Double Dosage of Acetaminophen

September 18, 2013

You have flu symptoms, so you’ve been getting some relief for the past two days by taking a cough and flu medicine every few hours. Late in the day, you have a headache and you think about grabbing a couple of acetaminophen tablets to treat the pain.

Stop right there.

What you may not realize is that more than 600 medications, both prescription and over-the-counter (OTC), contain the active ingredient acetaminophen to help relieve pain and reduce fever. Taken carefully and correctly, these medicines can be safe and effective. But taking too much acetaminophen can lead to severe liver damage.

Acetaminophen is a common medication for relieving mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches and to reduce fever. It is also used in combination medicines, which have more than one active ingredient to treat more than one symptom.

The National Institutes of Health (NIH) says that Americans catch one billion colds per year and as many as 20% of Americans get the flu. Moreover, 7 in 10 Americans use OTC medicines to treat cold, cough and flu symptoms.

Fathia Gibril, M.D., M.HSc., a supervisory medical officer at the Food and Drug Administration (FDA), explains that consumers looking for relief from a cold or the flu may not know that acetaminophen comes in combination with many other medications used to treat those symptoms. “So if you’re taking more than one medicine at a time,” she says, “you may be putting yourself at risk for liver damage.”

Symptoms of acetaminophen overdose may take many days to appear, and even when they become apparent, they may mimic flu or cold symptoms. The current maximum recommended adult dose of acetaminophen is 4,000 milligrams per day, To avoid exceeding that dose:

  • don’t take more than one OTC product containing acetaminophen,
  • don’t take a prescription and an OTC product containing acetaminophen, and
  • don’t exceed the recommended dose on any product containing acetaminophen.

“When you’re at the store deciding which product to buy, check the ‘Drug Facts’ label of OTC cold, cough and flu products before using two or more products at the same time,” Gibril says. If you’re still not sure which to buy, ask the pharmacist for advice.

Women’s Health FAQ

August 21, 2013

As Assistant Commissioner for Women’s Health at the Food and Drug Administration (FDA), Marsha B. Henderson directs the Office of Women’s Health. She has led women’s health research and educational programs at FDA for over 14 years.

Q: How does FDA work to protect and promote the health of women?

A: We provide women with the information they need to make decisions about the drugs and other medical products they use for themselves and their families. We support scientific and educational projects that promote a better understanding of health conditions that affect women. We also support research that looks for potential differences in how men and women respond to medicines.

Q: Can you provide an example of how men and women differ in response to medicines?

A: Medicines can sometimes cause people to have an irregular heart beat. This affects part of the heart’s electrical cycle called the QT interval, and blood doesn’t pump in and out of the heart at the right pace. This could lead to heart attacks or sudden death. We discovered that certain medicines cause this problem more often in women than in men.

My office provided the initial research grant that allowed scientists at FDA and Georgetown University to study this problem. Additional studies were conducted, and several drugs were removed from the market. FDA now requires that new products be studied to ensure that they do not affect the QT interval—a potentially life-saving requirement.

Q: Your office also works to ensure that women are included in clinical trials. Why is that important?

A: It’s now very clear that medicines and diseases often affect our bodies differently. Women’s body structure can also affect how well devices like hip implants and heart stents work for us. Having women included in clinical trials provides FDA with information that can be used to make better decisions about product safety for both men and women.

Q: Why have there been fewer women than men included in clinical trials?

A: In the 1960s, there were public health tragedies in other countries where babies were born with birth defects because their mothers took a medicine called thalidomide during pregnancy. Thanks to Dr. Frances Kelsey, a FDA scientist, we did not approve the drug for sale in the U.S. at that time. So, the problem did not affect as many women in this country. Nonetheless, the horror of thalidomide influenced FDA to set rules in 1977 that basically excluded women from participating in clinical trials. The ban was lifted in 1993. The Office of Women’s Health led this effort and worked with FDA’s review centers to change the regulations. The inclusion of women is much better today. Because some challenges remain, we continue to support projects on women in clinical research.

Q: What else are you working on?

A: The Office of Women’s Health has an outreach program called “Take Time to Care” that connects women with easy-to-read materials and videos on everything from diabetes to hair dyes.

Q: How do you get the information to women?

A: Women can watch the videos and get free copies of our materials online at http://www.fda.gov/womens. We also work with a national network of partners who help disseminate our information. Our partners have ranged from health clinics and colleges to chain drug stores and the syndicated advice column “Dear Abby.”

Q: Dear Abby?

A: Yes. For several years, the “Dear Abby” column has announced our information kits during National Women’s Health Week in May to its 110 million readers. Partners like “Dear Abby” and Parade magazine have helped us reach out to women who wouldn’t necessarily think to look to FDA for free health information.

Q. Earlier you also mentioned research and training.

A: We fund grants for scientists at FDA and our sister agencies, such as the National Institutes of Health (NIH), to conduct research in areas like breast cancer imaging, device safety and hormones. These projects have produced more than 200 published articles that help health professionals better understand and treat women’s health problems. We also sponsor workshops for health professionals and we’ve partnered with NIH to develop free online courses which train researchers to look for sex differences.

Q: What is the greatest hope for improving women’s health?

A: Most of the chronic conditions like heart disease can be avoided, or certainly delayed, by healthy behavior—eating right, getting screenings and using medicines wisely. My hope is that women can use FDA resources to help them make healthy life choices.

Q: You seem happy in your work. Why?

A: I work with dedicated, enthusiastic scientists and advocates for women’s health. I enjoy mentoring the graduate students who come through our office. And I love the challenge of entrepreneurial government—building public-private partnerships.

Migraine Medications

August 12, 2013

If you’re one of the more than 30 million Americans who suffer from migraines, you know that calling them “just another headache” is like calling a hurricane “just another storm.”

Fortunately, says neurologist Eric Bastings, M.D., deputy director of the Division of Neurology at the Food and Drug Administration (FDA), there are practical measures you can take to prevent painful migraines and FDA-approved medications to either stave off their onset or relieve their pain. There are two basic kinds of medications for migraine: abortive medications (also called acute medications) that treat migraines after they begin, and preventive medications that help keep migraines from developing in the first place.

In January 2013, FDA approved an acute medication that uses a widely-prescribed drug for treating migraines (sumatriptan, name brand Imitrex), but delivers the drug through a new mechanism — a transdermal system in the form of a patch that can be wrapped around a patient’s upper arm or thigh. (Transdermal drug delivery is absorption through the skin.)

“Although consumers are familiar with using a patch for, say, smoking cessation, this is the first patch FDA has approved to treat migraines,” says Bastings.

What Causes a Migraine?

According to the National Institutes of Health (NIH), about 12 percent of the U.S. population experience migraines. Migraines affect both children and adults, but affect adult women three times more often than men.

Bastings explains that migraines are neurovascular headaches. They are characterized by throbbing and pulsating pain caused by the a temporary widening of blood vessels in the brain, triggered by abnormal activation of nerve pathways involved in the transmission of pain signals.

Characteristics of a migraine frequently include:

  • Pain typically on one side of the head
  • Pain that has a pulsating or throbbing quality
  • Moderate to intense pain that affects daily activities
  • Nausea or vomiting
  • Sensitivity to light or sound
  • Aura, visual disturbances that signal the beginning, such as dots, flashing lights or blind spots

Bastings also says that a number of studies show that migraines are underdiagnosed by patient and physician, alike. “Many people don’t recognize the symptoms as belonging to migraine,” he says. Or they don’t think of sharing information about the occasional headache with their physician, even if it is severe.

Hemorrhoids Websites

June 17, 2013

Whether you consider them a fit topic for conversation or not, it’s evident that people want information about hemorrhoids.

In Google’s annual roundup of popular search terms, hemorrhoids was the top trending health issue in the United States for 2012. (The “top trending health issue” means that this particular search had the highest amount of traffic over a sustained period in 2013 as compared to 2012.)

According to the National Institutes of Health (NIH), these swollen and inflamed veins in the lower part of the rectum or anus affect 75% of people at some point in their lives. Hemorrhoids are most common in adults ages 45 to 65, and particularly for women during pregnancy and after childbirth. Obesity and a sedentary lifestyle are also contributors.

The Food and Drug Administration (FDA) is responsible for evaluating a number of products used to treat and remove the often itchy and sometimes painful protuberances.

What causes hemorrhoids? How are they treated? Are there preventive steps you can take to keep from having hemorrhoids yourself?

Causes and Symptoms

For the most part, hemorrhoids are caused by increased pressure in the veins of the anus. There are two kinds of hemorrhoids: internal (not covered by skin), which form inside the rectum, and external (covered by skin), located near the anal opening.

“You often can’t see or feel the internal ones,” says FDA medical officer Herbert Lerner, M.D., a colon-rectal surgeon. “But straining during bowel movements and constipation can cause these hemorrhoids to bleed and occasionally push through the anal opening.” This is known as a protruding or prolapsed hemorrhoid, and it causes pain or irritation.

Sometimes blood pools in an external hemorrhoid and forms a clot, Lerner says, which can result in severe pain, swelling and inflammation. If the blood is dark red or black, you should call your health care professional, as it can be a sign of something more serious, he cautions.

Common symptoms of hemorrhoids include:

  • itching and pain (especially when sitting);
  • bright red blood on toilet tissue, stool, or in the toilet bowl;
  • pain during bowel movements; and
  • one or more hard, sore lumps near the anus.

According to National Institutes of Health, Veins are blood vessels that return deoxygenated blood from the outer parts of the body back to the heart and lungs. When veins become abnormally thick, full of twists and turns, or enlarged, they are called varicose veins. This happens most commonly in the veins in the legs and thighs.

Many people have no symptoms at all from their varicose veins, except for the fact that they are noticeable and their appearance can be embarrassing.   Other than cosmetic embarrassment, the most common symptoms of varicose veins are aching, discomfort and heaviness of the legs, which are usually worse at the end of the day.  Sometimes the ankle can swell, too.  These symptoms are not medically serious, but can be treated if they are sufficiently troublesome.

The goals of varicose vein treatment are to reduce symptoms and prevent complications. For some, the goal may be improved appearance. Home treatment – especially exercising, wearing compression stockings or any kind of home-made varicose veins treatment – is the first and often best approach.

People diagnosed with HIV—the human immunodeficiency virus that without treatment develops into AIDS—take antiviral medications to control the infection that attacks their immune system.

Now, for the first time, adults who do not have HIV but are at risk of becoming infected can take a medication to reduce the risk of sexual transmission of the virus.

The Food and Drug Administration (FDA) has approved the new use of Truvada—to be taken once daily and used in combination with safer sex practices—to reduce the risk of sexually acquired HIV-1 infection in adults who do not have HIV but are at high risk of becoming infected. (HIV-1 is the most common form of HIV.)

In two large clinical trials, daily use of Truvada was shown to significantly reduce the risk of HIV infection

  • by 42 percent in a study sponsored by the National Institutes of Health (NIH) of about 2,500 HIV-negative gay and bisexual men and transgender women, and
  • by 75 percent in a study sponsored by the University of Washington of about 4,800 heterosexual couples in which one partner was HIV positive and the other was not.

Debra Birnkrant, M.D., director of the Division of Antiviral Products at FDA, explains that Truvada works to prevent HIV from establishing itself and multiplying in the body. She notes that while this is a new approved use, Truvada is not a new product. It was approved by FDA in 2004 for use in combination with other medications to treat HIV-infected adults and children over 12 years old.

“In the 80s and early 90s, HIV was viewed as a life-threatening disease; in some parts of the world it still is. Medical advances, along with the availability of close to 30 approved individual HIV drugs, have enabled us to treat it as a chronic disease most of the time,” Birnkrant says.

“But it is still better to prevent HIV than to treat a life-long infection of HIV,” she says.

Birnkrant stresses that Truvada is meant to be used as part of a comprehensive HIV prevention plan that includes consistent and correct condom use, risk reduction counseling, regular HIV testing, and treatment of any other sexually-transmitted infections. Truvada is not a substitute for safer sex practices, she says.

To help prescribers and other health care professionals advise uninfected people considering taking Truvada, the medicine is being approved with a Risk Evaluation and Mitigation Strategy (REMS). The goals of the REMS are to inform prescribers and potential users of Truvada of the importance of taking the medication every day, the importance of regular HIV testing and the importance of using Truvada in combination with other measures known to reduce the risk of HIV infection. As part of the REMS, a voluntary training and education plan will be made available to potential prescribers. This program includes a medication guide and safety brochure for the prospective Truvada users that would detail the risks, recommended screening tests and key information to share with a health care professional.

About 1.2 million Americans have HIV. The body’s immune system is devastated by AIDS, leaving those who have it vulnerable to deadly infections. Each year, about 50,000 adults and adolescents in the U.S. are newly diagnosed with HIV.

Black Licorice

March 27, 2012

If you’re 40 or older, eating 2 ounces of black licorice a day for at least two weeks could land you in the hospital with an irregular heart rhythm or arrhythmia.

FDA experts say black licorice contains the compound glycyrrhizin, which is the sweetening compound derived from licorice root. Glycyrrhizin can cause potassium levels in the body to fall. When that happens, some people experience abnormal heart rhythms, as well as high blood pressure, edema (swelling), lethargy, and congestive heart failure.

FDA’s Linda Katz, M.D., says last year the agency received a report of a black licorice aficionado who had a problem after eating the candy. And several medical journals have linked black licorice to health problems in people over 40, some of whom had a history of heart disease and/or high blood pressure.

Katz says potassium levels are usually restored with no permanent health problems when consumption of black licorice stops.

Licorice, or liquorice, is a low-growing shrub mostly grown for commercial use in Greece, Turkey, and Asia. The National Institutes of Health (NIH) says the plant’s root has a long history of use as a folk or traditional remedy in both Eastern and Western medicine. It has been used as a treatment for heartburn, stomach ulcers, bronchitis, sore throat, cough and some infections caused by viruses, such as hepatitis; however, NIH says there are insufficient data available to determine if licorice is effective in treating any medical condition.

Licorice is also used as a flavoring in food. Many “licorice” or “licorice flavor” products manufactured in the United States do not contain any licorice. Instead, they contain anise oil, which has the same smell and taste. Licorice root that is sold as a dietary supplement can be found with the glycyrrhizin removed, resulting in a product known as deglycyrrhizinated licorice, or DGL, NIH says.

If you have a fondness for black licorice, FDA is offering this advice:

  • No matter what your age, don’t eat large amounts of black licorice at one time.
  • If you have been eating a lot of black licorice and have an irregular heart rhythm or muscle weakness, stop eating it immediately and contact your healthcare provider.
  • Black licorice can interact with some medications, herbs and dietary supplements. Consult a health care professional if you have questions about possible interactions with a drug or supplement you take.

If you’ve experienced any problems after eating licorice, contact the FDA consumer complaint coordinator in your area.