Health Highlights: Sept. 27, 2013
FDA Warns That Antibiotic Tygacil Shows Raised Death Risk 'Extremely Likely' That Humans are Main Cause of Climate Change: Report Colorado Cantaloupe Farmers Charged Over Listeria Outbreak Artifical Pancreas System Approved by FDA First Reported Cases of Krokodil Drug in U.S. Kids' Sunscreens Recalled for Potential Contamination
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
FDA Warns That Antibiotic Tygacil Shows Raised Death Risk
The antibiotic Tygacil is linked to an increased chance of death when used to treat serious infections, the U.S. Food and Drug Administration said Friday.
In issuing a black box warning, the agency asked that physicians limit their use of the intravenous medication.
Labeling for the Pfizer drug will now state that the medicine "should be reserved for use in situations when alternative treatments aren't suitable."
The warning is based on a new analysis that showed 2.5 percent of patients receiving Tygacil died, compared with 1.8 percent of patients receiving other antibiotics.
Pfizer said in a statement it will update the labeling, Dow Jones reported. "Pfizer encourages health care professionals to review all available information to find an antibiotic therapy that works best for each patient's clinical situation," the company said.
Approved for the treatment of a specific type of pneumonia and certain skin and intra-abdominal infections, Tygacil is not approved to treat diabetic foot infections or for hospital-acquired or ventilator-associated pneumonia. In 2012, sales of the drug surpassed $335 million, Dow Jones reported.
The agency's concerns with Tygacil first surfaced in 2010, when the FDA warned of an increased risk of death in clinical studies. Since then, the agency has analyzed data from 10 trials to arrive at the decision to issue a black box warning.
"In general, the deaths resulted from worsening infections, complications of infection or other underlying medical conditions," the agency said.
'Extremely Likely' That Humans are Main Cause of Climate Change: Report
It's "extremely likely" that human activity is the main cause of global climate change that has occurred since the 1950s, according to a new report by an international scientific group.
The words linking humans and climate change are the strongest used to date by the U.N.-sponsored Intergovernmental Panel on Climate Change. In an assessment released in 2007, the panel said it was "very likely" that global warming was man-made, the Associated Press reported.
The IPCC also addressed the apparent slowdown in global warming in the past 15 years, something that climate change skeptics say casts doubt on the scientific consensus on climate change.
Short-term climate records are sensitive to natural variability and don't in general reflect long-term trends, according to the IPCC report.
"An old rule says that climate-relevant trends should not be calculated for periods less than around 30 years," said Thomas Stocker, co-chair of the group that wrote the document, the AP reported.
Overall evidence of climate change has increased due to more and better observations, improved understanding of the climate system, and improved models to assess the impact of rising temperatures, the IPCC noted.
"Our assessment of the science finds that the atmosphere and ocean have warmed, the amount of snow and ice has diminished, the global mean sea level has risen and the concentrations of greenhouse gases have increased," said Qin Dahe, co-chair of the working group that wrote the report.
A summary of the report's key findings was released Friday and the full 2,000-page report will be released Monday. The IPCC assessments provide the scientific basis of U.N. negotiations on a new climate deal, the AP reported.
The panel now predicts that sea levels will rise 10-32 inches by the end of the century, compared with a rise of 7-23 inches predicted in the previous report. The new report also predicts that global average temperatures will rise by 0.5 to 8.6 degrees F by the end of the century.
"This is yet another wakeup call: Those who deny the science or choose excuses over action are playing with fire," U.S. Secretary of State John Kerry said in a statement, the AP reported.
"Once again, the science grows clearer, the case grows more compelling, and the costs of inaction grow beyond anything that anyone with conscience or common sense should be willing to even contemplate," Kerry added.
The new report should convince governments to take action on climate change, activists said.
"There are few surprises in this report but the increase in the confidence around many observations just validates what we are seeing happening around us," Samantha Smith, of the World Wildlife Fund, told the AP.
Colorado Cantaloupe Farmers Charged Over Listeria Outbreak
Two brothers who owned a Colorado cantaloupe farm linked to a listeria outbreak that killed 33 people and sickened 147 others pleaded not guilty to criminal charges related to the nationwide outbreak.
Eric and Ryan Jensen, ages 37 and 33, owned the now-bankrupt Jensen Farms. They appeared in court Thursday and each was charged with six midemenaor counts of introducing adulterated food into interstate commerce. The brothers pleaded not guilty, the Associated Press reported.
They were released on a $100,000 unsecured bond and their trial is scheduled for Dec. 2. If convicted of all six counts, they could face up to six years in prison and up to $1.5 million in fines.
The Jensens released a statement saying the outbreak was a "terrible accident" that shocked and saddened them. They also noted that the charges do not imply they knew about the contamination or that they should have known about it, the AP reported.
Artifical Pancreas System Approved by FDA
The first artificial pancreas system for people with diabetes has been approved by the U.S. Food and Drug Administration.
The MiniMed 530G with Enlite automatically stops insulin delivery to diabetics when glucose levels reach a certain point, Bloomberg News reported.
The FDA approved the system for use by people with diabetes who are at least 16 years old. The system is made by Medtronic Inc. of Minneapolis.
The new system's improved accuracy and ability to turn itself off for two hours is an advance over existing machines, which sound an alarm when glucose levels reach a preset level, Bloomberg reported.
First Reported Cases of Krokodil Drug in U.S.
The first calls in the United States about the use of a dangerous drug called krokodil were received in the past week by a poison control center in Phoenix, Ariz.
"As far as I know, these are the first cases in the United States that are reported. So we're extremely frightened," Dr. Frank LoVecchio, the co-medical director at Banner's Poison Control Center, told CBS News.
The real name for Krokodil, known for its use in Russia, is desomorphine. It is an opioid derivative of morphine and, like heroin and other opioids, it has a sedative and analgesic effect.
The drug is fast-acting and eight to 10 times more potent than morphine. It's easy to make a homemade version of the drug using codeine, iodine, gasoline, paint thinner, hydrochloric acid, lighter fluid and red phosphorus, CBS News reported.
"They extract (the drug) and even though they believe that most of the oil and gasoline is gone, there is still remnants of it. You can imagine just injecting a little bit of it into your veins can cause a lot of damage," LoVecchio said.
About 1 million people in Russia use krokodil and it has been found in other European countries as well, according to the New York State Office of Alcoholism and Substance Abuse Services.
Krokodil is Russian for crocodile and the nickname was given to the drug because users can develop scale-like, green skin, CBS News reported.
Kids' Sunscreens Recalled for Potential Contamination
Some Badger baby and children's sunscreen products are being recalled in the United States and Canada due to microbial contamination.
All lots of the company's 4-ounce SPF 30 Baby Sunscreen Lotion and one lot of its 4-ounce SPF 30 Kids Sunscreen Lotion are being recalled after tests revealed contamination with Pseudomonas aeruginosa, Candida parapsilosis and Acremonium fungi, the U.S. Food and Drug Administration said.
The affected lots include:
- SPF 30 Baby Sunscreen Lotion 4oz (UPC: 634084490091 & 634084490114) Lot #'s 3024A, 3057B, 3063A, 3063B, 3132A, 3133A.
- SPF 30 Kids Sunscreen Lotion (UPC: 634084490145 & 634084490169) Lot # 3164A.
The sunscreen products were sold online and at major retailers, pharmacies and independent food co-ops. Consumers with the products should not use them and may return them to the point of purchase for a full refund, the FDA said.
Consumers can also contact W.S. Badger Co. Inc. at 1-800-603-6100.