Feds and Meds

Qsymia Helps weight loss

HOW IT WORKS

Qsymia (formerly called Qnexa) combines phentermine, an appetite suppressant, and topiramate, a drug that controls epileptic seizures. Together, these meds work to suppress brain chemicals that trigger hunger. In a study, subjects taking Qsymia who ate a reduced-calorie diet and regularly exercised lost about 10% of their starting body weight over the course of a year.

WHO IT'S FOR

People with a medical, not cosmetic, need for weight loss. According to the FDA, that means anyone who is obese--with a body mass index (BMI) of 30 or greater--or overweight, with a BMI of 27 or more and at least one weight-related condition such as diabetes or high cholesterol. Pregnant women should steer totally clear, however, because of the risk of birth defects.

WHY IT'S CONTROVERSIAL

The FDA had rejected Qsymia in 2010 because of concerns that it raised the risk of heart problems and, when taken by pregnant women, birth defects. Its maker, Vivus, will monitor users for these side effects and distribute the drug only through specially registered pharmacies that ensure doctors and users are advised of the risks.

WHAT IT CHANGES

Qsymia is only the third prescription diet medication on the market, and Vivus has not yet decided how much the pill will cost. While it's not a cure-all for obesity, it certainly could make it easier for some to shed pounds--a significant edge in a country where 36% of the population is dangerously obese.

Truvada Lowers risk of HIV infection

HOW IT WORKS

Truvada combines two anti-HIV drugs--emtricitabine and tenofovir. Taking the combo once a day can flood the body with enough virus-disrupting power to overwhelm HIV immediately after infection. In studies submitted to the FDA, gay and bisexual men who took Truvada lowered their risk of infection by up to 42% compared with those taking a placebo; for heterosexual partners, that figure jumped to 75%.

WHO IT'S FOR

People who are HIV-negative but likely to be exposed to the virus, such as those with HIV-infected partners or those who engage in high-risk sexual activity. For now, too, it helps to have a healthy income: the drug costs about $13,000 a year when taken to treat HIV. Those relying on Truvada to prevent HIV would need to take it only when they're at risk of exposure, but the pills may still be too costly for many.

WHY IT'S CONTROVERSIAL

Some public-health experts--and even AIDS advocates--had argued against approval, citing concerns that the pill would lull users into a false sense of security about being protected from HIV. Truvada is not 100% effective in preventing infection, and using it improperly can allow strains of HIV that are resistant to the drug to thrive.

WHAT IT CHANGES

Treating HIV infection certainly helps control AIDS, but preventing it is the only way to wipe out the disease, which affects some 33.3 million people worldwide. Since there's no HIV vaccine so far, Truvada could become a critical part of curbing AIDS in the developing world, where most new infections occur among heterosexual couples.

Source: FDA