July, 2011Chantix (varenicline): Label Change – Risk of Certain Cardiovascular Adverse Events
Audience: Family Medicine, Cardiology [UPDATED 07/22/2011] FDA has approved an updated drug label for Chantix (varenicline) to include information about the efficacy and safety of the drug in two patient populations who may benefit greatly from…
Continue →Bill Would Let Health Researchers Ban Toxic Chemicals
New legislation could help health experts target and eliminate potentially harmful chemicals from commerce each year by labeling them as “high concern.” Under the bill, the director of the National Institute of Environmental Health Sciences (NIEHS) and a panel of experts could designate up to 10 chemicals each year to be banned. Those chemicals would become unlawful to use 24 months after the designation. The bill is to be introduced by Rep. Jim Moran, D-Virginia, and Sen. John Kerry, D-Massachusetts, …
Continue →Homelite Recalls Pressure Washer Surface Cleaner Attachments Due to Laceration Hazard; Sold Exclusively at Home Depot
The surface cleaner attachment’s nozzle and spray bar can break and detach, striking and/or breaking the unit’s plastic housing. The broken nozzle, spray bar and/or plastic housing can strike consumers, posing a laceration hazard.
Continue →Ski Helmets Recalled by Swix Sport USA due to Head Injury Hazard
The helmet provides insufficient shock absorption and resistance to penetration, posing a head injury hazard.
Continue →Multaq (dronedarone): Drug Safety Communication – Increased Risk of Death or Serious Cardiovascular Events
Audience: Healthcare Professionals ISSUE: FDA notified healthcare professionals that it is reviewing data from a clinical trial that evaluated the effects of the antiarrhythmic drug Multaq (dronedarone) in patients with permanent atrial…
Continue →Oral Osteoporosis Drugs (bisphosphonates): Drug Safety Communication – Potential Increased Risk of Esophageal Cancer
Audience: Geriatrics, Family Practice, Internal Medicine Includes: Fosamax (alendronate), Actonel (risedronate), Boniva (ibandronate), Atelvia (risedronate delayed release), Didronel (etidronate), and Skelid (tiludronate)
ISSUE: FDA notified…
Birth Defects Linked to Coal, Pesticides
Pregnant women exposed to coal and pesticides are up to four times more likely to have children with serious birth defects than women not exposed to those chemicals, a recent Chinese study found. Researchers detected high levels of synthetic pesticides and polycyclic aromatic hydrocarbons that come from inhaling smoke from burning coal in the placentas of women with birth defects. The study’s findings were published on Tuesday in the Proceedings of the National Academy of Sciences. The researchers looked at …
Continue →Target Recalls Children’s Task Lamps Due to Laceration and Fire Hazards
Lamps can overheat, causing the adhesive inside the lamp socket to melt and migrate into the bulb area of the socket. The cooled glue can adhere to the light bulb base and make the bulb difficult to remove which can result in a broken light bulb, posin…
Continue →Heavy Actos Use May Be Tied to Bladder Cancer
Patients taking Takeda Pharmaceuticals’ Actos at higher cumulative doses for longer periods of time may be at a higher risk of bladder cancer, according to the FDA. Although interim study reports suggested no overall link with cancer, an association was found amongst the heaviest users. The FDA said that the drug should not be used by patients with active bladder cancer. Patients with a family history of bladder cancer should be particularly cautious when taking the drug, the agency said. …
Continue →American Regent Injectable Products: Recall – Visible Particulates in Products
Audience: Pharmacy
Calcium Gluconate Injection, USP, 10%, 100 mL Pharmacy Bulk Package (Lot #1006)
Concentrated Sodium Chloride Injection, USP 23.4%, 30 mL Single Dose Vials (Lot #0362)
Methyldopate HCL Injection, USP 5ml Single Dose…
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