FDA approves Wegovy to reduce heart attack and stroke risk
Controversy surrounding diabetes drug, Ozempic, being used tor weight loss
The diabetes drug, Ozempic, has been in the headlines, causing quite a stir. Senior writer for Drugwatch.com, Terry Turner, joined LiveNow to discuss how some people are ending up in the hospital, for misusing Ozempic as a weight loss drug.
Wegovy, a popular weight-loss drug known for helping Americans lose weight, has just been approved by federal regulators on Friday to be used to reduce the risk of stroke, heart attacks and other serious cardiovascular problems in patients who are overweight or obese.
The U.S. Food and Drug Administration approved a label change requested by drugmaker Novo Nordisk that expands the use of semaglutide.
The agency made the decision based on the results of a study published in November that found that Wegovy cut the risk of severe heart problems – including heart attack, stroke and heart-related deaths.
The agency said Wegovy is the first medication approved to help prevent potentially life-threatening events in this population.
"Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health," said Dr. John Sharretts, who directs the FDA's division of diabetes, lipid disorders and obesity.
How Wegovy could change heart patient treatment
The drug’s FDA backing confirms that the new class of obesity medications helps improve health, not just lose weight.
"The hope is that insurers will start understanding that this is not a vanity drug," said Dr. Martha Gulati, a cardiologist at Cedars-Sinai Medical Center in Los Angeles, who estimated that nearly 70% of her heart patients could be eligible for treatment.
Ozempic, a lower-dose version of Wegovy, was previously approved to cut the risk of severe heart problems in people with that disease, but it typically costs around $1,300.
However, a spokesperson for AHIP, America's Health Insurance Plans, an industry trade group, said private insurers intend to evaluate the new federal approval for Wegovy before making coverage decisions.
Drugmakers and obesity advocates have been pushing for expanded coverage, including legislation that would require Medicare to pay for these new obesity drugs.
At issue has been whether the cost of the expensive medications will be offset by the savings of reduced spending on medical care related to obesity — and, now, heart disease.
Side effects of Wegovy
Some of the more serious side effects, according to the FDA include thyroid tumors and certain cancers. Low blood sugar, pancreas, gallbladder, kidney, or eye problems were also reported in patients who took the drug.
Roughly a third of the patients in the clinical trial reported serious side effects.
About 17% of the group that took Wegovy and about 8% of those who received a placebo left the study because of those effects.