The release of a Chantix study last week that linked the drug to numerous side effects has prompted the Food & Drug Administration (FDA) to initiate another safety review of the drug.  The review will mark the second such investigation for Chantix, which is already being scrutinized because of its association with psychiatric side effects, including suicide and depression.

Chantix is a popular anti-smoking drug made by Pfizer, Inc.  It was approved in 2006, and was the first nicotine receptor partial agonist – meaning it blocks nicotine receptors in the brain – on the market.  Last Tuesday, the Institute for Safe Medication Practices issued a report detailing Chantix adverse event repots to the FDA.  The report specifically cited  224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes.  There were also reports of traffic accidents and falls linked to Chantix.  As a result of the Institute’s report, the Federal Aviation Administration banned Chantix use by pilots and air traffic controllers.  Earlier this week, the Federal Motor Carrier Safety Administration said that “… it appears that medical examiners should not certify a driver taking Chantix because the medication may adversely affect the driver’s ability to safely operate a commercial motor vehicle.” (more…)

A recent study out of Germany found hormone replacement therapy (HRT) drugs – inlcuding Prempro and Premarin – taken for more than five years, increases one’s breast cancer risk, confirming earlier findings out of the United States.

Over 10,000 people between 50 and 74 were studied over six years: 3,464 breast cancer patients and 6,657 healthy women.  The German survey was prompted by the “MARIE” case-control study carried out by the German Cancer Research Center (DKFZ) and the University Hospitals in Hamburg-Eppendorf, Germany.  The study’s goal, which was financed by the German Cancer Aid (Deutsche Krebshilfe), was to determine hormone effects—on their own and with other factors—on breast cancer risk. (more…)

International Pharmaceuticals, Ltd. of Bradford, Massachusetts just announced that it is voluntarily recalling all of its supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving, after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by the agency of a sample from one lot of the product revealed it contained a potentially harmful undeclared ingredient, hydroxyhomosildenafil.

The FDA asserts that this ingredient is an analog of sildenafil, which is the active chemical ingredient of Viagra and other FDA-approved drugs used for Erectile Dysfunction (ED) in men to enhance sexual performance.  According to an FDA release, the use of undeclared chemicals poses a threat to consumers because they may harmfully interact with nitrates found in some prescription drugs—such as nitroglycerin—and may lower blood pressure to dangerous levels.  Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take such nitrates, says the FDA. (more…)

Vioxx maker Merck & Co. won two court victories this week, in Texas and New Jersey, as appeals courts reversed rulings in Vioxx lawsuits.  However, the Merck victories won’t affect the $4.85 billion settlement the company struck with thousands of Vioxx victims last November.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration (FDA) ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. (more…)

The Food & drug Administration (FDA) yesterday announced two food recalls, one for possible E. coli contamination and the other for possible Listeria contamination.

Orval Kent Foods is voluntarily recalling about 23,000 pounds of Amish Macaroni Salad in response to the results of a test conducted by the Ohio Department of Agriculture and Consumer Services, Division of Food Safety, for E. coli O157:H7. (more…)

The U.S. Consumer Product Safety Commission (UPSC), in cooperation with QuinCrafts of Dexter, Michigan, today announced a voluntary recall of the Makit & Bakit Jewelry Sets and Suncatcher sets as the clasps on some of the jewelry contains high levels of lead.

About 70,000 of the Makit & Bakit Jewelry Sets and Suncatcher sets are being recalled and included those QuinCrafts products containing children’s jewelry.  The recall includes the following items.  Item numbers can be found printed on the back of the packaging: (more…)

According to court papers just filed in the U.S. District Court in New Jersey on Thursday, several companies have agreed to pay a combined $24 million to pet owners to resolve a variety of lawsuits over contaminated pet food linked to the illness and death of animals.  The settlement involves Canada-based Menu Foods Income Fund and other pet food manufacturers and suppliers and is pending court approval.  This settlement is separate from the $8 million already paid to pet owners by some of the companies or their insurers.

Consumers in the U.S. and Canada filed over 100 lawsuits against multiple pet food makers after a massive recall of tainted pet food and treats last year.  An agreement in principle to settle the case was announced in April; lawyers for the plaintiffs and defendants said in the new court papers that a settlement had now been reached. (more…)

The death toll of yesterday’s New York City crane collapse now stands at two, and at least one other person has been seriously injured. All three were construction workers at the site. According to MSNBC, the first fatality involved a worker who was in the cab of the crane when it fell, and the second construction worker died at the hospital. In addition, one pedestrian was treated for minor injuries.

The crane involved in the accident was perched atop the Azure, a building currently under construction at 91st Street and 1st Avenue on Manhattan’s upper east side. The crane destroyed the penthouse and several other apartments at the Electra, an adjacent building. The tragedy occurred shortly after 8:00 a.m., at the height of rush hour. (more…)

The active ingredient in the acne drug Accutane— known generically as isotretinoin—more than doubles the risk of depression, according to a recent study.  The study is the first controlled investigation to find a statistically significant link between Accutane and depression, Dr Anick Berard, from CHU Sainte-Justine Research Centre in Montreal, and colleagues, state in a report in the Journal of Clinical Psychiatry.  “Current guidelines should possibly be modified to include psychiatric assessments of patients prior to and during isotretinoin therapy,” the researchers wrote.

Berard’s team studied 30,496 people from Quebec, Canada, who received at least one Accutane or isotretinoin prescription from 1984 through 2003.  During the study period, 126 of these individuals received a depression-related diagnosis, hospitalization, or treatment.  Also, based on earlier research, the researchers focused on isotretinoin use in the five months prior to the depression diagnosis—the risk period—as compared with a five-month period a year before the diagnosis—the control period.  After accounting for potential factors that might influence the results, isotretinoin exposure was associated with a greater than 2.6-fold relative risk of depression, the team found.  “Because depression could have serious consequences, close monitoring of isotretinoin users is indicated,” Berard and colleagues concluded. (more…)

Pacemakers can be hacked – relatively easily.  Now a research team that was able to hack the implantable defibrillators that keep sick hearts beating steadily are telling federal regulators that the problem needs to be addressed.

In recent years, over 100,000 patients in the US have been implanted with a defibrillator device – or pacemaker – that has helped to reduce medical visits.  The device and its technology enable patient information to be sent to a bedside monitor that then sends the data to a doctor.  Transmissions generally occur once daily. But researchers at the University of Massachusetts Amherst and the University of Washington have discovered that the defibrillator monitoring technology is vulnerable to hacking and—worse—reprogramming that could stop the defibrillators from providing a lifesaving shock. (more…)