Recalled Heparin and Saline Flushes May Be Contaminated
Pre-filled syringes containing either the anti-clotting agent heparin or normal saline solution may be contaminated with a dangerous bacterium and are being recalled by the manufacturer, the U.S. Food and Drug Administration said Friday.
Both types of pre-filled syringe are manufactured by North Carolina-based AM2 PAT Inc. The products were distributed nationwide under two brand names, Sierra Pre-Filled Inc. and B. Braun.
One lot of the heparin flush was found to be contaminated with Serratia marcescens bacteria, which caused patient infections. Infections with Serratia marcescens are capable of causing life-threatening illness or death, the FDA said.
Consumers or facilities who have any of the recalled products should stop using them immediately and return them to the distributor or place of purchase, the agency said.
The following products and codes are affected:
Heparin Lock Flush 100units/ml 5ml
Heparin Lock Flush 100units/ml 3ml
Heparin Lock Flush 10units/ml 5ml
Heparin Lock Flush 10units/ml 3ml
Heparin Lock Flush 10units/mL 3ml (6ml syringe)
Heparin Lock Flush 10units/mL 5ml (6ml syringe)
Normal Saline Flush 10ml
Normal Saline Flush 5ml
Normal Saline Flush 3ml
Any adverse reactions associated with use of these products should be reported to the FDA at 1-800-FDA-1088.
Smoking-Cessation Drug Chantix Gets Updated Warning
Packages of the smoking-cessation drug Chantix sold in the United States have been updated to more prominently display a warning that users should be monitored for suicidal behavior, depressed mood, and certain other serious mental health symptoms, MarketWatch reported.
Drug maker Pfizer Inc. said it made the label change after consultation with the U.S. Food and Drug Administration.
Since the drug was approved in the United States in May 2006, there have been a number of reports of erratic behavior, suicidal thoughts and other side effects in people taking Chantix. Last November, the FDA said it was investigating those reports and told doctors to monitor patients taking the drug, MarketWatch reported.
At that time, Pfizer added information about those potential side effects to the Chantix product label. The warning has now been moved to a more prominent location on the label to make it more obvious for doctors and patients.
There are 45 million Americans who smoke, and each year 70 percent report that they want to quit. Each smoker works to do so differently; the average former smoker makes eight to 11 attempts to quit, according to the American Legacy Foundation, which is dedicated to getting people to quit smoking.
The foundation says it has long recommended that smokers who want to increase their odds of quitting should make a plan, set a date, and talk with their physician to seek counseling on medications that will work best for them. They should also consider behavioral counseling in person or through telephone counseling from their state quitlines (1-800-QUIT-NOW).
The foundation was created as a result of the 1998 Master Settlement Agreement between attorneys general from 46 states, five U.S. territories and the tobacco industry.
FDA Approves New Test for Respiratory Viruses
A real-time test for four common respiratory viruses has been approved by the U.S. Food and Drug Administration. The ProFlu+ test provides results within as few as three hours.
Other respiratory virus tests are fast but not as accurate or are accurate but not as fast, the FDA said.
The ProFlu+ test can analyze a single sample for influenza A virus, influenza B virus, and respiratory syncytial virus A and B (RSV). These viruses can cause influenza, pneumonia and an infection of the airways called bronchiolitis. All the viruses are leading causes of lower respiratory tract infections.
"Antiviral drugs are most effective when initiated within the first two days of symptoms," Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said in a prepared statement. "This new test, which is part of the new era of molecular medicine, can help the medical community quickly determine whether a respiratory illness is caused by one of these four viruses and initiate the appropriate treatment."
The ProFlu+ test is made by Prodesse, Inc. of Milwaukee.
Virus May Be Linked to Deadly Skin Cancer
A new virus that may be linked to a rare but extremely deadly type of skin cancer called Merkel cell carcinoma has been identified by University of Pittsburgh Cancer Institute researchers, a finding that could lead to new cancer treatments.
The disease is most common in the elderly and in people with weakened immune systems, such as transplant patients and those with HIV/AIDS.
In this study, the researchers found that a new virus they named Merkel cell polyomavirus (MCV) was present in 80 percent of Merkel cell tumors, Agence France-Presse reported.
The researchers also found that the pattern of virus penetration in tumor cells indicates that infection occurs before the cells' growth into cancer. They believe MCV produces a carcinogenic protein that inhibits a gene that stops the growth of cancer cells.
The findings, published in the journal Science, need to be confirmed in future studies, the researchers said, AFP reported.
Concussions Afflict 10% to 20% of U.S. Combat Troops
Between 10 percent and 20 percent of U.S. combat troops deployed to Iraq or Afghanistan leave those war zones with concussions. And some don't realize they need treatment, says a report released Thursday by a task force on traumatic brain injury created by the U.S. Army Surgeon General.
Concussion is the common term for mild traumatic brain injury (TBI). Explosions are the most common cause of mild TBI among U.S. troops in Iraq and Afghanistan.
The Army has a handle on treating more severe brain injuries, but it is "challenged to understand, diagnose and treat military personnel who suffer with a mild TBI," said task force Chairman Brig. Gen. Donald Bradshaw, the Associated Press reported.
Headaches, nausea, dizziness, sleep and memory problems, light sensitivity, confusion and irritability are among symptoms caused by concussion. With treatment, more than 80 percent of patients make a complete recovery, according to the task force.
Concussion may be missed in soldiers who don't show any outward signs of head injury, such as bleeding, following an explosion or other incident, said Bradshaw, the AP reported.
CDC Investigates Illnesses Among Pig Plant Workers
U.S. health officials are investigating a possible link between worker illnesses at pig processing plants in Indiana and Minnesota. Two workers at the Indiana plant and 12 at the Minnesota plant developed symptoms that included changes in sensation and weakness in their limbs.
The affected employees at both plants worked in areas where compressed air was used to force the brains out of pigs' skulls, U.S. Centers for Disease Control and Prevention spokeswoman Lola Russell told the Associated Press.
The illness "may be associated with this particular technique of using high-pressure air to remove the pig's brain," she said.
The CDC checked practices at 25 large pork processing plants in 13 states and found only one other plant, in Nebraska, that used the same method to remove pigs' brains after slaughter. All three plants have voluntary stopped using this method, the AP reported.
Deadly Listeria Strain Found at Massachusetts Dairy Plant
The strain of listeria that killed three people has been found at a Massachusetts dairy processing plant. But health investigators still haven't determined exactly where contamination of the milk occurred at the Whittier Farms plant in Shrewsbury, the AP reported.
Since June, three elderly men died after drinking bacteria-contaminated milk from the plant. A pregnant women who drank the contaminated milk became sick and suffered a miscarriage, and another women also became ill after drinking milk from the plant.
No other cases of illness related to the contaminated milk have been identified and the public health risk is low, according to officials.
"We know that there's a problem in that plant and we have connected the patients to the products to the plant, now it would be nice to know exactly how that happened, but that is part of the ongoing investigation," Dr. Alfred DeMaria, state director of communicable disease control, told the AP.
Investigators analyzed more than 100 samples from the plant and found the deadly strain of listeria in seven bottles and on the floor near the homogenizer. Different listeria strains were detected inside four other bottles of milk and in an empty unwashed bottle, a bottle washer and a drain.