Tagged Articles

toxicity 22 articles

Cobalt and Chromium Toxicity from Metal-on-Metal Hip Resulted in Neuropsychiatric Symptoms

According to a study published in January in BMC Psychiatry, an online journal of psychiatric disorders, cobalt and chromium toxicity from metal-on-metal hip implant failure resulted in neuropsychiatric complications after revision surgery. Metal-on-metal hip implants are designed using a metal ball and metal socket made of a cobalt-chromium alloy. When the parts rub together during normal use, the parts may shed metal ions, which can pollute the bloodstream and damage the surrounding tissue. The normal range occurring in a person’s system due to normal environmental exposure is 0–20 nmol/l for cobalt and 0–100 nmol/l for chromium. Nine of the 10 patients in this ... Read More

Two more GranuFlo lawsuits filed against dialysis giant Fresenius

Two new lawsuits have been filed against Fresenius Medical Care North America, joining more than 300 lawsuits that allege two of the company’s dialysis products caused patients to suffer deadly heart attacks. Fresenius, the world’s largest provider of dialysis services and products, manufactures GranuFlo and NaturaLyte, concentrates that are administered to patients prior to dialysis to balance electrolytes. The products are used both in Fresenius facilities as well as dialysis clinics owned by competitor companies. GranuFlo and NaturaLye contain an ingredient that metabolizes into bicarbonate. However, these products contain more of the ingredient than competitor brands. In March 2012, the ... Read More

FDA lays out new rules to measure impurities in medications

The Food and Drug Administration (FDA) has laid down new rules for drug companies that detail acceptable levels of impurities – such as arsenic –allowed in medications as well as the processes for detecting them. The 81-page guidance outlines five different classifications for various elements including potentially dangerous ones like lead to relatively safe ones like zinc. The FDA created the guidance along with drug regulators in Europe and Japan as part of the International Conference on Harmonisation, an effort to establish “permitted daily exposure” (PDE) standards for potentially dangerous elements. The guidance details whether elements should be included in ... Read More

Another wrongful death lawsuit filed against Fresenius related to dialysis product

Another wrongful death lawsuit has been filed against Fresenius Medical Care, the world’s largest provider of dialysis products and services. The lawsuit alleges that a woman died after using two products created by the company during her dialysis treatment. Shirley Harris underwent dialysis treatment during which she received GranuFlo and NaturaLyte, two dialysate products made by Fresenius. The lawsuit alleges the products were improperly labeled, which caused her and other patients to experience significant health problems including heart attack, cardiopulmonary arrest, stroke, and/or sudden cardiac death. The lawsuit was filed by Shirley’s husband, Phillip, who claims the company failed to ... Read More

FDA sends warning letter to Fresenius about dialysis machine violations

It has been a year since Fresenius Medical Care North America, the world’s largest provider of dialysis services and products, issued a recall of two of its concentrate products for dialysis patients after unintended overdoses that may have contributed to sudden cardiac arrest, and for not previously reporting to the Food and Drug Administration (FDA) the error. Now the company is back under fire by the FDA, this time for a lapse in meeting federal design requirements on some of its dialysis machines. The letter states that “the organization did not conduct adequate design verification studies of its electron beam (E-beam) ... Read More

Drug study data often crunched to mask serious side effects

Clinical drug trials provide important data that help the Food and Drug Administration (FDA) determine if a drug is safe and effective enough to be marketed in the United States for a particular indication. But a new study has found that sometimes drug companies crunch numbers in a way to make a drug look better than it actually is. Researchers at Princess Margaret Cancer Centre reached that conclusion after reviewing data from 164 breast cancer trials. They found that a large number of the studies that reported no real benefit of a particular treatment were spun so that they focused ... Read More

Old drug found to be key treatment for non-Hodgkin lymphomas

A drug developed 50 years ago has reemerged as a new weapon in the fight against certain types of non-Hodgkin lymphomas, more than doubling progression-free survival rates and reducing side effects compared to a multi-drug cocktail that for years has been used to treat indolent non-Hodgkin lymphomas. The drug, bendamustine (Treanda), showed promising results when combined with another therapy, rituximab (Rituxan). Traditionally, the disease has been treated with a combination of five different drugs – rituximab, cyclophosphamide (Cytoxan), doxorubicin (Adriamycin), vincristine, and prednisone – called R-CHOP. Findings on bendamustine were presented this week at the annual meeting of the American ... Read More

BP oil spill pollutants turn up in migratory pelicans nesting in Minnesota

Petroleum compounds from BP’s oil spill in the Gulf of Mexico two years ago and some of the chemicals used to clean it are being found in pelican colonies nesting in Minnesota, according to a report by Minnesota Public Radio. Tens of thousands of pelicans descend on Marsh Lake in the western part of the state each year after wintering on the Gulf of Mexico. The birds span out across the Gulf, going as far south as Cuba to escape the colder weather. This year, some 34,000 American White Pelicans are raising about 17,000 chicks on Marsh Lake, making it ... Read More

Anti-seizure drugs carry new black box warning

Two drugs used to control types of seizures now carry the Food and Drug Administration’s strongest warning for severe hypotension and cardiac arrhythmias. The drugs also carry a new warning for  serious skin disorders including the potentially fatal Stevens Johnson Syndrome (SJS) and the more severe form of the disease, toxic epidermal necrolysis (TEN). Cerebyx (fosphenytoin sodium) Injection and Dilantin (phenytoin) are anticonvulsant drugs that work in the brain to block or slow down the spread of seizure activity. The cardiovascular risk with these drugs is associated with rapid infusion. The rate of intravenous administration of Cerebyx should not exceed ... Read More

New study finds FDA's seafood-safety analysis 'flawed and unrealistic'

We seem to live in a time when it has become normal for big business interests and politicians, when confronted with a problem, to say one thing while a group of independent scientists and researchers studying the same problem reach an entirely different conclusion. While industry and their legislative allies grab headlines, the “other” voices are generally ignored or relegated to the fringe. There’s probably no finer example of this information war than the BP oil spill, which continues to plague the Gulf of Mexico, despite what all the commercials and government officials want you to believe. So while scientists ... Read More