Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Expand Use of Fish Oil Drug Vascepa: FDA Panel
Approved use of the prescription-strength fish oil drug Vascepa should be widened to include more patients at risk for heart attack and stroke, a U.S. Food and Drug Administration advisory panel recommended Thursday.
Vascepa is currently approved for patients with extremely high levels of triglycerides, a type of fat in the blood associated with heart disease, the Associated Press reported.
Drug maker Amarin is seeking FDA approval for the use of Vascepa in patients who have lower blood fat levels but still have a risk of heart problems, despite taking cholesterol-lowering statins. A month’s supply of Vascepa costs roughly $300.
The FDA panel unanimously voted Thursday in favor of expanded use of Vascepa. Their decision was based on research showing that the drug can reduce rates of dangerous heart problems in high-risk patients, the AP reported.
“There is no doubt this drug could benefit a substantial portion of the U.S. population and meet an unmet need,” said panel member Dr. Jack Yanovski, a hormone specialist at the U.S. National Institutes of Health.
But Phillip Posner, the patient representative on the panel, noted that, “”I do not want to see this become what I call cardio candy.”
The FDA, which is not required to follow the panel’s recommendation but typically does, is expected to make a decision by the end of the year, the AP reported.
Warning Letter About OTC Drugs Sent to Dollar Store: FDA
Dollar Tree has been sent a warning letter for selling over-the-counter (OTC) drugs made by foreign companies with serious, multiple violations of federal manufacturing laws, the U.S. Food and Drug Administration says.
The drugs include Dollar Tree’s Assured Brand OTC drugs and other drug products sold by Dollar Tree Co., which operates stores under the Dollar Tree and Family Dollar names.
The contract manufacturers used by Dollar Tree to make the OTC drugs have received warning letters from the FDA for violations such as not testing raw materials or finished drugs for pathogens and quality.
In its warning letter to Dollar Tree, the FDA outlines a number of corrective actions the company needs to take, including a system to ensure that they do not import impure drugs.
Dollar Tree said that it is cooperating with the FDA and plans to meet with the agency, CNN reported.
“We are committed to our customers’ safety and have very robust and rigorous testing programs in place to ensure our third-party manufacturers’ products are safe,” Randy Guiler, vice president of investor relations at Dollar Tree, said in a company statement.
“Each of the items referenced in the report are topical, and not ingestible, products. As always, we are cooperating with the U.S. Food and Drug Administration [FDA]. We plan to meet with the FDA in the near future and expect that our plans will satisfy their requirements in all regards,” the statement said, CNN reported.
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Posted: November 2019