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Plaintiff claims Actos bladder cancer warnings were not strong enough to convey risks

Takeda Pharmaceutical Co., attempted to convince a Philadelphia jury that it adequately warned of bladder cancer risks on the label of its type 2 diabetes drug Actos by presenting testimony from a former senior official with the Food and Drug Administration (FDA) David Feigal Jr., an expert witness for the drug company, said that Takeda had funded several studies to gauge the cancer risks with its once-blockbuster drug and had included that information on the drug’s insert. However, plaintiff Frances Wisniewski claims differently. She took Actos for seven years and developed tumors in her bladder. Her lawsuit alleges that Takeda ... Read More

FDA approves new at-home colon cancer screening test

The Food and Drug Administration (FDA) has approved a new at-home stool sampling test that can detect colon cancer with more than 90 percent accuracy. The FDA gave unanimous approval to Exact Sciences Corp.’s Cologuard, a DNA-based test, finding it offered patients and physicians another option to screen for colorectal cancer. “Fecal blood testing is a well-established screening tool, and the clinical data showed that the test detected more cancers than a commonly used fecal occult (blood) test,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. ... Read More

Antioxidant vitamin supplements may speed lung cancer growth

Taking vitamin supplements is thought to help ward off health problems like cancer, but a new study shows they may actually worsen conditions in some people. Swedish researchers gave antioxidants to laboratory mice with early-stage lung cancer. Rather than staving off the cancerous growths in mice, the supplements caused the tumors to multiply and become so aggressive that the animals died twice as fast as the mice that did not receive the supplements. The researchers theorized that the extra vitamins actually blocked one of the body’s key cancer-fighting mechanisms. General health recommendations cannot be based on animal studies, researchers pointed ... Read More

Novel trials aim to speed approval of experimental breast cancer drugs

Two experimental breast cancer drugs showed promising results in a closely watched study designed to enable the accelerated approval of medication that addresses unmet medical need in the treatment of serious or life threatening conditions. The drugs include AbbVie Inc’s veliparib, a treatment for an especially aggressive type of breast cancer known as triple negative, for which there are few effective treatments, and Puma Biotechnology Inc.’s neratinib, designed to treat a different type of breast cancer known as Her2-positive. Both drugs were tested in an unconventional mid-stage trial involving patients with confirmed breast cancer whose disease is considered curable but ... Read More

Erectile dysfunction may be a sign of more serious problems

Men who suffer from erectile dysfunction may be given drugs such as Viagra, Levitra or Cialis to treat their condition, but many of these men may be better served with a testosterone replacement therapy, according to a “Dear Pharmacist” article in the Sun Sentinel. However, men should first want to discuss the long-term effects of the hormone replacement therapy. “Giving a man one of those super sex pills … is the equivalent of jump-starting their car every two miles, rather than just fixing the battery,” the article reads. “Why do men medicate themselves every weekend, when they can fix the ... Read More

Study links insulin therapy to bladder cancer deaths in diabetics

Type 2 diabetics on insulin therapy are more likely to die from bladder cancer than those using other treatments, a new study suggests. Researchers with the Department of Internal Medicine at the National Taiwan University College of Medicine in Taipei, followed more than 86,000 patients with type 2 diabetes aged 25 or older from 1995 through 2006 for bladder cancer deaths. They concluded that patients who used insulin to keep their blood sugar levels in check were nearly twice as likely to die from bladder cancer compared to those who did not use insulin. Patients who used insulin and who ... 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

European regulators skeptical about new prescription diet pills

European drug regulators are leery about approving the new weight loss drug Belviq because of safety concerns, including heart valve problems and psychiatric side effects in patients, and tumors observed during studies on lab rats. Belviq is currently under review by an advisory panel for the European Medicines Agency (EMA), which is expected to make a recommendation for the EMA by March whether to approve the drug. Arena Pharmaceuticals, the drug’s maker, has been working with the agency to answer questions and clear up any matters that stand in the way of approval. But its chances may be slim. The ... Read More

FDA approves Belviq, first weight loss drug in more than a decade

A new prescription weight-loss pill has been approved by the Food and Drug Administration (FDA), making it the first diet pill to hit the U.S. market in more than a decade. Arena Pharmaceuticals Belviq (lorcasserin) was deemed safe enough to get a nod by drug regulators, though the agency says studies showed only modest weight loss in clinical trials. Belviq was approved for adults who are obese or overweight with at least one medical complication such as diabetes or high cholesterol. The drug should be used with a healthy diet and exercise. The FDA first rejected Belviq in 2010 after ... Read More

Experimental diet pill hopes to win FDA approval

Arena Pharmaceuticals and Eisai Co. have put their experimental diet pill back into clinical trials in hopes of gaining approval from the Food and Drug Administration (FDA). Qnexa, a combination of the weight loss drug phentermine and the antiepileptic medication topiramate (Topamax), was rejected by the FDA last fall because there was not enough data to measure the benefit/risk profile. The FDA also raised questions about early animal trials that showed the drug caused cancerous tumors in laboratory rats. The latest clinical trial involves nearly 2,500 overweight and obese men and women. Each were randomly assigned to diet and exercise ... Read More