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life-threatening 105 articles

Dialysis solutions recalled due to potential contamination

Baxter International is recalling two lots of Dianeal Low Calcium Peritoneal Dialysis Solution with 2.5 percent Dextrose 5000mL (Ambu-Flex II) because oxidized stainless steel, garment fiber and PVC particulate matter was present during the manufacturing process and seen floating in the solution. If the particulate within the solution is injected into patients it could cause local inflammation with foreign body reaction or result in adhesion formation. The matter could also potentially serve as a focal point for infection should any existing pre-existing peritonitis exist, which could be deadly to patients receiving the solution. The product labeling advises health care providers ... Read More

Injectable skin and blood infection treatment recalled

Certain lots of the injectable drug Cubicin (daptomycin), used to treat skin infections and certain blood stream infections, are being recalled because of the potential presence of glass particles in vials. The administration of glass particulate, if present in an intravenous drug, poses a potential safety risk to patients such as thromboemobolism or a life-threatening pulmonary emboli. Other adverse events that could result from administration of glass particulate include phlebitis, mechanical block of the capillaries or arteries, activation of platelets, or subsequent generation of microthrombi. It can also cause the formation of granulomas, which can result in a protective local ... Read More

Pre-diabetes diagnoses benefit drug companies more than patients

Non-diabetics with higher-than-recommended blood sugar levels and thus at risk for developing type 2 diabetes are considered pre-diabetic, however classifying large numbers of people with pre-diabetes offers more benefit to drug companies than those diagnosed with the condition, researchers argue. In an editorial published in the British Medical Journal, researchers with University College London and the Mayo Clinic in Minnesota said that labeling people as pre-diabetic increases the likelihood that they will be prescribed medication prematurely, which would at best only briefly delay the onset of illness. It would also prematurely expose them to potential side effects from the drugs. John ... Read More

Hospira recalls intravenous fluid replacement due to mold contamination

Hospira Inc. is issuing a nationwide recall of one lot of Lactated Ringers and 5 % Dextrose Injection because a bag of the intravenous fluid replacement was found to be contaminated with mold. One customer reported seeing particulate within the solution of the primary flexible container of Lactated Ringers and 5% Dextrose Injection. “The particulate was identified as a filamentous-like structured particulate indicative of mold,” according to a Food and Drug Administration (FDA) safety communication. “Analysis of the primary container and overwrap indicated a puncture in the same physical location, causing the primary container to leak.” If a patient is ... Read More

Testosterone therapy prescribed generously despite potentially dangerous side effects

The number of prescriptions for testosterone replacement therapy for men 40 years of age and older has risen 300 percent between 2001 and 2011, and a quarter of the most recent testosterone therapy users have never had their blood levels checked to determine if the need the medication, according to a study published in JAMA Internal Medicine. The research was spearheaded by Jacques Baillargeon, an epidemiologist at the University of Texas Medical Branch in Galveston, who wondered if the increase in advertising for testosterone treatments was resulting in an increase in prescriptions for the drugs. The ads offered relief from ... Read More

MBL granted A-Rod therapeutic use exemption for testosterone therapy

Yankees third baseman Alex Rodriguez, best known as A-Rod, was using a testosterone treatment during the 2007 season under a therapeutic use exemption from Major League Baseball, according to a new book titled Blood Sport: Alex Rodriguez, Biogenesis and the Quest to End Baseball’s Steroid Era. Testosterone supplements are a prescription medication approved by the Food and Drug Administration (FDA) to boost testosterone levels in men who have low levels of the hormone in their blood, a condition known as hypogondalism. The condition can result in symptoms such as low libido, weight gain, and fatigue. In recent years, aggressive marketing ... Read More

Antidepressant use during pregnancy remains controversial issue

A new study suggesting that there is no increased risk of heart defects in newborns exposed to antidepressants in the first three months of gestation is being criticized by medical experts. “While this is an excellent group of researchers, there are some serious flaws with this study,” says Dr. Adam Urato, maternal-fetal medicine specialist at Tufts Medical Center in Boston. “This isn’t rocket science. We know that exposing developing babies to synthetic chemicals is almost always a really bad idea and should be avoided whenever possible. This study does nothing to alter that common sense concolusion.” The study, conducted by ... Read More

Drug to treat rare disorders recalled for third time since August

Alexion Pharmaceuticals has issued the third recall since August of its sole approved drug Soliris after visible particles were seen in some vials during periodic testing. If injected, the particles could pose safety risks to patients in two general areas – first it could cause immune reaction and blood clots. Secondly, particles could cause blockage of blood flow in vessels, which could be life threatening. Soliris is approved as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare, acquired, potentially life-threatening blood disease; and patients with atypical hemolytic uremic syndrome, (aHUS), a rare disease in children that causes ... Read More

Statins fail to offer benefit to patients with serious lung diseases

Studies using statin medication to treat patients with chronic obstructive pulmonary disease (COPD) or acute respiratory distress syndrome (ARDS) failed to show any respiratory benefit to patients and as a result were halted early. The research was conducted after observational studies raised the possibility that the cholesterol-lowering medication might improve outcomes in people with these life-threatening lung conditions. The COPD study involved 885 patients with COPD who were given either simvastatin (Zocor) or placebo. Patients who were currently taking statins were excluded from the study. After 641 days of follow-up, researchers found no significant difference in the rate of COPD ... Read More

Skin reaction warning added to Excedrin Migraine over-the-counter pain reliever

Safety labels of over-the-counter pain reliever Excedrin Migraine have been updated to include a warning for serious skin reactions, the Food and Drug Administration (FDA) announced. Symptoms of this allergic reaction include skin reddening, blisters and rash. Consumers who use this medicine and develop a skin reaction are advised to stop use and seek medical attention right away. Excedrine Migraine contains 250 mg acetaminophen, 250 mg aspirin and 65 mg caffeine. This combination of drugs is used to treat pain caused by tension headaches, migraine headaches, muscle aches, menstrual cramps, arthritis, toothaches, the common cold, and nasal congestion. In 2013, ... Read More