Strengthen Chantix Warnings: Study
Warnings about the risks of suicidal behavior and depression associated with the stop-smoking drug Chantix need to be strengthened, according to a new study.
It concluded that the psychological risks of Chantix (varenicline) exceed those of nicotine replacement drugs and the rival stop-smoking drug Zyban (bupropion), ABC Newsreported.
The study was published today in the journal PLoS One.
"Among all the treatments we have for smoking cessation, Chantix is the worst," Dr. Curt Furberg, a professor of public health sciences at Wake Forest Baptist Medical Center and one of the study's authors, told ABC News.
"The FDA's own data show that Chantix is more dangerous than other treatments to stop smoking," he noted.
But an FDA spokeswoman said the drug is a safe and effective way to help smokers kick the habit, ABC News reported.
Last week, the agency said two federally-funded clinical trials involving a total of more than 26,000 patients showed that Chantix did not increase depression and suicidal thoughts compared with other stop-smoking treatments.
Chantix was approved by the FDA in 2006. The agency in 2009 placed a "black box" warning label on Chantix and Zyban to alert doctors and patients about the risk of depression, hostility and suicidal thoughts associated with the drugs.
Expand Vytorin's Use to Include Some Kidney Patients: FDA Panel
The cholesterol drug Vytorin should be approved to prevent heart attack and stroke in some patients with kidney disease, a U.S. Food and Drug Administration advisory panel recommends.
In a 16-0 vote, the panel decided the drug should be approved to treat kidney disease patients who aren't on dialysis, but they voted 10-6 against using the drug to treat patients with end-stage renal disease on dialysis treatment, Bloomberg News reported.
An FDA review released before the advisory panel meeting said a clinical trail showed that Vytorin reduced the risk of "major vascular events" in kidney disease patients by 16 percent compared with a placebo.
While the FDA is not required to follow its advisory panels' recommendations, it generally does so.
Merick and Co.'s Vytorin is a combination of the cholesterol drugs Zetia and Zocor,Bloomberg reported.
Laser Treatment Turns Brown Eyes Blue
A new laser procedure can turn brown eyes blue, according to a California company.
The 20-second treatment destroys the natural brown pigment melanin in the iris and the change to blue occurs gradually over the following two to three weeks, CBS Newsreported.
Vision isn't affected but the color change is permanent, said Dr. Gregg Homer of Stroma Medical, the company that developed the experimental procedure.
Further testing is required and the treatment may be available in other countries within 18 months and in the U.S. within three years, according to Homer, CBS News reported.
The cost is expected be about $5,000.
One expert warned about possible complications. The pigment released from the iris has to go somewhere, Dr. Elmer Tu, an associate professor of clinical ophthalmology at the University of Illinois in Chicago and a spokesman for the American College of Ophthalmology, told CBS News.
He noted that a potentially blinding condition called pigmentary glaucoma is associated with chronic seepage of melanin into the fluid within the eye.
Dutch Psychologist's Studies Fraudulent: Investigators
A renowned Dutch psychologist committed academic fraud in several dozen published papers, according to a committee of investigators at three academic institutions where Diederik Stapel worked.
The investigators also said that more than a dozen doctoral theses that Stapel oversaw are also questionable, The New York Times reported.
Stapel, who is currently at Tilburg University and has also worked at the University of Groningen and the University of Amsterdam, has published about 150 papers.
The investigative committee concluded that Stapel falsified data and made up entire experiments. The committee did not release a list of papers that it had determined were fraudulent, The Times reported.
FDA Testing Pet Food for Salmonella
A nationwide program to test pet food and related products for salmonella has been launched by the U.S. Food and Drug Administration because there is evidence that tainted pet food is making owners sick.
In October, agency investigators began taking samples of pet treats, dry pet food and pet diet supplements from retailers, wholesalers and distributors, the Wall Street Journalreported.
The testing includes products for dogs, cats, rabbits, reptiles, aquarium fish, birds and rodents such as mice, guinea pigs and hamsters.
In a memorandum released this week, the FDA said it is "particularly concerned about salmonella being transmitted to humans through pet foods, pet treats, and supplements for pets that are intended to be fed to animals in homes, where they are likely to be directly handled or ingested by humans," the Wall Street Journal reported.
To highlight the need for testing, the FDA cited Centers for Disease Prevention and Control data showing that 70 people became ill from January 2006 to December 2007 in connection with salmonella-tainted dry dog food made in Pennsylvania.