U.S. Food and Drug Administration
FDA Consumer magazine
July-August 2001
Table of Contents
The prescription drug Pepcid (famotidine), used for the short-term treatment of heartburn and peptic ulcers, is now available in generic form. The FDA approved more than two dozen companies' generic versions in April and May, following the end of Pepcid's patent protection, held by Merck Laboratories, on April 15.
The FDA also approved in May one generic version of over-the-counter Pepcid-AC tablets.
Famotidine is available as a tablet and an injection. The drug treats heartburn and non-cancerous ulcers of the digestive system by reducing the amount of stomach acid produced. Felt as a burning sensation in the chest, heartburn is caused by stomach acid eating away at the esophagus.
Heartburn is not life-threatening, but it may be a sign of a more serious problem, such as gastroesophageal reflux disease (GERD). GERD occurs when the muscle valve at the lower end of the esophagus malfunctions, allowing stomach acid to flow up into the esophagus. Left untreated, GERD can cause complications such as Barrett's esophagus (a pre-cancerous condition of the esophagus).
An estimated 15 million Americans experience heartburn every day, according to the American College of Gastroenterology.
In April, the FDA approved Paxil (paroxetine) to treat generalized anxiety disorders (GAD). The drug is already approved for treating social anxiety disorder, depression, panic disorder, and obsessive-compulsive disorder.
General anxiety disorder affects about 4 million adult Americans and about twice as many women as men, according to the National Institute of Mental Health. People with the condition experience exaggerated, worrisome thoughts and tension about routine life events, lasting at least six months. GAD is accompanied by physical symptoms like fatigue, trembling, muscle tension, headache, and nausea.
The effectiveness in treating GAD was established in two clinical trials in adults with GAD. Paxil has not been studied in children or adolescents with GAD. The effectiveness of Paxil in the long-term treatment of GAD (more than eight weeks) has not been evaluated in clinical trials.
GlaxoSmithKline, Research Triangle Park, N.C., manufactures Paxil.
The FDA has approved Ventolin HFA (albuterol sulfate HFA), a new version of the Ventolin metered-dose inhaler (MDI) for asthma and other obstructive lung diseases.
Unlike the currently marketed version of Ventolin, this new inhaler uses an alternative propellant called HFA (hydrofluoroalkane) to propel medication rather than chlorofluorocarbons (CFCs). GlaxoSmithKline, Research Triangle Park, NC, manufactures both Ventolin products.
The approval of Ventolin HFA means that there are now two albuterol HFA MDIs approved for use in the United States. The first, Proventil HFA, marketed by Key Pharmaceuticals of Kenilworth, N.J., was approved in 1996. The availability of the two albuterol HFA MDIs offers patients important alternatives to their present albuterol CFC medications.
Since 1978, the use of CFC-propelled aerosol products in this country has been sharply reduced because of increasing evidence that CFCs contribute to the depletion of the Earth's protective ozone layer.
With time, it is expected that these and other CFC-free alternatives will prove to be fully acceptable replacements for the current CFC products, allowing for eventual removal of albuterol CFC MDIs from the market. The removal would occur through a process of public rulemaking, allowing patients, doctors, and others to provide input before the agency takes any actions.
Abuse of the prescription pain reliever OxyContin has escalated over the last year, particularly in rural areas of the eastern United States. FDA experts are discussing strategies to curb OxyContin abuse with the drug's manufacturer Purdue Pharma L.P., Stamford, Conn., and several federal agencies, including the National Institute on Drug Abuse, the Substance Abuse and Mental Health Services Administration, and the U.S. Drug Enforcement Agency. At the same time, the FDA is working closely with Purdue Pharma to ensure that patients who need OxyContin still have access to it.
The FDA approved OxyContin in 1995 to treat chronic, moderate to severe pain. The drug is designed to be swallowed whole to slowly release the drug's active ingredient, oxycodone, over a 12-hour period. But abusers often chew the tablets, crush them and snort the powder, or dissolve them in water and inject the drug for a fast high. OxyContin abusers sometimes commit fraud and theft to sustain their habits. Forgery or alteration of prescriptions is known to occur.
In some cases OxyContin can be obtained easily in clinics; for a brief visit and the appropriate presenting complaint, patients may leave with a prescription for OxyContin. Many physicians are not formally trained to identify drug-seeking behavior.
Several deaths have resulted from OxyContin abuse in Kentucky, Ohio, Virginia, and West Virginia, though the exact number is unknown. Some of these deaths have been associated with OxyContin along with other pain relievers, drugs for anxiety and sleep disorders, marijuana, and alcohol.
Purdue Pharma announced in May that it is temporarily suspending shipments of the highest dosage of the drug (160 milligram tablet) until it has studied the illicit use of OxyContin further.
The FDA has issued a health advisory to announce serious risks associated with the use of Sporanox (itraconazole) products and Lamisil (terbinafine hydrochloride) tablets. Sporanox and Lamisil are used to treat nail, skin, and other fungal infections. The FDA's concerns do not apply to the topically applied versions of Lamisil such as cream and solution.
Both Sporanox and Lamisil have been associated with serious liver problems resulting in liver failure, the need for transplantation, and death. The FDA also believes there is a small but real risk of developing congestive heart failure associated with the use of Sporanox.
The agency has added new information to the labeling for Sporanox, now stating that Sporanox should not be given to treat fungal nail infections in patients with evidence of cardiac dysfunction. The Sporanox warning also includes important information about heart-related adverse events caused by drug interactions.
Given the possible serious risks associated with Sporanox products and Lamisil tablets, the new labeling for both now recommends that health-care professionals obtain nail specimens for laboratory testing to confirm the diagnosis before prescribing the medications for fungal nail infections.
The FDA encourages patients and health-care professionals to report adverse events associated with Sporanox and Lamisil to the FDA's MedWatch program. Reports may be submitted by phone at 1-800-332-1088, by fax at 1-800-332-1078, by mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch/.
The FDA has cleared a new device that helps restore the heartbeat of infants and young children experiencing cardiac arrest. The automated external defibrillator (AED) systems marketed up to this time are restricted to use on adults and children over 8 years old.
According to the American Heart Association, all known heart diseases can lead to cardiac arrest and sudden cardiac death. Most of the cardiac arrests that lead to sudden death occur when the electrical impulses in the heart become rapid (ventricular tachycardia) or chaotic (ventricular fibrillation) or both. This irregular heart rhythm (arrhythmia) causes the heart to stop beating suddenly. Some cardiac arrests are due to extreme slowing of the heart (bradycardia).
AEDs are lifesaving devices used to treat ventricular fibrillation. An AED delivers an electric shock through the chest wall to the heart through conductive adhesive pads. A computer analyzes and interprets the patient's heart rhythm and helps the user decide when the infant or child needs the lifesaving shock. AEDs are prescription devices, intended for use by physicians or specially trained and certified individuals.
The new device, made by Agilent Technologies Inc., Heartstream Division, of Seattle, is an adaptation of the firm's previously approved AED. It is equipped with specially designed pediatric defibrillation pads that deliver about one-third less electrical energy than a standard AED so it can be used on infants and children under age 8 or weighing up to 55 pounds. The connector for the pads is a pink teddy bear to ensure that the user can identify them quickly and accurately.
The firm will conduct a follow-up study of up to 50 children worldwide to evaluate how well the device performs in actual use.
The FDA has approved the first injectable drug to prevent heartworm disease in dogs. One injection provides six months of heartworm protection. The drug, ProHeart 6 (moxidectin sustained release injectable for dogs), is an alternative to currently available heartworm prevention drugs that must be given on a monthly or daily basis.
Heartworm disease is a serious and potentially fatal condition of dogs, cats, and other species of mammals. The parasite that causes heartworm disease is Dirofilaria immitis. It is transmitted through the bite of a mosquito. The adult stage of the parasite is found in the heart and major blood vessels of infected animals.
Canine heartworm infection has been found in dogs in all 50 states. All dogs, regardless of their age, sex, or habitat, are susceptible to heartworm infection. The highest infection rates (up to 45 percent) in dogs not maintained on heartworm preventive are found within 150 miles of the Gulf of Mexico and Atlantic Coast from Texas to New Jersey and along the Mississippi River and its major tributaries. Other areas of the United States have lower incidence rates (5 percent or less) of canine heartworm disease.
Fort Dodge Animal Health, Fort Dodge, Iowa, is the manufacturer of ProHeart 6, which will be available by prescription from a licensed veterinarian. It is approved for use in dogs 6 months of age and older and also treats existing hookworm (Ancylostoma caninum) infections.
Effective April 30, the FDA's Center for Veterinary Medicine (CVM) withdrew the approvals of two new animal drug applications (NADAs). Sponsored by Abbott Laboratories, the NADAs provide for use of sarafloxacin antimicrobial drugs to help keep poultry from dying of Escherichia coli (E. coli) infection. One is NADA 141-017 for SaraFlox (sarafloxacin hydrochloride) WSP, a water-soluble powder used in the drinking water of broiler chickens and growing turkeys. The other is NADA 141-018 for SaraFlox (sarafloxacin hydrochloride) Injection, an injectable solution used in 18-day fertile broiler eggs and day-old broiler chickens.
Last year, CVM informed Abbott Laboratories that, on the basis of new data and information, there is a potential for humans to develop antibiotic-resistant infections from consuming poultry that has been treated with fluoroquinolones such as sarafloxacin. Specifically, CVM has determined that:
•The use of fluoroquinolones in poultry causes the development of fluoroquinolone-resistant Campylobacter (a bacterium that can cause disease in humans);
•This fluoroquinolone-resistant Campylobacter is transferred to humans and is a significant cause of the development of fluoroquinolone-resistant Campylobacter infections in humans; and
•Fluoroquinolone-resistant Campylobacter infections are a hazard to human health. (See "Antibiotic Resistance From Down on the Chicken Farm," January-February 2001 FDA Consumer.)
Fluoroquinolones also are approved for use in humans, and they are considered to be one of the most valuable antimicrobial drug classes available to treat human infections because of their spectrum of activity, safety, and ease of administration. This class of drugs is effective against a wide range of human diseases and is used to both treat and prevent bacterial infections in the community and in hospitals.
Physicians use fluoroquinolones routinely to treat foodborne diseases, which have a major public health consequence in the United States. After CVM informed Abbott Laboratories of this human food safety question, Abbott requested voluntary withdrawal of approval of NADAs 141-017 and 141-018.
Further information about CVM's concern about antimicrobial resistance related to drug use in food-producing animals may be found at www.fda.gov/cvm/antimicrobial/antimicrobial.html.
Food safety leaders from Central America took part in an FDA training program on good agricultural practices (GAPs) and good manufacturing practices (GMPs) in the spring. Participants represented Panama, Guatemala, Nicaragua, El Salvador, Honduras, Costa Rica and the Dominican Republic, and included representatives from government, business, academia, health, and agriculture.
The FDA's Center for Food Safety and Applied Nutrition (CFSAN) joined with the U.S. Department of Agriculture/Foreign Agricultural Service Cochran Fellowship Program and the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) at the University of Maryland to develop and sponsor the two-week program.
The program featured classroom instruction and visits to farms, packing houses, and agricultural research stations. The first segment took place at the University of Maryland Inn and Conference Center in College Park, and included discussions on food safety strategy, trade issues, and hazard identification, in addition to an intensive review of Gaps The second segment, held in Antigua, Guatemala, allowed participants to observe how the good agricultural practices outlined in the first part of the course are applied.
CFSAN conducts training around the world on Gaps and GMPs as part of its National Food Safety Program. The United States has taken major steps to ensure the safety of domestically grown produce, and the FDA has leveraged its ability to do the same with imported produce through teamwork with the USDA's Cochran Fellowship Program and JIFSAN. For more information, contact CFSAN at 1-888-SAFEFOOD or go to www.cfsan.fda.gov/~dms/fs-toc.html.
Serious Product Problem? Report ItHealth professionals can report serious adverse reactions or other product problems to FDA's MedWatch program by:
FDA encourages consumers to report through their doctors, but if they prefer, they may submit the MedWatch form themselves. |
The health monitoring device for home use pictured on page 14 of the May-June issue of FDA Consumer was incorrectly identified in the photo caption. The device should have been identified as the HomMed Sentry III, cleared for marketing by the FDA in March 2001.
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