Tagged Articles

heparin 106 articles

Study: Declining Use of IVC Filters Did Not Result in Rise of PE

According to Healio, an online medical news journal, a population-based retrospective cohort study has determined that a decline in the use of vena cava filters did not result in a rise of pulmonary embolism (PE) among trauma patients. Frederick B. Rogers, MD, MS, medical director of trauma and acute care surgery at Penn Medicine Lancaster General Health, and colleagues wrote, “Despite a precipitous decline of vena cava filter use in trauma, PE rates remained unchanged during this period. Taking this association into consideration, vena cava filters may have limited utility in influencing the rates of PE.” Guidelines for trauma patients recommend using ... Read More

China heparin producer warned by FDA over violations of current good manufacturing practices

U.S. Food and Drug Administration (FDA) officials inspecting Chinese drug maker Dongying Tiadong Pharmaceuticals Co., Ltd., found “significant deviations” from current good manufacturing practices in its manufacturing of the blood thinner heparin. Dongying Tiadong was warned by French regulators over similar violations last March. The agency cited the company in its testing of crude heparin batches saying it failed to adequately investigate and document out-of-specification (OOS) results “repeatedly and without justification.” “Disregarding the OOS results, and resampling and retesting without scientific justification, constitutes ‘testing into compliance.’ This practice is unscientific and objectionable under current good manufacturing practices,” the agency said ... Read More

FDA warns drug manufacturer Hospira to clean up its act

Hospira Inc. has received a warning letter from the Food and Drug Administration (FDA) regarding “significant violations” at the drug manufacturing company’s Mulgrave, Australia, plant. The warning came after the agency inspected the plant and found issues with multiple Hospira injectable drugs including vial-to-vial variability in oxygen levels in the company’s mitoxantrone injections to recurrent instances of visible crystal particles in carboplatin products. The FDA noted similar violations in May 2012 and April 2013, and that Hospira had not taken effective corrective action to address the problems. The agency also pointed out that the company had received numerous consumer complaints about ... Read More

Chinese pet treats sickened thousands of animals; will humans be next?

The rash of pet illnesses and deaths from possibly tainted jerky treats made in China has raised questions whether federal officials are doing enough to endure imported foods are thoroughly inspected and deemed safe for humans. More than 3,600 dogs and 10 cats were sickened or died after eating the jerky treats, however the Food and Drug Administration (FDA) says it has yet to identify what in the treats made the animals sick. About 580 of the cats and dogs that fallen ill have died from health problems including kidney failure and gastrointestinal bleeding. In an effort to identify the ... Read More

Tainted lots of heparin recalled

Certain lots of the blood thinner heparin are being recalled because testing revealed that the drug is contaminated with trace amounts of oversulfated chondroitin sulfate (OSCS). The recall includes seven lots of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun Medical Inc. that were manufactured in 2008 and expire on October 31, 2010 and November 30, 2010. Heparin is a widely used blood thinner used to treat and prevent blood clots. In March 2008, major recalls of heparin were announced due to severe adverse reactions and deaths from lots manufactured in a China facility that a Food ... Read More

India’s booming drug market raises questions about quality

Drugs are becoming a booming business in India and are expected to grow 13 percent this year alone to just over $24 billion. With tougher patent laws and a more mainstream focus in the global drug industry, India is slowly beginning emerge as a solid exporter of drugs. However, what most critics see in the Indian drug industry is not as much growth as it is quality issues. China is another major exporter of drugs and raw materials for the industry, with more than 300 plants approved by the Food and Drug Administration (FDA). Comparatively, India has about 900 approved ... Read More

Baxter faces numerous lawsuits over tainted heparin scandal

As many as 300 product-liability lawsuits may be filed in the Illinois state court against drug maker Baxter International Inc., by people injured by or families who lost loved ones to contaminated batches of the blood thinner heparin. Per a judge’s order last year, attorneys are working to convert an aggregate lawsuit to individual claims against the Deerfield, Illinois-based drug company. The complaints accuse Baxter and its supplier, Scientific Protein Laboratories LLC, of negligence, alleging Baxter’s heparin was unsafe for the intended use. The lawsuits seek money damages. The nightmare began in late 2007, as reports of serious allergic reactions ... Read More

Revised boxed warning placed on blood thinners

A group of blood thinners used to reduce the risk of deep vein blood clots in patients has updated their products’ safety labeling and revised the boxed warning to include a risk of epidural or spinal hemotomas in some patients, according to an announcement by the Food and Drug Administration (FDA). The FDA places boxed warnings, also known as black box warnings, on drugs that, based on medical studies, carry a significant risk of serious adverse side effects or death. The blood thinners included in this announcement include Arixtra (fondaparinux sodium) Solution for subcutaneous injection; Fragmin (dalteparin sodium injection) for ... Read More

FDA notifies public about changes to heparin potency

The blood thinner heparin will now include a new reference standard and test method that is used to determine the potency of the drug and detect impurities that may be present in it, according to a safety alert issued by the Food and Drug Administration (FDA). The change is effective as of October 1, 2009, and will harmonize the USP unit dose with the WHO International Standard unit does, which will result in an approximately 10 percent reduction in the potency of the heparin marketed in the United States. The alert was issued to pharmacists, physicians, hospital risk managers and ... Read More

USP updates standards for heparin

A recent report in Huliq News documents efforts by the U.S. Pharmacopeial (USP) Convention to improve the safety of blood thinner heparin by revising its written and physical standards for the drug. The update comes at the request of the U.S. Food & Drug Administration (FDA) following a 2008 public health crisis when more than 200 people died after being administered contaminated heparin. According to its web site, U.S. Pharmacopeia is an official public standards-setting authority for all prescription and over-the-counter medicines and other health care products manufactured in the United States. It is a non-governmental, not-for-profit public health organziation ... Read More