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 7.

FDA Okays Drug Combo for Advanced Breast Cancer
The FDA has approved a combination of lapatinib (Tykerb) and letrozole (Femara) to treat hormone-positive and HER2-positive advanced breast cancer in postmenopausal women.
Source: MedPage Today Product Alert - February 1, 2010 Category: Drugs & Pharmacology Source Type: alerts

Class 3 Drug Alert (Action within 5 days): Schering-Plough Ltd - IntronA 18, 30 and 60 million IU solution for injection (Recombinant interferon alfa-2b) - EL (10)A/02
Source: Defective Medicines Report Centre Area: Other Library Updates > Drug Alerts Dear Healthcare Professional, Schering-Plough Ltd IntronA 18 million IU solution for injection EU/1/99/127/031-033 IntronA 30 million IU solution for injection EU/1/99/127/034-036 IntronA 60 million IU solution for injection EU/1/99/127/037-039 (Recombinant interferon alfa-2b) Presentation &n...
Source: NeLM - Drug Alerts - January 28, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Updates Myeloma Drug Label for New Risks
WASHINGTON (MedPage Today) -- The FDA revised the dosage and safety information for the myeloma and mantle cell lymphoma drug bortezomib (Velcade) to reflect an increased toxicity risk.
Source: MedPage Today Product Alert - January 27, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Recalls Millions of Huber Needles
More than two million Huber needles (MedPage Today) -- used with implanted ports to treat chronic conditions -- have been recalled, the FDA announced.
Source: MedPage Today Product Alert - January 26, 2010 Category: Drugs & Pharmacology Source Type: alerts

Feds Find Twice Max Dose of Stimulant in Weight Drug Fake
WASHINGTON (MedPage Today) -- FDA laboratory tests showed counterfeit samples of the weight-loss drug Alli contain twice the maximum recommended dose of sibutramine, the potentially dangerous active ingredient in another diet pill.
Source: MedPage Today Product Alert - January 25, 2010 Category: Drugs & Pharmacology Source Type: alerts

MS Walking Drug Gets FDA Nod
WASHINGTON (MedPage Today) -- The FDA approved the first drug for improved walking in patients with multiple sclerosis, the tablet dalfampridine (Ampyra).
Source: MedPage Today Product Alert - January 23, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Warns of Fake OTC Weight-Loss Drug
WASHINGTON (MedPage Today) -- The FDA warned patients of a counterfeit version of an over-the-counter weight-loss drug, which replaces the drug's active ingredient orlistat with the potentially harmful sibutramine.
Source: MedPage Today Product Alert - January 19, 2010 Category: Drugs & Pharmacology Source Type: alerts

Emphysema Drug Is Safe, FDA Finds
Inhaled tiotropium bromide (Spiriva HandiHaler) for COPD does not pose a special risk for cardiovascular events, the FDA found after reviewing data from a large placebo-controlled trial.
Source: MedPage Today Product Alert - January 15, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Warns Against Leaky Baby Food
WASHINGTON (MedPage Today) -- The FDA is warning consumers about two brands of baby food recalled because of leaking and swollen packaging that may indicate bacterial contamination.
Source: MedPage Today Product Alert - January 14, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Cracks Down on Spa and Beauty Device Maker
WASHINGTON (MedPage Today) -- The FDA has announced a consent decree with medical device manufacturer Sybaritic that requires the company to cease production and distribution of laser surgery, dermatological, and spa devices until it complies with the agency's quality standards.
Source: MedPage Today Product Alert - January 11, 2010 Category: Drugs & Pharmacology Source Type: alerts

FDA Recalls Cracked Catheter
WASHINGTON (MedPage Today) -- The FDA initiated a class 1 recall, its most serious type, of a vein and artery catheter because the device may crack near its radiopaque marker band and may cause fatal injury, the agency said in a prepared statement.
Source: MedPage Today Product Alert - January 7, 2010 Category: Drugs & Pharmacology Source Type: alerts

Class 3 Drug Alert (Action within 5 days): Aurum Pharmaceuticals - Amiodarone Hydrochloride 50 mg/ml Concentrate - PL 12064/0123 - EL (10)A/01
Source: Defective Medicines Report Centre Area: Other Library Updates > Drug Alerts Dear Healthcare Professional, Aurum Pharmaceuticals Amiodarone Hydrochloride 50 mg/ml Concentrate PL 12064/0123 Batch Number Expiry Date Pack Size First Distributed 80593 &...
Source: NeLM - Drug Alerts - January 4, 2010 Category: Drugs & Pharmacology Source Type: alerts

No New Year's Joy from FDA
The usual year-end rush of FDA approvals has been slowed by regulatory speed bumps as encountered by Pfizer's updated pneumococcal conjugate vaccine Prevnar 13, and Basilea's anti-MRSA agent ceftobiprole.
Source: MedPage Today Product Alert - January 1, 2010 Category: Drugs & Pharmacology Source Type: alerts

MRI Injury Prompts Recall of Medical Blanket
WASHINGTON (MedPage Today) -- The FDA has announced a voluntary recall of the Thermoflect brand of heat reflecting blankets and other products so that they may be relabeled to reflect incompatibility with use in "magnetic resonance environments."
Source: MedPage Today Product Alert - December 29, 2009 Category: Drugs & Pharmacology Source Type: alerts

FDA Greenlights Flu Vaccine for Seniors
WASHINGTON (MedPage Today) -- The FDA has approved a more concentrated seasonal influenza virus subtypes A and B vaccine (Fluzone High-Dose) specifically for patients 65 and older.
Source: MedPage Today Product Alert - December 28, 2009 Category: Drugs & Pharmacology Source Type: alerts

Class 4 Drug Alert (Caution in use): Aurum Pharmaceuticals - Amiodarone Hydrochloride 50 mg/ml - PL 12064/0123 - EL(09)/A36
Source: Defective Medicines Report Centre Area: Other Library Updates > Drug Alerts Dear Healthcare Professional, Aurum Pharmaceuticals Amiodarone Hydrochloride 50 mg/ml PL 12064/0123 Concentrate for solution for injection or infusion Batch Number Expiry Date Pack Size &nb...
Source: NeLM - Drug Alerts - December 22, 2009 Category: Drugs & Pharmacology Source Type: alerts

DayQuil Packs Recalled for Lack of Childproofing
Procter & Gamble voluntarily has recalled one of its cold and flu medications because packages of blister packs labeled as child-resistant don't have child-resistant backing.
Source: MedPage Today Product Alert - December 21, 2009 Category: Drugs & Pharmacology Source Type: alerts

Implantable Hearing Aid Gets Nod from FDA Panel
WASHINGTON (MedPage Today) -- A FDA advisory panel has unanimously recommended FDA approval for the first fully-implantable hearing aid for patients with moderate to severe hearing loss.
Source: MedPage Today Product Alert - December 21, 2009 Category: Drugs & Pharmacology Source Type: alerts

FDA Okays New Indication for COPD Inhaler
WASHINGTON (MedPage Today) -- The FDA has expanded the approved indications for inhaled tiotropium bromide (Spiriva) to include reducing exacerbations of chronic obstructive pulmonary disease (COPD), in addition to its previous approval for COPD maintenance.
Source: MedPage Today Product Alert - December 18, 2009 Category: Drugs & Pharmacology Source Type: alerts

Class 4 Drug Alert (Caution in use): Teva UK Limited - Ondansetron IV Injection 2mg/ml (2ml) and 2 mg/ml (4ml) - PL 10622/0102 - EL(09)/A35
Source: Defective Medicines Report Centre Area: Other Library Updates > Drug Alerts Dear Healthcare Professional, Teva UK Limited PL 10622/0102 Ondansetron IV Injection 2mg/ml (2ml) and 2 mg/ml (4ml) (All supplied in Pliva livery) Teva UK Limited have informed us that they have not complied with regulatory undertakings to update the SPC or patient information leaflet contained in already distributed packs. All stock in the distribution chain is missing some safety information. We understand that it will be about four months before acceptable stock enters the supplyc...
Source: NeLM - Drug Alerts - December 17, 2009 Category: Drugs & Pharmacology Source Type: alerts

FDA Panel to Consider First Fully-Implantable Hearing Aid
WASHINGTON (MedPage Today) -- An advisory panel will consider whether to recommend FDA approval of the first fully-implantable hearing aid for patients with mild to severe hearing loss Friday.
Source: MedPage Today Product Alert - December 17, 2009 Category: Drugs & Pharmacology Source Type: alerts

FDA Gives Nod to First Generic Oral Disintegrating Alzheimer's Medication
WASHINGTON (MedPage Today) -- The FDA has approved the first generic version of an orally disintegrating tablet containing the Alzheimer's-related dementia drug donepezil (Aricept).
Source: MedPage Today Product Alert - December 16, 2009 Category: Drugs & Pharmacology Source Type: alerts

CLASS 2 Drug Alert, (Action Within 48 hours), DDD LIMITED, Recall of Eight Batches of Dentinox Teething Gel, PL 00133/5010R - EL(09)A/34
Source: Defective Medicines Report Centre Area: Other Library Updates > Drug Alerts Dear Healthcare Professional, DDD Limited Dentinox Teething Gel PL 00133/5010R (Cetylpyridium Chloride and Lidocaine Hydrochloride Teething Gel) Batch number Expiry Date Pack Size First Distributed BASEP09 SEP 2012 15G 28 October 2009 BBSEP09 SEP 2012 15G 06 October 2009 BGSEP09 SEP 2012 15G 26 October 2009 BLSEP09 SEP 2012 15G 16 November 2009 BFOCT09 OCT 2012 15G 13 November...
Source: NeLM - Drug Alerts - December 15, 2009 Category: Drugs & Pharmacology Source Type: alerts

CLASS 2 Drug Alert, (Action Within 48 hours), DDD LIMITED, Dentinox Teething Gel, PL 00133/5010R - EL(09)A/34
Source: Defective Medicines Report Centre Area: Other Library Updates > Drug Alerts Dear Healthcare Professional, DDD Limited Dentinox Teething Gel PL 00133/5010R (Cetylpyridium Chloride and Lidocaine Hydrochloride Teething Gel) Batch Number Expiry Date Pack Size First Distributed BASEP09 &n...
Source: NeLM - Drug Alerts - December 15, 2009 Category: Drugs & Pharmacology Source Type: alerts

FDA Cuts Food and Drug Restrictions for Parkinson's Medication
WASHINGTON (MedPage Today) -- The FDA reduced food and medication restrictions for the Parkinson's drug rasagiline (Azilect) on the tablet's prescribing information.
Source: MedPage Today Product Alert - December 15, 2009 Category: Drugs & Pharmacology Source Type: alerts

Class 2 Drug Alert (Action Within 48 Hours): Chefaro Uk Limited - Metatone - PL 02855/0017 - EL (09)A/33
Source: Defective Medicines Report Centre Area: Other Library Updates > Drug Alerts Dear Healthcare Professional, Chefaro UK Limited Metatone PL 02855/0017 Batch Number: 112 Expiry Date: 30/0/9/2009 Pack Size:300ml First Distributed: Oct 2009 Chefaro UK Limited is recalling the above batch due to the presence of very small amounts of petrol found in this product...
Source: NeLM - Drug Alerts - December 9, 2009 Category: Drugs & Pharmacology Source Type: alerts

Cold Medicine Recalled after Day and Night Switch
WASHINGTON (MedPage Today) -- Drug manufacturer Bayer initiated a voluntary recall of one lot of mislabeled cold formula liquid gel capsules with consultation from the FDA.
Source: MedPage Today Product Alert - December 9, 2009 Category: Drugs & Pharmacology Source Type: alerts

Panel Recommends Everolimus in Kidney Transplant
WASHINGTON (MedPage Today) -- An FDA advisory panel said the antirejection drug everolimus appears safe and effective for use in kidney transplant patients, but should be marketed with a risk mitigation plan.
Source: MedPage Today Product Alert - December 7, 2009 Category: Drugs & Pharmacology Source Type: alerts

FDA Approves New Lead for Chronic Pain
The FDA has approved a new surgical lead for chronic pain management in neurostimulation therapy.
Source: MedPage Today Product Alert - December 7, 2009 Category: Drugs & Pharmacology Source Type: alerts

FDA Warns of Sterilizer Malfunction
WASHINGTON (MedPage Today) -- The FDA cautioned that postapproval changes made to a low-heat medical device sterilizer pose a safety threat to patients and healthcare workers alike.
Source: MedPage Today Product Alert - December 4, 2009 Category: Drugs & Pharmacology Source Type: alerts

FDA Updates Warning for Pregnant Women on Antiepileptic Drugs
WASHINGTON (MedPage Today) -- The FDA has issued a statement reminding patients and doctors that valproate sodium, valproic acid, and divalproex products increase the risk of birth defects in babies exposed to the chemicals during pregnancy.
Source: MedPage Today Product Alert - December 4, 2009 Category: Drugs & Pharmacology Source Type: alerts

FDA Okays Low-Dose Local Estrogen
WASHINGTON (MedPage Today) -- The FDA has approved a low-dose local estrogen therapy, a 10 mcg formulation of the estradiol vaginal tablet Vagifem for atrophic vaginitis, drugmaker Novo Nordisk announced.
Source: MedPage Today Product Alert - December 3, 2009 Category: Drugs & Pharmacology Source Type: alerts

Desipramine Warnings Expanded
New warnings have been added to the label for the antidepressant drug desipramine HCl (Norpramin), describing potentially fatal effects in patients with a family history of certain cardiac conditions.
Source: MedPage Today Product Alert - December 2, 2009 Category: Drugs & Pharmacology Source Type: alerts

FDA Okays First Subcutaneous HAE Drug
WASHINGTON (MedPage Today) -- The FDA has approved ecallantide (Kalbitor), the first subcutaneous treatment for acute hereditary angioedema (HAE) attacks, for patients 16 and older.
Source: MedPage Today Product Alert - December 2, 2009 Category: Drugs & Pharmacology Source Type: alerts

Class 4 Drug Alert (Caution in use): Aurum Pharmaceuticals Limited - Acetylcysteine 200mg/ml Injection - PL 12064/0026 - EL (09)A/32
Source: Defective Medicines Report Centre Area: Other Library Updates > Drug Alerts Dear Healthcare Professional, Aurum Pharmaceuticals Limited Acetylcysteine 200mg/ml Injection (Acetylcysteine) PL 12064/0026 Aurum Pharmaceuticals Limited have informed us that there is an error in the patient information/professional leaflet contained in all batches of Acetylcysteine 200mg/ml Injection 10ml currently on the market. The error concerns the dose to be given to chi...
Source: NeLM - Drug Alerts - November 25, 2009 Category: Drugs & Pharmacology Source Type: alerts

FDA Warns of Bacteria in Nasal Spray
WASHINGTON (MedPage Today) -- Several lots of Vicks Sinex nasal spray have been recalled because of bacteria found in the solution during a quality control inspection, the FDA announced.
Source: MedPage Today Product Alert - November 20, 2009 Category: Drugs & Pharmacology Source Type: alerts

Class 2 Drug Alert (Action within 48 hours): Procter & Gamble (Health & Beauty Care) Ltd - Vicks Sinex Micromist - PL 00129/0133 EL (09)A/31
Source: Defective Medicines Report Centre Area: Other Library Updates > Drug Alerts Dear Healthcare Professional, Procter & Gamble (Health & Beauty Care) Ltd Vicks Sinex Micromist PL 00129/0133 (Oxymetazoline Hydrochloride 0.05% w/v aqueous nasal spray solution) Procter & Gamble (Health & Beauty Care) Ltd are recalling the above batch due to the detection during routine testing of microbial contaminat...
Source: NeLM - Drug Alerts - November 19, 2009 Category: Drugs & Pharmacology Source Type: alerts

CLASS 2 Drug Alert (Action Within 48 Hours): Pinewood Laboratories Limited, Boots Heartburn Relief Peppermint Flavour, EL (09)A/30
Source: Defective Medicines Report Centre Area: Other Library Updates > Drug Alerts Dear Healthcare Professional, Pinewood Laboratories Limited Boots Heartburn Relief Peppermint Flavour (PL 04917/0027) Peptac Peppermint Liquid (Ivax Pharmaceuticals UK) (PL 04917/0027) Peptac Liquid Aniseed Flavour (Ivax Pharmaceuticals UK) (PL 04917/0021) (Oral suspensions containing sodium alginate 250mg, sodium bicarbonate 133.5mg and calcium carbonate 80mg per 5ml) Boots Heartburn Relief Peppermint Flavour Pinewood ...
Source: NeLM - Drug Alerts - November 17, 2009 Category: Drugs & Pharmacology Source Type: alerts

FDA Warns of Wound Therapy Complications
WASHINGTON (MedPage Today) -- Negative pressure wound therapy (NPWT) may, rarely, cause bleeding, infection, and death, the FDA cautioned.
Source: MedPage Today Product Alert - November 17, 2009 Category: Drugs & Pharmacology Source Type: alerts

Decision-Support Software Aid PE Diagnosis (CME/CE)
Hand-held computers and decision-support software improved diagnostic decision making for suspected pulmonary embolism, French researchers said.
Source: MedPage Today Product Alert - November 16, 2009 Category: Drugs & Pharmacology Source Type: alerts

FDA Says Yes to Non-Hormonal Menorrhagia Drug
The FDA has okayed tranexamic acid tablets (Lysteda) for the treatment of menorrhagia, the agency announced.
Source: MedPage Today Product Alert - November 16, 2009 Category: Drugs & Pharmacology Source Type: alerts

FDA Says Yes to Nonhormonal Menorrhagia Drug
The FDA has okayed tranexamic acid tablets (Lysteda) for the treatment of menorrhagia, the agency announced.
Source: MedPage Today Product Alert - November 16, 2009 Category: Drugs & Pharmacology Source Type: alerts

Class 2 Drug Alert (Action within 48 hours): Reckitt Benckiser Healthcare (UK) Ltd, Gaviscon Advance Peppermint Flavour (Oral suspension containing sodium alginate 500mg), EL (09)A/29
Source: Medicines and Healthcare Products Regulatory Agency Area: Other Library Updates > Drug Alerts Reckitt Benckiser Healthcare (UK) Ltd are recalling the above (see pdf attachment fo batch numbers) lots due to a low level microbial contamination detected in one of the batches. The contamination causes spoilage of the product and a phenolic or antiseptic smell. The product should smell of peppermint. The microbial contamination is not likely to be harmful to normally healthy consumers. However, if this product is being used by patients with suppressed immune systems, such as patients on chemotherapy, the ris...
Source: NeLM - Drug Alerts - November 15, 2009 Category: Drugs & Pharmacology Source Type: alerts

Industry Urges Online-Specific Rules for Adverse Event Reports
WASHINGTON (MedPage Today) -- The FDA should clarify which adverse events drug and device companies are required to report when such events are discussed by patients in an online forum, a variety of panelists told the agency during a two-day hearing on social media.
Source: MedPage Today Product Alert - November 13, 2009 Category: Drugs & Pharmacology Source Type: alerts

FDA Warns of Contamination in Drugs for Rare Illnesses
Some products used to treat rare, serious, and life-threatening diseases may be contaminated with a number of foreign particles, the FDA cautioned in a newsbrief today.
Source: MedPage Today Product Alert - November 13, 2009 Category: Drugs & Pharmacology Source Type: alerts

Spinal Replacement Devices Recalled
All lots of a device used to replace collapsed, damaged, or unstable vertebral bodies in the spine have been recalled by its manufacturer, the FDA said.
Source: MedPage Today Product Alert - November 13, 2009 Category: Drugs & Pharmacology Source Type: alerts

FDA Begins to Shape Rules for Online Drug, Device Ads
WASHINGTON (MedPage Today) -- Drug and device companies are urging the FDA to establish clear guidelines that can allow the industry to discuss and promote their products in the murky world of online social media.
Source: MedPage Today Product Alert - November 12, 2009 Category: Drugs & Pharmacology Source Type: alerts

FDA Okays New Treatment for T-Cell Lymphoma
WASHINGTON (MedPage Today) -- The FDA has approved romidepsin (Istodax) for patients with cutaneous T-cell lymphoma who have received at least one prior systemic therapy.
Source: MedPage Today Product Alert - November 6, 2009 Category: Drugs & Pharmacology Source Type: alerts

Class 2 Drug Alert (Action within 48 hours): Abraxis BioScience Ltd - Abraxis 5mg/ml powder for suspension for infusion - EL (09)A/28Rev 1
Source: Medicines and Healthcare Products Regulatory Agency Area: Other Library Updates > Drug Alerts Batch Number - 405693A Expiry Date - 12/2009 Pack Size - Single 50 ml vials First Distributed - 12/2008 The batch number quoted in yesterdays drug alert which was checked by the company has now been reported as incorrect. Please ignore the communication sent yesterday and replace it with this document. We apologise for the inconvenience you have experienced. Abraxis BioScience Ltd are recalling all remaining stock of the above batch as a precautionary measure. Particulate matter has been found i...
Source: NeLM - Drug Alerts - November 5, 2009 Category: Drugs & Pharmacology Source Type: alerts