Table of Contents
FDA Consumer magazine
November-December 1999
A first-of-its-kind inhaled drug can reduce the time it takes flu sufferers to recover from their fevers, headaches, muscle aches, coughs, and sore throats.
FDA approved the drug Relenza (zanamivir) in July to treat adults and adolescents aged 12 and over with flu types A and B. These types are responsible for flu epidemics and cause most symptoms.
It is the first anti-viral drug approved to treat influenza since the agency approved Flumadine (rimantadine) in 1993.
Clinical studies showed that for the drug to be effective, patients needed to start treatment within two days of the onset of symptoms. The drug seemed to be less effective in patients whose symptoms weren't severe or didn't include a fever.
Relenza is a powder that is inhaled twice a day for five days from a breath-activated plastic device called a Diskhaler. Patients should get instruction from a health-care practitioner in the proper use of the Diskhaler, including a demonstration when possible.
Relenza has not been shown to be effective--and may carry risk--in patients with severe asthma or a lung condition called chronic obstructive pulmonary disease. Some patients with mild or moderate asthma experienced bronchospasm (marked by shortness of breath) after using Relenza. Anyone who develops bronchospasm should stop taking the drug and call their health-care provider. Patients with underlying respiratory disease should have a fast-acting inhaled bronchodilator available when taking Relenza.
The clinical trials of Relenza, some of which were done in Europe and the Southern Hemisphere, involved more than 1,000 patients with influenza type A and about 120 who had influenza type B. The drug's safety and effectiveness have not been established for influenza prevention.
Relenza is marketed by Glaxo Wellcome Inc., Research Triangle Park, N.C.
A new urine test that can detect the pneumonia-causing bacterium Streptococcus pneumoniae in 15 minutes has been approved by FDA.
Approved in August, the Binax test can help doctors diagnose pneumonia more quickly than in the past and begin antibiotic treatment sooner.
The test is done by dipping a swab into a urine specimen and inserting it into the test device. A positive result indicates that the patient most likely has pneumococcal pneumonia, but the health professional should also review a patient's symptoms to rule out other possible causes of pneumonia.
According to FDA, the Binax test is much easier to use than conventional methods for diagnosing pneumonia, which primarily use saliva and mucus or blood, and can be lengthy, complex, and sometimes unreliable.
In studies conducted by the manufacturer, Binax Inc., Portland, Maine, the test was found to be 93 percent accurate in detecting S. pneumoniae when testing urine samples from 373 patients known to have pneumococcal pneumonia, and 78 percent accurate when testing urine from 215 patients with typical symptoms of pneumonia who may not have had the disease. Test results were not reliable in people who had been vaccinated for pneumonia within the previous five days.
Child vaccine linked to bowel obstruction ... Vaccinations against rotavirus, the leading cause of diarrhea in children, have been temporarily halted after a surveillance system run by the national Centers for Disease Control and Prevention and FDA linked the vaccine's use in infants to a rare bowel obstruction known as intussusception. FDA approved the vaccine, RotaShield, in 1998 for infants as young as 6 weeks of age to protect against rotavirus infection. Twenty-five cases of bowel obstruction were reported within three to seven days after children were vaccinated, which prompted the investigation. Symptoms of bowel obstruction include persistent vomiting, bloody stools, black stools, and abdominal distention. To report suspected intussusception cases, call the Vaccine Adverse Event Reporting System at 1-800-822-7967 (24 hours a day), or use the form on the Internet at www.fda.gov/cber/vaers/vaers.htm.
Detectors find swallowed metal ... Hand-held metal detectors are just as accurate as x-rays in finding coins and other metallic objects swallowed by children, according to a recent study. Not only that, they're cheaper and radiation-free. Teams of investigators scanned 176 subjects suspected of having swallowed a metallic object. In most cases the object was detected. While coins may pass uneventfully into the stomach, coins that become lodged in the esophagus can cause complications and possibly death if not detected early. (Archives of Pediatric and Adolescent Medicine, August 1999)
As part of a crackdown on illegal prescribing and selling of drugs over the Internet, FDA is teaming up with other federal and state agencies to identify and take action against sites that break the law.
Under federal and state laws, a patient generally must be examined physically by a licensed health-care practitioner before receiving a prescription drug for the first time. The patient then has the prescription filled by a registered pharmacist in a licensed pharmacy that meets state practice standards.
Reputable on-line drug companies can offer consumers a convenient service while complying with these laws. But an increasing number of Websites--based both in the United States and abroad--sell potent drugs without valid prescriptions or meaningful interaction with a health-care professional. Often sales are based only on a buyer's answers to a questionnaire. Patients who use these services risk adverse side effects, dangerous drug interactions, and harm from contaminated, counterfeit or outdated drugs.
FDA's enforcement plan includes:
FDA urges consumers to avoid buying drugs from Websites that are not registered with search engines, that offer to prescribe drugs without a physician-patient relationship, that sell unapproved medicines or require linking to another site to buy the drug, and that don't provide a U.S. phone number and address.
Television and radio ads promoting prescription drugs directly to consumers are not expected to change much under an FDA guidance recently finalized.
As in a 1997 draft version, the final guidance issued in August states that broadcast ads should ordinarily provide a toll-free telephone number and Internet address where consumers can get more information. Ads also should refer consumers to their health-care providers and to product brochures or print advertisements.
The approach aims to give people more information about a drug even if they are sensitive about their privacy.
Consumers can view the guidance document and find responses to frequently asked questions about direct-to-consumer drug advertising by visiting FDA's Website at www.fda.gov/cder/guidance/index.htm and making a selection under "Advertising." To comment on the final guidance, write to FDA's Dockets Management Branch (HFA-305), 5630 Fishers Lane, Rockville, MD 20852.
Some adult brain cancer patients now have another option for treating their disease.
The oral treatment temozolomide (Temodar) was approved by FDA in August to treat a form of brain cancer called anaplastic astrocytoma in patients who relapsed following initial treatment with radiation and chemotherapy.
Temozolomide was granted accelerated approval, a process FDA applies to some drugs for serious or life-threatening conditions. In a single study of the drug, tumors resistant to previous chemotherapy with two other drugs partially shrank and disappeared in 7 out of 54 patients. The most common side effects of temozolomide included headaches, nausea, vomiting, fatigue, and low blood counts.
At least 18,000 new cases of brain cancer are diagnosed each year in the United States, a figure which represents about 2 percent of all adult cancers. More than 50 percent of brain cancer cases are tumors that can cause severe disabilities such as motor dysfunction, seizures, and vision abnormalities.
As a condition of approval, FDA is requiring the manufacturer, Schering-Plough Corp., Madison, N.J., to further study the drug's effects on patients' survival or quality of life.
Certain former visitors to the United Kingdom should not be blood donors in the United States, according to a new guidance issued by FDA.
The new restrictions, issued in August, are a precautionary step designed to reduce the theoretical risk of transmitting a fatal degenerative disease called new variant Creutzfeldt-Jakob disease (nvCJD). The disease has been linked to the disease bovine spongiform encephalopathy, often referred to in the popular press as BSE or "mad-cow disease."
New variant CJD has been found almost exclusively in the United Kingdom, which includes England, Scotland, Wales, Northern Ireland, the Isle of Man, and the Channel Islands. No cases of BSE or nvCJD have been identified in the United States.
FDA's guidance to blood establishments (like a similar guidance issued by Canada's health ministry) asks blood centers to exclude potential donors who have spent six or more cumulative months in the United Kingdom between Jan. 1, 1980, and Dec. 31, 1996. Also excluded are donors who have received non-U.S.-licensed insulin from cows or other injectable products made from cattle in countries with documented cases of BSE.
While no evidence exists to suggest that nvCJD can be transmitted by blood, blood products, or injectable products made from cattle, studies are under way to evaluate these possibilities.
FDA's new guidance also will no longer recommend that blood centers withdraw from use plasma derivatives from donors at risk for or who have been diagnosed with classic CJD, which has not been found to be transmitted by blood or blood products. The agency's previous guidance recommended that blood centers permanently defer these donors and that the blood centers immediately retrieve, quarantine and destroy any blood products or plasma derivatives from these donors.
FDA expects blood centers to implement the guidance by early 2000. For a complete copy of the guidance, visit FDA's Website at www.fda.gov/cber/guidelines.htm.
Keeps on ticking ... People with implanted heart devices, under normal conditions, are not at risk when exposed to electronic detection systems, say researchers from the Indiana University School of Medicine and two other medical organizations. In a study of 170 people, the implanted heart devices were triggered when the subjects lingered in the detection system. But researchers say the interaction was minor and no one was harmed. Just as a precaution, however, experts say implant patients should not linger more than 15 seconds within anti-theft or airport security machines. (Circulation, July 1999)
Don't go for the burn ... Sunbathers don't head indoors until they start to burn, say researchers who studied time spent in the sun by 87 French and Swiss college students. Half of the students used sunscreen with a protection factor of 10 and the other half sunscreen with a factor of 30. The students were not told which lotion they received. Users of the stronger sunscreen spent 25 percent more time in the sun, the study found. Researchers concluded that sunscreens tend to encourage prolonged sun exposure because they delay sunburn, which helps explain why previous studies have linked sunscreen use with higher skin cancer rates. (Journal of the National Cancer Institute, August 1999)
Calcium does a body good ... Americans are facing a serious shortage of calcium, say experts from the University of Colorado and Creighton University. Nutrition professors told attendees at a calcium nutrition meeting that three out of four Americans do not get enough calcium, starting in childhood. This is an important finding, now that the benefits of calcium may extend beyond the bones to include lowering blood pressure and preventing colon cancer, experts say.
Coming soon: FDA Science Forum ... To see how FDA determines which foods, drugs, biologics, and medical devices are safe and effective enough to make it to the marketplace, the agency, along with co-sponsors Sigma Xi and the American Association of Pharmaceutical Scientists, invites consumers, health professionals, industry, and the general public to attend the 2000 FDA Science Forum Feb. 14 and 15 at the Washington Convention Center in Washington, D.C. FDA Commissioner Jane Henney, M.D., and top scientists from FDA and around the world will address emerging issues in the safety of FDA-regulated products. To register, call (703) 548-3000 or go to www.aaps.org/edumeet/fdasf/index.html on the Internet. [Update, Feb. 2, 2002: This URL is now inactive. For information on the 2000 FDA Science Forum, visit www.cfsan.fda.gov/~frf/sxsfin00.html]
Under a rule recently finalized by FDA, drug products containing colloidal silver or silver salts are not recognized as safe and effective. These products, labeled to treat a wide variety of illnesses in adults and children, including AIDS, cancer, syphilis, scarlet fever, shingles, herpes, and pneumonia, have caused some people's skin to take on a permanent blue-gray discoloration.
FDA concluded that colloidal silver products (suspensions of silver particles in a gelatinous base) are misbranded because adequate directions cannot be written to allow consumers to use them safely. These products are also misbranded, FDA said, when their labeling falsely suggests that there is substantial scientific evidence to establish that they are safe and effective for their labeled uses. (See the enforcement action involving colloidal silver in this issue.)
The FDA final rule, which was published in the Aug. 17 Federal Register and became effective Sept. 16, requires that any colloidal silver product intended to be used as a drug will have to be approved by FDA under the agency's new drug application procedures before being marketed.
Another tick-borne bacteria detected in people ... For the first time, researchers at the University of Minnesota have detected in humans a tick-borne bacterial infection that was thought to sicken only dogs. Evidence does not suggest that dogs are spreading the potentially deadly ehrlichiosis, which is similar to Lyme disease. But the ticks bite both humans and dogs and may be jumping from one to the other. (New England Journal of Medicine, July 1999)
Doggie flea product a danger to cats ... Some flea and tick products labeled only for use on dogs can be fatal to cats, cautions a report by the U.S. Pharmacopeia's Veterinary Practitioners' Reporting Program. Certain "spot-on" products, which contain the active ingredient "concentrated permethrin," are intended only for dogs and can be highly toxic to cats. The report cautions cat owners to read flea and tick product labels carefully. (Journal of the American Veterinary Medical Association, July 1999)
New Number for Food Information ... FDA's toll-free Food Information Line has a new number: 1-888-SAFEFOOD (1-888-723-3366). The information line is open 10 a.m. to 4 p.m., Eastern time, Monday through Friday.
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