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The drug Campral (acamprosate) has been approved by the FDA for treating alcohol-dependent individuals who want to continue to remain alcohol-free after they have stopped drinking. Campral is the first new drug approved for alcohol abuse in a decade.
Alcoholism, or alcohol dependence, is a disease. The consequences of alcohol misuse are serious and, in many cases, life threatening. Heavy drinking can increase the risk for certain cancers, especially those of the liver, esophagus, throat, and voice box (larynx). Heavy drinking can also cause liver cirrhosis, immune system problems, brain damage, and harm to the fetus during pregnancy. Chronic alcoholism continues to be a widespread and debilitating disorder that places a tremendous burden on society in terms of health care costs, lost wages, and personal suffering.
How Campral works is not fully understood, but the drug is thought to act on the brain pathways related to alcohol abuse. Campral was demonstrated to be safe and effective by multiple clinical studies involving alcohol-dependent people who had already been withdrawn from alcohol (detoxified). Campral proved superior to an inactive substance (placebo) in maintaining abstinence. This was indicated by a greater percentage of people who were treated with the drug being assessed as continuously keeping off alcohol consumption throughout treatment.
The most common side effects reported for patients taking Campral in clinical trials included headache, diarrhea, flatulence, and nausea. Campral is not addicting.
Campral may not be effective in people who are actively drinking at the start of treatment, or in people who abuse other substances in addition to alcohol. Treatment with Campral should be part of a comprehensive management program that includes psychosocial support.
Campral is manufactured by Merck KGaA of Darmstadt, Germany, and will be distributed in the United States by Forest Laboratories Inc. of New York City.
After being approved for several other purposes since 1989, including improving the appearance of frown lines between the eyebrows, Botox now can treat severe underarm sweating (primary axillary hyperhidrosis) that cannot be managed by topical agents.
Botox (botulinum toxin type A) is a protein produced by the bacterium Clostridium botulinum. When used to treat underarm sweating, small injected doses of the sterile purified botulinum toxin stop release of the chemical messenger acetylcholine, temporarily blocking the nerves in the underarm that stimulate sweating.
Before being treated for underarm sweating, patients should be evaluated for other potential causes of the problem. The most common adverse events associated with the new treatment included injection site pain and hemorrhage, sweating in other parts of the body, flu-like symptoms, headache, fever, itching, and anxiety.
Botox was first approved in December 1989 to treat the eye muscle disorders blepharospasm and strabismus. Since then, it has been approved to treat a neurological movement disorder causing severe neck and shoulder muscle contractions (cervical dystonia). In 2002, it was approved as Botox Cosmetic to improve frown lines.
The safety and effectiveness of Botox for sweating that occurs in other areas of the body have not been established.
Do you have a friend, neighbor, or family member who hasn't seen a doctor, nurse, or other health care professional in quite a while? The U.S. Department of Health and Human Services suggests that you take charge and "Take a Loved One to the Doctor" on Sept. 21, 2004.
Americans are encouraged to take charge of their health on that day--or any day--by visiting a health care professional, making an appointment for a visit, attending a health event in the community, or helping a friend, neighbor, or family member do the same.
Launched by HHS Secretary Tommy G. Thompson and Tom Joyner, a nationally syndicated radio personality and chairman of the event, the annual campaign is designed to reduce health disparities affecting racial and ethnic minorities by encouraging individuals to go to a doctor or health professional for a health screening.
Take a Loved One to the Doctor Day is part of "Closing the Health Gap," an ongoing campaign partnership that combines HHS' medical expertise with the broadcast resources of ABC Radio Networks and the efforts of hundreds of national and community-based organizations. In 2003, 500 national and local organizations signed on as partners in the Take a Loved One to the Doctor Day campaign by organizing screening, health fairs, and other events promoting health and wellness.
"Because of Doctor Day, thousands of Americans are showing their family, friends and colleagues how much they care by taking someone to the doctor. This one preventive measure can help add years to your life," Thompson says. "Preventable diseases take a terrible toll on our nation, especially in minority communities. Doctor Day is about bringing people to health care early, when diseases can be prevented or treated successfully. It is also about creating awareness, providing information and motivating Americans to make healthier lifestyle choices."
For campaign information and materials on the Closing the Health Gap program or Take a Loved One to the Doctor Day, including a tool kit to help communities organize local health events, call (800) 444-6472 or visit www.healthgap.omhrc.gov.
The FDA is warning consumers against using infant formula imported from China because the safety and nutritional adequacy of the products are unknown.
Although no illnesses or injuries associated with Chinese infant formula have been reported to date, an analysis by the New York State Department of Agriculture and Markets food laboratory found that a Chinese infant formula called Guan Wei Yuan contained less than 14 percent of the minimum amount of protein per serving required by federal regulations. The analysis also found the formulas contained only one-fourth of the required amount of fat per serving, and only minute amounts of the declared calcium and magnesium levels.
There is no guarantee that this product, as a potential sole source of nutrition, would provide adequate nutrients for an infant, FDA officials say. Infants who are fed this formula according to instructions provided with the product could become severely ill or die.
Federal law requires that infant formula sold in the United States must be registered with the FDA at least 90 days before marketing. Manufacturers are required to provide assurances that they are following good manufacturing practices and quality control procedures and that the formula will allow infants to thrive. Such assurances have not been provided for any infant formulas from China.
Consumers are advised to report any adverse reactions related to infant formula immediately to health care providers as well as to the FDA and state and local agencies.
The FDA has alerted the public to a number of reported adverse events associated with so-called "permanent makeup," a form of tattooing called micropigmentation. The procedure is used to apply lip liner, eyeliner, or eyebrow color. The adverse events are associated with certain ink shades of the Premier Pigment brand of permanent makeup inks, which are manufactured by the American Institute of Intradermal Cosmetics, doing business as Premier Products of Arlington, Texas.
Reactions that have been reported include swelling, cracking, peeling, blistering, and scarring as well as formation of chronically inflamed tissue mass associated with an infection (granulomas) in the areas of the eyes and lips. In some cases, the effects reported caused serious disfigurement, resulting in difficulty in eating and talking.
In July 2003, the manufacturer reported to the FDA its intent to remove five of its ink shades from the market. However, the agency has obtained additional reports of adverse events involving ink shades not included in the firm's removal effort. While the investigation continues, the FDA is alerting consumers to associated adverse event reports received about Premier Products ink shades identified on its Web site at www.cfsan.fda.gov/~dms/cos-tat2.html.
The FDA considers tattoos, including permanent makeup, to be cosmetics. And the agency considers the pigments used in the inks to be color additives requiring premarket approval under the Federal Food, Drug, and Cosmetic Act. However, the agency traditionally has not regulated tattoo inks or pigments used in them. The actual practice of tattooing is governed by state and local regulations.
The FDA urges people to report adverse reactions from tattoos and permanent makeup to state and local health authorities. Adverse events also may be reported to the FDA's Emergency Operations Center at (301) 443-1240 or the Center for Food Safety and Applied Nutrition Adverse Events Reporting System (CAERS) at (301) 436-2405. People also may send e-mail to CAERS@cfsan.fda.gov.
The first test approved for detecting antibodies to anthrax will soon be available in state and private labs. Before FDA approval of the Anthrax Quick ELISA test in June 2004, few laboratories other than those operated by the Centers for Disease Control and Prevention (CDC) and the U.S. Army could test blood for antibodies to anthrax.
The test helps confirm a diagnosis of anthrax in people by showing that a person's immune system has responded to a protein produced by the anthrax-causing bacteria--Bacillus anthracis. The test is quicker and easier to interpret than previous antibody testing methods. It can be completed in less than an hour, compared with about four hours for previous testing methods. Immunetics Inc. of Boston produced the test with funding from the CDC.
Anthrax is a serious infectious disease that most commonly occurs in wild and domestic cattle, sheep, and other herbivores. Humans can contract anthrax by handling products from infected animals or by breathing in or coming in close contact with B. anthracis spores from infected animal products, such as unprocessed hides and bones. Anthrax also can be transmitted to humans when anthrax spores are used as a bioterrorist weapon. Twenty-two people became ill and five died after letters containing anthrax were sent through the mail in 2001.
In July 2004, the FDA approved a new image analysis system designed to help radiologists detect solid lung nodules. Such nodules can indicate lung cancer.
The ImageChecker CT CAD software system uses computer-aided detection software to analyze computed tomography (CT) images of the chest. The system, which is the first of its kind for use with CT chest exams, highlights areas in the images that appear to be solid nodules.
In a clinical study, 15 radiologists independently reviewed 90 cases from lung CT scans and then reviewed the cases again using the ImageChecker system. Radiologists were able to identify more nodules with the new system than they could without it, improving their ability to detect lung nodules that require further evaluation.
The software system is manufactured by R2 Technology Inc. of Sunnyvale, Calif.
A New Jersey judge has found that two products sold as dietary supplements and another touted as a cosmetic are unapproved new drugs under federal law because they were being marketed as treatments for cancer and HIV without FDA approval. The three products are BeneFin, a purported treatment for cancer, MGN-3, marketed as an HIV treatment, and SkinAnswer, promoted as a treatment for skin cancer. BeneFin is produced from shark cartilage, MGN-3 is a rice bran extract, and SkinAnswer is a skin cream.
On July 9, 2004, U.S. District Judge William G. Bassler permanently enjoined the defendants, Lane Labs-USA Inc. and its president, Andrew J. Lane, from distributing drug products unless they are first approved for marketing by the FDA or are distributed under an Investigational New Drug application for purposes of conducting a clinical trial. Bassler also ordered the defendants to pay restitution to all purchasers of the products since Sept. 22, 1999.
"Today's action by Judge Bassler sends a strong signal that the promotion and sale of unapproved drug products, especially for the treatment of cancer and other serious diseases, will not be tolerated," said Dr. Lester M. Crawford, Acting FDA Commissioner.
The FDA issued a warning letter to the company and Lane in September 1997. Nevertheless, the promotions of BeneFin, MGN-3, and SkinAnswer continued through mass mailings, Internet sites, and employee statements.
The government's request for a permanent injunction was based on the defendants' demonstrated unwillingness to comply with the law.
Women who are breast-feeding should not use the unapproved drug domperidone to increase milk production due to safety concerns, the FDA says. The drug is excreted in breast milk and could expose a breast-feeding infant to unknown risks.
Published reports and case studies have cited cardiac arrhythmias, cardiac arrest, and sudden death in people receiving an intravenous form of domperidone, which has been withdrawn from the market in several countries. In areas where the oral form of domperidone continues to be available, labels for the product contain specific warnings against its use by breast-feeding women.
Recognizing the immense health benefits that breast milk provides for a nursing infant, the FDA has issued the warning, not to discourage women from breast-feeding, but rather to inform them of the potential harm from using this particular drug while breast-feeding. In fact, the U.S. Department of Health and Human Services' Office on Women's Health and the Advertising Council announced in June 2004 the launch of a new national campaign that encourages first-time mothers to breast-feed exclusively for six months.
The FDA has issued six warning letters to pharmacies that compound products containing domperidone and firms that supply the drug for use in compounding. Compounding, as it relates to pharmacies, includes the preparation, mixing, assembling, packaging, or labeling of a drug in response to a prescription written by a licensed health care practitioner. The letters state that all drug products containing domperidone, whether compounded or not, violate the Federal Food, Drug, and Cosmetic Act because they are unapproved new drugs and misbranded. Further violations may result in enforcement actions, including seizure, according to the FDA letters.
In addition, the agency has alerted field personnel to watch for any attempts to import domperidone so that it can be detained and refused entry into the United States. Importation of domperidone-containing products also is a violation of the law.
Daniel G. Schultz, M.D., has been named director of the FDA's Center for Devices and Radiological Health (CDRH) by Dr. Lester M. Crawford, Acting FDA Commissioner.
Schultz leads the center that is responsible for the review of medical devices, as well as radiation-emitting products such as magnetic resonance imaging equipment and X-ray machines. He also will oversee implementation of the Medical Device User Fee and Modernization Act of 2002, which authorizes the FDA to collect user fees for its review of medical device marketing applications and sets performance goals for the reviews.
In April 1994, Schultz joined the FDA as a medical officer in the General Surgery Branch of CDRH. He went on to become chief medical officer in the Division of Reproductive, Abdominal, and Radiological Devices. He later served as director of the Office of Device Evaluation.
Schultz received a medical degree from the University of Pittsburgh in 1974. After entering the Commissioned Corps of the U.S. Public Health Service in July 1975, he worked as clinical director of the Tuba City Indian Hospital on the Navajo reservation in Arizona. He is board-certified in general surgery and family practice and is a Fellow of the American College of Surgeons.
Schultz has been acting director at CDRH since April 1, 2004.
A new use for a robotic device that assists surgeons in the operating room was cleared by the FDA in July 2004.
Now approved to assist in coronary bypass surgery, the da Vinci Endoscopic Instrument Control System allows a surgeon to perform heart surgery while seated at a console with a computer and video monitor. A fiber-optic instrument with a small video camera gives doctors a magnified internal view of the surgical site on a television screen.
The surgeon uses handgrips and foot pedals on the console to control robotic arms, which perform surgery with a variety of tools. A built-in "wrist" at the end of the tools helps the surgeon perform more exact and intricate motions.
The da Vinci surgical system is already cleared for general abdominal laparoscopic surgeries such as gall bladder removal and to treat severe heartburn, for general chest surgery using an endoscope that doesn't involve the heart, and for thorascopically assisted heart procedures such as mitral valve repair. The system is manufactured by Intuitive Surgical Inc. of Sunnyvale, Calif.
Did you know that among all Americans with high blood pressure, Mexican-Americans are less likely than whites or African-Americans to know that they have it? Or that one-third of Hispanics with diabetes are undiagnosed?
Those statistics, prepared by the U.S. Department of Health and Human Services Office of Minority Health, highlight the need to reinforce the commitment to improve consumer access to health information, especially to Hispanic communities, according to Dr. Lester M. Crawford, Acting FDA Commissioner.
Crawford and Jane Delgado, Ph.D., president and CEO of the National Alliance for Hispanic Health, are working together to provide timely, accurate, and scientifically based health information to Hispanics to help them take active steps to prevent disease and stay healthy.
As part of that effort, the FDA and the Alliance are promoting National Hispanic Heritage Month, Sept. 15 through Oct. 15, 2004. The outreach effort promotes two sources of consumer health information:
The FDA and the U.S. Department of Agriculture (USDA) have taken three actions to strengthen existing safeguards that protect consumers against the agent that causes bovine spongiform encephalopathy (BSE), also known as "mad cow disease."
In July 2004, the FDA published an interim final rule (IFR) that prohibits the use of certain materials from cattle that could carry the BSE-infectious agent in human food, dietary supplements, and cosmetics. These high-risk materials, known as "specified risk materials" (SRMs), include the brain, skull, eyes, and spinal cord of cattle 30 months of age or older, and a portion of the small intestine and tonsils from all cattle, regardless of their age. Also prohibited are materials from non-ambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated beef.
This IFR, in conjunction with IFRs issued by the USDA in January 2004, will minimize human exposure to materials that may put people at risk for a disease similar to BSE called variant Creutzfeldt-Jakob disease (vCJD). Scientific studies have demonstrated that SRMs could contain the BSE agent when derived from cattle that are harboring the BSE agent. Consumption of products contaminated with the agent that causes BSE is the likely cause of vCJD in people. This rule was effective immediately, but the FDA is accepting comments until Oct. 12, 2004, for consideration before publishing a final rule.
In a second action, the FDA published a proposed rule requiring manufacturers and processors of human food, dietary supplements, and cosmetics derived from certain cattle materials to maintain records showing that prohibited materials are not used in their products.
Finally, the USDA and the FDA jointly published an advance notice of proposed rulemaking (ANPR) requesting comments and scientific information on additional measures to help prevent the spread of BSE. In the ANPR, the FDA is requesting comments on potential new controls on animal feed, including:
The FDA's current animal feed rule, which became effective in 1997, helps prevent the establishment and spread of BSE through feed in the United States. FDA and state investigators inspect animal feed firms to ensure compliance with the rule. According to the latest inspection results of July 17, 2004, among companies handling material prohibited in feed for ruminants, compliance rates remain greater than 99 percent.
For more information, visit:
www.fda.gov/oc/opacom/hottopics/bse.html
or
www.fsis.usda.gov/oa/topics/bse.htm.