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Medication Safety News
Consumermedsafety.org: ISMP Drug Alerts
MedlinePlus Health News
- Stop Bugging Me!
Source: HealthDay - 
Related MedlinePlus Page: Head Lice
- FDA Rules Out Bisphosphonate, Thigh Fracture Link
U.S. regulators said on Wednesday they have found no link between oral bisphosphonate osteoporosis medications such as Merck & Co Inc's Fosamax and certain thigh bone fractures.
Source: Reuters Health
Related MedlinePlus Pages: Fractures, Leg Injuries and Disorders, Medicines
- Alternative to Statins Shows Promise
Broader study needed to check for possible long-term effects, experts say
Source: HealthDay
Related MedlinePlus Pages: Cholesterol, Medicines, Statins
- Doctors Turning to Cardiac Catheterization Too Quickly
Study finds only a third of those who get invasive procedure have vessel blockage
Source: HealthDay
Related MedlinePlus Pages: Chest Pain, Emergency Medical Services
- Entire Family Genome Sequenced for First Time
Children receive 30 mutations from each parent, researchers find
Source: HealthDay
Related MedlinePlus Page: Genes and Gene Therapy
- For Tough Head Lice, Pill Tops Lotion
Ivermectin may offer alternative for hard-to-treat infestations, study shows
Source: HealthDay
Related MedlinePlus Pages: Head Lice, Medicines
- Gene Mutations Identified for Charcot-Marie-Tooth Syndrome
Researcher's personal genome used to study neurological disorder
Source: HealthDay
Related MedlinePlus Pages: Charcot-Marie-Tooth Disease, Genes and Gene Therapy
- Panel Finds Many Women Can Avoid Repeat C-Sections
Vaginal delivery after Cesarean often safe, but roadblocks remain, experts say
Source: HealthDay
Related MedlinePlus Pages: Cesarean Section, Childbirth
- Cell Transplant May Help Treat Vitiligo
Surgery improved appearance of white patches due to skin disease, doctors say
Source: HealthDay
Related MedlinePlus Page: Vitiligo
- Longtime Smokers May Find Protection from Parkinson's
Finding could help unravel mysteries of neurological and motor disease
Source: HealthDay
Related MedlinePlus Pages: Parkinson's Disease, Smoking
FDA: What's New Drugs
- Drugs@FDA Data Files
Data files updated through March 10, 2010.
- New and Generic Drug Approvals
Updated 3/9/2010
- FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures
- Current Drug Shortages
Current Drug Shortages: Gemifibrozil Tablets 3/9/2010, Heparin Sodium Large Volume Premixed Infusion Solutions (updated) 3/8/2010, Cerezyme (imiglucerase) Injection (updated) 3/2/2010, Propofol Injection 3/1/2010, Ephedrine Injection 2/25/2010, Propofol Injection (updated) 2/24/2010, Acyclovir Tablets and Capsules (updated) 2/22/2010, Technetium Tc99m Generators (updated) 2/18/2010, Vecuronium Injection (updated) 2/12/2010, Thyroid (desiccated) tablets 2/12/2010, Mexiletine Capsules (150mg, 200mg, and 250mg) 2/12/2010
- Paragraph IV Patent Certifications
Updated list.
- Pediatric Exclusivity Statistics
Updated list.
- Status of OTC Rulemakings
Updated list.
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA)
Updated list.
- ANDA (Generic) Drug Approvals
Updated listing.
- Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
FDA: Consumer Health Information
FDA: MedWatch Safety Alerts (Human Medical Products)
- Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures
FDA review of available data have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.
- Beckman Coulter UniCel DxC Synchron Clinical System – Ion Selective Electrode Flow Cell: Class I Recall
Incorrect sodium results may be caused by build-up of protein, bacteria, and sample tube additives in the ion selective electrode flow cell.
- Abiomed AB5000 Circulatory Support System: Class I Recall
Device computer may shut down without an alarm, which can lead to serious injuries or death.
- WinRho SDF (Rho(D) Immune Globulin Intravenous (Human): Risk of Intravascular Hemolysis
Cases of intravascular hemolysis and its complications have been reported in patients treated for immune thrombocytopenic purpura with WinRho.
- Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife, NK, Responder models): Class I Recall
UPDATED 03/08/2010: Recall classified as Class I, expanded list of affected models. Originally posted 02/09/2010
- Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: Class I Recall
Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.
- Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall
Reports of serious injuries and at least one death have been associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity.
- OneTouch SureStep Test Strips (LifeScan): Recall
Test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.
- StatSpin Express 4 Centrifuges Model 510: Class I Recall
Rotor may break and eject pieces of the rotor which may cause serious physical injury to bystanders and expose them to blood-borne infectious micro-organisms.
- Invirase (saquinavir): Ongoing safety review of clinical trial data
Possible association with abnormal heart rhythms when used in combination with Norvir (ritonavir).
Reuters: Health News
- "Personal" study shows gene maps can spot disease
WASHINGTON (Reuters) - Two studies published on Wednesday show it is possible to sequence the entire gene maps of families with inherited diseases and pinpoint the offending bit of DNA.
- Peanut allergy linked to worse asthma in kids
NEW YORK (Reuters Health) - Among children and teenagers with asthma, those who also have peanut allergies may have more or more-severe asthma attacks, a new study suggests.
- U.S., Canadian health officials OK Polish isotopes
CHICAGO (Reuters) - U.S. and Canadian health officials have approved the use of the medical isotopes created at a Polish nuclear reactor, a move that will help ease a shortage of the materials used in millions of diagnostic tests, health products provider Covidien said Thursday.
- Doctors fail to cut cholesterol enough
LONDON (Reuters) - Only half of patients at high risk of heart disease are given the right targets for cutting their cholesterol and millions may suffer heart attack or stroke due to doctors' poor advice, scientists said on Thursday.
- Vaginal birth after cesarean underused: panel
NEW YORK (Reuters Health) - If you're pregnant and have had a cesarean section before, chances are you'll have one again. In at least one-third of US hospitals, a repeat cesarean is the only option, and nine in 10 women end up getting one -- a fact that had experts worried at a national conference this week on vaginal birth after cesarean, or VBAC.
- U.S. says "drugged driving" growing threat
VIENNA (Reuters) - Motorists under the influence of drugs are a growing threat on U.S. roads, while the number who drink and drive has fallen thanks to education and law enforcement, a top U.S. drug control official said on Tuesday.
- Prostate test 'public health disaster': discoverer
WASHINGTON (Reuters) - The most commonly used tool for detecting prostate cancer, routine PSA screening, has become "a hugely expensive public health disaster," its discoverer said on Wednesday.
- FDA rules out bisphosphonate, thigh fracture link
BOSTON (Reuters) - U.S. regulators said on Wednesday they have found no link between oral bisphosphonate osteoporosis medications such as Merck & Co Inc's Fosamax and certain thigh bone fractures.
- Canadian vaccination study proves 'herd immunity'
CHICAGO (Reuters) - Inoculating children against flu protects more people of all ages in the larger community, probably because young people tend to spread viruses through physical play, Canadian researchers said on Tuesday.
- Despite law, drug safety still a concern at FDA
WASHINGTON (Reuters) - Recent new powers have helped the U.S. Food and Drug Administration combat contaminated medications, counterfeit pills and other safety woes, but more work is needed to address lingering concerns about drug risks, FDA officials said on Wednesday.
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