Smiths Medical and the FDA announced a nationwide voluntary recall of Portex uncuffed pediatric tracheal tubes in 2.5, 3.0 and 3.5 mm sizes, after some were made with internal diameters slightly smaller than labeled, risking airway obstruction or inability to ventilate.
Section archive
Page 12 of 13
Government
Updates from the FDA, CDC and other agencies.
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Government
CDC recommendations for use of antiviral drugs in flu treatment and prevention
CDC's updated interim guidance for the 2009-2010 season recommends oseltamivir or zanamivir for everyone hospitalized with suspected or confirmed influenza, and generally for people at higher risk of complications, including children under 5 and adults 65 and older.
Government
Updated Guidance for Child Care and Early Childhood Programs
CDC's guidance for early childhood programs in the 2009-2010 flu season recommends children and providers with influenza-like illness stay home until 24 hours after fever resolves without medication, and offers a menu of tools to escalate if flu grows more severe.
Government
Who should get H1N1 vaccine?
The CDC's Advisory Committee on Immunization Practices sets out which groups should receive the H1N1 monovalent vaccine first, naming target groups totalling an estimated 159 million people. The recommendations weigh July 2009 epidemiologic data against the supply expected from mid-October.
Government
FDA Thwarts Marketing of Ibuprofen Pain Relief Ointments
The FDA sent warning letters to six companies selling ibuprofen ointments, a form the drug has never been cleared for. Marketers claim the gels avoid the stomach and cardiovascular risks of pills; the agency says no verifiable proof backs that. The firms have two weeks to respond.
Government
CDC Guidance for Businesses and Employers To Plan and Respond to the 2009–2010 Influenza Season
CDC guidance tells employers outside health care what to do to slow seasonal and 2009 H1N1 flu at work and keep operating through the 2009-2010 season, including extra measures if conditions worsen and new advice on when a worker who is ill may return.
Government
FDA Lessens Drug Restriction for Dying Patients
The FDA launched a website explaining expanded access, or compassionate use, for patients with serious or life-threatening illness who are ineligible for clinical trials. Requests go case by case, and the drug's maker must agree and work with the patient's physician.
Government
"Crucial" to keep schools open: CDC
New CDC guidelines urge schools to weigh the risks of closing against the cost of interrupting learning if swine flu spreads this fall. Officials recommend hand washing, covering coughs, screening students on arrival, sending sick children home, and H1N1 vaccination when doses arrive in October.
Government
FDA Requiring Black Box Warnings for Certain Arthritis Drugs
After reviewing 30 cases of children who developed cancer on TNF blockers, FDA is requiring black box warnings on Humira, Cimzia, Enbrel and Remicade and a 10-year Cimzia study. The Arthritis Foundation notes these patients already face higher cancer risk untreated.
Government
FDA warns consumers not to use Clarcon products
US Marshals seized skin sanitizers and protectants from Clarcon Biological Laboratory's Utah plant after the FDA found harmful bacteria in them. The FDA told consumers to discard the listed products, though it said no illnesses had been reported.
Government
FDA: Avoid body building products with steroids
FDA sent a warning letter to American Cellular Laboratories over eight “Xtreme” body building products it says contain synthetic steroids, not steroid-like ingredients. Adverse event reports in men aged 22 to 55 include liver injury, stroke, kidney failure and pulmonary embolism.
Government
FDA and Public Health Experts Warn About Electronic Cigarettes (PR)
An FDA laboratory analysis of electronic cigarette samples found carcinogens and toxic chemicals including diethylene glycol, an antifreeze ingredient. Public health experts warned the flavoured, warning-free devices are marketed to young people and could deepen nicotine addiction.
Government
WHO: Spread of swine flu inevitable
The WHO will stop publishing global tables of swine flu case counts, saying lab confirmation has become extremely difficult, and instead asks countries to watch for clusters of severe cases, unusual transmission patterns and surges in emergency room visits.
Government
FDA Reviewing Preliminary Safety Information on Asthma Drug Xolair
Interim data from EXCELS, an ongoing study of about 5,000 Xolair-treated asthma patients and 2,500 controls, suggests a disproportionate increase in heart and cerebrovascular events. The FDA is not changing the labeling or telling patients to stop the drug while it reviews the findings.
Government
FDA Okays new anti-HIV drug
FDA granted tentative approval to Matrix Laboratories' fixed-dose abacavir, lamivudine and zidovudine tablet for treating HIV-1 in adults. Patent rights bar US marketing, but the tablet becomes eligible for purchase under PEPFAR, and fixed-dose tablets cut pill burden and may aid adherence.
Government
New Hampshire Medical Marijuana Bill Vetoed by Governor Lynch
New Hampshire Governor John Lynch vetoed a bill letting patients possess small amounts of marijuana for medical use, saying it still had too many defects and noting federal law bans possession. The bill's author, Rep. Evalyn Merrick, who has multiple myeloma, vowed to seek an override.
Government
FDA Requires Makers of Darvon, Darvacet, to Issue Strong Warnings
Rather than ban Darvon and Darvocet as its own panel urged, the FDA will require a boxed warning on painkillers containing propoxyphene and ask makers to detail the drug's toxicity in overdose. Critics say it is so weak that patients may take extra doses.
Government
Acetaminophen and Liver Injury: Q & A for Consumers
Ahead of a June 2009 FDA advisory committee meeting on acetaminophen-related liver injury, this Q&A explains what the drug is, where it appears (Tylenol, Vicodin, Percocet, cold and sleep combinations), and that exceeding the recommended amount can cause liver damage up to acute failure and death.
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