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injection 21 articles

Hospira recalls heparin vials due to contamination with human hair

Hospira, Inc., is recalling one lot of its blood thinner Heparin after confirming that a piece of human hair was found floating in a sealed vial. The nationwide user-level recall involves one lot of Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL) in 0.9 percent Sodium Chloride Injection, 500 mL, NDC 0409-7620-03 Lot 41-046-JT with expiration date of 01NOV 2015. The injection of particulate material, such as human hair, may cause local inflammation, phlebitis, and/or low-level allergic response. Capillaries, which may be as small as the size of a red blood cell, approximately seven microns in diameter, ... Read More

Hospira recalls one lot of high blood pressure treatment Labetalol

Hospira Inc. has issued a nationwide recall for one lot of the beta blocker Labetalol Hydrochloride injection used to treat high blood pressure due to foreign matter floating in the solution. This is Hospira’s fifth recall of injectable solutions in four weeks due to contaminated solution. The latest recall was initiated after embedded particulate were seen within the glass vials and visible particles floating in the solution. The embedded particulate was identified as stainless steel and the floating particulate as iron oxide. The particles may block the solution of the drug during administration, which could cause a delay in therapy. However, ... Read More

FDA approves Endo’s new Aveed testosterone injections

U.S. drug regulators gave Irish drugmaker Endo Pharmaceuticals the green light to manufacture and market its long-lasting testosterone injection Aveed in the United States, making it the latest addition to a growing list of testosterone-replacement therapies drug companies are aggressively marketing to men in the U.S. and other countries. Endo Pharmaceuticals said the U.S. Food and Drug Administration (FDA) approved Aveed to treat men with hypogonadism, commonly referred to as “low testosterone” or “low T,” a condition in which the body produces lower than normal levels of the hormone. Men with abnormally low testosterone levels often experience declines in muscle, ... Read More

European advisors give nod to GSK’s new type 2 diabetes treatment

A medical products advisory committee for the European Medicines Agency (EMA) has recommended approval for the marketing of GlaxoSmithKline’s type 2 diabetes treatment albiglutide. The experimental treatment would be marketed under the name Eperzan. If approved, Europe would be the only country in the world to offer the new drug. The EMA is not required to follow the recommendation of its advisory committee, but it typically does. Albiglutide is in a newer class of type 2 diabetes drugs known as glucagon-peptide-1 (GLP-1) receptor agonists. Other drugs in this class include the brand name drugs Byetta and Victoza. These currently marketed ... Read More

Parenteral nutrition products for feeding tubes recalled

Baxter International is recalling two lots of CLINIMIX and one lot of CLINIMIX E injection parenteral nutritional products for complaints that particulate matter was found floating in the products. If infused into patients, the particulate could block blood vessels and cause heart attacks, strokes or damage to other organs such as the kidneys or liver. Patients could also experience allergic reactions, local irritation, and inflammation in tissues and organs. To date, there have been no reported adverse events associated with this issue, and the root cause of the contamination has been identified and resolved, the company reports. CLINIMIX is a ... Read More

Type 2 diabetes drug Victoza may improve vascular health but poses cancer risk

Victoza, a type 2 diabetes treatment that works to regulate glucose, may improve the condition of arteries and possibly protect against heart attack or stroke, a new report shows. However, that benefit will have to be weighed against the drug’s cancer risks. Victoza, also known as liragliutide, is an injection made by Novo Nordisk to treat high blood sugar in type 2 diabetics. Many people may be familiar with the drug’s former spokesperson, celebrity chef Paula Deen, who after accepting the company’s offer to front their drug, admitted she was diagnosed with type 2 diabetes two years prior. She has ... Read More

Injectable Reglan, Zofran recalled due to hazardous vial defect

Some injectable medications used to treat severe acid reflux and other gastrointestinal conditions are being recalled because tiny strands of glass were found in some vials. If the glass comes loose and is injected in to patients, it could cause serious and potentially life threatening consequences. The nationwide recall involves one lot of metoclopramide injection and two lots of ondansetron injection. Metocloparmide is known by the brand name Reglan and is used to treat gastric esophageal reflux disease (GERD), and a heartburn condition known as gastroparesis in diabetics. Ondansetron, known by the brand names Zofran and Zuplenz, prevents nausea and vomiting ... Read More

Type 2 diabetes drug Bydureon recalled throughout Europe

About 92,000 vials of the type 2 diabetes drug Bydureon are being recalled throughout Europe because some of the vials of the long-acting medication were not fully filled. Bydureon is a weekly injectable version of the drug exenatide. It is the same medication in the type 2 diabetes drug Byetta. The affected drug, jointly marketed by AstraZeneca and Bristol-Myers Squibb Co., was recalled from the Netherlands, Ireland, Sweden, Finland and Spain. No Bydureon vials sold in the United States are affected. Spokesmen for the companies say that injecting under-filled vials should not pose any health concerns to patients. Bydureon has a ... Read More

Anesthetic vials recalled due to contamination

Two lots of the anesthetic Bupivacaine manufactured by Hospira Inc. have been recalled because small particles were seen floating or embedded in vials of the injectable drug. The recall involves one lot of 0.25% Bupivacaine HCl injection and one lot of 0.75% Bupivacaine HCL injection, both of which come in single-dose vials. The particulate was identified as stainless steel ranging in size from 542 microns to 1,700 microns in the 0.25% vials, and as iron oxide with an average size of 2,000 microns in the 0.75% vials. If medication from contaminated vials are injected into patients the foreign particulates could ... Read More

New diabetes drug controls blood sugar better than other widely prescribed treatments

A new, once-weekly injection for the treatment of type 2 diabetes controls blood sugar levels better than three other widely prescribed diabetes drugs, late-stage clinical trials show. The drug, dulaglutide, made by Eli Lily and Co., was pitted against the long-used insulin drug metformin, and newer type 2 medications Byetta, made by Bristol-Myers Squibb, and Januvia, made by Merck & Co. Januvia is one of the leaders in diabetes treatment with sales topping $4 billion a year. Dulaglutide performed better at lowering blood sugar levels compared to metformin, Byetta and Januvia. Patients on dulaglutide also lost twice as much weight ... Read More