U.S. Food and Drug Administration
FDA Consumer magazine
November-December 2000
Table of Contents
A first-of-its-kind hearing device has been approved that sends vibrations to the brain rather than simply magnifying sound like traditional hearing aids. The surgically implanted device is for adults with moderate to severe nerve hearing loss, not for the profoundly deaf.
Implanted in the skull bone behind the ear, the Vibrant Soundbridge device converts sound into mechanical energy and transfers the energy to the wearer's middle ear via a wire. The energy vibrates delicate structures in the middle ear in much the same way that sound normally would, allowing the brain to interpret the vibrations as sound.
In clinical studies, the Vibrant Soundbridge was shown to improve hearing about as much as conventional hearing aids. On the plus side, the new device was less visible than some standard hearing aids, and it wasn't hampered by earwax and moisture, which can be problematic with conventional devices.
But the surgery to implant the Vibrant Soundbridge entails the usual risks from surgical procedures, including infections and anesthesia risks. Other complications reported by patients in clinical studies included worsened hearing (2 percent), permanently altered taste (2 percent), long-term pain in the ear (5 percent), and a permanent feeling of "fullness" in the ear (16 percent).
FDA approved the implant in August based on a U.S. study of 81 patients, supporting data from European studies, and the recommendation of an FDA advisory committee. The device's manufacturer, Symphonix Devices Inc., San Jose, Calif., is doing an 18-month follow-up study to determine the implant's long-term safety and effectiveness.
The first inhaled corticosteroid for young children with asthma was approved by the Food and Drug Administration in August. Pulmicort Respules (budesonide inhalation suspension), a synthetic hormone, is for use in a nebulizer--a device that turns liquid into an aerosol so the drug can be inhaled through a mask or mouthpiece. FDA approved the drug for children one to eight years old; before this, no corticosteroid was available for children younger than four.
Inhaled corticosteroids are considered by many asthma experts to be standard care for asthma sufferers with persistent symptoms and are believed to be effective in reducing the inflammation in the airways that may lead to an asthma attack.
Pulmicort Respules is designed for use once or twice daily to prevent asthma attacks, but it should not be used to treat acute attacks of asthma. Acute asthma attacks should be treated with a fast-acting inhaled bronchodilator (a drug that quickly opens up the lung's airways). Improvement in asthma control following treatment with Pulmicort Respules can start in a few days, but it may take four to six weeks for full effects to occur.
The drug is generally well tolerated. The most frequent side effects reported by patients using Pulmicort Respules were respiratory infection, coughing, and congestion. In addition, studies have shown that inhaled corticosteroids may reduce a child's growth by an average of one centimeter per year. The effect of corticosteroids on eventual adult height is not known. The effect on growth appears to be related to both the dosage and duration of exposure to the drug. Physicians or other care providers should work with the children and their families so that the child is receiving the lowest dose that maintains adequate asthma control.
Children using the inhalant who have not been vaccinated and have not had chicken pox or measles, but who are exposed to these diseases, should see a doctor immediately.
Pulmicort Respules is manufactured by the AstraZeneca Group of Wayne, Penn.
A drug that has been used for more than a decade to treat a variety of serious infections in millions of patients has now become the first antimicrobial approved in the United States to protect people against a possible biological weapon. FDA recently approved the antimicrobial Cipro (ciprofloxacin) to prevent or slow down the progression of an inhaled anthrax infection following exposure to the bacteria.
Based on what FDA has described as a "public health need," the agency granted accelerated approval in August for the new use of Cipro. Approval was based on information about ciprofloxacin needed to kill anthrax bacteria and a significantly improved survival rate for monkeys that received ciprofloxacin following exposure to anthrax bacteria compared with animals that did not receive an antimicrobial.
The most common adverse reactions to Cipro include nausea, vomiting, diarrhea, abdominal pain, rash, headache, and restlessness. Because of concerns about the drug's long-term safety, including its effects on cartilage, Cipro was never before approved for use in children. But because inhaled anthrax can be lethal, FDA in this case approved its use in youngsters while studies continue of Cipro's long-term safety in this population.
Cipro is made by Bayer Corp., West Haven, Conn.
A controlled-release form of a widely used drug that treats attention deficit-hyperactivity disorder (ADHD) has been approved by the Food and Drug Administration. The drug methylphenidate, best known as Ritalin, must be taken two or three times a day when given in the immediate-release form; the new extended-release formulation requires only a single daily dose.
FDA approved Concerta, a controlled-release form of methylphenidate, in August to treat the symptoms of ADHD, which include inattention, hyperactivity and impulsiveness. Concerta is administered once in the morning, as opposed to current immediate-release forms of methylphenidate, which must be taken two or three times daily.
Methylphenidate has long been prescribed for the treatment of ADHD, but use of the immediate-release forms can be disruptive to a child's daily schedule, requiring the child to visit the school nurse, who administers the drug. Concerta may eliminate the need for in-school and after-school dosing.
Typically, children and adults suffering with ADHD make careless mistakes, fidget, interrupt others, talk excessively, and have problems paying attention. The disorder first appears during childhood.
The side effects associated with Concerta include headache, stomach pain, insomnia, and decreased appetite. Concerta may not be appropriate for patients with certain types of gastrointestinal disorders. Concerta is manufactured and marketed by ALZA Corp. of Mountain View, Calif.
The blockages in arteries that can lead to a heart attack or sudden death appear to start forming early in life, in young adults and adolescents as young as 15, according to a recent study. Some teenagers and young adults with risk factors for heart disease--things like high cholesterol, high blood pressure, and obesity--have fatty plaques in their heart arteries indicating the earliest signs of atherosclerosis, while others are already in the more dangerous advanced stages, according to the study.
Researchers at the Southwest Foundation for Biomedical Research in San Antonio, Texas, looked at the left coronary arteries (large blood vessels that supply blood to the heart muscle) from the autopsies of 760 men and women aged 15 to 34 who had died from an accident, murder, or suicide. Autopsies of American soldiers killed in combat during the Korean War first alerted researchers that the biological changes leading to heart attacks and stroke begin early in life. Autopsies of American casualties during the Vietnam War found similar trends. Despite decades of awareness, the trend continues.
In the San Antonio study, young people who had high blood levels of "bad" cholesterol (called low-density lipoproteins, or LDL) were about 2 1/2 times more likely to have advanced plaque blockages than those who did not have high LDL levels. And those who were obese were more than 2 1/2 times more likely than the others to have advanced plaques, regardless of cholesterol levels or other risk factors.
In total, about 2 percent of the 15- to 19-year-old men and 20 percent of 30- to 34-year-old men in the study had advanced plaques. While no women aged 15 to 19 had advanced plaques, 8 percent of women aged 30 to 34 did.
According to the study's lead author, Henry C. McGill Jr., M.D., early risk factors "may be a significant predictor of a person's chance of developing heart disease later in life."
The study suggests the need to tailor messages about heart disease prevention to children, according to the study's authors, and to recommend nutritional guidelines for heart disease prevention to children as well as adults. (Circulation, July 24, 2000)
Men who receive either of two kinds of treatment for testicular cancer appear to be at increased risk for leukemia, according to a recent study. Researchers found leukemia in men who received radiation therapy and in some taking cisplatin, a chemotherapy drug commonly used to treat testicular cancer.
The risk for men taking radiation therapy was three times greater than in those not receiving radiation, and men who received higher doses were at even greater risk. Cisplatin, a standard part of most testicular cancer chemotherapy combinations, also increased the risk of leukemia to three times higher than normal, and men receiving especially high doses were at greater risk for leukemia.
Researchers point out, however, that the benefits of both treatments far outweigh the small risk of leukemia. (Journal of the National Cancer Institute, July 19, 2000)
Women taking Lotronex to treat irritable bowel syndrome will start getting a plain-language consumer Medication Guide along with their pills. The Lotronex guide cautions patients to be aware of rare, but serious, side effects that have been reported in some people taking the drug. It spells out important information about the prescription drug, its possible risks, and what consumers can do to avoid problems.
This is the first time the Food and Drug Administration has required an FDA-approved Medication Guide under regulations that went into effect in 1999.
Irritable bowel syndrome (IBS) is a condition affecting up to 15 percent of Americans that is marked by chronic abdominal pain, diarrhea, or constipation. Lotronex was approved earlier this year for treating the pain and discomfort of women who have the diarrhea-predominant form of IBS. It has not been shown to help men with the condition. Since its approval, FDA has received reports of several cases of serious complications from constipation in patients taking Lotronex, some of which resulted in hospitalization and surgery. Cases of ischemic colitis, an inflammatory condition caused by reduced blood flow to the intestines that also sometimes requires surgery, have been reported as well.
The Lotronex guide cautions women whose main IBS symptom is constipation not to take the drug. It warns further that patients taking Lotronex should contact their doctor immediately if they experience constipation, and should stop taking the drug if they develop severe constipation, new or worsening abdominal pain, or bloody stools. It counsels patients to discuss with their doctors how troublesome their IBS symptoms are and the benefits and risks of the drug, so that they can decide if Lotronex is the right medication choice.
The popular impotence treatment drug Viagra may have another use, according to a study conducted at Johns Hopkins University School of Medicine. Researchers say that Viagra could be an effective remedy for a digestive condition common among people with diabetes that blocks or slows the passage of food from the stomach to the intestine, known as gastroparesis.
Gastroparesis, which commonly affects up to 75 percent of diabetic individuals, causes bloating, loss of appetite, vomiting and dehydration, and can complicate efforts to control blood sugar levels with medication because it disrupts the timing of the digestive process. Viagra appears to cause smooth muscles in the digestive tract to relax in the same way it prompts smooth muscles in the penis to ease and facilitate an erection. (Journal of Clinical Investigation, August 2000)
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