FDA Will Track Drugs to Fight Counterfeiting
Federal regulators will begin requiring wholesalers to track who handles the pharmaceuticals they sell, to help combat a rise in counterfeit drugs entering the legitimate market.
The decision Friday by the U.S. Food and Drug Administration is expected to take effect Dec. 2. In practice, the move could affect the distribution system for medicines, requiring distributors to provide factory-to-pharmacy documentation of the chain of custody of drug products -- its so-called "pedigree" -- throughout the distribution system.
The FDA believes that radio-frequency identification (RFID) technology is the most promising way to track drugs as they move through the supply chain. However, the agency said that it will hold off requiring drug manufacturers and distributors to use the technology, until more businesses adopt the electronic track-and-trace tags, the Associated Press reported Friday.
The FDA urges U.S. consumers to purchase drugs only from state-licensed U.S. pharmacies and to be alert to changes in packaging, labeling, color, taste, pill shape or unanticipated side effects. Before buying drugs over the Internet, consumers should look for the Verified Internet Pharmacy Practice Sites (VIPPS) seal on the Web site.
Safety Group Cites Sharp Drop in Firefighter Deaths
The U.S. National Fire Protection Association said Friday that 87 on-duty firefighters died in the United States in 2005, the third lowest toll since the fire-safety group began tracking deaths almost 30 years ago. Sudden cardiac deaths remained the leading cause of fatalities.
For the third straight year, the group said, firefighters were more likely to die responding to or returning from alarms and not at the scene of a fire. Of 26 deaths occurring in transit for 2005, 13 were due to sudden cardiac death and 10 were due to vehicle collisions or rollovers.
Particularly distressing, the group noted, were 11 firefighter deaths that occurred during training activities. The safety organization is conducting a special analysis of 100 training fatalities that occurred between 1996 and 2005.
Factors contributing to the drop in fatalities included decreases in deaths associated with wildland fires and the number of firefighters struck and killed by vehicles, the group said in a statement. It has compiled fatality figures for firefighters since 1977.
Lawsuits Filed Over Lipitor Side Effects
Two men filed suit in New York State Supreme Court this week against Pfizer Inc., claiming the company didn't issue loud-enough warnings about the potential side effects of its popular anti-cholesterol drug Lipitor.
"It ruined my life," said Michael Mazzariello, a 47-year-old attorney from New York City and one of the plaintiffs. Mazzariello said he couldn't walk without a cane, tend his garden or lift his 1-year-old child.
A second lawsuit was filed by Charles M. Wilson, a former insurance executive from Atlanta, who claimed similar side effects made him ill.
The Associated Press reported Thursday that Mazzariello did manage to stand by himself at a news conference in Manhattan to say that the symptoms subsided once he stopped taking the drug, but that he still felt pain.
Pfizer has vowed to fight the lawsuits, calling them "baseless." A company spokesman said that all potential side effects of the drug are included on its labeling and that research has repeatedly shown that the drug is safe for a vast majority of users.
Lipitor, a type of statin used to lower cholesterol, is the top-selling medication in the world and brings in more than $12 billion a year for Pfizer.
Polio Outbreak in Namibia Puzzles WHO
An polio outbreak that has killed 7 people and paralyzed 33 more in the southern African nation of Namibia has left World Health Organization officials puzzled over its unusual course.
Polio normally attacks infants and young children, not adults, and Namibia had been free of the disease for a decade, The New York Times reported Friday. Vaccine stocks were low only enough for routine vaccination of infants and people were turned away when supplies ran out.
When new vaccine shipments arrive, the outbreak should be brought under control with relative ease, Dr. David L. Heymann, the WHO director general's representative for polio eradication, told the newspaper.
Namibia, home to 2 million people on Africa's southwest coast, has been headlines all week because of the recent birth there of Shiloh Nouvel Jolie-Pitt, the daughter of actors Angelina Jolie and Brad Pitt. Acccording to the Times, the baby was born in a coastal resort -- about 150 miles from the capital, Windhoek, where the polio outbreak occurred.
Drug Company Halts Enrollment of Children in Antibiotic Trial
The pharmaceutical company Sanofi-Aventis has stopped enrolling children in clinical trials of an antibiotic that some reports said could cause liver failure in adults.
The drug maker said it halted tests on its own Thursday to ensure that trials of the antibiotic Ketek complied with U.S. Food and Drug Administration requirements, the Associated Press reported Friday.
On Thursday, The New York Times cited internal FDA memorandums that said some safety officials believed the company should remove Ketek from the market, severely restrict its use or add a prominent warning label about its potentially fatal side effects. The company denied the suspension was linked to the newspaper's report.
Ketek is currently approved only for adults and is used to treat sinusitis, bronchitis and pneumonia. The company had been testing the drug as a treatment for ear infections and tonsillitis in nearly 4,000 infants and children in more than a dozen countries, including the United States.
Amsterdam Opens Clinic for Young Video Game Addicts
The Netherlands is opening Europe's first detox clinic for young video game addicts who've got too much game.
Keith Bakker, director of Amsterdam-based Smith & Jones Addiction Consultants, said video games look innocent enough but compulsive play is as addictive as gambling or taking drugs.
"We have kids who don't know how to communicate with people face-to-face because they've spent the last three years talking to somebody in Korea through a computer," Bakker told the Associated Press. "Their social network has completely disappeared."
The eight-week program will include counseling for gamers and introductions to alternative activities that don't need a mouse-click to enjoy.
A New Twist to the 'Sex and the Headache' Story
Wake Forest University medical researchers say that some headaches may pack more than just a wallop.
Reporting in an upcoming issue of Headache, the team say migraine-headache sufferers reported higher levels of sexual desire than those with other types of headaches.
The researchers said sexual desire and migraine headaches have been linked to levels of serotonin, a brain chemical that also plays a role in depression. An excess of serotonin may be associated with decreased libido, and migraine sufferers are reported to have low system levels of the brain chemical.