Scientific evidence shows that taking an aspirin daily can help prevent a heart attack or stroke in some people, but not in everyone. It also can cause unwanted side effects.

According to Robert Temple, M.D., deputy director for clinical science at the Food and Drug Administration (FDA), one thing is certain: You should use daily aspirin therapy only after first talking to your health care professional, who can weigh the benefits and risks.

Who Can Benefit?

“Since the 1990s, clinical data have shown that in people who have experienced a heart attack, stroke or who have a disease of the blood vessels in the heart, a daily low dose of aspirin can help prevent a reoccurrence,” Temple says. (A dose ranges from the 80 milligrams (mg) in a low-dose tablet to the 325 mg in a regular strength tablet.) This use is known as “secondary prevention.”

However, after carefully examining scientific data from major studies, FDA has concluded that the data do not support the use of aspirin as a preventive medication by people who have not had a heart attack, stroke or cardiovascular problems, a use that is called “primary prevention.” In such people, the benefit has not been established but risks—such as dangerous bleeding into the brain or stomach—are still present.

Caution Needed With Other Blood Thinners

When you have a heart attack, it’s because one of the coronary arteries (which provide blood to the heart), has developed a clot that obstructs the flow of blood and oxygen to the heart. Aspirin works by interfering with your blood’s clotting action.

Care is needed when using aspirin with other blood thinners, such as warfarin, dabigatran (Pradaxa), rivaroxaban (Xarelto) and apixiban (Eliquis).

What about people who have not had heart problems or a stroke but who, due to family history or showing other evidence of arterial disease are at increased risk? Is an aspirin a day a safe and effective strategy for them?

Again, Temple emphasizes, the clinical data do not show a benefit in such people.

He adds, however, that there are a number of ongoing, large-scale clinical studies continuing to investigate the use of aspirin in primary prevention of heart attack or stroke. FDA is monitoring these studies and will continue to examine the evidence as it emerges.

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‘Real Cost’ of Tobacco

February 19, 2015

The Food and Drug Administration (FDA) has launched its first public health education campaign—”The Real Cost”—to prevent and reduce tobacco use among at-risk young people ages 12-17. Mitch Zeller, J.D., director of FDA’s Center for Tobacco Products (CTP), explains why the agency is undertaking this effort and how it will work.

Q: Why has FDA launched a youth tobacco prevention campaign? 

A: Tobacco use is the leading preventable cause of disease, disability, and death in the United States, responsible for more than 480,000 deaths each year. But the consequences of tobacco use are not limited to adults. Tobacco use is almost always initiated and established during adolescence. More than 3,200 young people under age 18 smoke their first cigarette every day in the United States—and another 700 become daily smokers. FDA sees a critical need for targeted efforts to keep young people from starting on this path. Reducing the number of teens who start smoking will diminish the harmful consequences that tobacco use has on the future health of our country. “The Real Cost” campaign ads will run nationwide beginning on February 11.

Q: Tell us more about the campaign and its target audience.

A: As FDA’s first campaign to prevent youth tobacco use, “The Real Cost” targets the 10 million young people ages 12-17 who are open to trying smoking or who have already smoked between one puff and 99 cigarettes in their lifetime. These youths share important characteristics that put them at risk for tobacco use. They are more likely to live chaotic, stressful lives due to factors such as socioeconomic conditions; be exposed to smoking by friends and family; and use tobacco as a coping mechanism or a way to exert control or independence. Additionally, many at-risk youths who experiment with cigarettes do not consider themselves smokers, do not believe they will become addicted, and are not particularly interested in the topic of tobacco use. We want to make these teens hyperconscious of the risk from every cigarette by highlighting consequences that young people are concerned about, such as loss of control due to addiction and health effects like tooth loss and skin damage.

Q: How is FDA going to implement the campaign?

A: We’ll use paid advertising to surround teens with the “The Real Cost” message. This includes advertising on TV, radio and the Internet, as well as in print publications, movie theaters and outdoor locations like bus shelters. We plan to reach more than 9 million youths with our messages as many as 60 times a year.

Q: How will FDA know if the campaign is working?

A: FDA is going to evaluate the campaign over time to see if it’s effective. We’re going to conduct a longitudinal study, meaning that we are going to try to follow the same 8,000 youths over a two-year period. We will assess key changes in their tobacco-related knowledge, attitudes, beliefs and behaviors over several years to measure the impact and effectiveness of the campaign. In-person, baseline data collection started in November 2013 in 75 media markets across the country. Ultimately, we want to see if exposure to the campaign is associated with a decrease in smoking among youth.

Q: Is this campaign funded by U.S. tax dollars?

A: No. User fees collected from the tobacco industry fund all FDA’s tobacco-related activities, including educating the public about the harms of tobacco use.

Q. Is this FDA’s only youth tobacco prevention campaign?

A: This initial FDA effort is the first of several distinct youth-focused campaigns being launched in the next two to three years. Other youth tobacco prevention campaigns will target additional audiences such as African American, Hispanic, Asian/Pacific Islander and American Indian/Alaskan Native youths, rural youths, and lesbian, gay, bisexual and transgender youths.

Q: How can I get involved?

A: FDA’s goal is to keep “The Real Cost” campaign authentic through a peer-to-peer approach. The campaign website and social channels are intended for teens. We recommend that adults use and share the materials on FDA’s resource page, including campaign information and customizable resources such as posters, postcards and campaign flyers. All materials are available for free download and many will soon be available for ordering through the campaign’s clearinghouse. Stakeholders who work with youth audiences can help extend the campaign by encouraging teens to share campaign messages with their peers, or by sharing our resources with other youth-focused organizations.

Food for a Healthy Heart

February 3, 2015

Making healthy food choices is one important thing you can do to reduce your risk of heart disease — the leading cause of death of men and women in the United States.

According to the American Heart Association, about 80 million adults in the U.S. have at least one form of heart disease—disorders that prevent the heart from functioning normally—including coronary artery disease, heart rhythm problems, heart defects, infections, and cardiomyopathy (thickening or enlargement of the heart muscle).

Experts say you can reduce the risk of developing these problems with lifestyle changes that include eating a healthy diet. But with racks full of books and magazines about food and recipes, what is the best diet for a healthy heart?

Food and Drug Administration nutrition expert (FDA’s) Barbara Schneeman says to follow these simple guidelines when preparing meals:

  • Balance calories to manage body weight
  • Eat at least 4.5 cups of fruits and vegetables a day, including a variety of dark-green, red, and orange vegetables, beans, and peas.
  • Eat seafood (including oily fish) in place of some meat and poultry
  • Eat whole grains—the equivalent of at least three 1-ounce servings a day
  • Use oils to replace solid fats.
  • Use fat-free or low-fat versions of dairy products.

The government’s newly released “Dietary Guidelines for Americans 2010” also says Americans should reduce their sodium intake. The general recommendation is to eat less than 2,300 mg. of sodium a day. But Americans 51 or older, African-Americans of any age, and people with high blood pressure, diabetes, or chronic kidney disease should restrict their intake to 1,500 mg. The government estimates that about half the U.S. population is in one of those three categories.

Packaged and Restaurant Food

Schneeman, who heads FDA’s Office of Nutrition, Labeling, and Dietary Supplements, says one way to make sure you’re adhering to healthy guidelines is by using the nutrition labels on the packaged foods you buy.

“Product labels give consumers the power to compare foods quickly and easily so they can judge which products best fit into a heart healthy diet or meet other dietary needs,” Schneeman says. “Remember, when you see a percent DV (daily value of key nutrients) on the label, 5 percent or less is low and 20 percent or more is high.”

Follow these guidelines when using processed foods or eating in restaurants:

  • Choose lean meats and poultry. Bake it, broil it, or grill it.
  • In a restaurant, opt for steamed, grilled, or broiled dishes instead of those that are fried or sautéed.
  • Look on product labels for foods low in saturated fats, trans fats, and cholesterol. Most of the fats you eat should come from polyunsaturated and monounsaturated fats, such as those found in some types of fish, nuts, and vegetable oils.
  • Check product labels for foods high in potassium (unless you’ve been advised to restrict the amount of potassium you eat). Potassium counteracts some of the effects of salt on blood pressure.
  • Choose foods and beverages low in added sugars. Read the ingredient list to make sure that added sugars are not among the first ingredients. Ingredients in the largest amounts are listed first. Some names for added sugars include sucrose, glucose, high fructose corn syrup, corn syrup, maple syrup, and fructose. The nutrition facts on the product label give the total sugar content.
  • Pick foods that provide dietary fiber, like fruits, beans, vegetables, and whole grains.

Feel like getting creative in the kitchen? The National Heart, Lung, and Blood Institute has come up with dozens of delicious heart-healthy recipes—many in Spanish.

FDA is clarifying dosing recommendations and warnings for the antidepressant Celexa (citalopram hydrobromide). In August 2011, the agency issued a Drug Safety Communication stating that citalopram should no longer be used at doses greater than 40 milligrams (mg) per day because it could cause potentially dangerous abnormalities in the heart’s electrical activity. Use of citalopram is discouraged at any dose for people with certain medical conditions. However, because some patients may lack viable alternatives, the citalopram label (the package insert that comes with a prescription medicine) has been changed to describe precautions they should take when using it. The revised label also describes lower doses that should be taken by people over 60 years old.

Risk: Changes in the electrical activity of the heart—specifically, prolongation of the QT interval, a measure of the heart’s electrical activity— can lead to a risk of a potentially fatal abnormal heart rhythm called Torsades de Pointes. People at risk for developing QT prolongation include those with underlying heart conditions and those who tend to have low levels of potassium and magnesium in their blood.

Recommendations

  • Do not stop taking citalopram or change your dose without talking to your health care professional. Stopping citalopram suddenly can cause withdrawal effects.
  • If you are currently taking a citalopram dose greater than 40 mg per day, talk to your healthcare professional.
  • Seek immediate care if you experience an irregular heartbeat, shortness of breath, dizziness, or fainting while taking citalopram.
  • If you are taking citalopram, your health care professional may occasionally order an electrocardiogram (ECG, EKG) to monitor your heart rate and rhythm.
  • Your health care professional may also order tests to check levels of potassium and magnesium in your blood.
  • Read the Medication Guide for citalopram carefully and discuss any questions you have with your health care professional.
  • Health care professionals and patients are encouraged to report any side effects related to the use of these products to MedWatch.