Drugs & Pharmacology Alerts This is an OPML file. It can be used to export all the MedWorm RSS feeds on this topic into your personal RSS reader (usually you have to save this file to your own computer before clicking on an Import OPML command in your own feed reader to upload the file which will then import all the feeds) or it can be used by webmasters to integrate MedWorm feeds with their own website. This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader, such as GoogleReader, or to display this data on your own website or blog. Subscribe to this data using MyMedWorm.Subscribe to this data using GoogleReader.Subscribe to this data using Bloglines.Subscribe to this data using MyYahoo.

This page shows you the most recent publications within this specialty of the MedWorm directory. This is page number 6.

FDA Okays Third Pancreatic Enzyme Product
WASHINGTON (MedPage Today) -- The FDA has approved a third branded pancrelipase -- Pancreaze -- to improve digestion in patients who do not produce sufficient pancreatic enzymes.
Source: MedPage Today Product Alert - April 14, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Hears Testimony on Prescription Drug User Fee Act
ROCKVILLE, Md. (MedPage Today) -- The FDA on Monday launched the start of a two-year process to reauthorize the landmark Prescription Drug User Fee Act (PDUFA) program, which charges drug companies fees to fund the agency's research into drug safety and efficacy.
Source: MedPage Today Product Alert - April 13, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Dials Up Heat on Radiology Device Firms
The FDA has told dozens of companies producing radiation-emitting devices that they need to do a better job of fixing software and other defects.
Source: MedPage Today Product Alert - April 10, 2010 Category: Drugs & Pharmacology Source Type: alerts

Nonsterile Eye and Nose Drops Recalled
The manufacturer of several eye and nasal drops has voluntarily recalled a number of its products due to potentially nonsterile conditions at its manufacturing facilities.
Source: MedPage Today Product Alert - April 8, 2010 Category: Drugs & Pharmacology Source Type: alerts

Fat Loss Spas Warned About False Claims
The FDA is warning consumers about "false and misleading" claims for products used in a procedure aimed at getting rid of body fat.
Source: MedPage Today Product Alert - April 8, 2010 Category: Drugs & Pharmacology Source Type: alerts

Tests Confirm That 'New' Heparin Is Less Potent
WASHINGTON (MedPage Today) -- The FDA found that the new monograph for the blood-thinning drug heparin is 10% less effective than the old monograph, the agency said in a brief.
Source: MedPage Today Product Alert - April 7, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA to Start Enforcing 2007 Pediatric Device Regulations
WASHINGTON (MedPage Today) -- The FDA says it will start requiring device manufacturers to provide assessment information for devices used by pediatric patients.
Source: MedPage Today Product Alert - April 3, 2010 Category: Drugs & Pharmacology Source Type: alerts

Hackers Could Target Medical Devices
Although no such attacks have yet been reported, medical devices could be susceptible to hackers, and a thorough security analysis should be done as part of FDA approval, researchers argue.
Source: MedPage Today Product Alert - April 2, 2010 Category: Drugs & Pharmacology Source Type: alerts

Diet Supplement Pulled Because of Undisclosed Drug
WASHINGTON (MedPage Today) -- The makers of a dietary supplement initiated a voluntary recall of their product due to an undeclared amount of aildenafil and dangers posed by the alpha-adrenergic blocker phentolamine.
Source: MedPage Today Product Alert - April 2, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Approves Injectable Varicose Vein Drug
WASHINGTON (MedPage Today) -- The FDA has approved the injectable varicose vein treatment polidocanol (Asclera).
Source: MedPage Today Product Alert - April 1, 2010 Category: Drugs & Pharmacology Source Type: alerts

Class 2 Drug Alert (Action within 48 hours): Acino Pharma GmbH - Clopidogrel 75 mg Tablets - EL (10)A/09
Source: Medicines and Healthcare products Regulatory Agency (MHRA) Area: Other Library Updates > Drug Alerts Dear Healthcare Professional, Acino Pharma GmbH Clopidogrel 75mg Tablets (Stock distributed in both Ratiopharm UK livery and Sandoz UK livery) EU/1/09/554/003 (Ratiopharm UK livery) EU/1/09/547/003 (Sandoz UK livery) Statement Acino Pharma GmbH is carrying out a precautionary medicine recall of several batches of Clopidogrel 75mg tablets at wholesale and pharmacy level. In the UK the product has been distributed in both Ratiopharm UK and Sandoz UK packaging. Clopidogrel is...
Source: NeLM - Drug Alerts - March 30, 2010 Category: Drugs & Pharmacology Source Type: alerts

Class 2 Drug Alert (Action within 48 hours): P.I.E. Pharma Limited and Star Pharmaceuticals Limited - Multiple product Drug Alert, parallel imports - EL (10)A/08
Source: Medicines and Healthcare products Regulatory Agency (MHRA) Area: Other Library Updates > Drug Alerts Dear Healthcare Professional, P.I.E. Pharma Limited Star Pharmaceuticals Limited Multiple product Drug Alert, parallel imports P.I.E.Pharma Limited: Product name Generic name PLPI number ...
Source: NeLM - Drug Alerts - March 30, 2010 Category: Drugs & Pharmacology Source Type: alerts

Class 3 Drug Alert (Action within five days): Landmark Pharma Limited Timoptol 0.5% Ophthalmic Solution, 5 ml (Timolol Maleate 0.5% Ophthalmic Solution) PL PI 21828/0107 - EL (10)A/07
Source: Medicines and Healthcare products Regulatory Agency (MHRA) Area: Other Library Updates > Drug Alerts Dear Healthcare Professional, Landmark Pharma Limited Timoptol 0.5% Ophthalmic Solution (Timolol Maleate 0.5% Ophthalmic Solution) PLPI 21828/0107 (Parallel import) Landmark Pharma Limited is recalling all unexpired stock of the above parallel imported product because of errors on the carton label, as follows: The active ingredient content is incorrect. The text reads 'Each 5ml contains 5mg of timolol maleate'. It should read 'Each ml contains 5 mg timolol ma...
Source: NeLM - Drug Alerts - March 30, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Approves Diarrhea Drug for Liver Use
WASHINGTON (MedPage Today) -- The FDA approved the travelers' diarrhea drug rifaximin (Xifaxan) for the risk recurrence reduction of overt hepatic encephalopathy in patients with advanced liver disease.
Source: MedPage Today Product Alert - March 26, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Recommends Temporary Suspension of Use of Rotavirus Vaccine
WASHINGTON (MedPage Today) -- The FDA is recommending that clinicians temporarily stop using Rotarix rotavirus vaccine because of contamination with viral DNA.
Source: MedPage Today Product Alert - March 23, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Okays Drug for Rare Amonia-Blood Disorder
WASHINGTON (MedPage Today) -- The FDA has approved a drug for the treatment of a rare genetic disorder that causes too much amonia to form in the blood.
Source: MedPage Today Product Alert - March 22, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Okays Drug for Rare Ammonia-Blood Disorder
WASHINGTON (MedPage Today) -- The FDA has approved a drug for the treatment of a rare genetic disorder that causes too much ammonia to form in the blood.
Source: MedPage Today Product Alert - March 22, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Recalls Unsterilized Ear Drains
The FDA has issued a class I recall for a single of an ear drainage bobbin that was shipped without being sterilized.
Source: MedPage Today Product Alert - March 21, 2010 Category: Drugs & Pharmacology Source Type: alerts

More Lots of BP Drug Recalled
The manufacturer of the injectable calcium channel blocker clevidipine (Cleviprex) voluntarily recalled an additional four lots of the drug because of debris floating in the suspension.
Source: MedPage Today Product Alert - March 20, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Clears Non-Abusable Insomnia Treatment
WASHINGTON (MedPage Today) -- The FDA approved doxepin (Silenor) for use in patients with long or short term insomnia and sleep maintenance difficulty.
Source: MedPage Today Product Alert - March 19, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Okays First Totally Implanted Hearing Aid
WASHINGTON (MedPage Today) -- The FDA has approved the first implanted hearing aid device for moderate to severe sensorineural hearing loss in adults.
Source: MedPage Today Product Alert - March 18, 2010 Category: Drugs & Pharmacology Source Type: alerts

Boston Scientific Announces Inventory Retrieval of ICDs and CRT-D
WASHINGTON (MedPage Today) -- Boston Scientific is "working closely with the FDA" to get its cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) back on the market, according to a spokesperson for the company.
Source: MedPage Today Product Alert - March 17, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA on the Lookout for Fake Surgical Mesh
WASHINGTON (MedPage Today) -- The FDA cautioned healthcare professionals and consumers of counterfeit surgical mesh products marketed as a known brand of the soft tissue support.
Source: MedPage Today Product Alert - March 15, 2010 Category: Drugs & Pharmacology Source Type: alerts

Class 3 Drug Alert (Action within five days): Teva UK Limited - Glibenclamide 5 mg Tablets in Teva UK Limited and Generics (UK) Limited Livery PL 00289/0048 - EL (10)A/06 Rev 1
Source: Medicines and Healthcare Products Regulatory Agency Area: Other Library Updates > Drug Alerts Dear Healthcare Professional, Teva UK Limited Glibenclamide 5mg Tablets (Teva UK Limited and Generics (UK) Limited Livery) PL 00289/0048 Product in Teva UK Limited Livery Batch number Expiry date Pack size First distributed 7T88HL &nbs...
Source: NeLM - Drug Alerts - March 14, 2010 Category: Drugs & Pharmacology Source Type: alerts

Vaccine Court Again Rejects MMR-Autism Theory
Special masters in the federal "vaccine court" have reiterated that there is no evidence supporting a causal link between thimerosal-containing vaccines and autism.
Source: MedPage Today Product Alert - March 13, 2010 Category: Drugs & Pharmacology Source Type: alerts

Botulinum Toxin Okayed for Arm Spasms
WASHINGTON (MedPage Today) -- The FDA has approved a new indication for botulinum toxin type A (Botox) as a flexor muscle spasm treatment for the elbow, wrist, and fingers in adult patients.
Source: MedPage Today Product Alert - March 10, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Okays Botox Use in Elbow, Wrist, Muscle Spasms
WASHINGTON (MedPage Today) -- The FDA has approved a new indication for onabotulinumtoxin A (Botox) as a flexor muscle spasm treatment for the elbow, wrist, and fingers in adult patients.
Source: MedPage Today Product Alert - March 10, 2010 Category: Drugs & Pharmacology Source Type: alerts

Class 3 Medicines Recall (Action within five days): Teva UK Limited - Glibenclamide 5 mg Tablets in Teva UK Limited and Generics (UK) Limited Livery - PL 00289/0048 - EL (10)A/06
Source: Medicines and Healthcare Products Regulatory Agency Area: Other Library Updates > Drug Alerts Dear Healthcare Professional, Teva UK Limited Glibenclamide 5mg Tablets (Teva UK Limited and Generics (UK) Limited Livery) PL 00289/0048 Product in Teva UK Limited Livery Batch number Expiry date Pack size First distributed 7T88HL ...
Source: NeLM - Drug Alerts - March 9, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Okays 20% Skin-Injection Immunodeficiency Treatment
WASHINGTON (MedPage Today) -- The FDA has approved a new primary immunodeficiency treatment, Immune Globulin Subcutaneous 20% Liquid (Hizentra), as a once-weekly replacement therapy.
Source: MedPage Today Product Alert - March 9, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Okays First Skin-Injection Immunodeficiency Treatment
WASHINGTON (MedPage Today) -- The FDA has approved the first 20% subcutaneous primary immunodeficiency treatment, immune globulin subcutaneous 20% liquid (Hizentra), as a once-weekly replacement therapy.
Source: MedPage Today Product Alert - March 8, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Recalls Catheter Sheath That May Block Arteries
WASHINGTON (MedPage Today) -- The FDA has initiated a class I recall on transseptal sheath introducer kits (HeartSpan, CHANNEL FX, Torflex, Braided Guiding Introducer Kit) because of potential sheath breakage that may lead to injury or death.
Source: MedPage Today Product Alert - March 7, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA, Baxter Recall Dialysis System that May Malfunction
WASHINGTON (MedPage Today) -- The FDA and manufacturer of the HomeChoice and HomeChoice PRO dialysis systems notified patients of a class I device recall -- the FDA's most severe -- after a number of reported injuries and one death.
Source: MedPage Today Product Alert - March 5, 2010 Category: Drugs & Pharmacology Source Type: alerts

Class 2 Drug Alert (Action within 48 hours): Teva UK Ltd - Epirubicin Hydrochloride 2 mg/ml solution for injection or infusion in vials - PL 00289/1162 - EL (10)A/05
Source: Defective Medicines Report Centre Area: Other Library Updates > Drug Alerts Dear Healthcare Professional, Teva UK Ltd Epirubicin Hydrochloride 2mg/ml Solution for injection or infusion in vials PL 00289/1162 Pack Size Batch Number Expiry Date First Distributed 5ml 09D09PB &nb...
Source: NeLM - Drug Alerts - March 4, 2010 Category: Drugs & Pharmacology Source Type: alerts

Class 2 Drug Alert (Action within 48 hours): Winthrop Pharmaceuticals UK Ltd Alimemazine Tartrate 7.5 mg/5 ml Syrup - PL 17780/0465 - EL (10)A/04
Source: Defective Medicines Report Centre Area: Other Library Updates > Drug Alerts Dear Healthcare Professional, Winthrop Pharmaceuticals UK Ltd Alimemazine Tartrate 7.5mg/5ml Syrup Batch Number: BN4 Expiry Date: Oct 2012 Pack Size: 1x100ml First Distributed: 27 November 2009 PL 17780/0465 Winthrop Pharmaceuticals UK limited is recalling all remaining stocks of the above batch of Alimemazine Tartrate 7.5mg/5ml Syrup. This action is being taken as a precautionary measure because the Company has become aware that there...
Source: NeLM - Drug Alerts - March 4, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Okays GHD Pen for Kid Use
WASHINGTON (MedPage Today) -- The FDA approved pre-filled injection pens of the endogenous growth hormone disorder drug somatropin (Norditropin) for adult and youth patients.
Source: MedPage Today Product Alert - March 4, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Okays Generic of BPH Drug
WASHINGINTON (MedPage Today) -- The FDA approved the first generic version of the benign prostatic hyperplasia (BPH) medication tamsulosin (Flomax).
Source: MedPage Today Product Alert - March 3, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Recalls Centrifuge that Spins Out of Control
WASHINGTON (MedPage Today) -- The FDA initiated a class I, its most serious class, recall of the StatSpin Express 4 centrifuge due to potential injury caused by the device ejecting rotor shrapnel and blood during a malfunction.
Source: MedPage Today Product Alert - March 2, 2010 Category: Drugs & Pharmacology Source Type: alerts

New Drug for Genetic Disorder Gets Final FDA Nod
WASHINGTON (MedPage Today) -- The FDA has formally approved the enzyme replacement therapy velaglucerase alfa (VPRIV) -- already okayed for pre-approval marketing -- for pediatric and adult patients with Gaucher disease.
Source: MedPage Today Product Alert - February 28, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Approves Aerosol CF Treatment
WASHINGTON (MedPage Today) -- The FDA has approved the inhalant cystic fibrosis treatment aztreonam (Cayston) for patients 8 and older with P. aeruginosa.
Source: MedPage Today Product Alert - February 26, 2010 Category: Drugs & Pharmacology Source Type: alerts

New Version of Pneumococcal Vaccine Gets Okay
WASHINGTON (MedPage Today) -- The FDA has approved a 13-valent version of the pneumococcal conjugate vaccine Prevnar for use in pediatric patients 6 months to 5 years old.
Source: MedPage Today Product Alert - February 25, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Okays Once-Daily Parkinson's Drug
WASHINGTON (MedPage Today) -- The FDA has approved an extended release version of pramipexole (Mirapex ER) for patients with early Parkinson's disease.
Source: MedPage Today Product Alert - February 24, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Okays Meningitis Vaccine
WASHINGTON (MedPage Today) -- The FDA has approved Novartis' (Menveo), a quadrivalent vaccine to prevent meningitis in patients 11 to 55.
Source: MedPage Today Product Alert - February 23, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Burns Ear Candle Marketers
WASHINGTON (MedPage Today) -- The FDA has alerted consumers about the dangers of ear candles -- hollow fabric cones soaked in beeswax marketed for treatment of various conditions without FDA approval.
Source: MedPage Today Product Alert - February 22, 2010 Category: Drugs & Pharmacology Source Type: alerts

Use of Medical Technology Way Up, Report Says
Use of medical technology (MedPage Today) -- from MRI and joint replacement to organ transplants, new drugs, and electronic health records -- grew dramatically over a decade, according to a report from the National Center for Health Statistics.
Source: MedPage Today Product Alert - February 22, 2010 Category: Drugs & Pharmacology Source Type: alerts

Oncology Drug Gets Black Box Warning
WASHINGTON (MedPage Today) -- A black box warning -- which includes cautions about potentially fatal renal, hepatic, and gastrointestinal damage -- has been added to the labeling for the oncology drug deferasirox (Exjade), the FDA announced.
Source: MedPage Today Product Alert - February 19, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Says LABA Asthma Drugs Not for Solo Use
Long-acting beta agonist (LABA) agents should never be used alone in children or adults with asthma, the FDA said today in announcing label changes and other initiatives intended to promote safe use of these popular drugs.
Source: MedPage Today Product Alert - February 18, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Warns About Potential for OTC Drug Mix-Up
WASHINGTON (MedPage Today) -- The FDA has issued a warning about serious adverse events that can result when the stomach pain reliever and anti-diarrheal Maalox Total Relief is taken as an antacid like other Maalox products.
Source: MedPage Today Product Alert - February 18, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Approves REMS for Drugs That Combat Anemia
WASHINGTON (MedPage Today) -- The FDA has announced a formal strategy to reduce the risks of erythropoiesis-stimulating agents (ESAs) for cancer patients who take the drugs to treat anemia caused by chemotherapy.
Source: MedPage Today Product Alert - February 17, 2010 Category: Drugs & Pharmacology Source Type: alerts

Class 2 Drug Alert (Action within 48 hours): AstraZeneca UK Ltd - Citanest 1% solution for injection, multi-dose vials 10mg/ml, prilocaine hydrochloride - EL (10)A/03
Source: Defective Medicines Report Centre Area: Other Library Updates > Drug Alerts AstraZeneca UK Ltd is recalling all remaining stock of batches of the above product expiring before the end of 2011. This action is being taken because routine stability testing has indicated that the preservative levels may become too low after 24 months from manufacture. A list of the batches to be recalled is included below. For medical information enquiries please contact AstraZeneca UK medical information on 0800 783 0033. Any affected batches should be returned via its agents - AAH Pharmaceuticals or Alliance He...
Source: NeLM - Drug Alerts - February 14, 2010 Category: Drugs & Pharmacology Source Type: alerts

AED Recalled, May Fail During Resuscitation
WASHINGTON (MedPage Today) -- The FDA alerted healthcare professionals and consumers of a voluntary recall of a defibrillator that may fail during a resuscitation attempt.
Source: MedPage Today Product Alert - February 11, 2010 Category: Drugs & Pharmacology Source Type: alerts