Topics in This Issue:

Home Glycated Hemoglobin Test for People With Diabetes

The FDA has cleared the first over-the-counter test that measures glycated hemoglobin in people with diabetes to help monitor how well they are managing their disease.

The test, called Metrika A1cNow, had been available previously only by prescription and most often performed by lab technicians. Over-the-counter status means that consumers now can buy the test without a prescription and use it at home with results available immediately. The test is manufactured by Metrika Inc. of Sunnyvale, Calif.

People with diabetes should check their glycated hemoglobin level two to four times a year to monitor long-term control over blood glucose (sugar) levels. The level of glycated hemoglobin provides information on the average level of glucose in the body over a 90- to 120-day period.

This test provides information to complement that obtained from daily finger-stick blood glucose tests, which measure glucose at a single point in time.

Diabetes is a chronic disease in which blood glucose levels are too high. Abnormally high levels of glucose can damage the small and large blood vessels, possibly leading to blindness, kidney disease, amputation of limbs, stroke, and heart disease. About 17 million Americans have diabetes. Many of them may find the new home glycated hemoglobin test helpful.

Consumers can get more information about Metrika A1cNow on the Web at www.metrika.com or by sending an e-mail to dsmica@cdrh.fda.gov.

Combination Vaccine for Children

In December 2002 the FDA announced approval of Pediarix, a combination vaccine that protects infants against diphtheria, tetanus, whooping cough (pertussis), polio, and disease due to the hepatitis B virus. Pediarix is the only vaccine marketed in the United States that contains DTaP (diphtheria and tetanus toxoids and acellular pertussis), hepatitis B vaccine (recombinant), and inactivated poliovirus vaccine (IPV) for administration as one injection.

Pediarix is recommended for administration as a 3-dose primary series to infants at approximately 2, 4, and 6 months of age. Pediarix should not be given to infants before the age of 6 weeks, and is not indicated for infants born to mothers who are infected with hepatitis B or whose hepatitis B status is not known. Such infants should receive hepatitis B vaccine shortly after birth and complete their immunizations according to a recommended schedule. The 2003 Childhood Immunization Schedule is available from the Centers for Disease Control and Prevention.

In a trial with the administration of the vaccine at 2, 4, and 6 months of age, immune responses induced by Pediarix were generally similar to those induced by vaccines administered separately. The most frequently reported adverse reactions to Pediarix were pain, swelling, and redness at the site of the injection, fever, and fussiness. In clinical studies, fever occurred more frequently after administration of Pediarix than when the vaccines were administered separately.

DTaP vaccine, hepatitis B vaccine and IPV are all currently available in the United States as separate vaccines.

Pediarix is marketed by SmithKline Beecham Pharmaceuticals of Philadelphia.

Prozac for Pediatric Use

The antidepressant Prozac (fluoxetine) has been approved by the FDA to treat children and adolescents ages 7 to 17 for depression and obsessive-compulsive disorder (OCD). The agency's action in January marked the first approval of one of the newer types of antidepressants (selective serotonin reuptake inhibitors or SSRIs) for treating depression in this population.

Depression affects up to 2.5 percent of children and about 8 percent of adolescents in the United States, according to the National Institute of Mental Health. Symptoms of depression include depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia (abnormally excessive sleep), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or thoughts of suicide.

OCD is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are repetitive and purposeful, and intentional behaviors (compulsions) that are recognized as excessive or unreasonable. The condition affects about 2 percent of the population and typically begins during adolescence or early childhood.

Common side effects associated with use of Prozac in children and adolescents were similar to those experienced by adults, and include nausea, tiredness, nervousness, dizziness, and difficulty concentrating. After 19 weeks of treatment with Prozac in one clinical trial, children and adolescents gained on average about half an inch less in height and about two pounds less in weight compared to those treated with a placebo. The clinical significance of this observation on long-term growth is not known. Further research will evaluate any potential impact of Prozac on long-term growth in children.

Prozac is marketed by Eli Lilly and Company of Indianapolis. The drug is also approved for major depressive disorder in adults, bulimia, and panic disorder.

Consumer Alert on Foreign Drugs

The FDA advises that consumers should not buy the following prescription drugs over the Internet:

Although these drugs have important benefits for many people, they have serious known risks and so are available in the United States only under specially created safety controls. These safety controls are bypassed when the drugs are purchased over the Internet or imported from foreign sources. Drugs purchased from foreign Internet sources are not the FDA-approved versions of the drugs, and are not subject to FDA-regulated manufacturing controls or FDA inspection of manufacturing facilities.

In December 2002, the FDA added these drugs to an existing import alert, which advises FDA field personnel of the possible importation of these drugs, provides guidance for their detention and refusal of admission into the United States, and also advises U.S. Customs Service personnel to refer any attempted importation to the local FDA field office.

For additional information, see:

To learn more about how to buy prescription drugs safely, see the FDA's guide, "Buying Prescription Medicines Online: A Consumer Safety Guide."

Strattera Approved to Treat ADHD

Strattera (atomoxetine) has been approved by the FDA as the first new drug in 30 years to treat symptoms of attention-deficit/hyperactivity disorder (ADHD). Between 3 percent and 7 percent of children and about 4 percent of adults have ADHD, according to the American Psychiatric Association. Symptoms include inattention, hyperactivity and impulsiveness. People with ADHD may make careless mistakes, fidget, interrupt others, talk excessively, and have problems paying attention.

Strattera has a different mechanism of action from the existing stimulant-like drugs that have been used to treat ADHD. Because Strattera does not appear to have a potential for abuse, it will not be classified as a controlled substance. The drug was studied in children, adolescents, and adults. Studies indicate that Strattera significantly improves ADHD symptoms when compared to a placebo. Side effects of Strattera include decreased appetite; upset stomach, nausea or vomiting; and tiredness. Some of the most common adverse effects in adults were problems with sleeping, dry mouth, dizziness, and sexual side effects.

Strattera will be marketed by Eli Lilly and Company of Indianapolis.

Forteo Approved for Osteoporosis Treatment

Postmenopausal women who are at high risk for having a bone fracture now have a new treatment option for osteoporosis.

Forteo (teriparatide) is the first approved agent for treating osteoporosis that stimulates new bone formation. The drug is administered by injection once daily in the thigh or abdomen. Daily injections stimulate new bone formation, leading to increased bone mineral density.

An estimated 10 million Americans--80 percent of them women--suffer from osteoporosis, a progressive thinning of bones that may lead to an increased risk of spine, wrist and hip fractures. Forteo contains a portion of human parathyroid hormone, which is the primary regulator of calcium and phosphate metabolism in bones.

Among other benefits, studies of Forteo showed it reduced risk of vertebral and non-vertebral fractures in postmenopausal women. The effects of Forteo on fracture risks for men have not been studied.

Side effects reported with Forteo, which is made by Eli Lilly and Company of Indianapolis, included nausea, dizziness, and leg cramps.

Gleevec Approved for First-Line Treatment of CML

Gleevec (imatinib mesylate) has been approved by the FDA as a first-line treatment of chronic myeloid leukemia (CML), an uncommon, life-threatening form of cancer.

Gleevec was first approved by the agency in May 2001 for the advanced stages of CML. At that time, the drug was also indicated for use as a second-line treatment for the chronic phase of CML after failure of interferon-alpha therapy.

CML occurs when two different chromosomes break off and reattach on the opposite chromosome, forming the so-called "Philadelphia chromosome." This leads to a blood cell enzyme being "turned on" all the time, and as a result, potentially life-threatening levels of mature and immature white blood cells occur in the bone marrow and blood. Gleevec works by blocking the rapid growth of white blood cells.

Gleevec is now approved for the treatment of all three stages of CML--CML myeloid blast crisis, CML accelerated phase, and CML in chronic phase--either before or after use of other therapy. The only known cure for CML is still by a bone marrow transplant.

The most common side effects reported with use of Gleevec include nausea, vomiting, fluid retention, muscle cramps, fatigue, skin rash, and headache. Gleevec, which is also approved to treat gastrointestinal stromal cancer, is manufactured by Novartis Pharma AG for Novartis Pharmaceuticals Corp. of East Hanover, N.J.

Clozaril Approved for Reducing Risk of Suicide

Clozaril (clozapine), a drug used to treat schizophrenia for more than a decade, has been approved by the FDA for a new use: reducing the risk of recurrent suicidal behavior.

The drug was first approved in 1989 for treating schizophrenia in patients who do not respond to other therapies. The agency says the drug also may be useful for people with schizophrenia or schizoaffective disorder (exhibiting features of both schizophrenia and mania or depression) who have a history of attempted suicide, hospitalization, or suicidal thoughts and who are judged to be at chronic risk for re-experiencing suicidal behavior.

Schizophrenia is a brain disorder that affects about 1 out of 100 people and usually begins in young adults. About 20 percent to 40 percent of people with schizophrenia and schizoaffective disorder attempt suicide. The annual number of suicides associated with schizophrenia in the United States is estimated at 3,600.

Because people who take Clozaril are at risk for a life-threatening blood disorder called agranulocytosis, they must have frequent blood tests. These tests are necessary to detect the blood disorder early enough so the person can stop the drug immediately. Seizures are another common serious side effect of the drug, which is manufactured by Novartis Pharmaceuticals Corp. of East Hanover, N.J.

Recombinant DNA Product for Rheumatoid Arthritis

HUMIRA (adalimumab), a new product produced by recombinant DNA technology, has been approved by the FDA to treat rheumatoid arthritis.

HUMIRA is a human-derived antibody that binds to human tumor necrosis factor alpha (TNF alpha). TNF is naturally produced by the body and is involved with normal inflammatory and immune responses.

People with rheumatoid arthritis, a disease that affects more than 2 million Americans, have high levels of TNF in the lubricating fluid in joints (synovial fluid). The extra TNF plays an important role in both the pathologic inflammation and the joint destruction that are hallmarks of rheumatoid arthritis. By working against the inflammatory process, HUMIRA, like other TNF blockers, has proved to be effective in controlling symptoms of the disease.

HUMIRA is indicated for reducing signs and symptoms and inhibiting the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs.

HUMIRA, marketed by Abbott Laboratories of Abbott Park, Ill., is administered as a single injection every other week. The package carries a bolded warning stating that serious, sometimes fatal, infections have been reported with the use of TNF-blocking agents, including HUMIRA. Patients with rheumatoid arthritis should discuss therapy options with their physicians.

Temporary Halt on Gene Therapy Trials

In a precautionary measure, the FDA has placed a temporary "clinical hold" on all active gene therapy trials using retroviral vectors to insert genes into blood stem cells. A clinical hold is the mechanism used by the agency when it does not believe, or cannot confirm, that a study can be conducted without unreasonable risk to the patients.

The FDA took the action in January after it learned that a second child treated in a French gene therapy trial developed a leukemia-like condition. Both this child and another, who had developed a similar condition in August 2002, had been successfully treated by gene therapy for X-linked severe combined immunodeficiency disease (X-SCID), also known as "bubble baby syndrome."

Infants with X-SCID have a gene defect that leads to a complete lack of white blood cells that can fight infection. Without treatment, they die from complications of infectious diseases during the first year of life. The only treatment for this condition has been a bone marrow transplant.

In early results of the French study, in which a normal gene is inserted into blood stem cells of patients with X-SCID, nine of the 11 children had promising results and were able to leave the hospital and lead relatively normal lives.

When notified of the first adverse event in August 2002, the FDA initially issued a temporary halt after identifying three U.S. gene therapy studies that closely resemble the French trial. The agency's action stopped enrollment of human subjects in those trials.

By late January, the FDA's continuing review of adverse event reports from all U.S. studies involving retroviral vectors had found no evidence of leukemia caused by the gene therapy. However, as a precaution, with notification of the second event, the FDA issued a clinical hold on all gene therapy trials using retroviral vectors in blood stem cells. A retroviral vector, or a modified retrovirus, is a type of virus that inserts its genetic code directly into a cell's chromosome, substituting corrective genes for a cell's defective ones.

The temporary hold reflects the FDA's appreciation that it may be appropriate to continue some of these trials after they are updated to reflect this new risk information. The agency will consider and evaluate specific requests for clinical indications for fatal or life-threatening disorders for which there are no viable alternative treatments.

The FDA continues to review the data from the adverse events in France, as well as the risks and potential benefits of all ongoing gene therapy trials, and will continue to work closely with the National Institutes of Health's Office of Biotechnology Activities to oversee gene therapy studies in the United States.

Warning Recommended for Products Containing AHAs

The FDA is considering a recommendation that cosmetics manufacturers add a "sunburn alert" to the labels of products containing alpha hydroxy acids (AHAs). The statement would warn consumers of the increased risk of skin sensitivity to ultraviolet (UV) radiation that may occur, and would give steps to take to minimize that risk.

The proposed guidance, published in the Dec. 2, 2002, Federal Register, was prompted by studies on the safety of topically applied AHAs in cosmetic products performed by the Cosmetic, Toiletry, and Fragrance Association and the FDA. Studies showed that topically applied AHAs increase skin sensitivity to UV radiation during application, and that the sensitivity diminishes one week after discontinuing application.

The period for public comment ended Jan. 31, 2003, and the FDA will address the comments before publishing a final guidance.

Raw Meat Diets for Pets and Zoo Animals

Pet owners increasingly are feeding their animals manufactured foods that contain raw meat. But giving animals these minimally processed foods creates a risk to public health and the animals, according to the FDA's Center for Veterinary Medicine (CVM).

To address this risk, CVM has provided a proposed guideline to manufacturers of foods that contain raw meat, or other raw animal tissues, for pets and zoo animals. The guideline, called a draft guidance, provides important safety and nutritional information and was made available in December 2002 for comment from the public, industry and others.

In addition to bacterial contamination, the draft guidance warns manufacturers about the dangers of dental or gastrointestinal trauma when bone is included in other than ground form. It also recommends the use of irradiation and proper transport and storage of raw meat products by manufacturers, distributors, and retailers to minimize contamination and disease transmission. The draft guidance also recommends participation in the U.S. Department of Agriculture's voluntary inspection program and the development and implementation of a Hazard Analysis and Critical Control Point (HACCP) program.

To view the draft guidance, go to the CVM Web site, select guidance documents, and then find guidance number 122. A public comment period on the draft closed on March 3, 2003. CVM will use the comments in preparing the final guidance for industry.