Updates

First Blood Test for Breast Cancer

The first blood test to help determine whether a woman's breast cancer has recurred was recently approved by FDA.

The Truquant BR Radioimmunoassay (RIA) test kit measures CA 27.29, an antigen found in the blood of patients with breast and certain other types of cancer. As breast cancer progresses, the blood level of CA 27.29 rises. Test results can be analyzed in a few hours at a hospital laboratory.

In clinical studies of 166 women who had previously had breast cancer, the test found the cancer antigen in 15 out of the 26 women who had recurrence. It also indicated cancer in 8 of 140 patients who did not have recurrence.

Because the immunoassay did not detect the cancer antigen in all cases and detected it falsely in some, the new test is not intended as the sole basis for the detection of cancer recurrence, which can only be made after the test results are verified by other procedures, such as mammography, magnetic resonance imaging, and x-rays.

The test kit is manufactured by Biomira Diagnostics, Inc., of Rexdale, Ontario.

Public Can Comment on Mammography Regs

The public has until July 2, 1996, to comment on FDA's recently proposed regulations to enhance current requirements for high-quality mammography.

The agency published proposed new rules on April 3, 1996, to expand and strengthen interim regulations effective since late 1993. The rules support FDA's implementation of the 1992 Mammography Quality Standards Act, which requires that mammography facilities meet quality standards, be accredited by an FDA-approved accreditation body and certified by FDA, and be inspected annually.

The proposed regulations would:

strengthen interim requirements for the qualifications and training of personnel performing mammography and interpreting mammograms
require that mammography equipment meets specified design and performance criteria
expand mammography reporting requirements so that doctors and patients receive results quickly
add a consumer complaint requirement to ensure that consumer complaints are followed up adequately
add requirements for special methods of examining women with breast implants and for training personnel to do the exams properly.

FDA is also asking for comments on alternative approaches to ensuring quality mammography that would keep the facilities' administrative requirements to a minimum.

To comment on the proposed rules, write to: FDA Dockets Management Branch, HFA-305, Docket No. 95N-0192, Rockville, MD 20857.

For names and locations of FDA-certified mammography facilities, call the Cancer Information Service toll-free at (1-800) 4-CANCER, or (1-800) 422-6237. [Update, May 2001: A list of FDA-certified mammography facilities is also available from FDA's Center for Devices and Radiological Health.]

AIDS Drug Approved in 42 Days

The third in a new class of drugs for treating HIV infection was granted accelerated approval in record time--42 days after FDA received the drug's application for marketing.

FDA granted early approval to indinavir (Crixivan), a protease inhibitor, last March 13 for use alone or in combination with nucleoside analog drugs, such as AZT (zidovudine, marketed as Retrovir), in people with HIV or AIDS.

The agency's accelerated approval process allows early marketing approval for a product based on laboratory markers, but the sponsor must continue with studies to show the product provides true clinical benefit, such as extending life or slowing disease progression.

Studies reviewed by FDA indicated that indinavir alone or in combination with the nucleoside analogues AZT or 3TC (lamivudine, marketed as Epivir) can improve such laboratory markers as CD4 cell counts, an indicator of immune system strength, and viral load, a measure of the amount of virus that can be detected in the blood. Patients receiving indinavir alone or indinavir with AZT or 3TC had a marked increase in their CD4 levels and a marked decrease in their viral load.

Major side effects included, infrequently, kidney stones and, frequently, increases in bile production.

The drug is manufactured by Merck & Co. Inc.

First Screen Approved for HIV Antigens

FDA recommends that all registered blood and plasma establishments this month start using the first blood test approved to screen blood donors for antigens of HIV-1, the virus responsible for most AIDS cases in the United States.

The agency approved the new test, the Coulter HIV-1 p24 Antigen Assay, on March 14 and also allows it for diagnosing HIV-1 infection and monitoring progress of the disease.

The test should not replace currently used HIV antibody tests for routine patient testing and counseling in a medical setting, according to the Centers for Disease Control and Prevention. Antibody testing is still the most efficient way to diagnose HIV routinely in individual patients.

Current donor screening detects HIV antibodies, which typically appear within three months of infection. The new test detects antigens, which are proteins of the virus. Antigens can be detected about one week earlier than antibodies.

According to medical literature estimates, HIV-1 antigen screening could prevent five to 10 cases a year of AIDS transmitted by blood transfusion. It reduces the "window" period, when donors may be HIV-infected but still have negative antibody tests.

In clinical studies, the test detected HIV-1 antigens before antibodies were detected in 80.6 percent of cases. The test also correctly identified HIV-1 negative specimens 99.95 percent of the time, based on analyses of more than 300,000 normal blood donations.

The Coulter test will be marketed to blood establishments by Ortho Diagnostic Systems Inc., a subsidiary of the Johnson and Johnson Company, Raritan, N.J.

Nicotine Nasal Spray to Help Smokers Stop

The first prescription nicotine nasal spray to help adults who are trying to quit smoking has been approved by FDA. The product is not recommended for use in children.

The agency based its approval, last March 25, on results of studies with 730 patients given various doses of the nasal spray or placebo. All patients received other supportive therapy for quitting, such as counseling. Nearly 54 percent of patients given the drug stopped smoking for six weeks, as opposed to 27 percent of the patients given placebo. About 25 percent of patients receiving the drug stopped smoking for at least one year, while only 13 percent in the placebo group reached this goal. The effectiveness of the nasal spray is comparable to other stop-smoking aids such as nicotine gum or patches.

It is recommended that patients use nicotine nasal spray for three months. Because nicotine is addictive, it is possible to become dependent on the nasal spray. Patients' chances of becoming dependent on the nasal spray increase if they use it longer than six months. Therefore, this product should be used no longer than six months.

Common side effects of the spray are nasal or sinus irritation. Although most people can tolerate these effects, the spray is not recommended for people with nasal or sinus conditions, allergies, or asthma.

The spray will be sold under the name Nicotrol NS by McNeil Consumer Products Co. of Fort Washington, Pa., under license from Pharmacia of Sweden.

Cancer Initiatives to Expand Access to Therapies

Four initiatives to improve patient access to promising new cancer therapies are under way at FDA. FDA is:

shortening approval times for cancer treatments by recognizing that tumor shrinkage is often an early indicator of a treatment's effectiveness
working with pharmaceutical companies to make promising cancer therapies approved by foreign countries available to cancer patients before the product is approved here
improving the therapy review process
making it easier for investigators to test new uses for cancer therapies already on the market.

FDA announced the initiatives last March. For a backgrounder providing more information, write to FDA, HFI-40, Rockville, MD 20857. The backgrounder is available on FDA's World Wide Web site at http://www.fda.gov/opacom/backgrounders/cancerbg.html. Additional information on the initiatives can be found at http://www.fda.gov/opacom/7reinvnt.html. [Note (6-4-2003): These documents are no longer available on the FDA Web site.]

Acupuncture Needles No Longer Investigational

The needles used for acupuncture no longer need "investigational use" labeling. FDA recently reclassified them for "general acupuncture use" by qualified practitioners.

Acupuncture needles, which are used as part of a centuries-old Chinese healing technique, are medical devices under FDA regulations. Last March, the agency reclassified the needles from class III, a category that requires clinical studies, to class II, which means they can be used by licensed, registered or certified acupuncture practitioners. As with other class II devices, the needles are required to have proper labeling, and good manufacturing practices must be followed.

The agency's decision to reclassify acupuncture needles was based on a review of available data on acupuncture and the needles used for this purpose.

Before a firm can market acupuncture needles in the United States, it must obtain clearance from FDA through the premarket notification (510k) process.

Manufacturers must include on the label the statement "for single use only" and provide information about device material sterility and compatibility with the body. The needles must also bear a prescription label restricting use to qualified practitioners as determined by individual states.

Foreign manufacturers must meet the same premarket clearance and manufacturing quality requirements as U.S. manufacturers.

Street Drug Alternatives with Ephedrine

Consumers should not buy or consume ephedrine-containing dietary supplements whose labels portray them as apparent alternatives to illegal street drugs because these products pose significant health risks--possibly even death.

These products contain botanical, or so-called "natural," sources of ephedrine. Ephedrine is an amphetamine-like stimulant that can dangerously affect the nervous system and heart. Any of the following ingredients listed on a label indicates ephedrine: ma huang, Chinese ephedra, ma huang extract, ephedra, Ephedra sinica, ephedra extract, ephedra herb powder, epitonin, or ephedrine.

Consumers who have an injury or adverse effect after taking a supplement or any product containing ephedrine should call (1-800) FDA-4010. Health professionals who have treated patients suffering from an adverse event should report it to FDA's medWatch hot line: (1-800) FDA-1088.

Possible adverse effects of ephedrine range from heart attack, stroke, seizures, psychosis, and death to less significant problems such as dizziness, headache, gastrointestinal distress, irregular heartbeat, and heart palpitations. The clinically less significant problems may indicate the potential for more serious effects.

Labels on many ephedrine-containing dietary supplements appear to be directed to adolescents and young adults, implying the products can produce a "high." FDA considers that such promotion and claims violate the Federal Food, Drug, and Cosmetic Act, even as amended by the Dietary Supplement Health and Education Act of 1994, which governs U.S. marketing of supplements.

The agency is investigating the production and marketing of ephedrine-containing products marketed as alternatives to illegal street drugs, such as "ecstacy."

Labeling Change for Lindane Lice Treatments

Revised labeling now required by FDA for lice and scabies treatments containing the insecticide lindane (gamma benzene hexachloride) encourages using the prescription products only if other approved therapies without lindane have not worked.

The labeling also advises health-care providers and parents not to confuse prolonged itching with a reinfestation of these parasitic infections. Even after successful treatment, itching can continue, due to residual inflammation in the skin.

FDA required the revisions because of concerns that some parents may be unintentionally medicating beyond the recommended procedure when children continue to scratch. In other cases, parents may overuse the products in their zeal to treat children as quickly as possible. This increased exposure raises the likelihood of adverse reactions.

The drug's label already warns parents that neurotoxicity (damage to nerves or nerve tissue) is possible, especially among infants.

FDA investigated claims that lindane causes neurological damage in children. After reviewing available data, agency scientists concluded that lindane is generally safe and effective if used according to its approved directions, but that overuse can be harmful. Previously, an FDA advisory committee made the same determination.

FDA Consumer magazine (June 1996)