Food and Drug Administration
The Food and Drug Administration generally supports the recommendations that were recently made to the agency by the Psychopharmacologic Drugs and Pediatric Advisory Committees regarding reports of an increased risk of suicidality (suicidal thoughts and actions) associated with the use of certain antidepressants in pediatric patients. FDA has begun working expeditiously to adopt new labeling to enhance the warnings associated with the use of antidepressants and to bolster the information provided to patients when these drugs are dispensed.
The Food and Drug Administration (FDA) has approved a plastic lens that is permanently implanted into the eye to correct moderate to severe nearsightedness. The lens, called an intraocular lens (IOL), is similar to the type of lens implanted in the eye to restore vision following cataract surgery. Manufactured by Ophtec USA Inc., of Boca Raton, Fla., the new lens is intended to reduce or eliminate nearsightedness in adults, and will offer people another alternative to glasses, contact lenses and laser surgery such as LASIK.
An estimated 454,383 people suffered injuries from medical devices -- ranging from wheelchair accidents to careless toothbrushing -- in one 12-month period from 1999-2000, say researchers from two federal regulatory agencies. The devices were responsible for an estimated 58,000 hospitalizations, but the accidents were fatal in less than one in a thousand cases. ''A majority of the total estimate appeared to reflect incidents where an unintentional traumatic injury occurred, with no explicit malfunction or personal misuse of the device,'' says Brockton J. Hefflin, M.D., the lead researcher.
The Food and Drug Administration (FDA) today announced the availability of a qualified health claim for reduced risk of coronary heart disease (CHD) on conventional foods that contain eiscosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega-3 fatty acids. Typically, EPA and DHA omega-3 fatty acids are contained in oily fish, such as salmon, lake trout, tuna and herring. These fatty acids are not essential to the diet; however, scientific evidence indicates that these fatty acids may be beneficial in reducing CHD.
The Food and Drug Administration has approved a Humanitarian Device Exemption for an implanted device to treat children who have Thoracic Insufficiency Syndrome, a term used to describe patients who have severe deformities of the chest, spine, and ribs that prevent normal breathing and lung development. An HDE is a special category of approval that allows a manufacturer to market a device on a limited basis to diagnose or treat patients with rare medical conditions--those that affect fewer than 4,000 people annually in the United States. Manufacturers of such products must demonstrate that the product is safe and has probable benefit to the patient which outweighs any risk of injury or illness that may be associated with its use.
The Food and Drug Administration has cleared for marketing a new laboratory blood test that will help doctors screen newborn infants for a variety of inherited diseases. The test is done on blood from newborn heel-stick samples--the same kind 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 Food and Drug Administration has approved a new antibiotic drug for dogs, giving veterinarians a ne w once daily tre atment option to treat skin infections (wounds and abscesses) which are common problems among dogs. The product is called ''Simplicef '' (cefpodoxime proxetil), developed by Pharmacia & Upjohn Co ., of Kalamazoo, Michigan, a division of Pfizer, Inc. The drug is an extended spectrum cephalosporin that is effective in the treatment of skin infections in dogs caused by susceptible strains of Staphylococcusintermedius, Staphylococcusaureus, Streptococcuscanis, Escherichiacoli, Pasteurellamultocida, and Proteusmirabilis.
The Food and Drug Administration today announced the approval of two drugs, pentetate calcium trisodium injection and pentetate zinc trisodium injection for treating certain kinds of radiation contamination. The FDA is approving these two drugs as part of its ongoing effort to provide the American public the best available protection against nuclear accidents and terrorist threats.
A drug once considered for cancer chemotherapy is advancing in clinical trials to test its effectiveness in fighting a virus from the herpes family that threatens transplant patients. Researchers developed the compound maribavir. It is licensed by ViroPharma, which announced today that maribavir is headed for phase 2 clinical trials for the treatment of cytomegalovirus infection in stem cell transplant patients. New drugs go through three phases of clinical trials before the Food and Drug Administration decides on their approval.
United States Attorney Carol C. Lam announced that a Grand Jury sitting in the Southern District of California returned an eight-count indictment against San Diego-based corporation Metabolife International, Inc., and its founder, Michael J. Ellis. The indictment charges both defendants with six counts of making false, fictitious and fraudulent representations to the Food and Drug Administration, and two counts of corruptly endeavoring to influence, obstruct and impede proceedings concerning the regulation of dietary supplements containing ephedra being conducted by the FDA.
The Food and Drug Administration (FDA) has approved a new image analysis system designed to help radiologists review computed tomography (CT) images of the chest to aid in the detection of solid nodules in the lungs. Such nodules can be malignant.
"At yesterday's hearing, [Judge] Sullivan questioned why the Food and Drug Administration did not formally issue a ruling that the vaccine was safe and effective against inhalation anthrax until late December 2003. That move came 18 years after the vaccine was first proposed to the FDA for use against inhalation anthrax, but just a week after Sullivan had temporarily halted the military inoculation program."
http://www.washingtonpost.com/wp-dyn/articles/A55581-2004May25.html
Judge Sees Little Evidence To Support Anthrax Vaccine
By Carol D. Leonnig
Washington Post Staff Writer
Wednesday, May 26, 2004; Page A25
U.S. Department of Health and Human Services Secretary Tommy G. Thompson and Agriculture Secretary Ann M. Veneman today announced three actions being taken to further strengthen existing safeguards that protect consumers against the agent that causes bovine spongiform encephalopathy (BSE, also known as ''mad cow disease'').
The Food and Drug Administration (FDA) today cleared the marketing of a robotic-like system to assist in coronary artery by-pass surgery in which there is direct access to the chest using standard open chest technique (sternotomy) or a smaller surgical incision (thoracotomy).
The Food and Drug Administration is alerting the public to a number of reported adverse events associated with individuals who have undergone certain micropigmentation procedures, a form of tattooing, used to apply ''permanent makeup'' for lip liner, eyeliner, or eyebrow color. To date, FDA has been made aware of more than 50 adverse events and is investigating additional reports sent to the manufacturer. Reactions that have been reported include swelling, cracking, peeling, blistering, and scarring as well as formation of granulomas (chronically inflamed tissue mass associated with an infection) in the areas of the eyes and lips. In some cases, the effects reported caused serious disfigurement, resulting in difficulty in eating and talking.
