U.S.
Food and Drug Administration
FDA Consumer magazine
January-February 2003
Table of Contents
In November, the FDA approved the Kremers Urban Development Company's drug application for 10-milligram and 20 milligram omeprazole delayed-release capsules. This approval allows the first marketing of a generic omeprazole product to compete with AstraZeneca LP's Prilosec, which treats persistent heartburn and other symptoms of gastroesophageal reflux disease.
This is not the first approved generic omeprazole, but it is the first approval of a generic omeprazole that does not infringe on patents held by AstraZeneca. The FDA approved the omeprazole application for Andrx Pharmaceuticals, Inc., in November 2001. But Andrx has not been able to market its generic omeprazole because of patent infringement concerns.
Health and Human Services Secretary Tommy G. Thompson says this approval of generic omeprazole represents a win-win situation. Thompson says, "For those who are successfully taking this prescription, it means potential savings, and for those who could not afford the brand-name drug, it means greater access to a successful medication at a lower cost."
Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the brand-name price. According to the Congressional Budget Office, generic drugs save consumers an estimated $8 billion to $10 billion a year at retail pharmacies.
The FDA ensures that a generic drug is as safe and effective as the brand-name drug, and that it is manufactured to the same high quality standards. A generic drug is identical to the brand name drug in dosage form, strength, route of administration, and most labeled uses.
Kremers Urban Development Company is an affiliate of Schwarz Pharma Inc. of Milwaukee.
The FDA has approved Claritin (loratadine) as an over-the-counter (OTC) allergy drug product. The drug was previously available only with a prescription. Claritin is approved for seasonal allergic rhinitis--a condition that causes runny nose, nasal congestion, sneezing, and itchy nose, throat, eyes, and ears. About 10 percent to 30 percent of adults in the United States suffer from seasonal allergy symptoms.
"By making it easier to get this widely-used drug, today's action will enable many people to get less sedating, effective relief for their allergy symptoms more quickly and at a lower cost," FDA Commissioner Mark B. McClellan, M.D., Ph.D., said of the approval, which was announced on Nov. 27, 2002. When drugs move from prescription to OTC status, the price typically declines.
Claritin's approval for OTC marketing was based on the FDA's criteria for determining appropriate drugs for OTC use: that the drug in question treats a condition that consumers can diagnose and manage themselves, that the drug is sufficiently safe for use by consumers without direct prescriber supervision, and that the drug's label explains potential adverse effects and conditions of use with clear, understandable directions.
McClellan said, "This approval reflects FDA's commitment to bringing prescription drugs to over-the-counter when they can be safely used without a prescription." The approval also marks a milestone in the FDA's work with the National Transportation Safety Board to improve public awareness of concerns about prescription and OTC drug products that cause drowsiness.
Because OTC antihistamines already on the market may cause drowsiness, the FDA requires them to carry warnings about driving or operating machinery. Claritin was approved in April 1993 as one of the first new-generation antihistamines developed to be less sedating than traditional antihistamines.
Claritin is manufactured by Schering-Plough Corp., based in Kenilworth, N.J.
The FDA has approved a new rapid HIV diagnostic test kit that provides results with 99.6 percent accuracy in as little as 20 minutes.
Using a drop of blood collected from a finger-stick, the OraQuick Rapid HIV-1 Antibody Test can quickly and reliably detect antibodies to HIV-1, the virus involved in most AIDS cases in the United States. Unlike other antibody tests for HIV, OraQuick can be stored at room temperature, requires no specialized equipment, and may be considered for use outside of traditional laboratory or clinical settings.
Health and Human Services Secretary Tommy G. Thompson says that many HIV-infected people who come to public clinics for HIV testing do not return a week later to receive their test results. "With this new test," he says, "in less than a half an hour they can learn preliminary information about their HIV status, allowing them to get the care they need to slow the progression of their disease and to take precautionary measures to help prevent the spread of this deadly virus."
To perform the test, a blood sample is collected from a person and transferred to a vial, where it is mixed with a developing solution. The test device, which resembles a dipstick, is then inserted into the vial. In as little as 20 minutes, the test device will indicate if HIV-1 antibodies are present in the solution by displaying two reddish-purple lines in a small window on the device.
People who take the rapid tests will get the results directly from their doctor's office or clinic. As with all screening tests for HIV, if the OraQuick test indicates that HIV antibodies are present, the result must be confirmed with an additional specific test. The OraQuick test has not been approved to screen blood donors. The test is manufactured by OraSure Technologies Inc. of Bethlehem, Pa.
The Centers for Disease Control and Prevention (CDC) has estimated that one-quarter of the approximately 900,000 HIV-infected people in the United States are not aware that they are infected. Because of the potential public health benefits of rapid HIV testing, the CDC and the Centers for Medicare and Medicaid Services are working with other officials to make the test widely available.
The FDA seized dietary supplements from an Oregon company after determining that the product's manufacturer was making unsubstantiated medical claims.
After investigating the firm's Internet site, the FDA requested that the U.S. Marshals Service seize hundreds of bottles of Kirkman's HypoAllergenic Taurine Capsules. Humphrey Laboratories of Lake Osewego, Ore., doing business as Kirkman Laboratories, claimed that the product treats autism, a neurobehavioral disorder that begins in early childhood.
Under the Federal Food, Drug, and Cosmetic Act, all labeling on dietary supplements must be truthful and not misleading and may not make any claims that the product will cure, mitigate, treat, or prevent disease. Claims that the capsules treat autism caused the firm's product to be a misbranded food and an unapproved new drug.
No illnesses have been reported in association with this product.
The FDA recently updated its 1999 health advisory on the risks of eating raw sprouts. The bacteria Salmonella and E. coli O157:H7 have been linked to mung bean and alfalfa sprouts, and resulting foodborne illness has affected people of all ages. Healthy people infected with these bacteria may have diarrhea, nausea, abdominal cramping, and fever for several days. For people at high risk, such as children, the elderly, and those whose immune systems are compromised, E. coli infection could lead to serious complications, including hemolytic uremic syndrome, which can result in kidney failure or death. Salmonella infection in high-risk groups can also cause serious illness.
Some segments of the sprout industry have greatly enhanced the safety of their products by following recommendations in guidance issued in 1999 by the FDA's Center for Food Safety and Applied Nutrition. However, adherence to this guidance has not been universal, and outbreaks linked to raw and lightly cooked sprouts have continued to occur.
To significantly reduce the risk of illness, the FDA advises consumers to cook all sprouts thoroughly before eating. Consumers who eat out and who wish to reduce their risk of foodborne illness should specifically request that raw sprouts not be added to their food, such as sandwiches and salads.
Homegrown sprouts also present a health risk if eaten raw or lightly cooked. Many outbreaks have been attributed to contaminated seed, which can grow high levels of harmful bacteria during sprouting, even under clean conditions.
The FDA will continue to closely monitor the safety of sprouts and will take further actions as necessary.
The FDA has cleared for marketing a new laboratory test for Group B Streptococcus (Group B strep) in pregnant women.
The test, the IDI-Strep B test, made by Infectio Diagnostic Inc. of Sainte-Foy, Quebec, can provide results in one hour. In contrast, the standard method of culture testing takes between18 and 48 hours for results. The new test is performed on a swab sample taken from the vagina and rectum.
Group B strep is a leading cause of illness and death among newborns in the United States. It can be acquired during birth from mothers who unknowingly have the organism. An estimated 10 percent to 30 percent of pregnant women have Group B strep. However, antibiotic treatment of the mother during labor can prevent transmission to the newborn.
Pregnant women are typically screened for Group B strep two to four weeks before labor begins using the standard culture method, as recommended by the Centers for Disease Control and Prevention. If the test is positive for Group B strep, the woman is given four hours of antibiotic treatment during labor.
Use of this standard screening method has led to a 70 percent decline in the incidence of Group B strep during the past decade. However, because of the time needed to culture samples and the four hours needed for antibiotic treatment, it is only useful for women who are tested at least several days before labor begins--not those who start labor early, or who do not have the advantage of prenatal care. The new IDI-Strep B test, with timely results, could be particularly beneficial for these women when they first go into labor.
The FDA has approved a heart assist pump to be implanted permanently in certain terminally ill patients who are not eligible for heart transplant.
The device, called HeartMate, is a left ventricular assist device (LVAD) made by Thoratec Corporation of Pleasanton, Calif. The device assists weakly beating hearts by taking over the work of the heart's main pumping chamber, the left ventricle.
HeartMate was previously approved solely as a bridge to transplantation for patients eligible for heart transplants and waiting for an available heart. This recent approval expands the availability of HeartMate to certain people with severe end-stage congestive heart failure who are not eligible for heart transplants. An estimated 20,000 to 30,000 people in the United States may fall in this category.
"Heart technology is developing rapidly and holds great promise for the future," says FDA Deputy Commissioner Lester M. Crawford, D.V.M., Ph.D. "LVAD devices like the one approved ... can add months to the lives of terminally ill heart patients. In the future, these devices may be able to extend life even longer and ultimately may have a major impact on the treatment of heart failure."
The FDA approved the device for expanded use based on the results of a randomized clinical trial conducted by Thoratec in cooperation with the National Institutes of Health and on the recommendation of an FDA advisory committee.
Implanting the device requires major surgery for already seriously ill people. In the clinical trial, 32 percent of the patients had bleeding that required re-operation, 41 percent developed an infection, and 10 percent had a stroke.
The FDA is requiring Thoratec to implement a post-approval patient registry to obtain additional long-term safety and effectiveness data.
The FDA has issued a warning to a Web site operator for promoting and selling an herbal product called Yellow Jackets. The product was being promoted as an alternative to illicit street drugs, and could pose a serious risk to consumers. The warning, called a cyber letter, is an e-mail sent by the agency to notify the company of potential violations. The FDA issued the cyber letter to the Internet address of Mr. Xoch Linnebank of the Netherlands.
According to Linnebank's Web site, the Yellow Jackets product contains ephedra and other herbal ingredients, including kola nut extract (a source of caffeine). There does not appear to be any legitimate drug use for this product, and its sale as a substitute for a controlled substance would be illegal. "Consumers should not purchase or use these or similar products available through the Internet or elsewhere," says FDA Deputy Commissioner Lester M. Crawford, D.V.M., Ph.D.
Cyber letters give foreign Web site operators an explanation of statutory provisions that govern interstate commerce of drugs in the United States. The letters also warn that future shipments of products may be detained at the border and subject to refusal of entry. Copies of each letter are sent to regulatory officials in the country in which the Web site operator is based.
A document called "Guidance for Industry: Street Drug Alternatives," which explains the FDA's policy on products that are promoted as street drug alternatives, is available at on this Web site.
Consumers who want more information about online drug sales, or who wish to report Web sites that they believe are promoting illegal products, can contact the FDA.
The FDA and Pharmacia Corporation are advising health-care professionals about new warnings and information in the product labeling of Bextra (valdecoxib), a drug approved for treatment of osteoarthritis, rheumatoid arthritis and menstrual pain (dysmenorrhea). The labeling is being updated with new warnings following postmarketing reports of serious adverse effects, including serious allergic reactions (anaphylactoid reactions). As these reactions can be life-threatening, people who start Bextra and experience a rash should discontinue the drug immediately. In addition, the labeling will state that the drug is contraindicated--not to be used--in patients allergic to sulfa-containing products.
Health-care professionals are encouraged to report any unexpected adverse or serious events associated with the use of Bextra directly to Pharmacia Corporation, Peapack, N.J. at 1-800-323-4204 or to the FDA MedWatch program at 1-800-FDA-1088.
The FDA has approved two new products to treat opiate dependence.
In October 2002, the FDA approved Subutex and Suboxone tablets, which work by preventing symptoms of withdrawal from heroin and other opiates.
The new products represent two new formulations of buprenorphine. Subutex (buprenorphine hydrochloride) is intended for use at the beginning of drug abuse treatment. Suboxone (buprenorphine hydrochloride and naloxone hydrochloride) is intended to be the formulation used in maintenance treatment for opiate addiction. Naloxone was added to Suboxone to guard against intravenous abuse of buprenorphine.
Both drugs are supplied in 2 milligram and 8 milligram tablets, which are placed under the tongue and must be allowed to dissolve.
Subutex and Suboxone were studied in more than 2,000 people and shown to be safe and effective treatments. Side effects most commonly seen with both drugs include cold- or flu-like symptoms, headaches, sweating, sleeping difficulties, nausea, and mood swings. These effects usually peak in the beginning of treatment and may last a number of weeks.
Clinical data indicate that the risk of serious diminished breathing may be less with buprenorphine than other opioids when used in high doses or in overdose situations. Nonetheless, buprenorphine has been associated with deaths due to diminished breathing, especially when used with alcohol or other central nervous system depressant drugs, according to reports from France, where it has been available for several years.
Based on the potential for abuse of Subutex and Suboxone, the FDA and the U.S. Department of Health and Human Services recommended that the Drug Enforcement Administration (DEA) place the active ingredient buprenorphine in Schedule III under the Controlled Substances Act. Subutex and Suboxone are the first narcotic drugs available for the treatment of opiate dependence that can be prescribed in an office setting under the Drug Addiction Treatment Act of 2000. Subutex and Suboxone are manufactured by Reckitt Benckiser Healthcare in Hull, England.
The FDA has approved a small metallic implant to be placed into the fallopian tubes of women who wish to be permanently sterilized. Unlike other currently available surgical sterilization procedures for women, placement of the device does not require an incision or general anesthesia.
The product, approved in November 2002, is the Essure System manufactured by Conceptus Inc., of San Carlos, Calif. The FDA speeded review of the product because of its potential benefit to women seeking an alternative means of sterilization.
During the implantation procedure, the physician inserts one of the devices into each of the two fallopian tubes. This is done with a special catheter that is inserted through the vagina into the uterus, and then into the fallopian tube. The device, which resembles a tiny spring, works by inducing scar tissue to form over the implant, blocking the fallopian tube and preventing fertilization of the egg by the sperm.
The FDA based its approval of the device primarily on a review of two clinical studies of safety and effectiveness conducted by the manufacturer and on the recommendation of an FDA advisory committee. No serious adverse events were reported from either clinical study.
In the smaller of the two studies, 181 women had the device implanted in both fallopian tubes for at least 24 months; no pregnancies have been reported. In the second study, 439 women between the ages of 21 and 40 who had the device implanted reported no pregnancies after one year. Two-year data on an additional 16 women also showed no pregnancies.
In the clinical studies, doctors failed to place the device in both fallopian tubes at first attempt in about 1 out of 7 women. As a condition of approval, Conceptus will conduct a post-approval study to document the placement failure rate with newly trained physicians and to identify potential reasons for this failure. Conceptus also will be required to follow all study participants from both clinical studies for at least five years to evaluate long-term contraceptive effectiveness.
Women who choose this device for sterilization should be aware that the procedure is irreversible. Women should also know that pregnancies following sterilization can occur, even many years after the procedure, and that such pregnancies are at increased risk to be ectopic (outside the uterus), a life-threatening condition.