entry or expansion by other manufacturers of microprocessor knees is not likely to be timely or sufficient to offset the anticompetitive effects of the merger. The complaint notes that it routinely takes firms more than two years just to develop a microprocessor knee, even when they are building on existing microprocessor knee technology. In addition to issuing an administrative complaint, the Commission authorized agency staff to seek a temporary restraining order, preliminary injunction, and ancillary relief in federal court, should doing so be necessary to ensure the Freedom Innovations business remains viable and to preserve the Commission ability to order effective relief if staff prevails in the administrative trial on the merits. The Commission vote to issue the administrative complaint and to authorize staff to seek a temporary restraining order and preliminary injunction in federal court was 2-0. NOTE: The Commission issues an administrative complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The issuance of the administrative complaint marks the beginning of a proceeding in which the allegations will be tried in a formal hearing before an administrative law judge.