Pharmacists Warned of Dispensing Errors and Confusion Over Durezol and Durasal


The FDA is taking time to warn pharmacists about potential dispensing errors that could occur as a result of a mix-up between 2 drugs with very similar brand names. Confusion over the two medications could cause patients to be given the wrong prescription and subsequently endure serious injuries. The two brands in question are Durezol [...]

Parents Perplexed by New Dosing Information for Infants’ Acetaminophen


Following the introduction of a less-concentrated version of liquid acetaminophen for infants, the U.S. Food and Drug Administration has suggested that parents and caregivers double-check the labels on all liquid acetaminophen products prior to administering any of the medicine to their child. The main problem, according to the FDA, is that the low-concentration medications are [...]

French Health Regulators Finally Acknowledge Safety Concerns Over PIP Breast Implants


Almost 11 years ago, the U.S. Food and Drug Administration sent an agency investigator to France in order to inspect a plant run by breast implant manufacturer, Poly Implant Prothese (PIP). After the inspection was completed, U.S. health authorities issued a warning letter to PIP’s founder in June of 2000, outlining more than 10 manufacturing [...]

Study Suggests New Models of Hip Implants Not Better

depuy hip

The results of a new study have revealed that recent technology for artificial hips and keens did not perform any better than older, less expensive designs. The study, which was published this week, utilized data collected from Australia’s orthopedic registry and encompassed information on implants introduced between the years 2003 and 2007. The findings were [...]

Ranbaxy Allocates $500 Million to Resolve Compliance Dispute


Japanese drug maker, Daiichi Sankyo, announced that its Indian unit, pharmaceutical giant, Ranbaxy Laboratories, Ltd., had reached an agreement with the U.S. Food and Drug Administration regarding its manufacturing practices. The company’s settlement with the FDA outlines its intent to improve procedures and policies in its production facilities in order to ensure data integrity and [...]

FDA Requires Ischemic Event Warning be Added to Multaq Label


The U.S. Food and Drug Administration has ordered drug maker, Sanofi-Aventis, to update the label for its anti-arrhythmic medication, Multaq, in order to inform users of the increased risk for death or serious cardiovascular events when taken by patients with permanent atrial fibrillation. The FDA has approved Multaq (dronedarone) to treat atrial flutter and paroxysmal [...]

Federal Regulators Require Warning on Boston Scientific’s Promus Element Heart Stent

promus heart stent

Last month, the FDA approved Boston Scientific’s Promus Element Heart Stent, a tiny tubular device designed to open diseased arteries. Interestingly, the agency issued its approval of the device, even after receiving reports that the stent could potentially become deformed after it is implanted. The problem, officially known as longitudinal stent deformation, also occurs in [...]

MS Patient Dies After Starting Novartis Drug, Gilenya


Novartis AG, manufacturer of the drug, Gilenya (fingolimod), confirmed this week that a 59 year old patient suffering from multiple sclerosis passed away after beginning treatment with the drug, the first of its kind to be approved by the FDA to treat the neurological disease. Novartis noted that this is the first reported death to [...]

Contamination Concerns Prompt EMA to Recommend Vistide Recall


The European Medicines Agency (EMU) last month asked for the recall of several products manufactured by Ben Venue Laboratories over particle contamination concerns. At the time, Gilead’s antiviral medication Vistide (cidofovir) was not included on the list of products recommended for recall, as the drug was undergoing sterilization in an effort to lower the risk [...]

Use of Ortho Evra Patch Backed by FDA Advisory Panel


Last week, an FDA advisory panel voted 19 to 5 that the Ortho Evra birth control patch should remain on the market, finding that its benefits outweigh its potential risk for blood clots. While the panel’s final vote ultimately backed the continued use of the patch, it also recommended that information regarding the increased risk [...]