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Lipitor diabetes lawsuits mount since FDA warning five months ago

Lawsuits against Pfizer by women who say the company’s cholesterol-lowering statin Lipitor caused them to develop type 2 diabetes have skyrocketed in recent months, shooting up from 56 to nearly 1,000 in the past five months, according to a Reuters review of federal court filings. The lawsuits allege Pfizer knew of the possible side effect but failed to adequately warn the public. In 2012, the Food and Drug Administration (FDA) warned that Lipitor and other statins could increase blood sugar levels which could lead to a “small increased risk” of type 2 diabetes. Studies show the risk is higher among ... Read More

FDA warns of side effects from unapproved use of Expressions product as dermal filler

The Food and Drug Administration (FDA) is warning doctors that Expression brand injectable product made by Enhancement Medical should not be used as a dermal filler because the product has not been approved for this use and adverse events have been reported. These events include swelling, tenderness, firmness, lumps, bumps, bruising, pain redness, discoloration, itching, and the development of hard nodules. Expression is a hyaluronic acid, and is approved by the FDA only as an intranasal splint, and is intended to minimize bleeding and swelling and to prevent the septum and the nasal cavity from sticking together. Intranasal splints are ... Read More

Drug companies race to win market approval for new alternative to cholesterol-lowering statins

An experimental medication aiming to replace statin drugs as a cholesterol-lowering treatment has cleared nine clinical trials in a race for Food and Drug Administration (FDA) approval. Sanofi and Regeneron Pharmaceutical’s alirocumab reportedly met the goal of lowering bad cholesterol after 24 weeks of treatment more than placebo or other medications, and reducing the rate of heart attack, stroke and death in one test. Previous tests have shown a 47 percent drop in bad cholesterol with alirocumab. Sanofi and Regeneron are racing against drug maker Amgen, Inc., to get new cholesterol treatments on the market. Both drugs are in a ... Read More

Lawsuit alleges Monster energy drink killed Kansas City man

A Kansas City woman has filed a lawsuit against Monster Energy Drink alleging the beverage caused her husband’s death. Heather Felts said her husband Shane drank a Monster beverage a day for two weeks to help boost his energy level. On June 24, 2012, they had dinner together and went to bed. At about 2 a.m., Heather says she awoke to a “thump” and found her husband on the bathroom floor. They rushed him to the hospital but it was too late. Shane was dead. Heather claims that Monster Energy Drinks markets itself as a dietary supplement, but it is ... Read More

Man suffers paranoid psychosis, cognitive impairment after taking Hepatitis C treatment

A frightening new side effect has emerged with the standard treatment for the hepatitis C – paranoid psychosis and cognitive impairment, according to a report published in a recent issue of General Hospital Psychiatry. According to the report, a 55-yearold male was diagnosed with paranoid psychosis and cognitive impairment after being treated for four months with interferon-based hepatitis C virus antiviral therapy. The psychosis stopped after he continued the therapy and he began treatment with the antipsychotic medication risperidone (Risperdal), however the cognitive impairment could not be reversed. Months later when doctors attempted to lower his dosage of risperidone, the paranoid ... Read More

Hospira recalls injectable anesthetic Lidocaine due to particles floating in solution

Hospira, Inc., is recalling one lot of its injectable drug Lidocaine because of a confirmed report of discolored solution with visible particles floating in it as well as particulate embedded in the molded glass container. Hospira has identified the particulate as iron oxide, and said it is due to a supplier’s glass defect. Hospira is working with its supplier on implementing corrective and preventative actions. To date, no adverse events have been reported related to this recall, however if patients are injected with the particles – depending on the particle size and number – it could block administration of the ... Read More

Hospital CO2 detector accessories recalled due to life threatening defect

GE Healthcare is recalling accessories for its CO2 detectors because they may cause the device to fail or to provide incorrect CO2 values for mechanically and spontaneous ventilated patients. Physicians rely on these devices to make decisions, and if those decisions are based on incorrect readings from these machines, permanent, irreversible impairment or life threatening changes could occur in patients, such as inadequate exchange of gasses (hypoventilation), causing an increased concentration of CO2 (hypercapnia), which can be deadly. The recall involves GE Healthcare single-width airway modules (E-MiniC) and accessories and Extension Modules (N-FC, N-FCREC). It is classified as a Class ... Read More

Canadian regulators warn consumers about cardiovascular risks of testosterone drugs

Canada’s national health regulators have issued a warning to consumers and health care providers about the serious risks associated with the use of testosterone-replacement drugs, which are being prescribed to increasing numbers of men as a treatment for low natural testosterone levels. Health Canada said its safety review of testosterone drugs involved evaluating the currently available studies and reports on the cardiovascular risks the drugs presented. In the course of its safety review, the agency found “a growing body of evidence suggesting a possible association between the use of testosterone replacement products and cardiovascular risk.” As in the U.S., men ... Read More

European advisors recommend approval of new combination type 2 diabetes treatment

An advisory panel for European drug regulators is recommending approval for a new type 2 diabetes drug combining the long-acting insulin degludec with Victoza (liraglutide). The favorable recommendation of Novo Nordisk’s drug Xultophy, previously known as IDegLira, was based on clinical trials that show the once-daily injection lowers blood sugar levels more than each of the medications on its own. If approved by the European Medicines Agency, Xultophy could hit the European market by early 2015. Combination therapies for type 2 diabetes are becoming more popular since many diabetics require medication and continually require additional drugs as the disease progresses. ... Read More

Risperidone side effects send patients to the emergency room

Adverse effects of antipsychotic medications such as Risperdal (risperidone) send more than 20,000 people in the United States to the emergency room each year, prompting the American Psychiatric Association to issue an advisory to clinicians to carefully evaluate patients before prescribing the drugs to ensure that the use of antipsychotic medications are clinically warranted. Antipsychotic adverse effects were the cause of three times more emergency room visits than side effects from sedatives, four times more than stimulants, and five times more than antidepressants. The antipsychotic side effects that drive most people to the emergency room for treatment include extreme restlessness, ... Read More