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FRIDAY, March 8, 2024 (HealthDay News) — Wigovy (semaglutide), a reduced version of the blockbuster diabetes drug Ozempic, was approved by the U.S. Food and Drug Administration on Friday for the prevention of heart attacks, strokes and cardiac death. Ta.
“Wegovy is the first weight-loss drug approved for use in the prevention of life-threatening cardiovascular events in adults with cardiovascular disease who are obese or overweight.” said Dr. John Sharetz, FDA’s Center for Drug Evaluation and Research said in an agency statement.
“This patient population is at high risk for cardiovascular death, heart attack, and stroke. Providing treatment options that are proven to reduce this cardiovascular risk is a major advance for public health.” explained.
According to the FDA, more than 70% of U.S. adults are overweight or obese, further increasing the risk of heart attack and stroke.
In one multinational study involving more than 17,600 people, participants received injections of Wegovy or a placebo. All participants received standard care management of blood pressure and cholesterol, as well as counseling on exercise and healthy eating.
“Wegovy significantly reduced the risk of serious adverse cardiovascular events.” [cardiovascular death, heart attack and stroke]occurred in 6.5% of participants who received Wegovy, compared with 8% of participants who received a placebo,” the FDA said.
It is believed that this expanded approval from the FDA could remove barriers for insurance companies to cover Wegovy. That could significantly expand the number of people who could be prescribed the drug.
Officials say Wegovy has potential side effects including nausea, diarrhea, vomiting, constipation, abdominal (stomach) pain, headache, fatigue, indigestion (indigestion), dizziness, bloating, belching, flatulence, and low blood sugar. said. Diabetes, bloating, heartburn.
Patients taking Wegovy may suffer from inflammation of the pancreas (pancreatitis), gallbladder problems (including gallstones), hypoglycemia, acute kidney injury, hypersensitivity reactions, diabetic retinopathy (damage to the retina of the eye), and decreased heart rate. rise, you may also face an increased risk of suicide. actions or thoughts.
Using Wegovy with insulin also increases the risk of hypoglycemia, so people taking insulin should consult their doctor before starting Wegovy, the FDA said.
“Wegovy Prescription Information” [also] This product contains a boxed warning to inform health care professionals and patients about the risk of C-cell thyroid cancer and should not be used by anyone with a personal or family history of medullary thyroid cancer. says the FDA.
For more information
For more information about Wegovy and similar drugs, visit Cleveland Clinic.
Source: U.S. Food and Drug Administration, News Release, March 8, 2024
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