Table of Contents
FDA Consumer magazine
July-August 1999
In response to six deaths and other serious, nonfatal infections in patients taking the rheumatoid arthritis drug Enbrel (etanercept), the drug's marketers are expanding the product's warning about use in patients with infections.
Enbrel was approved last November to treat moderate-to-severe, active rheumatoid arthritis in patients who did not respond well to other treatments. When it was approved, the drug's labeling said it should not be given to patients with a blood infection called sepsis and should be discontinued if a patient develops a serious infection.
Since the drug's approval, 30 of the estimated 25,000 patients treated with Enbrel reportedly developed sepsis or other serious infections.
Based on adverse reaction reports to FDA and one of the drug's marketers, Immunex Corp., the new labeling expands the sepsis warning to include patients with any active infection, including those that are chronic or localized. The new labeling also recommends that:
Immunex has informed physicians of the new safety concerns and the labeling revisions.
So far, controlled clinical studies have not shown an increase in serious infections in patients treated with Enbrel. It is unclear without further scientific studies whether Enbrel is the actual cause of the serious infections in rheumatoid arthritis patients, but significant concerns remain, and FDA has asked Immunex to do additional studies to assess the risk.
As a condition of the drug's more recent May approval to treat some cases of juvenile rheumatoid arthritis, FDA is also requiring Immunex to follow all pediatric users and report how they do on the drug.
FDA asks people to report all cases of sepsis or other serious infection to the agency's MedWatch program, by calling 1-800-FDA-1088 (1-800-332-1088) or through the Internet at www.fda.gov/medwatch/. Also, health professionals may call Immunex Professional Services, Seattle, at 1-800-IMMUNEX (1-800-466-8639) or co-marketer Wyeth-Ayerst Laboratories, Philadelphia, at 1-800-934-5556.
A newly approved anti-obesity drug works by blocking the body's absorption of fat, not by suppressing the appetite like other diet drugs.
Xenical (orlistat), approved by FDA in April, decreases a person's fat absorption by about 30 percent by preventing the body from breaking down dietary fats into smaller, absorbable molecules. It is the first anti-obesity drug in a drug class known as lipase inhibitors.
Xenical is for obese patients with a body mass index (BMI, a measure of weight in relation to height) of 30 or more, or for patients with a BMI of at least 27 who also have high blood pressure, high cholesterol, or diabetes. (A person 5 feet 5 inches tall who weighs 180 pounds, for example, would have a BMI of 30.)
In seven long-term clinical trials of more than 4,000 patients, 57 percent of those who completed one year of treatment with Xenical lost at least 5 percent of their baseline body weight, compared with 31 percent of patients treated with a placebo for the same length of time.
The recommended dose of Xenical is one capsule with each main meal that includes fat. During treatment, the patient should be on a nutritionally balanced, reduced-calorie diet that contains no more than 30 percent of calories from fat. Also, because Xenical reduces the absorption of some fat-soluble vitamins and beta carotene, patients should take a supplement containing fat-soluble vitamins (A, D, E and K) and beta carotene.
The drug's most common side effects are oily spotting, gas with discharge, fecal urgency, fatty/oily stools, and frequent bowel movements.
Xenical is made by Roche Laboratories Inc., Nutley, N.J.
Some mildly nearsighted people may now opt for acrylic eye implants to improve their vision rather than glasses, contacts, or eye surgery.
In April, FDA approved tiny, crescent-shaped devices called KeraVision Intacs that, when surgically implanted into the cornea (the membrane that covers the eye), can flatten the cornea and reduce or eliminate mild nearsightedness.
The Intacs implants are considered permanent, although they can be removed if necessary.
FDA approved the implants only for use in patients 21 or older. The safety and effectiveness of the implants have not been established for moderate or severe nearsightedness.
Approval was based on the manufacturer's safety and effectiveness data and the recommendation of the Ophthalmic Devices Panel, a group of outside experts. In clinical studies of 450 eyes, 97 percent of eyes were corrected to 24/40 or better and 74 percent were corrected to 20/20 or better.
Thirty-nine patients chose to have their Intacs removed because of side effects (such as glare or halos) or because they were unhappy with the corrected vision.
When the implants are removed, vision usually returns to its presurgery level, but some patients may experience vision problems such as glare or halos around lights.
At FDA's request, the implants' maker, KeraVision Inc., Fremont, Calif., is continuing to collect data on patients to determine the long-term effect of the implants on the cornea.
A new device will help radiologists determine whether a woman should be evaluated further when the results of her mammogram are unclear.
Approved by FDA in April, the T-Scan 2000 can potentially help identify women who should be referred for early biopsy and reduce the number of negative biopsies.
The T-Scan uses a hand-held scanner placed on the breast to evaluate certain suspicious areas detected on the mammogram. A computer connected to the scanner displays an image of the breast areas in question. The image is based on differences in the flow of electricity in malignant tumor tissue and surrounding normal tissue.
The T-Scan is intended as a follow-up to mammography, and does not replace mammography or other conventional methods of detecting or diagnosing breast cancer (such as clinical breast examination, ultrasound, or biopsy evaluation.)
Approval of the device was based on the results of three clinical studies of safety and effectiveness performed by the device's manufacturer, TransScan Medical Inc., Ramsey, N.J., and on the recommendation of an advisory panel of outside experts.
As a condition of approval, TransScan Medical is required to conduct a postmarketing study on the effects of hormonal changes during the menstrual cycle on the device's ability to detect and distinguish among breast abnormalities.
Cancer's many faces . . . At one time cancer was thought to be a single disease that attacked different tissues. Then, over the years, it was recognized to be a hundred different diseases as determined by the particular tissue involved and the kind of cells within that tissue that were growing out of control. Now scientists at Memorial Sloan-Kettering Cancer Center in New York believe that cancer comes in countless variations, each with a genetically determined molecular "fingerprint" that indicates how deadly it is likely to be and how aggressively it should be treated. With this understanding, doctors can identify tumors insensitive to a particular form of treatment and prescribe the most effective therapy.
Prompted by reports of at least three deaths and several severe adverse reactions, FDA in May warned the public about a new group of products sold on the Internet, in health food stores, and through ads in muscle-building magazines. The agency declared one of the new products--1,4 butanediol (BD)--a Class I health hazard, meaning its use could pose a potentially life-threatening risk.
FDA considers BD products unapproved new drugs, and the products have been seized to prevent their sale and further illnesses and deaths.
Marketed alternatively as sleep aids, "party drugs," and dietary supplements, these BD-related products chemically resemble two other hazardous substances that FDA considers unapproved new drugs--gamma hydroxybutyric acid (GHB) and gamma butyrolactone (GBL). FDA has issued several warnings about GHB and GBL. Health officials believe that manufacturers of these products are renaming them and substituting BD for GBL.
Considered as dangerous as GHB and GBL, BD can cause dangerously low respiratory (breathing) rates, unconsciousness, vomiting, seizures, and death. Also, BD may increase the effects of alcohol and is even more dangerous when consumed with other depressant drugs.
Products that contain BD include Revitalize Plus, Serenity, Enliven, GHRE, SomatoPro, NRG3, Thunder Nectar, and Weight Belt Cleaner. The labels of suspect products may list 1,4 butanediol, tetramethylene glycol, gamma butyrolactone, or 2(3H)-furanone di-hydro as ingredients.
In issuing its warning on BD products, FDA said it could not ensure the effectiveness or safety of any sleep-aid product other than FDA-approved drugs. "People who use unapproved sleep inducement products, especially without proper medical supervision, may be unnecessarily exposing themselves to serious harm," the agency said.
A device that uses jets of salty water to remove blood clots from blocked heart arteries or blood vessels grafted in bypass operations has received approval from FDA.
The AngioJet System offers an alternative treatment to "clot-busting" drugs such as tissue plasminogen activator (t-PA).
Because blockages in heart arteries are sometimes complicated by blood clots--which can cause a heart attack or death--doctors often use clot-busting drugs to clear the clots before performing angioplasty. But many patients cannot take such drugs, so the AngioJet System gives them another option.
Several clinical studies showed the device's effectiveness. For example, in one trial where 180 patients were treated with the AngioJet System and 169 with urokinase, a clot-busting drug, results were similar. Another study showed that the AngioJet System could be used effectively with other treatments to remove blood clots during a heart attack.
FDA approved the AngioJet System less than six months after the manufacturer, Possis Medical, Minneapolis, submitted the marketing application.
An egg a day . . . Eating one egg a day does not increase the risk for heart attacks or strokes, says a Brigham and Women's Hospital study of over 80,000 women and a separate study of nearly 38,000 men. Among healthy men and women, no significant differences in risk for heart disease or stroke were reported between those eating an average of up to one egg daily and those averaging less than one weekly. Diabetics, however, did face greater risks of heart attacks or strokes with a higher level of egg consumption.
FDA has approved the first at-home test kit for detecting the hepatitis C virus, the nation's most common blood-borne infection and a major cause of liver damage.
The Hepatitis C Check, approved April 29, allows consumers to collect a blood sample on a piece of filter paper and mail it to a laboratory that tests for antibodies to the hepatitis C virus (HCV). The laboratory screens the sample with an FDA-licensed test for antibodies and confirms any positive samples with a different FDA-licensed test.
Consumers can obtain the results of their home tests anonymously by phone from an automated system or a health-care counselor. The kit's manufacturer, Home Access Health Co., Hoffman Estates, Ill., also offers education and counseling about HCV and referrals to doctors.
Hepatitis C, which affects about 4 million Americans in its chronic form, can cause cirrhosis (irreversible and potentially fatal liver scarring), liver cancer, or liver failure. It is responsible for 8,000 to 10,000 deaths a year in the United States.
The Hepatitis C Check may not detect the virus if it was contracted in the previous six months. Also, the test does not show if the infection is presently active. This must be determined by a doctor's evaluation and additional testing.
(For more information about hepatitis C, see "Hepatitis C: New Treatment Helps Some, but Cure Remains Elusive" in the March-April 1999 FDA Consumer.)
A mandatory hepatitis vaccine? ... The national Centers for Disease Control and Prevention wants children in 11 western states with a high incidence of hepatitis A to be vaccinated against the disease. CDC recommends that states with at least 20 cases out of every 100,000 people--including Arizona, Alaska, California, Idaho, Nevada, New Mexico, Oklahoma, Oregon, South Dakota, Utah, and Washington--get the vaccine. Hepatitis A is a highly contagious virus that can damage the liver. It is spread by personal contact when hands aren't washed after bathroom use or by contaminated food or water. An effective vaccine has been available since February 1995.
Bottled water sold in interstate commerce is safe to drink, FDA said following the release in March of a privately funded report that questioned the safety of such water. However, the agency said it would review the report, which was based on a four-year study by the environmental health group National Resources Defense Council, and would welcome other suggestions on how to improve the quality of bottled water.
NRDC's study found that of 1,000 bottles of 103 brands of bottled water tested, about one-third contained such contaminants as synthetic organic chemicals, bacteria, and arsenic. The organization said it undertook the study as part of a petition it submitted to FDA calling on the agency to strengthen its regulation and oversight of bottled water.
NRDC said FDA's bottled water regulations should apply nationally, as well as within every state. Currently, FDA regulates only bottled water sold in interstate commerce--not water manufactured and sold solely within a state. State authorities regulate the latter, although state laws governing bottled water are often based on FDA's standards.
FDA said in a published statement in March that its regulations cover all aspects of plant and manufacturing operations, equipment and procedures, as well as administrative matters, such as record-keeping and employee training.
These regulations "help protect the public against any health problem that could conceivably occur with bottled water products," the agency said.
In addition, those most vulnerable to Listeria infections, such as pregnant women, the elderly, and those with weakened immune systems, also should:
What you don't know can hurt you . . . How likely are consumers to respond to foods being recalled by a manufacturer? Not very, say researchers at the Centers for Disease Control and Prevention. In a study that tracked how consumers reacted to a recall of food contamination with Salmonella bacteria that had sickened an estimated 224,000 people, consumers weren't any more likely to have thrown away the product. More than 25 percent thought the product was still "okay." And 31 percent who had heard the warning and still had the product simply ignored the warning and ate the food anyway. Federal officials urge consumers who learn about a potentially tainted product to check their cabinets and refrigerators and throw out any found. Most food stores will offer a full refund for recalled food.
Double dose . . . The recommended daily allowance for vitamin C should be doubled or even tripled, say government researchers, because of increasing evidence over the last two decades of the vitamin's cancer-fighting ability when consumed in fruits and vegetables. The National Institutes of Health says the allowance should be 100 to 200 milligrams instead of the current 60 milligrams established by the National Academy of Sciences in 1980. But researchers are not sure if benefits come from the vitamins themselves or from the vitamins plus other components of the food containing the vitamins. And they add that there is such a thing as too much vitamin C: 200 milligrams is the maximum the body can absorb. Larger amounts can increase the risk of kidney stones.
The first drug for treating and preventing recurring stomach ulcers in horses and foals older than 4 weeks was recently approved by FDA.
The agency approved GastroGard (omeprazole) in March for these types of ulcers in horses, which are a common problem in stressful environments and can lead to death, especially among foals. Omeprazole was previously approved under the trade name Prilosec for intestinal and stomach ulcers and certain other stomach conditions in humans.
GastroGard is sold by Merial Limited, Iselin, N.J., and is available only through a licensed veterinarian. The safety of the drug in pregnant or lactating mares is not known
"Today" to return "tomorrow" . . . Once hailed as the most popular contraceptive available, the Today Sponge is coming back after the manufacturer removed it from the market in 1995 because it would be too expensive to correct the factory flaws FDA found. A small pharmaceutical company recently resurrected the nonprescription birth-control device after buying the rights to the product. Many women favored the sponge because of its simplicity, convenience, and the low risk of side effects. It is expected to be available again in drugstores, following FDA's final inspection of production operations, sometime in the fall.
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