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Federal Prosecutors Delve into Fresh Bribery Allegations Against Biomet

Biomet has announced that prosecutors have decided to extend the medical device maker’s probation another year as they look into new evidence that the company may have helped bribe government officials in Mexico and Brazil.

Biomet settled a similar case in 2012 by paying $17 million and striking a so-called deferred prosecution agreement that withheld criminal charges as long as the device maker did not participate in any other questionable behavior for three years. The foreign bribery allegations have dampened Biomet’s $13.35 billion merger with its rival Zimmer Holdings. Zimmer could reconsider the deal if criminal charges are filed. The U.S. Justice Department’s decision to extend Biomet’s probation rather than move forward with a settlement seems to imply that the merger is nearly complete, according to The New York Times (The Times). More Federal Prosecutors Delve into Fresh Bribery Allegations Against Biomet

Blockbuster Blood-Thinning Drug Linked to Higher Rates of Significant Bleeding Events in Some Patients

A new study published in The New England Journal of Medicine reveals that AstraZeneca’s blood-thinning drug Brilinta raises the risk of bleeding in some patients.

Many patients who have experienced heart attack or stroke in the last 12 months use aspirin as their first line of defense against a recurring event. For the study, researchers analyzed patients who took aspirin alone, or in conjunction with Brilinta. The study showed that 9.04 percent of patients taking aspirin alone suffered strokes of heart attacks, but that number dropped to 7.77 percent among those taking aspirin plus a 60-milligram dose of Brilinta. Increasing the dose of Brilinta to 90 milligrams resulted in a slight reduction of effectiveness. However, there was a sharp increase in major bleeding events, from 1.06 percent of people taking aspirin alone to 2.3 percent for Brilinta users, an increase in risk of 217 percent, according to Tech Times. More Blockbuster Blood-Thinning Drug Linked to Higher Rates of Significant Bleeding Events in Some Patients

Women Taking Birth Control Pills Have Tripled Risk of Crohn’s Disease, Research Suggests

Research suggests that the use of birth control pills can increase the risk of Crohn’s disease, Daily Mail reports. The rate of the digestive tract disorder has increased since the 1960’s, when the pill became increasingly popular. Birth control pills may be linked to Crohn’s through sex hormones, which can create an ideal environment for Crohn’s to develop. Researchers also predict that the risk is even higher with the “morning-after pill” since it contains even more hormones.

Patients with Crohn’s disease have inflammation in the digestive system, mostly in the intestines. As a result, patients have difficulty digesting food effectively. Common symptoms are diarrhea, fatigue and anemia. Crohn’s is a lifelong condition that currently has no cure.In some cases, patients’ symptoms are so severe that they are unable to work for long periods of time. More Women Taking Birth Control Pills Have Tripled Risk of Crohn’s Disease, Research Suggests

Arthritis Patients Taking NSAIDS are at Greater Risk for Gastrointestinal Events

Adverse GI events in at-risk rheumatic patients taking NSAID pain relievers may come on with little or no warning, researchers in Spain have found.

Angel Lanas, MD, of the University of Zaragosa School of Medicine in Spain, and his colleagues wrote in the April issue of Annals of the Rheumatic Diseases that GI adverse events are still common among at-risk patients taking nonsteroidal anti-inflammatory drugs (NSAIDs) to ease rheumatoid diseases and the benefits associated with them may not outweigh the risks. MedPage Today viewed the study. More Arthritis Patients Taking NSAIDS are at Greater Risk for Gastrointestinal Events

Chantix Users who Drink may Have Seizures, Become Aggressive, or Black Out, the FDA Warns

Federal health officials warned on Monday that the quit-smoking drug, Chantix, may cause users who drink to have seizures, become aggressive, or black out.

The U.S. Food and Drug Administration (FDA) approved an update to the drug’s label to reflect the warning back in September, but the agency said it released the information now to make patients aware of the change, and so they can “consider this new information when making prescribing decisions,” Reuters reported. More Chantix Users who Drink may Have Seizures, Become Aggressive, or Black Out, the FDA Warns

Obesity Drug Cardiovascular Trial Released Early, may be Based on “Likely False” Data

A top U.S. Food and Drug Administration (FDA) official told Forbes last week that Orexigen, the drug company behind the obesity drug Contrave, may be facing fines, civil penalties and even withdrawal of the drug from the market in what the U.S. Food and Drug Administration (FDA) is calling “unreliable,” “misleading,” and “likely false” heart study results that the company released early.

The results of a big heart safety study of Contrave were released by Orexigen last Tuesday through a patent and a filing with the U.S. Securities and Exchange Commission, to the FDA’s chagrin. The trial results were released early to about 100 employees of the drug company in order to show it to the FDA to prove that drug does not raise heart risks. The FDA began requiring these tests for diabetes and obesity drugs in 2008. The problem is that the results were made public, and experts fear Contrave may be prescribed based on too small of a study group, according to Forbes. More Obesity Drug Cardiovascular Trial Released Early, may be Based on “Likely False” Data

New Generation of Weight-Loss Drugs may Increase Some Patients’ Risk for Colon Cancer, Researchers Warn

Researchers at Mount Sinai Hospital in Toronto, Canada, are warning that a new generation of weight-loss drugs that mimic the after-effects of gastric bypass and other stomach-shrinking surgeries may put patients at increased risk for colon cancer.

Weight-loss surgeries have generally been linked to a decreased risk for many types of cancers, except for colon cancer. “A large nationwide retrospective cohort study of 15,905 obese subjects treated with bariatric surgery revealed a significantly increased incidence of colorectal cancer, relative to obese control subjects,” the authors of the study, viewed by Medical Daily, wrote. The scientists noted that as length of time since gastric bypass surgery increased, so did the rate of colorectal cancer. More New Generation of Weight-Loss Drugs may Increase Some Patients’ Risk for Colon Cancer, Researchers Warn

FDA Tells Testosterone Drug Makers to Update Their Product Labels to Reflect Health Risks

Federal health officials will require testosterone replacement drug manufacturers to clarify on their products that testosterone drugs are only approved to treat low testosterone levels caused by disease or injury, not normal aging, and may cause serious health consequences.

As men age, their testosterone naturally decreases, particularly after the age of 40. In recent years, aging men have increasingly sought help in “boosting” their energy and libido. The U.S. Food and Drug Administration (FDA) is warning doctors that testosterone replacement drugs have not been established as safe or effective for treating low libido, fatigue, and other normal signs of aging. The agency also warned that testosterone replacement drugs may increase the risk of heart attack, stroke and other cardiovascular problems. Going forward, drug makers will be required to clarify this information on their products’ labels, according to the Associated Press (AP). More FDA Tells Testosterone Drug Makers to Update Their Product Labels to Reflect Health Risks

FDA Issues Warning Over Potentially Dangerous Supplement Containing Powerful Antidepressant

The U.S. Food and Drug Administration (FDA) told consumers on February 28 to be extra vigilant when purchasing weight loss supplements, specifically mentioning OxyElite Pro, which was found to contain a powerful antidepressant drug.

OxyElite Pro is a thermogenic supplement which boosts metabolism and burns fat by increasing the body’s internal temperature. The product sickened 24 people with acute, non-viral hepatitis in 2013 in Hawaii. One person died, 11 had to be hospitalized, and two patients had to have liver transplants. All of the cases involved young to middle-age adults who suddenly fell ill and needed to be hospitalized in various stages of liver failure. OxyElite Pro use was the only factor the patients had in common. More FDA Issues Warning Over Potentially Dangerous Supplement Containing Powerful Antidepressant

Close to 13,000 GE MRI Systems Recalled Over Potentially Deadly Magnet Problem

MRI-Systems-Recalled

GE Healthcare issued a “field corrective action” earlier this month regarding 12,968 MR systems manufactured with Magnet Rundown Units (MRU) that could become disconnected and result in life-threatening consequences. Last week, the U.S. Food and Drug Administration (FDA) followed suit and issued a Class I recall of GE MRIs.

The problem came to the attention of GE Healthcare when an MRU on an MRI in India was found to be disconnected. The company immediately notified its customers of the issue after an MRI in India was found to be disconnected. In the field corrective action letter, the firm instructed its customers to conduct a five-step test to ensure that the magnet is connected to the system. If the MRI test does not perform accordingly, GE “strongly recommends” that customers stop using it and immediately call their GEHC representative. A GE field engineer will be sent to each site to ensure that the test was conducted and to conduct a free follow-up test, according to DOTmed.com. More Close to 13,000 GE MRI Systems Recalled Over Potentially Deadly Magnet Problem