Health Highlights: Nov. 15, 2012
Glaxo Pays $90 Million in Avandia Settlement Reports Cite Caffeinated Energy Drink in Deaths States Prepare to Deal With Stoned Drivers
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Glaxo Pays $90 Million in Avandia Settlement
GlaxoSmithKline has agreed to pay $90 million to settle charges in the U.S. that it illegally promoted the Avandia diabetes drug.
In the claims, 37 states and the District of Columbia said that Glaxo misled consumers about whether Avandia caused heart attacks and strokes, Bloomberg News reported.
Under the settlement, the company must also make changes to the way it discloses and uses safety data about its drugs.
The settlement "is tough, fair and it holds GlaxoSmithKline accountable for how the company marketed Avandia," Tom Horne, Arizona's attorney general, said in an e-mailed statement to Bloomberg.
Glaxo has already paid more than $3 billion to settle government investigations of its marketing of Avandia and other medications, along with patient lawsuits over the diabetes drug.
Reports Cite Caffeinated Energy Drink in Deaths
A highly-caffeinated energy drink called 5-Hour Energy may have been involved in 13 deaths over the last four years, according to reports submitted to the U.S. Food and Drug Administration.
Since 2009, the product has been cited in about 90 filings with the FDA, according to agency records reviewed by The New York Times. More than 30 of those filings involved serious or life-threatening problems such as heart attacks, convulsions and even a spontaneous abortion.
When an incident report is filed with FDA, it does not mean that a product was responsible for, or in any way contributed to, a death or injury.
The distributor of 5-Hour Energy is Living Essentials of Farmington Hills, Mich. It is a unit of the product's producer, Innovation Ventures. In a statement, Living Essentials said 5-Hour Energy is safe when used as directed and that it is "unaware of any deaths proven to be caused by the consumption of 5-Hour Energy," The Times reported.
Unlike most energy drinks that look like beverages, 5-Hour Energy comes in a two-ounce bottle called a shot. The amount of caffeine in each bottle is not disclosed by the company, but a Consumer Reports article said it was about 215 milligrams.
In comparison, an eight-ounce cup of coffee can contain between 100 and 150 milligrams of caffeine, according to The Times.
Energy drinks are becoming a major issue for the FDA. Last month, the agency said it had received five fatality filings mentioning the popular energy drink, Monster Energy. Since then, producer Monster Beverage of Corona, Calif. has repeatedly stated that its products are safe and were not the cause of any of the health problems reported to the FDA.
Some lawmakers want the FDA to increase its regulation of energy drinks and the New York State attorney general is investigating the practices of several energy drink producers, The Times reported.
There is not enough scientific evidence to justify changes in how it regulates caffeine or other ingredients in energy products, according to the FDA.
The agency is looking into the death reports that cited 5-Hour Energy, Daniel Fabricant, director of the FDA's division of dietary supplement programs, told The Times.
While medical information in such reports could rule out a connection with 5-Hour Energy, other reports could lack sufficient information to determine what part, if any, a product might have played in a death, Fabricant said.
States Prepare to Deal With Stoned Drivers
With recreational marijuana use soon to be legal in Washington and Colorado, officials in the two states are trying to determine how they'll deal with the issue of stoned drivers.
Colorado's measure legalizing marijuana does not make any changes to the state's driving-under-the influence laws, which has politicians and police worried about the impact on road safety, the Associated Press reported.
Washington's measure does change DUI laws by setting a new blood test limit for marijuana. Police are training to enforce that limit.
"We've had decades of studies and experience with alcohol," Washington State Patrol spokesman Dan Coon told the AP. "Marijuana is new, so it's going to take some time to figure out how the courts and prosecutors are going to handle it. But the key is impairment: We will arrest drivers who drive impaired, whether it be drugs or alcohol."
While there are portable breath tests for alcohol, there's no simple way to determine if a driver is impaired from recent marijuana use. Tests for current marijuana impairment measure for active THC in the blood, and those levels typically drop within hours of marijuana use. THC is the psychoactive chemical in marijuana.
While marijuana legalization activists agree that people should not smoke marijuana and drive, there is disagreement about setting a standard comparable to blood-alcohol limits, according to Betty Aldworth, outreach director for Colorado's Campaign to Regulate Marijuana Like Alcohol.
Currently, most convictions for drugged driving are based on police observations, which are followed up by a blood test.
"There is not yet a consensus about the standard rate for THC impairment," Aldworth told the AP.