U.S. Food and Drug Administration health news articles
Mislabeled ReliOn Insulin Syringes recalled in USThe U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling.
Updated labeling for psoriasis drug Raptiva approvedThe U.S. Food and Drug Administration announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab).
US FDA assessed melamine and melamine compounds in foodThe U.S. Food and Drug Administration (FDA) issued the results of its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant formula.
Statins do not increase risk of Lou Gehrig's DiseaseA U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The analysis was reported on Monday, Sept. 29, 2008 in Pharmacoepidemiology and Drug Safety.
Nplate bone marrow stimulator approved to treat low platelet countsThe U.S. Food and Drug Administration approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding.
Xenazine approved for treatment of chorea in Huntington's DiseaseThe U.S. Food and Drug Administration has approved Xenazine (tetrabenazine) for the treatment of chorea in people with Huntington's disease. Chorea is the jerky, involuntary movement that occurs in people with this disease.
Jalapeno, Serrano peppers not connected to Salmonella Saintpaul OutbreakJalapeno and Serrano peppers grown in the United States are not connected with the current Salmonella Saintpaul outbreak, informed by the U.S. Food and Drug Administration.
Boxed warnings on fluoroquinolone antimicrobial drugsThe U.S. Food and Drug Administration (FDA) requests boxed warnings on fluoroquinolone antimicrobial drugs. FDA seeks this to strengthen warnings concerning increased risk of tendinitis and tendon rupture.
SPOT-Light HER2 CISH kit approved for breast cancer patientsSPOT-Light HER2 CISH kit - a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab) has been approved by the U.S. Food and Drug Administration.
US Food Protection Plan shows significant progressThe U.S. Food and Drug Administration's Food Protection Plan Progress Report in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007.
Avoid raw red tomatoes in New Mexico, TexasThe Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes.
New drug labels better for pregnant & nursing mothersNew drug labeling system would provide better information about any prescription drug to pregnant women and nursing mothers as FDA proposes new rule to provide updated information on the use of prescription drugs and biological products during pregnancy and breast-feeding.
GSK's new vaccine Rotarix to prevent gastroenteritis by rotavirusThe U.S. Food and Drug Administration announced the approval of Rotarix, the second oral U.S. licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children. Rotarix is a liquid and given in a two-dose series to infants from 6 to 24 weeks of age.
FDA to establish offices in ChinaIn an important development, the U.S. Food and Drug Administration has received approval from the U.S. State Department to establish eight full time permanent FDA positions at U.S. diplomatic posts in the People's Republic of China, pending authorization from the Chinese government.
Tussionex cough medicine with hydrocodone warningThe U.S. Food and Drug Administration issued an alert on the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension in response to numerous reports of adverse events--including death--associated with the misuse and inappropriate use of this potent cough medication.
Guidelines for information on unapproved uses of medical productsThe U.S. Food and Drug Administration (FDA) today issued draft guidance on "Good Reprint Practices" for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices.
Baxter's multiple-dose vial Heparin causing allergyThe U.S. Food and Drug Administration announced today that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high "bolus" doses of the drug.
First decellularized heart valve approved in USCryoLife, Inc., (NYSE: CRY) a biomaterials, medical device and tissue processing company, today announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its CryoValve(R) SG pulmonary human heart valve processed with the Company's proprietary SynerGraft technology.
Adverse reactions linked to Botox use, warns FDAThe U.S. Food and Drug Administration today notified the public that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.
FDA updates guidance to seafood processors after recent ciguatera poisoningThe U.S. Food and Drug Administration (FDA) issued a letter to seafood processors, advising them of recent illnesses linked to consuming fish carrying the ciguatera toxin, which has led to cases of ciguatera fish poisoning (CFP) in consumers.
Pfizer's anti smoking Chantix latest safety informationChantix (varenicline), a prescription medication used to help patients stop smoking reported to have certain adverse effects like changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior. US FDA issued a Public Health Advisory to alert health care providers, patients, and caregivers.
Epilepsy drugs may raise suicide risk, warns FDAAn increased risk of suicidal thoughts and behaviors (suicidality) in patients who take drugs called antiepileptics to treat epilepsy, bipolar disorder, migraine headaches, and other conditions, reported by U.S. Food and Drug Administration (FDA).
Ongoing review of cholesterol drug VytorinThe U.S. Food and Drug Administration (FDA) is informing the public that the agency will conduct a review of Merck and Schering Plough's recent trial once the FDA receives the final study results.
Intelence, etravirine HIV Drug approved in USUS FDA approved Tibotec Therapeutics' Intelence, etravirine tablets for the treatment of HIV infection, to be used in combination with other anti-HIV medications, in adults who have failed treatment with other antiretrovirals.
Ortho Evra contraceptive transdermal birth control patch label updateThe U.S. Food and Drug Administration (FDA) approved additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism.
Use OTC cough and cold products with careUS health agency FDA is recommending that over-the-counter (OTC) cough and cold products should not be used to treat infants and children less than 2 years of age because serious and potentially life-threatening side effects can occur from such use. OTC cough and cold products include decongestants, expectorants, antihistamines, and antitussives (cough suppressants) for the treatment of colds.
New test to detect and identify 12 respiratory virusesThe U.S. Food and Drug Administration has approved a new diagnostic test that detects 12 respiratory viruses, including strains of flu that have triggered epidemics.
Quick Test For Drug-Resistant Staph Infections MRSAThe U.S. Food and Drug Administration (FDA) announced it has cleared for marketing the first rapid blood test for the drug-resistant staph bacterium known as MRSA (methicillin-resistant Staphylococcus aureus), which can cause potentially deadly infections.
Bayer Diabetes Care recalls test strips for Contour TS Blood Glucose MeterBayer Diabetes Care has initiated a voluntary market recall of test strips (sensors) used exclusively with the Contour TS Blood Glucose Meter. In the course of its routine quality control monitoring processes the Company identified a manufacturing issue with test strips from specific lots that could result in blood glucose readings with a positive bias that is outside of our product specifications. Test results may demonstrate results 5 -17% higher.
Safety warning on fentanyl skin patch by US FDAThe US Food and Drug Administration issued its second safety warning about the fentanyl transdermal system, an adhesive patch that delivers a potent pain medicine through the skin. In July 2005, the agency issued a similar warning to the public and to health care providers, saying that the directions on the product label and on the patient package insert should be followed exactly in order to avoid overdose.
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