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Medication Safety News - Preventing Medication Errors
Risk Calculators - Check Risk for Medication Errors
Consumermedsafety.org: ISMP Drug Alerts
MedlinePlus Health News
FDA: What's New Drugs - Ask our Clinical Pharmacists
- New and Generic Drug Approvals
Drug Approval Listing

- Comunicado de la FDA sobre la seguridad de los medicamentos: Informe actualizado sobre la seguridad del medicamento Revlimid (lenalidomida) para el cáncer y el riesgo de nuevos tipos de neoplasias (nuevos tipos de cáncer)
El 7 de mayo del 2012, la Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) informó al público sobre el aumento en el riesgo de segundas neoplasias primarias (nuevos tipos de cáncer) en pacientes con mieloma múltiple de reciente diagnóstico, que tomaron Revlimid (lenalidomida).

- Updated Questions and Answers for Healthcare Professionals and the Public: Use an Approved Pancreatic Enzyme Product (PEP)
FDA has updated questions and answers about the safe use of approved pancreatic enzyme products.

- Newly Added Guidance Documents

- Current Drug Shortages
New/Updated Drug Shortages: AsmanexTwisthaler, Isoniazid Tablets, Ketorolac Injection, Methylphenidate HCl, Nalbuphine HCl Injection, Odansetron Injection 2 mg/mL, Potassium Chloride Injection 2 mEq/mL, Thiotepa for Injection, Ticlopidine Tablets 5/16/2012

- Drugs to be Discontinued
Drugs to be Discontinued: Digoxin Injection, Naltrexone Oral Tablets 5/16/2012

- Generic Drugs: Information for Industry
News and Announcements updated

- Medication Guides
Updated list of medication guides.

- FDA Drug Safety Communication: Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod)
The U.S. Food and Drug Administration (FDA) has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya (fingolimod). The agency also has evaluated additional clinical trial and postmarket data for Gilenya, including reports of patients who died of cardiovascular events or unknown causes.

- National Drug Code Directory

FDA: Consumer Health Information - Any Medicine Questions?
- FDA's MedWatch Safety Alerts: April 2012
FDA warns about a contaminated ultrasound gel, and a higher risk of blood clots with some birth control pills.

- FDA Unit Mobilizes for Emergency Response
During the outbreak of Salmonella Bareilly tied to spicy tuna sushi, , FDA's urgent-response team shifted into high gear.

- Consumer Update Analytics
This page contains links to all past Consumer Update Analytics web pages.

- It's a Small World, After All
New "Global Engagement" report opens a window of FDA's work around the world to guarantee the safety of imported foods, medical products and other regulated goods.

- FDA Continues Dialogue on 'Nano' Regulation
The Food and Drug Administration (FDA) is continuing a dialogue on nanotechnology by publishing draft guidelines on the use of nanomaterials in cosmetics and substances added to foods.

- Fentanyl Patch Can Be Deadly to Children
FDA is warning that improper use, storage and disposal of the fentanyl patch, a potent pain medication, can be deadly to children who swallow it or apply it to their own skin.

- MedWatch Safety Alerts: March 2012
The Food and Drug Administration (FDA) announces safety alerts and reviews for some widely used medications, skin creams and baby food.

- FDA's MedWatch Safety Alerts: February 2012
Learn about these and other safety alerts at http://www.fda.gov/Safety/MedWatch.

- FDA's China Offices Focus on Product Safety
After a series of safety scares involving Chinese exports, the Food and Drug Administration's China office has trained nearly 1,600 Chinese manufacturers and regulators on U.S. safety standards. They hope the training will head off future problems.

- FDA and ISMP Work to Prevent Medication Errors
FDA is working with the Institute for Safe Medication Practices (ISMP) to protect consumers from medication errors, which are preventable mistakes in labeling, packaging, prescribing, dispensing, and order communication.

FDA: MedWatch Safety Alerts (Human Medical Products)
- Zithromax (azithromycin): FDA Statement on risk of cardiovascular death
A retrospective cohort study reports small increase in risk of cardiovascular deaths and risk of all cause deaths associated with 5 day course of antibiotic drug

- Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose
UPDATED 05/14/2012. New recommendations for monitoring patients, and new contraindications, and dosing & administration information for use in certain patients.

- Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject: Recall - May Contain More Than the Intended Fill Volume
An overdose of Hydromorphone may result in life-threatening consequences, including respiratory depression (slowed breathing or suspension of breathing), low blood pressure, and reduced heart rate including circulatory collapse.

- Revlimid (lenalidomide): Ongoing Safety Review - Increased Risk of Developing New Malignancies
UPDATED 05/07/2012. Increased risk of developing acute myelogenous leukemia, myelodysplastic syndromes, and Hodgkin lymphoma in patients being treated with Revlimid.

- Certain Compounded Drugs from Franck's: FDA Issues Second Warning to Physicians
[UPDATED 05/04/2012] The Centers for Disease Control and Prevention (CDC) has advised healthcare personnel to avoid use of compounded products labeled as sterile from Franck’s during the ongoing investigation.

- Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs: Drug Safety Communication - Drug Interactions
UPDATED 04/26/2012. Label revised to state that co-administration of Victrelis with certain ritonavir-boosted human immunodeficiency virus protease inhibitors is not recommended. Originally posted 02/09/2012

- X-Rock: Recall - Undeclared Drug Ingredient
Undeclared active ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels.

- Roche Diagnostics Operations Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays: Recall – Doctors may receive a falsely low result
Customers should immediately discontinue use of any affected product.

- Brilliant Blue G Compounded by Franck's: Recall of Unapproved Drug - Ongoing Investigation of Fungal Endophthalmitis Cases
[UPDATED 05/04/2012] The Centers for Disease Control and Prevention (CDC) has advised healthcare personnel to avoid use of compounded products labeled as sterile from Franck’s during the ongoing investigation.

- Aliskiren-containing Medications: Drug Safety Comunication - New Warning and Contraindication
Risk of renal impairment, hypotension, and hyperkalemia with concomitant use of aliskiren with angiotensin receptor blockers (ARBs) or angiotensin converting enzyme inhibitors (ACEIs) in patients with diabetes.

Reuters: Health News - Create a Medication List
- Study unpicks gene changes behind breast cancer
LONDON (Reuters) - Scientists have mapped the complete genetic codes of 21 breast cancers and created a catalogue of the mutations that accumulate in breast cells, raising hopes that the disease may be able to be spotted earlier and treated more effectively in future.

- New York judge with cancer makes case for marijuana
NEW YORK (Reuters) - A cancer-stricken judge in New York has become an unlikely voice in support of legalizing the use of medical marijuana with the admission that he smokes pot to ease the side-effects of his treatments.

- Sex, age may affect athletes' concussion recovery
NEW YORK (Reuters Health) - Female and high school athletes may need more time to recover from a concussion than their male or college counterparts, a new study finds.

- Many pregnant women may not get STD tests
NEW YORK (Reuters Health) - Despite recommendations that pregnant women have tests for certain sexually transmitted diseases, many may not be getting them, a new study suggests.

- Breastfed babies may gain less weight
NEW YORK (Reuters Health) - Babies who are fed milk from their mothers' breasts gain less weight over their first year compared to babies fed milk -- breast or formula -- from a bottle, suggests a new study.

- Canada OKs Osiris drug; first stem cell therapy
BOSTON (Reuters) - Osiris Therapeutics Inc said on Thursday that Canadian health regulators have approved its treatment for acute graft-versus host disease in children, making it the first stem cell drug to be approved for a systemic disease anywhere in the world.

- GSK melanoma drug shows promise in early trial
LONDON (Reuters) - An experimental cancer drug developed by Britain's GlaxoSmithKline may add vital months to the lives of melanoma patients whose disease has spread to their brains, according to data from an early-stage trial published on Friday.

- Fewer girls completing all three HPV shots: study
NEW YORK (Reuters Health) - Among girls and women who get their first human papillomavirus, or HPV, vaccine, the percent who complete all three doses is dropping, according to a new study.

- FCC chooses spectrum for wireless medical devices
NEW YORK (Reuters) - The telecommunications regulator on Thursday announced plans to set aside a chunk of spectrum for connecting wireless medical devices to allow for more convenient and cost-effective health monitoring.

- South Carolina woman battles flesh-eating bacterial disease
CHARLESTON, South Carolina (Reuters) - A new mother of twins in Greenville, South Carolina, is the latest victim of a rare and potentially fatal flesh-eating bacterial infection, health officials said on Thursday.

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