U.S. Food and Drug Administration
FDA Consumer magazine
May-June 2001
Table of Contents
The Food and Drug Administration has approved two new drugs for the management of glaucoma. Glaucoma is the second leading cause of blindness in the United States and the leading cause of irreversible blindness in the world.
Glaucoma is characterized by an increase in the pressure within the eyeball from a fluid within the eye called the aqueous humor. This increase in eye pressure, if left untreated, damages the optic nerve and leads to blindness.
Lumigan (bimatoprost ophthalmic solution) and Travatan (travoprost ophthalmic solution) are new treatment options for people who cannot tolerate or who have not responded well to other medications that lower eye pressure. In studies of patients with elevated eye pressures, Lumigan and Travatan showed similar effects for lowering intraocular pressure. Both drugs, which are in the form of eye drops, work by increasing the drainage of aqueous humor out of the eye.
"Glaucoma is a serious eye disease affecting some two million older Americans," said Health and Human Services Secretary Tommy G. Thompson. "Early detection of glaucoma and management of raised eye pressure can usually prevent vision loss. These new drugs provide additional treatment alternatives to preserve vision as well as preserve an individual's quality of life."
Side effects associated with Lumigan and Travatan may include redness of the eye, gradual darkening of eye color, darkening of eyelid skin, and increased thickness, number, and darkness of eyelashes.
Allergan Inc. of Irvine, Calif., will market Lumigan. Alcon Laboratories Inc. of Fort Worth, Texas, will market Travatan.
The Food and Drug Administration has proposed new requirements that would give consumers increased access to information on clinical trials involving gene therapy or xenotransplantation. The rule, proposed Jan. 17, would ensure that people participating in clinical trials involving these technologies are fully informed of the risks, as well as the opportunities for curing a disease or reducing its symptoms.
Gene therapy and xenotransplantation have the potential to alleviate suffering and save lives. But they also hold unique risks for individuals who participate in the studies. Gene therapy is an experimental technique that treats disease by replacing defective genes or inserting new ones. Xenotransplantation refers to transplanting tissues or organs from animals into humans.
The FDA is proposing to make available information about side effects, including deaths, seen during clinical trials. But the names of study participants and proprietary commercial information would remain confidential.
The proposed rule also would ensure that FDA policies for public access to information on gene therapy and xenotransplantation studies are compatible with those of other government agencies that oversee these types of research. The 90-day comment period for the rule ended April 17. Comments will be considered in the FDA's development of a final rule.
If you take the prescription blood thinner warfarin, you should consult a doctor or pharmacist before using over-the-counter vaginal miconazole products. Miconazole is an antifungal drug found in some creams and suppositories to treat vaginal yeast infections, including Monistat.
The Food and Drug Administration recently issued a warning that bleeding or bruising may occur when warfarin and vaginal miconazole are used together. The agency has received two reports of abnormal blood clotting tests in women who used both drugs. One woman also developed bruises, bleeding gums, and a nosebleed.
The FDA has advised manufacturers of products containing miconazole to add a new warning to product labels and brochures telling consumers about the problem.
The Food and Drug Administration has approved a new use for the breast cancer drug Femara (letrozole). Femara had been approved to treat women with advanced breast cancer who had not responded to anti-estrogen drugs. The FDA's latest action approves the drug for use as a first-line treatment for postmenopausal women with advanced, metastatic, or hormone receptor positive or hormone receptor unknown breast cancers. Hormone receptor positive tumors are those that may grow when exposed to estrogen.
Femara was shown to be more effective than tamoxifen in a multinational study of more than 900 postmenopausal women whose locally advanced or metastatic breast cancers were not treatable by surgery or radiation.
Among those in the study, Femara significantly slowed the the time to progression of disease when compared to tamoxifen. With Femara, the median time to disease progression was 9.4 months, compared to 6 months with tamoxifen.
The incidence of side effects for Femara and tamoxifen was similar in the study. Side effects reported most frequently included bone pain, hot flushes, back pain, nausea, joint pain, and labored breathing.
Novartis Pharmaceuticals Corp., East Hanover, N.J., manufactures Femara.
The Food and Drug Administration has approved Cancidas Intravenous Infusion (caspofungin acetate), a new antifungal medication for people who cannot tolerate or who don't respond to standard treatments for infections caused by Aspergillus, a common type of fungus.
Most healthy people are unaffected by Aspergillus. But those with weakened or abnormal immune systems may develop invasive aspergillosis, a group of potentially serious fungal infections associated with the fungus Aspergillus.
Cancidas is the first approved drug in a new class of anti-fungal agents called echinocandins, which are believed to disrupt the creation of fungal cell walls. A study of 63 patients determined that 41 percent of patients overall had a favorable response to the drug. Forty-seven percent of people who were treated with Cancidas for more than seven days improved. Those who were unresponsive to previous therapies had a favorable response rate of 36 percent, and people who were intolerant of previous therapies had a favorable response rate of 70 percent.
Adverse events reported in people treated with Cancidas include fever, inflammation of a vein (phlebitis/thrombophlebitis), infused vein complications, headache, nausea, vomiting, rash, skin flushing, mild liver function test elevations, and one case of a hypersensitive reaction (anaphylaxis). Cancidas has not been studied as an initial therapy for invasive aspergillosis and it is not recommended for such use. Cancidas also should not be used with the immunosuppressant drug cyclosporine until more information is available on the interaction between the two drugs.
Merck & Co. Inc., Whitehouse Station, NJ, manufactures Cancidas.
The Food and Drug Administration and Bristol-Myers Squibb have warned that pregnant women taking the combination of the drugs Zerit (stavudine) and Videx or Videx EC (didanosine) with other antiretroviral agents to treat the virus that causes AIDS (HIV) may be at increased risk for organ damage and fatal lactic acidosis.
Lactic acidosis occurs when the body's cells are unable to convert food into usable energy. Excess acid accumulates, and vital organs such as the liver or pancreas may be damaged. Severe lactic acidosis is an infrequent complication of the class of HIV drugs known as nucleoside analogues.
This new warning follows three reported cases of fatal lactic acidosis, with or without pancreatitis, which occurred in pregnant women taking Videx and Zerit in combination with other HIV drugs. In addition, there have been several nonfatal cases of pancreatitis, with and without lactic acidosis or liver failure, occurring in pregnant women receiving this combination of drugs.
Bristol-Myers Squibb recommends that the combination of Videx and Zerit be prescribed for pregnant women only when the potential benefit clearly outweighs the potential risk. The FDA will strengthen the existing product warnings, indicating that women taking this combination drug therapy should be closely monitored for signs of liver damage and lactic acidosis. This syndrome may develop abruptly.
Health-care providers are encouraged to report any adverse events related to stavudine and didanosine to Bristol-Meyers Squibb at 1-800-426-7644. Reports may also be submitted to the FDA by phone (1-800-FDA-1088), by fax (1-800-FDA-0178), online at www.fda.gov/medwatch, or by mail to: MedWatch (HF-2), FDA, 5600 Fishers Lane, Rockville, MD 20857.
Burn victims, children with congenital defects, and people who are sight-impaired are just some of those who can benefit from donated human cells or tissues. Surgeons use an array of cell- or tissue-based products to repair or replace damaged or diseased areas, such as skin, tendons, bone, heart valves, and corneas.
A final regulation published on Jan. 19 will help the Food and Drug Administration better communicate with and regulate the human cell and tissue industry. The regulation requires all human cell, tissue, and cellular- and tissue-based product manufacturers to register and list their products with the FDA within the next two years. When fully implemented, the regulation will provide, for the first time, a complete database of tissue banks and other establishments that recover, process, store, and distribute human cells and tissues.
The new rule covers tissues not previously regulated, including reproductive tissues and certain hematopoietic (blood-forming) stem cells derived from umbilical cord blood and other blood sources. Hematopoietic stem cell transplants have been used to treat a variety of malignant diseases, such as leukemia and solid organ tumors. The regulation also applies to innovative human tissue uses, such as the use of manipulated human cells to treat viral infections, Parkinson's disease and diabetes.
This final rule is part of the FDA's comprehensive regulatory framework to help ensure the safety and quality of tissue products, including those employing new technologies. The FDA also has proposed two other rules on the use of human tissue. One, issued Sept. 30, 1999, focuses on "donor suitability"--the screening of donors to prevent transmission of infectious diseases. The second proposed rule, issued Jan. 8, focuses on "good tissue practice" and will help ensure that tissue-based products are free of communicable diseases and contamination during manufacturing. Written comments are being accepted on the latter proposed rule until May 8, 2001. For more information, visit www.fda.gov/cber/rules.htm.
People who require longer-term treatment of depression now have another treatment option. In February, the Food and Drug Administration approved Prozac Weekly (fluoxetine hydrochloride), the first prescription medication given weekly for the longer-term treatment of depression. It is intended for use by people whose symptoms have stabilized and who require continuing treatment.
Fluoxetine is cleared slowly from the body, which allows the drug to work when taken only once a week. In addition, the Prozac Weekly tablets are coated with a substance to help delay release of the drug into the bloodstream.
In a U.S. clinical trial involving 501 depressed people, the rates of relapse for those treated with either Prozac Weekly or a 20 milligram daily dose of Prozac were significantly lower than for those treated with an inactive pill (placebo). Prozac Weekly's most common side effects are similar to those of the daily dose and include nausea, headaches and insomnia. People interested in switching from the daily dose to Prozac Weekly should consult their physician.
According to the National Institute of Mental Health, depressive disorders affect more than 18 million Americans each year. Major depression is the leading cause of disability in the United States and worldwide. Almost twice as many women (12 percent) as men (7 percent) suffer from a depressive disorder each year.
Eli Lilly and Co. in Indianapolis manufactures Prozac Weekly.
People with schizophrenia now have available another drug treatment, although approval of the medication comes with a strong warning about a serious health risk and requires that the manufacturer change the drug's brand name.
The Food and Drug Administration approved Geodon (ziprasidone) to treat schizophrenia, a lifelong mental illness that affects a person's behavior, thinking, and emotions. The product will carry a warning on its labeling about possible heart problems associated with its use. The antipsychotic medication may cause a heart rhythm irregularity, and even death. People with significant heart disease should not use the drug.
Schizophrenia affects about 1 percent of the world's population. Typically, the illness strikes men and women in adolescence or young adulthood. Schizophrenia is chronic, often with multiple relapses and impaired daily functioning. People with schizophrenia may experience hallucinations and delusions.
The drug's manufacturer, Pfizer Inc., of New York, planned to market the medication under the name Zeldox, but the FDA believed it sounded too similar to other medications and had the potential to cause confusion. Pfizer settled on the alternative name Geodon.
The most common side effects reported with the drug, which was approved in February, included sleepiness and abnormal movements. Pfizer has agreed to continue studying the drug's effects on the heart.
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