Is a new weight-loss drug about to hit the market?
The U.S. Food and Drug Administration has ignited rampant discussion about the possibility, after announcing its plan to review the treatment known as Qnexa.
The reason for all the excitement? Clinical trials have shown that people who take Qnexa lose significant amounts of weight; a trial published in 2009 showed patients on the drug lost an average of nearly 17 kilograms (37 pounds).
The FDA rejected approval of the drug in 2010, however, because of nagging concerns it may increase the risk of birth defects and heart problems. On Friday, the FDA reiterated its stance that Qnexa may cause serious side effects.
But regulators have decided to review Qnexa's status after receiving additional information about the drug's effectiveness and safety.
If it gets the green light, the drug could lead to major changes in how obesity is treated. Although other weight-loss drugs are on the market, many fail to produce major changes or come with risk of serious side effects. One drug, sibutramine, sold under the brand name Meridia, was recalled in 2010 after studies showed it was linked to a higher risk of heart problems.
Although FDA approval doesn't guarantee the drug will be approved here, Health Canada officials often make decisions similar to those of their counterparts in the United States.
Despite the fact Qnexa isn't approved, many doctors are already prescribing it. The New York Times reported Friday that because Qnexa is essentially a mixture of two already-approved drugs, phentermine and topiramate, many doctors are prescribing it in an "off-label" capacity, a perfectly legal practice.
However, this has sparked significant concern among some in the medical community, who warn it's dangerous for patients to be taking a treatment when the side effects aren't fully understood.
The future of Qnexa will become more clear next week, when regulators will grill the drug maker in hopes of reaching a decision.
Are you struggling to lose weight? Would you be willing to risk serious side effects if a pill could help?
Would you be willing to risk serious side effects if a pill could help you shed pounds?
Carly Weeks