FDA Failed to Follow Credible Leads Involving Contaminated Heparin: Report
Two U.S. lawmakers say that FDA investigators failed to properly follow up on the source of contaminated heparin that caused severe allergic-type reactions in hundreds of people in late 2007 and early...
View ArticleNew Bill Proposes Giving FDA Greater Drug Recall, Supply Chain Authority
New legislation has been introduced that would give the FDA increased powers and reach to manage and ensure the security of the nation’s drug supply. On Tuesday, Senator Michael Bennet, of Colorado,...
View ArticleMisleading Drug Advertising a Chronic Problem for Baxter: FDA Warns
Federal regulators are warning Baxter Healthcare that it is overstating the benefits of Aralast, an emphysema drug, and say they have noticed that the company has a disturbing trend of overstating the...
View ArticleGAO Blasts FDA on Failing to Inspect Foreign Drug Plants
A new government report finds that the FDA is failing to inspect foreign drug manufacturing plants that may pose the greatest risk to public health if something should go wrong. While acknowledging...
View ArticlePartial Summary Judgment Granted in Baxter Heparin Lawsuit
An Illinois judge has determined that the contaminated heparin imported into the United States by Baxter International, Inc. in late 2007 and early 2008 was “unreasonably dangerous,” granting partial...
View ArticleHeparin Recall Lawsuit Ends in $625K Award in First of Hundreds of Claims
The family of an Illinois man was awarded $625,000 by a Cook County jury in the first of hundreds of lawsuits over Baxter heparin that was recalled several years ago after it was discovered counterfeit...
View ArticleUnsolved Heparin Contamination Subject of Congressional Investigation
U.S. lawmakers are requesting a host of documents from a number of pharmaceutical companies in an attempt to track down the source of contamination in the blood thinner heparin, which is believed to...
View ArticleMalpractice Lawsuit Over Blood Clots After Surgery Results in $1.4M Award
The family of a New York man and longtime public servant has been awarded $1.4 million in a wrongful death lawsuit filed over medical malpractice following a hip surgery. The complaint was filed by...
View ArticleFDA Guidance Seeks to Eliminate Heparin Contamination Risk
Federal health regulators have drafted new industry guidelines that are designed to ensure the quality of heparin following the deaths of nearly 150 people several years ago when contaminated batches...
View ArticleHeparin Label Update Aims to Clarify Dosage Strength
Federal drug regulators have ordered a warning label update for the blood thinner heparin, which is designed to better explain the drug’s dosage strengths. The FDA issued a drug safety communication...
View ArticleSenators Propose New Drug Tracking Safety Bill
A bipartisan group of U.S. senators have proposed a new bill that would create a national drug tracking system to fight stolen, counterfeit and potentially harmful drugs. The proposed bill (PDF) was...
View ArticleBill to Create Drug Tracking System Passes House
Lawmakers moved closer this week to creating a new program that will track all drug prescriptions in the United States, hoping to reduce the risks associated with stolen or counterfeit drugs. On...
View ArticleCovidien Monojet Prefill Flush Syringe Recall Issued Due to Infection Risk
A manufacturer has recalled 14 lots of prefill flush syringes due to a potential that they may be mislabeled and improperly sterilized, which could cause users to face a risk of infections or severe...
View ArticleLovenox Paralysis, Spinal Bleeding Problems Result in FDA Warning
According to a new warning issued by federal health regulators, side effects of the blood thinner Lovenox could increase the risk of spinal bleeding and even paralysis when patients undergo spinal...
View ArticleBlood Thinners, Diabetes Drugs and Opioids Cause Most Adverse Events in Older...
Federal researchers warn that one out of every 250 Americans may end up in the emergency room due to drug side effects, with many older Americans suffering serious bleeding events from Xarelto,...
View ArticleXarelto, Similar Blood Thinners May Increase Risk Of Stroke In Some Afib...
Side effects of Xarelto, Pradaxa, Eliquis, Warfarin and Heparin may actually increase the risk of stroke among some patients with atrial fibrillation, instead of preventing them as they were designed...
View ArticleRecalled BD PosiFlush Heparin Syringes, Saline Syringes Linked to Serratia...
Earlier this year, Becton Dickinson (BD) recalled a number of herparin flush syringes and pre-filled saline syringes, which have been linked to reports of Serratia marcenscens bacterium infections;...
View ArticleProblems at BD Syringe Manufacturing Plant Outlined in FDA Warning Letter
Becton, Dickinson & Co. failed to adequately monitor municipal tap water used during its manufacturing processes, which may have contributed to an infection outbreak and syringe recall issued...
View ArticleAspirin Just As Good As Other Blood Thinners At Preventing Clots Following...
The findings of a new study suggest that taking aspirin is just as effective at preventing blood clots following hip and knee replacement surgery as taking more powerful blood thinners, such as Pradaxa...
View ArticleCompounded Heparin Sodium Recall Issued Due To Lack Of Preservatives, Infant...
Federal health officials are warning about problems with compounded heparin products, which may contain preservatives that could seriously injure or kill infants and newborns. The FDA announced a...
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