July 11, 2015
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.”
IBS is a gastrointestinal disorder that affects the large intestine (colon) but doesn’t cause inflammation or permanent damage. Common symptoms of IBS include:
- Abdominal pain, bloating or cramping
- 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.”
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.
June 30, 2015
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.
June 14, 2015
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.
“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.
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.
May 30, 2015
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.
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.
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.
“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.
May 17, 2015
It’s the season when you take a timeout from school and your absence is actually excused. But if you’re traveling for spring break, you’ve got to stay safe.
The Office of Women’s Health (OWH) at the Food and Drug Administration (FDA) is taking new steps to ensure that young women have access to timely wellness information. OWH has launched a new web page with information about health issues to help you stay safe on vacation and beyond. The page is the latest in its ongoing College Women’s Campaign, a collaboration with more than 160 schools across the country to disseminate OWH health publications at college health centers and other campus locations.
“We know college women face a lot of pressures, and we want to make sure they take time to care for their health while they’re in school and on break,” explains Marsha Henderson, FDA’s assistant commissioner for women’s health.
The campaign spans a variety of topics, and here are five themes for spring break. So follow these tips, and enjoy your trip.
You may be tempted to “pre-tan” and then tan some more once you arrive. But don’t. Any increase in skin pigment (called “melanin”) is a sign of damage. Ultraviolet radiation from the sun can cause wrinkles and dark spots among other problems—and tanning puts you at higher risk for skin cancer. But the beach can still be a high point of your trip.
- Protective clothing. Wear a hat and protective clothing, and stay in the shade.
- Sunscreens. Wear a broad spectrum sunscreen that protects against UVA and UVB rays, and choose an SPF of 15 or higher. You need at least one ounce of sunscreen lotion (the size of a golf ball) to cover your body. Reapply at least every 2 hours, or every 40 to 80 minutes when swimming or sweating, according to the directions on the product label. And limit the time your skin is exposed to the sun between 10 a.m. and 2 p.m.
- Tanning beds. The lamps in the beds emit ultraviolet radiation that can be more intense and harmful than the sun. FDA recommends carefully reading the instructions and warnings before using these beds, and tanning pills and accelerators are not approved by the agency.
- Spray tans and bronzers. Know that spray-on tanning or bronzing products are not UV protective.
Prepare for your trip by asking your health care professional any questions, including those about side effects and interactions, before you go. Then follow his or her directions. Don’t skip doses, don’t share medication, and don’t take more than the suggested dose. Also check expiration dates in advance and keep your medicine with you when traveling. (If you’re flying, you don’t want to land in Cancun and have your prescriptions land in Cleveland.) Finally, keep a detailed list of what you’re taking. Ideally your travels will be smooth. But if you need to seek medical care this list will be helpful.
They’re convenient but can expose you to serious conditions such as eye infections and corneal ulcers—something you don’t want to deal with on vacation. To avoid problems, first make sure your contacts are prescribed by an eye care professional. Skip colored or decorative lenses sold in beauty supply stores and at the boardwalk, since they can damage your eyes. Second, wash your hands before touching lenses, and use sterile solution. Never expose your lenses to saliva or non-sterile water, including that from the tap, bottle or ocean. Non-sterile water can put you at risk for an eye infection. So remove your contacts before swimming or getting in the hot tub and follow your eye care professional’s other care and removal instructions. If your vision changes, your eyes get red, you have lots of tears, or your eyes hurt or feel itchy, take out your lenses and seek medical attention.
Whether you’re considering a non-permanent (e.g., henna) or a permanent addition (including makeup), think before you ink. Tattoos can cause allergic reactions and put you at risk for infections like HIV or hepatitis from unclean tools, practices or products. FDA has not approved any inks for injecting into your skin and does not regulate tattoo parlors. FDA also hasn’t approved henna or hair dye for skin use, and some people have reported serious problems after using henna, including allergic reactions such as rashes and scarring.
Time flies when you’re having fun, but take a few moments to sip H2O throughout the day. “When you’re traveling, it’s easy to become dehydrated because sometimes you don’t have access to water,” explains Shirley R. Blakely, Ph.D., R.D., a senior nutrition advisor with FDA. So when you spend a late afternoon at the beach (remember sun safety!) bring water and drink even before you feel thirsty, she advises. Also beware of ice or tap water in places where water isn’t safe to drink. If you don’t have access to safe water, Blakely recommends drinking an internationally known brand of a sugar- and caffeine-free carbonated beverage. Finally, Blakely says, “When traveling, you may find yourself overindulging.” For healthy eating, Blakely recommends following the dietary guidelines by making half your plate fruits and vegetables, and half your grains whole, to get enough fiber and other essential nutrients. “And if you’re faced with a smorgasbord, build your plate with fruits, vegetables and whole grains first, then add the protein source.”
April 25, 2015
When you’re buying soaps and body washes, do you reach for the bar or bottle labeled “antibacterial”? Are you thinking that these products, in addition to keeping you clean, will reduce your risk of getting sick or passing on germs to others?
Not necessarily, according to experts at the Food and Drug Administration (FDA).
Every day, consumers use antibacterial soaps and body washes at home, work, school and in other public settings. Especially because so many consumers use them, FDA believes that there should be clearly demonstrated benefits to balance any potential risks.
In fact, there currently is no evidence that over-the-counter (OTC) antibacterial soap products are any more effective at preventing illness than washing with plain soap and water, says Colleen Rogers, Ph.D., a lead microbiologist at FDA.
Moreover, antibacterial soap products contain chemical ingredients, such as triclosan and triclocarban, which may carry unnecessary risks given that their benefits are unproven.
“New data suggest that the risks associated with long-term, daily use of antibacterial soaps may outweigh the benefits,” Rogers says. There are indications that certain ingredients in these soaps may contribute to bacterial resistance to antibiotics, and may have unanticipated hormonal effects that are of concern to FDA.
In light of these data, the agency issued a proposed rule on Dec. 16, 2013 that would require manufacturers to provide more substantial data to demonstrate the safety and effectiveness of antibacterial soaps. The proposed rule covers only those consumer antibacterial soaps and body washes that are used with water. It does not apply to hand sanitizers, hand wipes or antibacterial soaps that are used in health care settings such as hospitals.
According to Rogers, the laboratory tests that have historically been used to evaluate the effectiveness of antibacterial soaps do not directly test the effect of a product on infection rates. That would change with FDA’s current proposal, which would require studies that directly test the ability of an antibacterial soap to provide a clinical benefit over washing with non-antibacterial soap, Rogers says.
Antibacterial soaps (sometimes called antimicrobial or antiseptic soaps) contain certain chemical ingredients that plain soaps do not. These ingredients are added to many consumer products in an effort to reduce or prevent bacterial contamination.
A large number of liquid soaps labeled “antibacterial” contain triclosan, an ingredient of concern to many environmental and industry groups. Animal studies have shown that triclosan may alter the way hormones work in the body. While data showing effects in animals don’t always predict effects in humans, these studies are of concern to FDA as well, and warrant further investigation to better understand how they might affect humans.
In addition, laboratory studies have raised the possibility that triclosan contributes to making bacteria resistant to antibiotics. Such resistance can have a significant impact on the effectiveness of medical treatments.
Moreover, recent data suggest that exposure to these active ingredients is higher than previously thought, raising concerns about the potential risks associated with their use regularly and over time.
April 9, 2015
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.
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.”