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People with diabetes who experience the pain associated with nerve damage (diabetic peripheral neuropathy) have a new treatment option--the first FDA-approved drug for managing the burning, tingling, and numbing sensations in the feet, legs, or hands that mark this condition.
The drug, Cymbalta (duloxetine), was approved in September 2004 for treating the condition, the most common complication of diabetes.
In clinical trials, people treated with Cymbalta reported less pain compared to those given an inactive substance (placebo). Fifty-eight percent of people treated with Cymbalta reported at least a 30 percent sustained reduction of pain. In comparison, 34 percent of people treated with a placebo reported sustained pain reduction. The most commonly reported side effects were nausea, dry mouth, constipation, and diarrhea. In some cases, patients experienced dizziness and hot flashes.
Cymbalta is manufactured by Eli Lilly and Company of Indianapolis.
Newborns can be screened for a variety of infant diseases using a new test done on blood from heel-stick samples--the same type of sample used for state-mandated newborn screening tests. The blood sample is measured for levels of amino acids and substances called free carnitine and acylcarnitines. The test, NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, provides screening information that, when used with clinical evaluation and other tools, can determine a newborn baby's risk for disorders related to metabolism of these substances.
While small amounts of these substances are found in everyone, abnormally high amounts, or abnormal patterns, may indicate different disease states called inborn errors of metabolism. These diseases include phenylketonuria (PKU), maple syrup urine disease (MSUD), medium chain Acyl-CoA dehydrogenase deficiency (MCAD), isovalericacidemia, homocystinuria, and hereditary tyrosinemia.
These diseases can cause developmental delay, seizures, mental retardation, and death. With early identification, many of the effects of these diseases can be significantly reduced, with improved outcomes and improved quality of life.
PerkinElmer Life and Analytical Sciences Inc. of Norton, Ohio, manufactures the screening test.
The FDA has announced the filing of a consent decree of permanent injunction against Rx Depot Inc. and Rx of Canada LLC, based on violations of the Federal Food, Drug, and Cosmetic Act. Both firms and corporate officers Carl Moore and David Peoples admitted liability for causing the importation of unapproved drugs from Canada, and they agreed to stop.
The defendants' illegal importation of drugs posed a significant public health threat, says Dr. Lester M. Crawford, Acting FDA Commissioner. This applies to unapproved drugs that are imported from foreign countries and U.S.-manufactured drugs that are imported back into the United States by parties other than the manufacturer. Because these drugs are not subject to FDA oversight and are not continuously under the custody of a U.S. manufacturer or authorized distributor, their quality is unpredictable. They could be outdated, contaminated, or counterfeit, or could contain the wrong amount of the active ingredient. The drugs may also have been held under uncertain storage conditions.
The consent decree permanently restrains the defendants from any illegal importation of prescription drugs. The decree gives the FDA inspection authority to ensure compliance and sets a penalty of $4,000 per day for any violation.
Two drugs that have been used for decades as investigational treatments in emergencies were approved by the FDA in August 2004 to treat radiation contamination due to plutonium, americium, or curium. Pentetate calcium trisodium injection (Ca-DTPA) and pentetate zinc trisodium injection (Zn-DTPA) help eliminate these radioactive materials from the body, lowering the risk of developing certain cancers and other biological effects. The drugs are the first approved to treat contamination by the three radioactive substances.
To encourage submission of new drug applications for the two drugs, the FDA announced in September 2003 the specific conditions and findings under which the products could be approved.
Radioactive materials could be released from laboratory or industrial accidents or through terrorist attacks using a radiation dispersal device, commonly called a dirty bomb. Contamination could occur through a variety of routes, including ingestion, inhalation, or direct contact through wounds. Ca-DTPA and Zn-DTPA are usually administered into the bloodstream, but for people whose contamination is only by inhalation, the drugs can be given by nebulized inhalation.
These products should not be administered at the same time. Ca-DTPA is more effective than Zn-DTPA during the first 24 hours after contamination. So if both products are available, Ca-DTPA should be given as the first dose. If additional treatment is needed, treatment should be switched to Zn-DTPA. After the initial 24 hours, Zn-DTPA and Ca-DTPA are similarly effective.
The main side effect of Ca-DTPA is the loss of certain essential metals such as zinc, which can be replaced by taking oral zinc supplements.
Ca-DTPA and Zn-DTPA are manufactured by Hameln Pharmaceuticals of Hameln, Germany.
New drug combinations to attack HIV, the virus that causes AIDS, and an injectable product to correct facial fat loss have been added to the list of approved treatments for people with HIV.
The FDA has approved two fixed-dose combination treatments for HIV-1 infection: Epzicom and Truvada. The control of HIV and AIDS generally requires simultaneous use of three or more drugs from different drug classes. Combination products bring together different HIV and AIDS drugs in a single medication or co-package to help make treatment regimens less complicated for people to follow.
Simplifying treatment regimens by reducing the number of pills and times per day patients need to take them provides significant public health benefits, says Dr. Lester M. Crawford, Acting FDA Commissioner.
Epzicom and Truvada are indicated for use in combination with other antiretroviral drug products from different classes for the treatment of adults with HIV-1 infection. Antiretroviral drugs attack HIV, which is a retrovirus, by interfering with the virus's ability to use specific enzymes that it needs to survive.
Epzicom is a fixed-dose combination of two antiretroviral drugs that are approved individually under the brand names Ziagen (abacavir sulfate) and Epivir (lamivudine). Truvada is a fixed-dose combination of two antiretroviral drugs that are approved individually under the brand names Viread (tenofovir disoproxil fumarate) and Emtriva (emtricitabine).
The FDA completed its review of Epzicom, a product of GlaxoSmithKline, in 10 months and its review of Truvada, a product of Gilead Sciences, in four months.
Sculptra, an injectable filler to correct facial fat loss in people infected with HIV, was recently approved under an expedited agency review. Sculptra is the first such treatment approved for a condition known as lipoatrophy, or facial wasting, a sinking of the cheeks, eyes, and temples caused by the loss of fat tissue under the skin.
Sculptra was shown to produce significant increases in skin thickness, adding volume to facial tissue and restoring shape in areas of the face with fat loss. After an initial treatment series, repeat treatments may be needed to maintain the correction. Studies reported an improvement in the quality of life among those treated and less of the anxiety and depression often associated with lipoatrophy.
Sculptra is an injectable form of poly-L-lactic acid, a biodegradable, biocompatible synthetic polymer from the family of alpha hydroxy acids that has been widely used for many years in dissolvable stitches, bone screws, and facial implants.
In studies, patients were given three to six injections of Sculptra at two-week intervals and were followed for two years. The studies showed that the product was safe and that it significantly improved facial appearance. Most side effects were related to the injection itself, and included nodules, redness, swelling, and bruising in the injection area.
Sculptra should be used only in people with HIV by health care providers who are fully familiar with the entire product package insert and product training materials provided by the drug maker, Dermik Laboratories of Berwyn, Pa. The FDA has not approved the use of the product for other indications, such as to treat wrinkles.
It is estimated that 900,000 to 1 million people in the United States are HIV-positive, although about one-third are not diagnosed. Some 50 percent will develop lipoatrophy. An estimated 150,000 to 350,000 people could potentially benefit from the new filler.
The FDA has approved a device for children who have thoracic insufficiency syndrome, a term used to describe severe deformities of the chest, spine, and ribs that prevent normal breathing and lung development.
The Vertical Expandable Prosthetic Titanium Rib, an implanted device, was approved in September 2004 under the humanitarian device exemption (HDE), which makes medical devices available on a limited basis for patients with rare medical conditions. The device is a curved metal rod that is attached to ribs near the spine using hooks located at both ends of the device. It is intended to help straighten the spine and separate ribs so that the lungs can grow and fill with enough air to breathe. The device is lengthened or replaced as the patient grows, requiring repeat operations every six months.
An HDE is a special regulatory marketing approval for medical devices that treat conditions affecting fewer than 4,000 people annually in the United States.
The new device, manufactured by Synthes Spine Co. of West Chester, Pa., is not intended to correct conditions other than chest wall instability. It should not be used in children younger than 6 months, girls older than 14, or boys over 16.
Federal and state agencies have announced a new collaboration to protect the nation's food supply from contamination. The U.S. Department of Agriculture, the FDA, and the Department of Homeland Security signed an agreement with the National Association of State Departments of Agriculture in September 2004. This agreement will improve federal-state response plans for food and agricultural emergencies.
For the first phase of the project, a group of federal, state, and local officials will gather information about how food and agricultural safety should be handled within the various states. During the second phase, the group will develop an interagency response plan and conduct exercises to test and refine it. Phase three, which will conclude by June 2005, involves developing guidelines on how federal agencies will assist local response and recovery efforts.
For more information, visit the Food Safety and Terrorism page on the FDA's Web site.
A plastic lens that is permanently implanted into the eye to correct moderate to severe nearsightedness has been approved by the FDA.
The lens, called the Artisan, is implanted in front of the eye's natural lens. It is intended for use in healthy eyes in people with stable vision.
Manufactured by Ophtec USA Inc. of Boca Raton, Fla., the Artisan is intended to reduce or eliminate nearsightedness in adults, and it will offer people another alternative to glasses, contact lenses, and laser surgery such as LASIK. However, the Artisan may not eliminate the need for glasses because it does not correct astigmatism. Glasses may need to be worn for night driving or other activities performed in low light. They may also be needed for reading.
Ophtec studied the use of the Artisan in the United States in 662 patients with moderate to severe nearsightedness. After three years, 92 percent had 20/40 or better vision--considered standard vision necessary to obtain a driver's license--and 44 percent had 20/20 or better.
One potential concern raised by the study was the loss of endothelial cells in the corneas of patients who received the implants. The endothelium is a layer of cells that lines the undersurface of the cornea and is essential to keeping the cornea clear. The three-year study data showed a continual steady loss of endothelial cells of 1.8 percent a year. It is not known whether this loss will continue at the same rate, or what the long-term effect of this device on the cornea's health might be. To minimize any potential long-term effects, the FDA is requiring the labeling for the new lens to specify that it should be used only on people whose corneal endothelial cells are dense enough to withstand some loss over time.
Other adverse events reported in the study by less than 1 percent of patients included retinal detachment, cataract development, and corneal swelling.
Health and Human Services Secretary Tommy G. Thompson has released a draft Pandemic Influenza Response and Preparedness Plan. A flu pandemic is a global event in which a new strain of flu virus circulates and infects large numbers of people. Unlike the gradual changes that occur in the influenza viruses that infect people each flu season, a pandemic influenza virus represents a major, sudden change in the virus' structure.
Flu pandemics are rare; three occurred during the 20th century. In 1968, the Hong Kong flu outbreak resulted in nearly 34,000 deaths. In 1957, the Asian flu pandemic killed about 70,000. And in 1918, the Spanish flu pandemic caused 20 million to 50 million deaths worldwide.
A pandemic could occur if strains of bird (avian) flu were to combine with the flu virus that affects humans. This could create a new strain that could spread easily among humans. There have been several different bird flu viruses identified in poultry in recent years. One of these viruses killed birds and some people in Asia. Cambodia, China, Indonesia, Japan, Laos, South Korea, Thailand, and Vietnam were affected by widespread flu outbreaks in poultry in early 2004. More than 100 million birds either died from the disease or were killed to contain the outbreaks. Human cases were reported only in Thailand and Vietnam. In the United States, there have been outbreaks of avian flu in poultry, one human case, and no reports of human deaths, according to the Centers for Disease Control and Prevention (CDC). The CDC and the World Health Organization continue to monitor avian flu activity.
Released in August 2004, the HHS plan aims to protect against pandemic influenza in five key areas: surveillance, vaccine development and production, antiviral stockpiling, research, and public health preparedness. The National Institute of Allergy and Infectious Diseases recently announced two projects that support development and production of investigational vaccines against strains of avian influenza.
View the draft plan on pandemic influenza on the Health and Human Services Web site.
An animal drug measure signed into law in August 2004 will help make more medications legally available to veterinarians and animal owners to treat minor animal species. The new law also will encourage the availability of treatments for uncommon diseases in the major animal species.
The major animal species are cattle, horses, swine, chickens, turkeys, dogs, and cats. Minor species are all other animals, including zoo animals, ornamental fish, parrots, ferrets, and guinea pigs. Some animals of agricultural importance, such as sheep, goats, catfish, and honeybees, are also classified as minor species.
The new law is expected to benefit people who own small or unusual pets, such as guinea pigs or ornamental fish, and to help zoo veterinarians treat their animals. Before this legislation, pharmaceutical companies could rarely afford to bring to market drugs for novel pets and zoo animals because the markets were too small to generate an adequate financial return. The new law modifies provisions of the Federal Food, Drug, and Cosmetic Act to provide some flexibility in getting limited-use drugs to market.
This is an excellent law that will help veterinarians better serve zoo animals, endangered species, and many other minor species, says Linda Tollefson, D.V.M., deputy director of the FDA's Center for Veterinary Medicine.
The official name of the law is The Minor Use and Minor Species Animal Health Act of 2004. Minor use drugs are drugs for use in major species that are needed for diseases that have a limited geographic range or affect a small number of animals.