U.S. Food and Drug Administration
FDA Consumer magazine
May-June 2002
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of Contents
The FDA has approved a treatment for one type of non-Hodgkin's lymphoma (NHL) that--for the first time--includes a monoclonal antibody combined with a radioactive chemical.
Monoclonal antibodies are just like the antibodies in the immune system that fight infection. However, monoclonal antibodies are genetically engineered in laboratories so that they can locate and bind to cancer cells.
Zevalin (ibritumomab tiuxetan), which must be used with Rituxan (rituximab), the first biotechnology product already approved for low-grade B-cell NHL, is approved for patients who have not responded to standard chemotherapy treatments or to Rituxan alone.
Zevalin and Rituxan are monoclonal antibodies that target white blood cells (B-cells), resulting in significant tumor shrinkage. Zevalin targets tumor cells with a high dose of radiation, reducing the amount of full-body radiation.
The newly approved Zevalin regimen is administered in two parts. Patients first receive Rituxan, followed by a form of Zevalin with a low dose of radioactive chemical for screening purposes. If patients' tumors are properly targeted with this procedure, they receive Rituxan again with a form of Zevalin that has a different radioactive chemical, which can provide a treatment benefit.
The Zevalin treatment regimen is more toxic than treatment with Rituxan alone. More than half of the patients in clinical trials experienced serious reductions in blood cell counts, including white blood cells and platelets, lasting for three to four weeks. Because of a small number of life-threatening concerns, the Zevalin regimen is only approved for patients in whom other treatments have failed.
The FDA has licensed the first nucleic acid test (NAT) system for screening donors of whole blood and blood components intended to be used in transfusion. This test uses a semi-automated system to simultaneously detect the presence of HIV, the virus that causes AIDS, and hepatitis C virus (HCV) in blood. At the same time, the test is expected to further ensure the safety of whole blood and blood components, including fresh plasma, red cells, and platelets, by permitting earlier detection of HIV and HCV infections in donors.
The approved test system was developed by Gen-Probe Inc., San Diego, Calif., and will be distributed by Chiron Corp., Emeryville, Calif.
Blood donors have been tested for evidence of HIV infection since 1985 and for evidence of HCV infection since 1990. Sensitive tests for detection of HCV and HIV antibodies and HIV antigens (proteins from the virus) have been increasingly used during the past decade. In rare instances, infections in donors have been missed using these tests because the appearance of antibodies requires time for the donor to develop an immune response, and detection of antigens requires time for a higher level of virus to appear in the bloodstream.
The NAT system is capable of uncovering more infectious donations than current tests because it spots viral genes rather than antibodies or antigens. Identification of viral genes permits detection earlier in the infection.
Despite recent controversy about the value of screening mammograms, Health and Human Services Secretary Tommy G. Thompson has reaffirmed his department's recommendation that women ages 40 and over should get screened for breast cancer every one to two years.
The debate about the value of mammograms was reignited by a review of existing studies that appeared in the Oct. 20, 2001, issue of The Lancet, a British medical journal. The review cited a number of possible flaws in the conduct of long-term mammography clinical trials, as well as in the methods used to analyze data. Results of these trials are used as a basis for guidelines and for screening recommendations by the National Cancer Institute (NCI) and other groups.
After careful consideration of the issues raised by The Lancet's review, Thompson, the NCI, and the U.S. Preventive Services Task Force (the leading independent panel of private-sector experts in prevention and primary care) say that mammograms remain an important tool for detecting breast cancer.
New studies are currently underway to supplement the data from the original clinical trials.
Recent reports indicate a potential risk of severe liver injury associated with the use of kava-containing dietary supplements. Kava (Piper methysticum) is a plant native to the islands of the South Pacific, where it is commonly used to prepare a traditional beverage. Supplements containing the herbal ingredient kava are promoted for relaxation (to relieve stress, anxiety and tension), sleeplessness, menopausal symptoms, and other uses. The FDA has not made a determination about the ability of kava dietary supplements to provide such benefits.
Although liver damage appears to be rare, kava-containing products have been associated with liver-related injuries--including hepatitis, cirrhosis, and liver failure--in over 25 reports of adverse events in other countries. Four people required liver transplants. In the United States, the FDA has received a report of a previously healthy young female who required a liver transplant, as well as several reports of liver-related injuries.
People who have liver disease or liver problems, or people who are taking drug products that can affect the liver, should talk to a physician before using kava-containing supplements.
Consumers who use a kava-containing dietary supplement and who experience signs of illness associated with liver disease should also consult a physician. Symptoms of serious liver disease include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms of liver disease can include nausea, vomiting, light-colored stools, unusual tiredness, weakness, stomach or abdominal pain, and loss of appetite.
The FDA urges consumers and health-care professionals to report any adverse events associated with the use of kava-containing products or other dietary supplements to the FDA's MedWatch program by calling its toll-free number (1-800-332-1088) or through the Internet.
The presence of kava in a supplement should be identified on the product label in the "Supplement Facts" box.
The FDA will continue to investigate the relationship, if any, between the use of dietary supplements containing kava and liver injury. The agency will alert consumers, and if warranted, take additional action as more information becomes available. For more information on dietary supplements, see www.cfsan.fda.gov/~dms/supplmnt.html.
| ava | kava root | Piper methysticum G.Forst. |
| ava pepper | kava-kava | rauschpfeffer |
| awa | kawa | sakau |
| intoxicating pepper | kawa-kawa | tonga |
| kava | kew | wurzelstock |
| kava pepper | Piper methysticum | yangona |
| Piper methysticum Forst.f. |
Well before the terrorist attacks on Sept. 11, 2001, the FDA had been working to counter terrorism. For example, in recent years the agency had been advising industry and consumers on food safety and security. And the FDA approved Cipro (ciprofloxacin) in August 2000 for use in people who develop inhalational anthrax.
After the attacks, the FDA's counter-terrorism efforts intensified. This included easing a potential medication shortage for the victims of the mailed anthrax powder by clarifying that the antibiotics doxycycline and penicillin G procaine are effective and approved for the treatment of all forms of anthrax infections.
More recently, thanks to $151 million in additional funding from Congress, the FDA has been able to initiate many steps that will strengthen the nation's defenses against terrorism. To safeguard the more than $250 billion worth of FDA-regulated food that Americans consume each year, the agency is hiring 673 new import investigators, laboratory analysts, compliance officers, criminal investigators, and other personnel. Some of these employees will support domestic inspections, but most will help monitor the safety of imported food.
The FDA's counter-terrorism mission also includes expediting the development, review and production of drugs, vaccines, blood products, and diagnostic tools for the prevention and treatment of terrorism-associated injuries. The agency is hiring 218 new employees who will carry out these functions.
The world's only vaccine to prevent Lyme disease is being discontinued because of poor demand, according to the product's manufacturer, GlaxoSmithKline, Research Triangle Park, N.C.
The FDA licensed LYMErix in December 1998 to prevent Lyme disease, a bacterial infection transmitted by ticks. Initially, hundreds of thousands of people received the vaccine. However, sales plummeted after highly publicized reports that some users suffered arthritis-like symptoms, muscle pain and other ailments following vaccination.
GlaxoSmithKline says that it is not discontinuing the product because of safety issues. The manufacturer maintains that the scientific record remains clear that the vaccine is safe and effective. The Centers for Disease Control and Prevention (CDC) confirmed that it found no unexpected safety problems with LYMErix after reviewing the data.
Lyme disease is caused by the bacterium Borrelia burgdorferi. These bacteria are transmitted to humans by the bite of infected deer ticks and cause more than 16,000 infections in the United States each year. Symptoms include a characteristic "bull's-eye" rash accompanied by nonspecific symptoms, such as fever, malaise, fatigue, headache, muscle aches, and joint aches. The incubation period from infection to onset of the rash typically is seven to 14 days but may be as short as three days or as long as 30 days.
The FDA continues to caution people who live or work in tick-infested areas to be vigilant for symptoms of Lyme disease, especially in the spring and summer months when they are likely to spend more time outdoors.
For more information on preventing Lyme disease, see "New Vaccine Targets Lyme Disease," May-June 1999 FDA Consumer.
The FDA has taken the final actions necessary to allow BioPort Corporation to begin routine distribution of licensed anthrax vaccine from the company's renovated facility.
The approval in January involved a supplement to BioPort's biologics license, approving Hollister-Stier Laboratories LLC in Spokane, Wash., as a contract filling facility for the Anthrax Vaccine Adsorbed (AVA). This allows Hollister-Stier to receive the vaccine from BioPort's manufacturing facility, fill vials with the vaccine, and ship them back to BioPort for distribution. This approval followed an FDA inspection of Hollister-Stier's facility and a satisfactory response to deviations noted during that inspection.
This latest approval follows the FDA's approval of BioPort's facility in Lansing, Mich., where AVA is manufactured, in December 2001.
"FDA has worked as quickly as possible to review these license supplements, including resolving outstanding issues with the firm, for the supplements to be approved. Our goal has always been to assure that the anthrax vaccine meets high standards for safety and efficacy," says Bernard A. Schwetz, D.V.M., Ph.D., the FDA's senior advisor for science. Due to the complex nature of biological products, the Public Health Service Act and FDA regulations require FDA approval of major changes made to a facility in which a licensed product is manufactured.
The company that had held the license for the anthrax vaccine since its approval in 1970, Michigan Biologics Products Institute, halted production of the anthrax vaccine in January 1998 to begin a renovation of the facility. In September 1998, the facility was sold to BioPort. The FDA is now satisfied that BioPort's renovated facility can produce a vaccine that meets FDA standards for safety and effectiveness.
The Department of Defense owns all lots of Anthrax Vaccine Adsorbed produced by BioPort in the renovated facility. Currently, the Centers for Disease Control and Prevention does not recommend vaccination for the general public to prevent anthrax infection.
The FDA has cleared for marketing a portable, pocket-sized 12-lead electrocardiogram (ECG) machine that monitors and records the heart's electrical activity. The device is a miniaturized version of a large standard ECG machine, and it performs the same functions.
The Pocketview ECG machine consists of a pocket-sized device and 12 leads that are placed on a person's body by a health-care professional to record information. Recorded data can be viewed on the device or transmitted to a computer for viewing using special software via mobile phone or other wireless networks. The Pocketview is capable of storing numerous ECGs and displaying up to four separate results on the computer screen for simultaneous comparison.
MicroMedical Industries Ltd. of Australia makes the pocket-sized ECG device.
A new toll-free hot line number that will allow people to reach a poison control center from anywhere in the United States is now available.
Poisoning is the nation's third most common form of unintentional death, according to the American Association of Poison Control Centers. In any given year there will be between 2 million and 4 million poisonings. Sixty percent of these exposures will involve children under six who are exposed to toxins in the home.
In February 2000, Congress passed legislation to stabilize and enhance a national system of poison control centers. This effort includes the new toll-free number and a nationwide public education campaign, and it provides funding to certified poison control centers to help maintain their essential capabilities.
The establishment of the hot line, 1-800-222-1222, commemorated this year's National Poison Prevention Week, recognized annually during the third week of March.
Other resources previously established to raise awareness of the dangers associated with unintentional poisonings and to promote prevention measures include:
All of these resources can be found at www.epa.gov. Click on "For Kids."
The low levels of sodium pentobarbital that dogs might receive through their food are unlikely to cause any health problems, according to an FDA study.
Pentobarbital is an anesthetizing drug used for dogs and other animals, such as horses and cattle. Because it is also widely used for humane euthanasia of dogs, cats and other animals, the most likely way that pentobarbital could get into dog food would be in rendered animal products. Rendered products come from a process that converts animal tissues to feed ingredients.
During the 1990s, the FDA's Center for Veterinary Medicine (CVM) received reports from veterinarians that pentobarbital seemed to be losing its effectiveness for anesthesia in dogs. Based on these reports, the center decided to investigate the theory that the dogs were exposed to pentobarbital through dog food, and that this exposure was making them less responsive to pentobarbital when it was used as a drug.
CVM developed and used a sophisticated process to detect and quantify minute amounts of pentobarbital in dog food. Upon finding pentobarbital residues in some samples of dry dog food, CVM scientists conducted further tests that led them to conclude that dogs eating dry dog food are unlikely to have any adverse health effects from the low levels of pentobarbital found in the dog food samples tested.
CVM scientists also developed a test to detect dog and cat DNA in the protein of dog food. Since pentobarbital is used to euthanize dogs and cats at animal shelters, finding pentobarbital in rendered feed ingredients could suggest that pets were rendered and used in pet food. Test results indicated a complete absence of protein material that would have been derived from euthanized dogs or cats. As a result of their study, CVM scientists assume the source of the pentobarbital in dog food is cattle or horses euthanized and then rendered.
After finding that the low levels of pentobarbital that dogs might receive through food are unlikely to cause them any adverse health effects, FDA officials did not think that further research into the issue was necessary. CVM officials say they plan to publish the study findings in peer-reviewed scientific journals.
CVM's studies and a summary report of the results are available at www.fda.gov/cvm/efoi/efoi.html.
A table listing safety-based drug withdrawals ("Why Drugs Get Pulled Off the Market," January-February 2002 FDA Consumer, page 16) incorrectly identified Glaxo Wellcome Inc., now GlaxoSmithKline, as the manufacturer of Hismanal. Hismanal, an antihistamine that was withdrawn in 1999, was manufactured by Janssen Pharmaceutica Inc., Titusville, N.J.
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