As technology provides more health care options, children are frequently diagnosed or treated with one or more medical devices.

If there are problems that prevent the safe use of pediatric medical devices, FDA wants to know about them. FDA wants caregivers to report problems or concerns to help ensure that pediatric devices can be used safely and deliver the intended benefits. And the agency wants to hear about the problems when they happen, especially if they might jeopardize the safety or care of a child.

Many Kinds of Devices

Medical devices range from the simple items in your medicine cabinet, like adhesive bandages, to complicated equipment, such as X-ray machines and pacemakers. Devices such as syringes and asthma inhalers help with the delivery of a drug or vaccine. Devices may be disposable, reusable or even implantable, such as cochlear implants (for severe hearing loss) and joint replacements. Devices might monitor a child’s breathing, oxygen level, blood sugar level or blood pressure.

Although adolescents and some older children may be involved with using their devices, often a parent or other adult will either need to supervise or be the primary user. FDA’s Center for Devices and Radiological Health (CDRH) considers patients through age 21 to be pediatric device users.

FDA has developed and administers regulations designed to ensure the safety and effectiveness of medical devices. Nevertheless, parents and caregivers should be aware of the potential for problems that may lead to the device working improperly, interfere with its effectiveness, or even harm the child. Some problems may be a result of a device not working as it should, while others might happen because of the way the parent or child uses the device. If a device is not easy to use, a child or caregiver could experience problems operating the device, which could in turn lead to an injury.

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.

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.

Children and Asthma

November 24, 2012

The news about children and asthma is both good and bad. Better treatments have banished the stereotype of the asthmatic child as frail and inactive, heavily relying on an inhaler to breathe. Children with asthma are now living active, independent lives.

The Food and Drug Administration (FDA) is working to make sure that the drugs and devices used to treat asthma—a chronic lung disease that inflames and narrows the airways—are safe and effective.

The bad news is that the number of reported cases of asthma in children has been rising. In 2010, there were 7 million children with asthma, 9.4% of Americans under 18, according to the Centers for Disease Control and Prevention, up from 6.5 million, or 8.9%, in 2005.

One reason may be that doctors are diagnosing more kids; illnesses once known as bronchitis or a croupy cough are now being recognized as asthma. Its symptoms may include coughing, wheezing (a whistling sound when you breathe), chest tightness and shortness of breath, according to the National Heart, Lung and Blood Institute (NHLBI).

Uncontrolled asthma can lead to chronic lung disease and a poor quality of life, and may slow growth. Benjamin Ortiz, M.D., a medical officer in FDA’s Office of Pediatric Therapeutics, recommends that parents work with a pediatrician, and an allergist or pulmonologist (lung specialist) if needed, to develop and follow an asthma action plan that details the treatment options when certain symptoms occur.

Triggers

“We know what makes asthma worse or better, but don’t know the primary cause,” Ortiz says. The things that make asthma worse are known as “triggers.” They include:

  • Season and climate changes
  • High levels of air pollutants
  • Tobacco smoke
  • Mold
  • Mites, roaches
  • Plant pollen
  • Pet dander
  • Strong scents, like perfumes

In addition, certain factors may increase a child’s risk of developing asthma:

  • Family history of asthma
  • Multiple episodes of wheezing before age 2
  • Living in crowded housing
  • A family member who smokes
  • Obesity
  • Early development of allergies or eczema

 

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.

You break out in a head-to-toe rash after applying a sunless tanning lotion. Your son’s skin is red and blotchy after he gets his face painted at the school carnival. Your daughter’s scalp is burned after using a hair relaxer.

If you’ve had a negative reaction to a beauty, personal hygiene, or makeup product, the Food and Drug Administration (FDA) wants to hear from you.

From morning until night—styling our hair for work to showering before bed—Americans depend upon personal care products. Most are safe, but some cause problems, and that’s when FDA gets involved.

“Even though these products are widely used, most don’t require FDA approval before they’re sold in stores, salons, and at makeup counters,” says Linda Katz, M.D., director of the agency’s Office of Cosmetics and Colors. “So, consumers are one of FDA’s most important resources when it comes to identifying problems.”

When you contact FDA, include the following information in your report:

  • the name and contact information for the person who had the reaction;
  • the age, gender, and ethnicity of the product’s user;
  • the name of the product and manufacturer;
  • a description of the reaction—and treatment, if any;
  • the healthcare provider’s name and contact information, if medical attention was provided; and
  • when and where the product was purchased.

And be sure to give the age, gender, and ethnicity of the person who had the reaction, says FDA scientist Wendy Good, Ph.D. Good, who analyzes reports about problems with cosmetics, says that information is important because it can help scientists spot trends.

When a consumer report is received, FDA enters the information into a database of negative reactions. Experts then look for reports related to the same product or similar ones. FDA scientists will use the information to determine if the product has a history of problems and represents a public health concern that needs to be addressed.

Dietary supplements, in general, are not FDA-approved. Under the law (Dietary Supplement Health and Education Act of 1994), dietary supplement firms do not need FDA approval prior to marketing their products. It is the company’s responsibility to make sure its products are safe and that any claims are true.

Just because you see a supplement product on a store shelf does NOT mean it is safe or effective. When safety issues are suspected, FDA must investigate and, when warranted, take steps to have the product removed from the market. However, it is much easier for a firm to get a product on the market than it is for FDA to take a product off the market.

FDA has worked with industry to recall more than 40 products marketed for weight loss with potentially harmful ingredients, and has issued consumer alerts about dozens more. The agency also has issued warning letters, seized products, and criminally prosecuted people responsible for these illegal diet products.