Irritable Bowel Syndrome Treatments

Irritable bowel syndrome (IBS) is an often misunderstood and underdiagnosed condition that affects about 15.3 million people in the United States.

No one remedy works for all patients, so there’s a great medical need to develop new therapies for IBS, says Andrew Mulberg, M.D., a gastroenterologist with the Food and Drug Administration (FDA). That’s why FDA is working to bring more treatments to the market.

“There’s a lot of new research about the role of carbohydrates, and specifically a nutrient called polyols, in triggering irritable bowel syndrome in some patients,” Mulberg says. “In addition, doctors, scientists and researchers are more closely examining the role of diet in IBS causes and treatments.”

What Is IBS?

IBS is a gastrointestinal disorder that affects the large intestine (colon) but doesn’t cause inflammation or permanent damage. Common symptoms of IBS include:

  • Diarrheas
  • Constipation
  • Abdominal pain, bloating or cramping
  • Gas
  • Mucus in the stool

The symptoms may come and go, and can change in the same patient. Sometimes the pain from IBS can be so severe that it’s disabling and patients can’t do routine things. In addition, severe diarrhea can lead to dehydration and an electrolyte imbalance.

Doctors don’t know what causes IBS, and there is no known cure. Studies estimate that as many as 20% of Americans suffer from IBS. Many people may not know they have this gastrointestinal disorder. They might have occasional diarrhea and constipation and think it’s caused by something they ate, or a virus, so they don’t see a doctor to get a proper diagnosis. When they do, doctors must first rule out that the symptoms aren’t caused by a disease or another condition.

“There are many conditions that have a female or male predominance, but we don’t understand why women have a higher prevalence of IBS,” says Mulberg, deputy director of FDA’s Division of Gastroenterology and Inborn Errors Products (DGIEP).

IBS is most common among people younger than 45, and patients usually first experience symptoms when they’re in their late 20s. People who have a family history of IBS are also more likely to develop the condition.

Depression, anxiety and other psychological problems are common in people with IBS, Mulberg says.

“Some people suffer from depression and IBS. The question is what’s primary or secondary – what came first?” he says. “Either way, antidepressants are not a cure for IBS.”

What You Can Do

Treatments for IBS vary from patient to patient and include changes in diet, nutrition and exercise. Some patients need stool softeners to treat constipation; others need antidiarrheal drugs to treat diarrhea.

“IBS is not like other chronic conditions, such as hypertension, which is constant. IBS is a variable condition. Even without treatment, the problem might go away in some patients. But the symptoms might return after a few months,” says Ruyi He, M.D., an internist and medical team leader with DGIEP.

No one medication works for all people suffering from IBS.

Most recently, FDA approved Linzess (linaclotide) to treat some adults who suffer from IBS with constipation and for chronic idiopathic constipation. Chronic idiopathic constipation is a diagnosis given to those who experience persistent constipation and do not respond to standard treatment. According to the National Institutes of Health, about 63 million people have chronic constipation.

In addition, FDA has approved Amitiza (lubiprostone) for IBS with constipation and one drug for IBS with diarrhea, Lotronex (alosetron).

“Drugs are a last option. Patients should try diet and lifestyle changes, especially exercise, before resorting to medication,” He says.

Certain foods and drinks can trigger IBS symptoms in some patients. The most common are foods rich in carbohydrates, spicy or fatty foods, milk products, coffee, alcohol and caffeine.

Medications for High Blood Pressure

Nearly one in three adults in the United States has high blood pressure, also called hypertension. High blood pressure is dangerous because it increases the risk of stroke, heart attack, heart failure, kidney failure, death.

“High blood pressure is often called the ‘silent killer’ because it usually has no symptoms until it causes damage to the body,” says Douglas Throckmorton, M.D., Deputy Director of FDA’s Center for Drug Evaluation and Research. Many studies have shown that lowering the blood pressure with drugs decreases that damage.

A Lifelong Condition

Blood is carried from the heart to all parts of the body in vessels called arteries. Blood pressure is the force of the blood pushing forward through the body and against the walls of the arteries. The higher the blood pressure, the greater the risk of stroke, heart attack, heart failure, kidney failure, and death.

Blood pressure is made up of two numbers:

  • The “top” number is the systolic blood pressure—the pressure while the heart is pumping blood out. According to the National Institutes of Health (NIH), this number should be less than 120 to be in the normal range.
  • The “bottom” number is the diastolic blood pressure—the pressure while the heart is filling up with blood, getting ready to pump again. According to NIH, this number should be less than 80 to be in the normal range.

It was once believed that only diastolic pressure (the “bottom” number) was important, but this is not true. Elevated systolic pressure alone, particularly common in older people, is just as dangerous as elevations of both systolic and diastolic pressure.

Blood pressure is elevated for two main reasons:

  • too high blood volume
  • too narrow blood vessels.

Most of the time, the cause of a person’s high blood pressure is unknown. Once it develops, high blood pressure usually lasts the rest of the person’s life. But it is treatable.

Some people can lower blood pressure by losing weight, limiting salt intake, and exercising, but for most people, these steps are not enough. Most people need medication for blood pressure control, and will probably need it all their lives.

Types of Medications

FDA has approved many medications to treat high blood pressure, including

  • Diuretics, or “water pills,” which help the kidneys flush extra water and salt from your body and decrease blood volume
  • Angiotensin converting enzyme (ACE) inhibitors and Angiotensin II receptor blockers (ARBs), reduce blood pressure by relaxing blood vessels
  • Beta blockers, which also cause the heart to beat with less force
  • Drugs that directly relax the blood vessels. These include calcium channel blockers (CCBs) and other direct dilators (relaxers) of blood vessels
  • Alpha blockers, which reduce nerve impulses that tighten blood vessels
  • Nervous system inhibitors, which control nerve impulses from the brain to relax blood vessels

Many people with high blood pressure may need more than one medication to reach their goal blood pressure. Your health care provider can tell you if you should be on medication and, if so, which drug(s) may be best for you.

Tips for Consumers

Controlling your blood pressure is a lifelong task. Blood pressure is only one of a number of factors that increase your risk of heart attack, stroke, and death. High cholesterol and diabetes are other risk factors. Lifestyle changes—such as weight loss, a healthy diet, and physical activity—can affect all three risk factors, but many people will also need medications.

Take your medicines and monitor your blood pressure. Take the medications prescribed for you regularly and don’t stop them except on the advice of your health care provider. Hypertension tends to worsen with age and you cannot tell if you have high blood pressure by the way you feel, so have your health care provider measure your blood pressure periodically. You may also want to buy a home blood pressure monitor, available in many drug stores, to measure your blood pressure more frequently. Your health care provider or pharmacist can help you choose the right device. Many drug stores also have blood pressure measuring devices you can use in the store.

Tell your health care provider about any side effects you are having. Some side effects may go away over time, others may be avoided by adjusting the dosage or switching to a different medication.

Fighting Allergy Season with Medications

You’re sneezing, your eyes are itchy and you feel miserable. Seasonal allergies aren’t just a nuisance, they are real diseases that can interfere with work, school or recreation, and can range from mild to severe.

May is National Asthma and Allergy Awareness Month, and many allergy treatment options are approved by the Food and Drug Administration (FDA). For the first time, these include three sublingual (under the tongue) prescription products to treat hay fever (also called “allergic rhinitis”)—with or without eye inflammation (called “conjunctivitis”)—caused by certain grass pollens and short ragweed pollen. The new products—Grastek, Oralair and Ragwitek—can be taken at home, but the first dose must be taken in a health care provider’s office.

About Allergies

An allergy is a heightened immune system reaction to a substance that your body has identified as an invader. If you have allergies and encounter a trigger—called an “allergen”—your immune system fights it by making antibodies, which causes your body to release chemicals called histamines. Histamines are responsible for symptoms such as repetitive sneezing and itchy, watery eyes.

Allergic rhinitis affects more than 30 million children and adults in the United States and more than 500 million people worldwide. It may be seasonal or year-round.

The seasonal allergy, often called “hay fever,“ typically occurs in the spring, summer or fall. If you have this, you may suffer from repetitive sneezing, and stuffy or runny nose and itching in the nose, eyes or on the roof of the mouth. Eye inflammation can occur when your eyes react to allergens with symptoms of reddening, itching and swelling.

Plant pollens usually cause seasonal allergies. Pollen allergies are common, and allergy-causing pollen can come from trees, weeds and grasses, according to the National Institute of Allergy and Infectious Diseases. Trees and grasses are typical spring culprits in the United States, while ragweed and other weeds ramp up in late summer and early fall.

Indoor substances, such as dust mites, often cause the year-round type of allergies. Molds can cause seasonal and year-round allergies.

Testing

If you suspect an allergy, see your health care provider, as conditions such as upper respiratory infections, sinus infections and eye infections can have similar symptoms.

“The first step is to get appropriate testing to determine what you’re actually reacting to,” says Jay Slater, M.D., an allergist and director of FDA’s Division of Bacterial, Parasitic and Allergenic Products.

Your health care provider can test you using injectable allergen extracts. Allergen extracts are sterile liquids made from natural substances such as molds, pollens or animal hair. FDA has licensed these products. Tests include:

  • a skin prick test, which involves placing the allergen extract on your skin and pricking so it goes under the skin’s surface. Your skin is studied for swelling or other signs of a reaction, which usually occurs in about 15 minutes.
  • an injection of a small amount of an allergen, or
  • a blood test, which can detect and measure antibodies to certain allergens.

Medications to Treat Symptoms

“After testing, you need to sort out results with your health care provider,” Slater says. “Take the results of the test and combine it with reflective thinking about when and where you’re experiencing symptoms. Then determine the best course of action.”

For instance, if you have a spring oak tree allergy you can try to avoid the allergen by limiting outdoor activities on high pollen-count days and keeping your windows closed. But airborne pollen can be hard to avoid, so your health care provider may also recommend prescription or over-the-counter medications to relieve symptoms.

Antihistamines reduce or block symptom-causing histamines and are available in many forms, including tablets and liquids.

“There are several different antihistamines. First-generation antihistamines include medications such as diphenhydramine, marketed under the brand name Benadryl. They have been available over the counter for a long time,” says Narayan Nair, M.D., a medical officer at FDA. “Newer second generation antihistamines have not been available over the counter as long. They include medications such as fexofenadine and loratadine, which are marketed under the brand names Allegra and Claritin, respectively.”

When choosing an over-the-counter antihistamine, patients should read the Drug Facts label closely and follow dosing instructions, Nair says. “Some antihistamines can cause drowsiness and interfere with the ability to drive or operate heavy machinery. The drowsiness can be made worse by taking sedatives or consuming alcohol,” he explains. “Also, patients with chronic conditions such as glaucoma, or an enlarged prostate should talk to their health care provider before taking certain antihistamines.”

In addition to the antihistamines, nasal sprays and eye drops can help improve some allergic symptoms. “Nasal sprays can help relieve nasal symptoms but they should only be used for a limited time without talking to a health care provider. If some nasal sprays are used longer than intended they can make the congestion worse,” Nair notes.

Can a Dietary Supplement Treat a Concussion?

Exploiting the public’s rising concern about concussions, some companies are offering untested, unproven and possibly dangerous products that claim to prevent, treat or cure concussions and other traumatic brain injuries (TBIs).

The Food and Drug Administration (FDA) is monitoring the marketplace and taking enforcement actions where appropriate, issuing warning letters to firms—the usual first step for dealing with claims that products labeled as dietary supplements are intended for use in the cure, mitigation, treatment, or prevention of disease. The agency is also warning consumers to avoid purported dietary supplements marketed with claims to prevent, treat, or cure concussions and other TBIs because the claims are not backed with scientific evidence that the products are safe or effective for such purposes. These products are sold on the Internet and at various retail outlets, and marketed to consumers using social media, including Facebook and Twitter.

One common claim: Using a particular dietary supplement promotes faster healing times after a concussion or other TBI.

Even if a particular supplement contains no harmful ingredients, that claim alone can be dangerous, says Gary Coody, FDA’s National Health Fraud Coordinator.

“We’re very concerned that false assurances of faster recovery will convince athletes of all ages, coaches and even parents that someone suffering from a concussion is ready to resume activities before they are really ready,” says Coody. “Also, watch for claims that these products can prevent or lessen the severity of concussions or TBIs.”

A concussion is a brain injury caused by a blow to the head, or by a violent shaking of the head and upper body. Concussions and other TBIs are serious medical conditions that require proper diagnosis, treatment, and monitoring by a health care professional. The long-term impact of concussions on professional athletes and children who play contact sports has recently been the subject of highly publicized discussions.

A growing body of scientific evidence indicates that if concussion victims resume strenuous activities—such as football, soccer or hockey—too soon, they risk a greater chance of having a subsequent concussion. Moreover, repeat concussions can have a cumulative effect on the brain, with devastating consequences that can include brain swelling, permanent brain damage, long-term disability and death.

“As amazing as the marketing claims here are, the science doesn’t support the use of any dietary supplements for the prevention of concussions or the reduction of post-concussion symptoms that would enable one to return to playing a sport faster,” says Daniel Fabricant, Ph.D., director of FDA’s Division of Dietary Supplement Programs.

The Claims

One of the first alarms raised about dietary supplements being promoted to treat TBI came from the U.S. Department of Defense.

“We first learned from the military about a product being marketed to treat TBI, obviously a concern with wounded veterans. We were taken aback that anyone would make a claim that a supplement could treat TBI, a hot-button issue,” says Jason Humbert, a senior regulatory manager with FDA’s Office of Regulatory Affairs. “That sparked our surveillance.”

FDA routinely monitors the marketplace. However, with more than 85,000 dietary supplements on the market and no product registration, products making false claims can slip through, at least for a time.

Typically, products promising relief from TBIs tout the benefits of ingredients such as turmeric and high levels of omega-3 fatty acids derived from fish oil. Turmeric is an Indian spice in the ginger family. For two omega-3 fatty acids typically found in oily fish—EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid)—FDA has recommended a maximum daily level of 2 grams per day from dietary supplements.

In its initial surveillance, FDA identified two companies selling multiple products claiming to prevent and treat concussions and other TBIs. One company claimed to have “the world’s first supplement formulated specifically to assist concussion recovery,” saying “it has the dynamic ability to minimize long-term effects and decrease recovery time.” A National Football League player testified to its “proven results in my own recovery” from a concussion, and an unnamed “licensed trainer” said he had incorporated it into his “concussion management protocol.”

Similar claims were made by the other company, which was selling four products claiming to protect against and help heal TBIs. FDA sent letters in 2012 warning both companies that their products were not generally recognized as safe and effective for treating TBIs, that the products were misbranded (a legal term meaning, in this case, that the labeling of the products did not have adequate directions for use), and that unless various violations cited in the letters were promptly corrected, the violations could result in legal action taken without further notice, such as seizure or injunction.

Both companies changed their websites and labeling.

In December 2013, FDA issued a warning letter to Star Scientific, Inc., for marketing its product Anatabloc with claims to treat TBIs. FDA continues to monitor the marketplace for products with similar fraudulent claims, and will take appropriate regulatory action to protect the public health.

“As we continue to work on this problem, we can’t guarantee you won’t see a claim about TBIs. But we can promise you this: There is no dietary supplement that has been shown to prevent or treat them,” says Coody. “If someone tells you otherwise, walk away.”

Wart Removers may be Flammable!

Some cryogenic wart removers—which remove warts from the skin by freezing them off—have caught fire during use at home, harming consumers or setting fire to items around the house.

Since 2009, the Food and Drug Administration (FDA)—which regulates wart removers as medical devices—has received 14 such reports about over-the-counter (OTC) wart remover products, which are a mixture of liquid dimethyl ether and propane.

Ten patients have described singed hair, blisters, burns or skin redness, according to FDA nurse consultant Karen Nast, RN. Nearby items have also caught fire.

“The labeling for these products clearly states that they are flammable and should be kept away from fire, flame, heat sources, and cigarettes,” Nast notes. In three of the reports, there was a candle nearby, but in the other 11 reports no ignition source was identified. “This is extremely concerning, especially because people may not be aware that everyday household items like curling irons and straight irons can be hot enough to be an ignition source for these products,” Nast says.

How to Use These Products

Warts are growths caused by human papillomavirus (HPV) infection. Most treatments using a mixture of liquid dimethyl ether and propane instruct users to follow certain steps.

First, the user presses on the nozzle of a small, pressurized canister (dispenser) containing the mixture. The dispenser releases the mixture, cooled to approximately -40 degrees Celsius, onto an applicator, saturating it. (In some products, the applicator is attached to the cap.) The user presses the applicator on the wart for the amount of time specified in the product directions. An average of three to four treatments is required for warts on thin skin. Warts on calloused skin, such as plantar warts on the soles of the feet, might take more treatments.

In the reports FDA has received, the dispenser generally caught fire when it was releasing the mixture.

Alternative Treatments

Warts can often disappear on their own without treatment in most people, says FDA dermatologist Markham Luke, MD. However, if you are not sure if your warts are cause for concern or if you have questions about using cryogenic products at home, it’s best to be on the safe side and talk with your health care professional before taking action, Luke says.

Your health care professional may prefer to remove the warts in the medical office, using treatments such as surgical paring, laser, or liquid nitrogen cryosurgical treatments. “The advantage is that the health care professional has been trained in providing the treatment safely and under controlled conditions,” he adds.

Alternatively, there are other types of OTC warts treatments available for use at home, such as topical applications of salicylic acid, which soften or loosen warts so they fall off or can be easily removed.

If you are going to use a cryogenic product at home, Luke recommends that you use it only as directed on the labeling, and that you heed warnings such as this one from a currently marketed product: “Extremely flammable. Do not pierce, burn or expose aerosol spray dispenser to excessive heat, even after use or when the dispenser is empty. This may cause dispenser to explode, causing serious injury.” Also be sure to use the product in a well-ventilated area, Luke says.

Nast says that while the FDA has received only 14 reports of fires related to cryogenic treatments to date, such occurrences are often under-reported. She encourages consumers to inform the FDA about similar experiences. “It’s important for us to know when and how problems like this happen,” she says.

Head Lice

Head lice. Every parent’s nightmare.

A year-round problem, the number of cases seems to peak when the kids go back to school in the fall and again in January, says Patricia Brown, M.D., a dermatologist at the Food and Drug Administration (FDA).

An estimated 6 to 12 million cases of head lice infestation occur each year in the United States in children 3 to 11 years of age, according to the Centers for Disease Control and Prevention. Head lice are most common among preschool children attending child care, elementary school children, and household members of children who have lice.

Contrary to myth, head lice are not caused by poor hygiene, Brown says. They are spread mainly by direct head-to-head contact with a person who already has head lice. You cannot get head lice from your pets; lice feed only on humans.

Lice don’t fly or jump; they move by crawling. But because children play so closely together and often in large groups, lice can easily travel from child to child, especially when they touch heads during playing or talking.

Blood-Sucking Bugs

Head lice are blood-sucking insects about the size of a sesame seed and tan to grayish-white in color. They attach themselves to the skin on the head and lay eggs (nits) in the hair.

According to Brown, you can check for head lice or nits by parting the hair in several spots. You can use a magnifying glass and a bright light to help spot them. Because head lice can move fast it may be easier to spot the nits. Nits can look like dandruff, but you can identify them by picking up a strand of hair close to the scalp and pulling your fingernail across the area where you suspect a nit. Dandruff will come off easily, but nits will stay firmly attached to the hair, Brown explains.

FDA-approved treatments for head lice include both over-the-counter (OTC) and prescription drugs, such as Nix and Rid, in the form of shampoos, creams and lotions. “Many head lice products are not for use in children under the age of 2, so read the label carefully before using a product to make sure it is safe to use on your child,” Brown says.

Although OTC drugs are available for treatment of head lice, Brown says your health care professional may prescribe drugs recently approved by the FDA, such as Ulesfia (approved in 2009), Natroba (approved in 2011) or Sklice (approved in 2012).

Steps for Safe Use

Follow these steps to use any head lice treatment safely and appropriately:

  • After rinsing the product from the hair and scalp, use a fine-toothed comb or special “nit comb” to remove dead lice and nits.
  • Apply the product only to the scalp and the hair attached to the scalp—not to other body hair.
  • Before treating young children, talk with the child’s doctor or your pharmacist for recommended treatments based on a child’s age and weight.
  • Use medication exactly as directed on the label and never more often than directed unless advised by your health care professional.
  • Use treatments on children only under the direct supervision of an adult.

Heading Off Head Lice

  • Teach children to avoid head-to-head contact during play and other activities at home, school, and elsewhere (sports activities, playgrounds, slumber parties, and camps).
  • Teach children not to share clothing and supplies, such as hats, scarves, helmets, sports uniforms, towels, combs, brushes, bandanas, hair ties, and headphones.
  • Disinfest combs and brushes used by a person with head lice by soaking them in hot water (at least 130°F) for 5–10 minutes.
  • Do not lie on beds, couches, pillows, carpets, or stuffed animals that have recently been in contact with a person with head lice.
  • Clean items that have been in contact with the head of a person with lice in the 48 hours before treatment. Machine wash and dry clothing, bed linens, and other items using hot water (130°F) and a high heat drying cycle. Clothing and items that are not washable can be dry-cleaned or sealed in a plastic bag and stored for two weeks.
  • Vacuum the floor and furniture, particularly where the person with lice sat or lay. Head lice survive less than one or two days if they fall off the scalp and cannot feed.
  • Do not use insecticide sprays or fogs; they are not necessary to control head lice and can be toxic if inhaled or absorbed through the skin.
  • After finishing treatment with lice medication, check everyone in your family for lice after one week. If live lice are found, contact your health care professional.

‘Real Cost’ of Tobacco

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

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.

Rare Disease Therapies

Patients often need advocates, and that can be especially true for people with a rare disease, who have unique problems and may have little or no support or available treatment.

The Food and Drug Administration (FDA) is committed to helping patients and advancing rare disease therapies through the development of “orphan” medical products, including drugs, biologics (such as a protein, vaccine or blood product), and devices used to treat a rare disease or condition. The Orphan Drug Act defines a disease as rare if fewer than 200,000 people in the United States have it.

FDA’s Office of Orphan Products Development (OOPD), in collaboration with the Center for Drug Evaluation and Research (CDER), is launching web-based educational resources for patients and industry on FDA-related rare disease topics. The first of these resources will debut Feb. 28, 2014, in recognition of International Rare Disease Day, and will cover topics that include how to interact with the agency and how to access therapies that are currently being studied.

Rare Disease Day, which is commemorated on the last day in February, is a global campaign to raise awareness of the more than 250 million people worldwide who suffer from rare diseases. About 7,000 rare diseases have been identified around the world; some have familiar names, such as cystic fibrosis and Lou Gehrig’s disease, but many don’t. Thirty million Americans have rare diseases, which can be chronic, progressive, debilitating, disabling, severe or life-threatening. About 80 percent of rare diseases are genetic, and about half of all rare diseases affect children.

FDA’s Office of Orphan Products Development

FDA is in a unique position to help those who suffer from rare diseases by offering several important incentives to promote the development of products for rare diseases, including:

  • granting orphan drug designation for drugs and biologics, which encourages companies to develop a product by giving them financial and other incentives;
  • providing grant funds to further the clinical development of drugs, biologics, medical devices and medical foods for the treatment of rare diseases;
  • granting humanitarian use device (HUD) designation for medical devices for rare diseases, which makes these products eligible to enter the market via a separate marketing pathway known as the Humanitarian Device Exemption (HDE) Pathway; and
  • providing grants to fund consortia to promote the development of pediatric devices, many of which are used to treat and diagnose rare diseases.

Gayatri R. Rao, M.D., J.D., director of OOPD, says 2013 was a record year for her office. The number of requests under FDA’s Orphan Drug Designation Program rose about 18% in 2013 over 2012. FDA received nearly 450 orphan-drug designation requests and designated 258 promising orphan drugs, a 40% increase over 2012, says Rao.

“While many factors may be contributing to the growth of orphan drug development, patients are continuing to drive the push for innovation and treatments,” she says.

In 2013, FDA approved 33 drugs for treating rare diseases. Since 1983, FDA has approved more than 450 drugs and biologic products for rare diseases. In the decade prior to the Orphan Drug Act, fewer than 10 treatments had been developed by industry for rare diseases.

“Last year, FDA funded 15 new orphan products grants for about $14 million, all supporting clinical research in rare diseases,” says Rao. “Many of the studies that we have funded have supported the approval of orphan drugs and devices for rare disease patients.”

On the device side, in 2013, FDA designated 16 medical devices for the treatment or diagnosis of rare diseases and approved two under the HDE pathway.

In addition, based on feedback from stakeholders, OOPD revamped its Pediatric Device Consortia (PDC) Grant Program.

“Now we focus more heavily on a consortium’s ability to provide more holistic advice on device development,” Rao says. “To bring a device to market, you need engineers, scientists, clinicians, business people and regulatory people collaborating for success.”

Consortia advise on all sorts of devices through various stages of development, from the prototype stage through animal testing, clinical testing and commercialization. OOPD received 14 PDC applications last year and funded half of them.

In addition to these incentive programs, last year, OOPD, in conjunction with CDER and FDA’s Center for Biologics Evaluation and Research (CBER), began administering the new Rare Pediatric Disease Priority Review Voucher Program to promote the development of new drugs and biologics for the prevention and treatment of rare pediatric diseases. In 2013, FDA received five requests for designation as a “rare pediatric disease” and designated three. In 2014, FDA awarded the first voucher under this program for the development of Vivizim to treat patients with a rare congenital enzyme disorder called Morquio A syndrome.

Seasonal Flu Vaccines

Many of the projected 135-139 million doses of influenza vaccines being produced for this flu season for use in the U.S. are now available to consumers from six manufacturers licensed by the Food and Drug Administration (FDA).

A variety of flu vaccines, including some that were not available during past influenza seasons, are available this year. In addition to the availability of vaccines that protect against three strains of influenza virus (trivalent), vaccines that protect against four strains of the virus (quadrivalent) will also be available this year.

In addition, a vaccine that is produced by growing the virus in cells rather than in eggs will be available for use in people 18 years of age and older.

Unlike eggs, cells can be frozen for later use to grow large volumes of cells for the production of vaccine. This could provide a faster start-up time of the manufacturing process for any unexpected need.

“New technologies are providing additional and diverse influenza vaccines, which helps to ensure an adequate supply in the Unites States,” said Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research.

“Influenza seasons are unpredictable and can be severe, even deadly,” she added. “Last year’s influenza season brought an increase in reported hospitalizations and deaths compared to recent years, and vaccination is the best defense to prevent influenza.”

All of the vaccines have been determined by FDA to be safe and effective. Getting vaccinated early, before flu season is in full swing, is key to prevention.

An Exacting Process

Manufacturing flu vaccines is an exacting and complex process. New vaccines must be produced each year because the viruses change from year to year and because the protection received the previous year diminishes over time.

Each February, before one flu season ends, the FDA, World Health Organization, the Centers for Disease Control and Prevention (CDC) and other public health experts collaborate on collecting and reviewing data to identify the virus strains likely to cause the most illnesses in the next flu season. Based on that information and the recommendations of an FDA advisory committee, FDA selects the strains for manufacturers to include in their vaccines for use in the United States.

Both egg-based flu vaccines and vaccines made with newer technologies work the same way; they trigger the immune system of the person receiving the vaccine to produce antibodies capable of attacking the virus.

Vaccines are available in a variety of delivery methods, as a needle into muscle, as a needle injected into skin (approved for ages 18 through 64), and as a nasal spray (approved for people ages 2 through 49). In addition, one vaccine made in a high dose formulation is approved for people 65 years of age and older.

The Procedure

Under traditional egg-based production methods, once the influenza viruses have been selected, they are adapted for use in manufacturing and provided to companies licensed by FDA. The manufacturers inject each virus strain into eggs, which are incubated for several days to allow the virus to multiply.

The virus-loaded fluid from the eggs is then harvested and purified.

Manufacturers grow each strain separately then test it, including for potency. Then the strains are mixed and tested again. Once divided into standard dosages, the vaccines are put into containers such as vials, syringes or sprayers.

Test results are submitted to FDA, along with samples from each batch, or lot. FDA reviews the test results and the samples before releasing the vaccine for distribution in the United States. Each lot, or batch, undergoes testing before release by FDA.

FDA also inspects the manufacturing facilities on a regular basis and continues to monitor the safety of the vaccines once they are in use by the public.

The level of effectiveness can depend on the health and immune system of individuals and how well a particular season’s vaccine strains match circulating flu strains.

There is a possibility of a less than optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. However, even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness and help prevent influenza-related complications.

CDC recommends that everyone six months of age and older get vaccinated soon after vaccine becomes available. Those people for whom vaccination is particularly important include young children, the elderly, pregnant women, and those who suffer from a variety of chronic illnesses, including asthma, diabetes and heart disease.

Although the winter months are usually the peak month for flu activity, influenza disease in people typically begins appearing in October.

FDA’s website has specific information about each flu vaccine, including the FDA-approved age range of use. The website also provides the names of the influenza viruses included in this season’s vaccines and an up-to-date list of the number of vaccine lots that have been released for each manufacturer.