Table of Contents
FDA Consumer magazine
March-April 2000
A drug previously approved to treat advanced breast cancer has received additional FDA approval for treating non-small cell lung cancer that does not respond to chemotherapy with cisplatin drugs.
Taxotere (docetaxel) may be used to treat non-small cell lung cancer that is locally advanced or has spread to other organs. Typically, this type of cancer, when diagnosed, has spread beyond the lungs and cannot be cured. But two recent clinical trials showed that patients treated with Taxotere had increased survival rates compared with those who received other treatments, such as the cisplatin-based drugs Navelbine (vinorelbine) or Ifex (ifosfamide).
Taxotere is made by Rhône-Poulenc Rorer, Collegeville, Pa.
To treat certain skin lesions that may lead to skin cancer if left untreated, FDA has approved a first-of-its-kind combined drug-device treatment.
Levulan Kerastick (aminolevulinic acid HCl) was approved to treat precancerous skin lesions called "actinic keratoses" (AK) on a patient's face and scalp.
In a two-stage treatment process, a doctor first topically applies aminolevulinic acid directly onto the individual AK lesions, then follows up 14 to 18 hours later with a special blue light.
AKs are rough, scaly red or brown patches on the skin that are found mostly on light-complected individuals, including over 50 percent of elderly fair-skinned people living in hot, sunny climates.
Approved Dec. 6, 1999, the Levulan Kerastick was designed to treat individual lesions, thereby reducing possible skin irritation of unaffected skin. It has not been approved for the treatment of AKs on the back or arms.
Other treatments for AKs include freezing or scraping the skin, electrosurgery, excision, laser surgery, and topical chemotherapy.
But the best method for combating skin cancer is still prevention, say medical experts. Commonsense measures such as wearing protective clothing, avoiding the midday sun, and wearing sunscreen with a sun protection factor (SPF) of at least 15 are still the best defenses.
The Levulan Kerastick, made by DUSA Pharmaceuticals Inc. of Valhalla, N.Y., will be marketed in combination with the light source BLU-U Blue Light Photodynamic Therapy Illuminator.
Women should get their original mammograms rather than copies, which are considered inferior, says FDA, when they need them for comparison with other mammograms or for follow-up clinical procedures. Facilities are required to transfer the original films under the Mammography Quality Standards Act (MQSA) final regulations, which became effective April 28, 1999. FDA also reminds women that facilities may not charge patients for copying their original mammograms, unless the patient requests copies or copies must be kept at the facility under state regulations. (For more information, see "FDA Sets Higher Standards for Mammography" in the January-February 1999 issue of FDA Consumer.)
AIDS no longer a leading killer ... AIDS deaths have dropped to the lowest level since 1987, moving the disease off the list of the 15 leading causes of death in the United States. According to the National Center for Health Statistics, the age-adjusted death rate linked to infection with the AIDS virus, dropped 21 percent to 4.6 per 100,000 persons in 1998, following a 48 percent decline from 1996 to 1997.
Government urges safer needles ... To protect thousands of workers from dangerous infections received when they accidentally prick themselves with a used needle, federal health officials recommended last November that hospitals and other health-care facilities use safer needles and syringes. The national Centers for Disease Control and Prevention says that some 600,000 to 800,000 health workers accidentally stick themselves each year, increasing their risk for infections such as hepatitis and HIV. The recommendations are voluntary and are intended to provide guidance for employers and workers. FDA has approved the sale of 50 types of specially protected needles and syringes, but the American Nurses Association says that only 15 percent of hospitals are using them.
An FDA final rule defines statements now allowed on dietary supplements, expands the number of acceptable product claims, and explains how FDA will distinguish allowable "structure/function" claims from disease claims.
The rule should help consumers choose appropriate dietary supplements without affecting the availability of these types of products.
Under the Dietary Supplement Health and Education Act of 1994, dietary supplements may, without prior FDA review, carry claims about the product's effect on the structure or function of the body. Prior agency review is necessary, however, for claims that a product can prevent, treat, cure, mitigate, or diagnose disease.
The final rule prohibits unreviewed disease claims that are either express, such as "prevents osteoporosis," or implied, such as "prevents bone fragility in post-menopausal women." Also, the rule clarifies that unreviewed disease claims are not allowed in the name of a product ("Carpaltum"), in a statement about the product's formulation ("contains aspirin"), or through the use of pictures, vignettes, or symbols (electrocardiogram tracings).
The new rule permits claims that do not relate to disease. Such claims include health maintenance claims ("maintains a healthy circulatory system"), claims for common, minor symptoms associated with life stages ("for common symptoms of PMS," "for hot flashes"), and other nondisease claims ("for muscle enhancement," "helps you relax").
The rule permits structure/function claims about certain common conditions associated with aging, menopause and adolescence. However, osteoporosis and other serious conditions associated with aging, menopause or adolescence will still be treated as diseases.
Although the rule, which went into effect 30 days after its Jan. 6 publication, allowed for structure/function claims associated with pregnancy, FDA announced on Feb. 9 that it would review concerns recently raised about this issue. Until the review is complete, the agency advises dietary supplement manufacturers not to make any claims related to pregnancy on their products based on the Jan. 6 rule. As always, FDA urges all pregnant women to consult their health-care providers before taking any dietary supplements or medication.
FDA is warning consumers not to buy or use a product sold for weight loss because it could cause serious health problems.
The product, Triax Metabolic Accelerator, contains a potent thyroid hormone that could cause heart attacks, strokes, and other serious health effects. It has been marketed in retail stores and on the Internet as a dietary supplement, but FDA considers it an unapproved drug.
Through its MedWatch reporting system, FDA learned of several people who had abnormal thyroid function test results while using Triax. These individuals sought medical attention because of symptoms such as severe diarrhea, fatigue, drowsiness, and extreme loss of weight after using the product.
The active ingredient in Triax Metabolic Accelerator is triiodothyroacetic acid (TRIAC). FDA urges consumers to stop using any product containing that ingredient and to seek medical attention if they experience insomnia, nervousness, sweating, or diarrhea.
Syntrax Innovations Inc., Cape Girardeau, Mo., marketed Triax Metabolic Accelerator. Missouri officials embargoed the product, preventing sale of the company's on-hand supply. The product's manufacturer, Pharmatech, Linden, Utah, agreed to stop distributing any product containing TRIAC.
Women still falling short on folic acid ... Although the federal government announced seven years ago that a type of birth defect is linked to a lack of folic acid, public health officials say these birth defects are still occurring. According to the March of Dimes, as many as 2,000 to 2,800 cases of neural tube birth defects (out of an estimated 4,000 per year) could be avoided in the United States if women of reproductive age consumed enough folic acid. FDA last year mandated that cereal and grain products be fortified with folic acid, but the fortification level was kept low (about 1,000 micrograms per day) because of a fear that too much folate can cause a dangerous blood disease, or can mask a vitamin B-12 deficiency.
Meat irradiation can boost food safety ... The U.S. Department of Agriculture, which regulates the meat industry, now allows refrigerated or frozen raw meat and meat products, such as ground beef, steaks, and pork chops, to be exposed to high levels of radiant energy. This irradiation process can eliminate or greatly reduce deadly E. coli bacteria and other hazardous microorganisms in raw meat. Irradiated meat and meat products must bear the international symbol for irradiation, the radura, along with a statement of its use. FDA approved irradiation of red meat in 1997.
A new drug that combines two anti-stroke treatments has been approved by FDA after studies showed that it can reduce stroke risk for some patients more than either ingredient alone.
FDA approved Aggrenox--which combines aspirin and dipyridamole--to reduce stroke risk in those who have already had a transient ischemic attack ("mini-stroke") or an ischemic stroke. Each year, 400,000 Americans suffer ischemic strokes, caused when a blood clot reduces or blocks blood flow to the brain.
In the two-year "European Stroke Prevention Study 2," which included more than 6,000 patients who had recently showed ischemic stroke-related symptoms, the combination drug reduced stroke risk by about 37 percent and the risk of stroke and death by about 24 percent, compared with a placebo.
Side effects linked to Aggrenox include headache, abdominal pain, dizziness, and nausea. Patients who are hypersensitive to any of the drug's ingredients should not take the drug.
Aggrenox, approved by FDA last November, is marketed by Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Conn.
With the approval of a new drug for epilepsy that can be safely combined with other anti-epilepsy medicines, adults with partial onset seizures--those that affect only one area of the brain--may soon be able to better control the disorder.
Epilepsy affects some 2 million people in the United States, causing them to have seizures with symptoms ranging from shaking of a single arm to loss of consciousness and generalized spasms. Brief disturbances in the brain's electrical activity occur when the nerves in the brain fire spontaneously, causing the seizures.
FDA approved the new therapy, Keppra (levetiracetam) in December after three multicenter clinical studies involving some 900 patients demonstrated the drug's effectiveness as an adjunct therapy. Because it is not metabolized through the liver, as are most of the two dozen or so other antiepileptics, it is unlikely to cause interactions with the other epilepsy drugs or other commonly used prescription medications, such as oral contraceptives.
In clinical studies of Keppra in more than 1,300 epileptic patients, no serious blood or liver-related toxicities were seen. The drug may, however, cause dizziness and sleepiness. The new drug will be manufactured and distributed by UCB Pharma Inc. of Smyrna, Ga.
Smoking cessation aids show similar results ... In one of the first studies to assess the effectiveness and ease of use of common nicotine replacement products, researchers at the Royal London School of Medicine and Dentistry found no significant differences in abstinence, cravings or withdrawal symptoms among 504 smokers. Participants, all over age 18, smoked an average of half a pack a day, were in good health, and had not tried to quit in the previous three months by using a nicotine replacement product. They used nicotine gum, the patch, a new nasal spray, and an inhaler in the study. Smokers were most likely to use the patch at its recommended dose. Some used the gum, inhaler or spray more sparingly than was recommended, possibly to save money. At the end of the 12-week period, about one in five people in each group had managed to stay off cigarettes. (Archives of Internal Medicine, September 1999)
Keep on walking ... Women who walk briskly for at least three hours a week could cut their heart attack risk by 30 to 40 percent, says a long-term study of 72,000 women aged 40 to 65. Brisk walking for five hours or more a week cut heart attack risk by more than 40 percent. And those who added another 90 minutes a week doing vigorous exercise, such as aerobics, cut their risk almost in half. Even women who had been sedentary most of their lives began to benefit when they started exercising, and as little as an hour a week of brisk walking helped reduce heart attack risk. Several studies have shown that the findings apply equally to men. (New England Journal of Medicine, August 1999)
Life extended by kidney transplants ... People who receive kidney transplants live an average of 10 years longer than those who continue on dialysis, says a study by the University of Michigan et al. The study also showed that transplant patients have a better quality of life by avoiding dialysis. Of the 43,584 people in the United States currently on the waiting list for kidney transplants, the United Network for Organ Sharing reported that 12,166 received operations last year. (New England Journal of Medicine, December 1999)
A drug previously OK'd by FDA for treating depression, obsessive-compulsive disorder, and panic disorder has now become the first drug approved to help those suffering from another psychiatric condition: post-traumatic stress disorder (PTSD).
Two studies showed Zoloft (sertraline hydrochloride) to be effective in treating adults diagnosed with PTSD, a condition marked by re-experiencing a traumatic event that evoked feelings of intense fear, helplessness, or horror.
People with PTSD can relive the traumatic event in flashbacks or dreams, according to the American Psychiatric Association, and may experience symptoms such as irritability and angry outbursts, sleep disturbance, impaired concentration, and loss of interest in significant activities. A PTSD diagnosis requires that the symptoms last at least a month and significantly interfere with one's social life, work, or other activities.
In the two multicenter studies of Zoloft, women as a group seemed to benefit most from Zoloft, with little effect seen in men. Scientists don't know why this apparent gender difference exists.
Common side effects of Zoloft include dry mouth, stomach upset, and sleepiness.
The drug, marketed by Pfizer Inc., New York, was approved for PTSD last December after an FDA advisory committee recommended its approval.
Possible link in Alzheimer's ... An enzyme thought to play a role in the formation of beta-amyloid, a protein associated with Alzheimer's disease, may have been isolated by California researchers, says a new study. Researchers at Amgen Inc. report that they found an enzyme called beta-secretase that is thought to start the process that leads to the formation of beta-amyloid, which collects in the brains of Alzheimer's patients and kills neurons, the central feature in the disease process. Researchers believe that identifying the correct enzyme could lead to drugs that would block beta-amyloid formation. Alzheimer's disease is a deadly disorder that gradually destroys the brain, causing slow loss of memory and the ability to reason. (Science, October 1999)
A prescription arthritis drug is now also approved for treating a much less common disorder that can greatly increase young people's risk of colon and rectal cancer.
Celebrex (celecoxib), which is in a class of drugs called COX-2 selective nonsteroidal anti-inflammatory drugs, can help reduce the number of colorectal polyps in those with the rare genetic disorder "familial adenomatous polyposis" (FAP). It has been approved since 1998 to treat the symptoms of osteo- and rheumatoid arthritis.
To treat the genetic disorder, Celebrex should be used with other therapies--typically, surgical removal of all or much of the lower intestine (colon and rectum) by early adulthood and careful monitoring of any remaining lower intestinal tissue.
The December 1999 approval of Celebrex for the potentially life-threatening FAP was an accelerated approval based on the drug's ability to reduce the number of colorectal polyps. In a six-month study of Celebrex in 83 patients, sponsored in part by the National Cancer Institute, patients receiving the drug experienced a 28 percent reduction in the number of polyps, compared with a 5 percent reduction in those getting a placebo. The most common side effects were diarrhea and indigestion.
Because the ultimate benefit to FAP patients of reducing colorectal polyps is not known, FDA is requiring the manufacturer, G.D. Searle & Co., Chicago, to conduct further studies to determine the drug's clinical value, as well as to establish whether the effect of Celebrex will continue after patients stop taking the drug.
The first topical solution approved by FDA for treating fingernail and toenail fungus may offer relief to Americans suffering from these sometimes painful types of infections.
Penlac Nail Lacquer (ciclopirox) Topical Solution 8% is a synthetic antifungal agent that inhibits the growth of dermatophytes, a type of fungus that grows on the skin, hair and nails. Infected nails can become white, thick and brittle and can cause people pain when they walk or do other simple activities.
Penlac is applied to all affected nails and adjacent skin once a day with an applicator brush over the previous coat, and removed every seven days. Treatment consists of up to 48 weeks of daily applications, weekly trimmings by the patient, and monthly professional removal of the unattached, infected nail.
While approved just last December to provide topical therapy for nail fungus, Penlac's active ingredient has been marketed for other uses worldwide for 25 years, and in the United States since 1982.
The nail lacquer is manufactured by Aventis Pharma Deutschland GmbH, Frankfurt, Germany.
Hard liquor not the spirit ... The steady drop since the 1970s in death rates from cirrhosis, a condition in which inflammation and scarring gradually destroy the liver, is due to a decline in alcohol consumption, says a study by researchers at the University of California at San Francisco. Cirrhosis deaths rose by 75 percent between 1950 and the early 1970s. Following a peak in 1973, when 33,350 Americans died of the disease, cirrhosis mortality began to decline. By 1993, the cirrhosis death rate had dropped to 7.9 deaths per 100,000 people. Alcohol use had declined moderately from 10.45 liters of alcohol per capita among people of drinking age in the early 1980s to 8.36 liters by the mid-1990s. (British Medical Journal, September 1999)
Back pain treatments similar ... Conventional medicine appears to work about as well as spinal manipulation at treating lingering back pain, says a three-month study by doctors and osteopaths at the Rush Presbyterian-St. Luke's Medical Center in Chicago. Other studies have shown that many backaches go away within a month, regardless of the treatment. The new study involved patients who had been in pain for at least three weeks but less than six months. There was no difference in how the two groups felt at the end of three months, and pain had decreased by half in both. (New England Journal of Medicine, November 1999)
Is internal cleansing healthful? ... Using a product that's too strong for your digestive tract could cause several days' worth of diarrhea--with nausea, stomach cramps, and vomiting--FDA warns. Internal "cleansers" such as teas, powders, herbal capsules, and fiber pills claim to increase the body's performance by ridding the system of environmental toxins, unfriendly bacteria, or crusted food waste that has lingered too long in the intestine. But doctors at the Human Nutrition Research Center at Tufts University say that gastrointestinal tract cells turn over every three days, which is not enough time for food crusting to take place. The body also has its own avenue of defense against such toxins, and the liver works nonstop to neutralize potentially harmful compounds. FDA has received several reports of serious adverse events associated with using such cleansers.
For more than 40 years, physicians have implanted medical devices in people to save lives, restore function, or enhance the human form. Experts estimate that 8 to 10 percent of all Americans, some 20 million to 25 million people, carry some form of implanted device, from complex machines like a computerized heart pacemaker to structural supports such as an artificial joint to something as simple as the sliver of plastic used to repair cataracts.
Yet, little information is available about the long-term safety and effectiveness of many implanted devices because no one--not the Food and Drug Administration, not the manufacturers, nor any other organization--tracks an implant from cradle to grave. While estimates can be made about the useful lifespan of some devices, the longevity or failure rate of many others is unknown. To start the search for a solution, the National Institutes of Health hosted the Technology Assessment Conference on Improving Medical Implant Performance Through Retrieval Information in January.
"The idea of the conference is that if you can learn about the devices, how they age--how they wear, all the things that can happen to a device--then you can improve the next generation of devices," says David W. Feigal Jr., M.D., director of FDA's Center for Devices and Radiological Health. The only way to gather that kind of information is to systematically retrieve and analyze medical devices after they have stopped functioning, either because of failure or patient death.
NIH's panel of independent experts, co-chaired by former Assistant Secretary of Health Edward N. Brandt Jr., M.D., and Julia R. Weertman, an engineer from Northwestern University, sifted through the available data to identify the impediments to collecting this kind of information. They discovered that significant barriers include the costs associated with retrieval and "the fear of litigation affecting manufacturers, hospitals, physicians, and investigators."
Cost is a substantial problem. Insurance companies pay to have medical devices implanted to improve a patient's health, but do not pay to remove them, especially if the patient has died. There is little incentive for medical device manufacturers to pick up the tab, even though the research would benefit them.
"We re-proposed that NIH fund a series of centers that would collect specimens of medical devices" that had been removed from patients, Feigal says. The retrieved devices would then be analyzed to determine what made them a failure or a success. For example, a patient might walk on a hip implant for 25 years but die of a heart attack. The implant would be considered a success, and device designers would like to know why it worked so well.
Even if the funding became available, legal concerns still get in the way. "The American public accepts the failure of biological implants," says Brandt. "A transplanted heart or liver doesn't work. That's unfortunate but those things happen. But the public never seems to think that a mechanical device, an artificial hip or pacemaker, is going to wear out, though they have plenty of experience of that with their household appliances and automobiles. They tend to think that it is a mechanical thing, and it is going to be OK."
So when an implanted device fails, the search for the guilty begins. Concern about litigation prevents physicians, hospitals and manufacturers from even gathering information on a failed or removed medical device because they fear the information might be used against them in court. The committee recommended that FDA and NIH sponsor a second "conference on the relationship between (and possible adverse effects of) litigation and medical innovation."
The risk of litigation may be increased by the fact that "patient expectations of the benefits of medical implants are often unduly high," the committee concluded. This occurs, in part, because "information presented to the patients may be poorly understood, misleading or inadequate." The committee recommended that FDA and NIH develop a multifaceted education campaign to provide realistic information about implanted devices and the need for retrieval. The campaign would include a Website linked to existing databases for devices and provide background information to consumers about implants, informed consent, and even provide patients with a card that describes the device they carry in their body. The card also could serve as an implant "donor" consent form, analogous to an organ donor card, to simplify postmortem retrieval.
"There are some unique opportunities for us to learn more, especially when you have the ability to look at a problem across manufacturers," Feigal says, "which FDA can do."
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