 |
 |
 |
FDA Home Page | Search
FDA Site | FDA A-Z Index | Contact
FDA
Topics in This Issue:
The FDA has cleared for marketing a high-tech tag intended to provide additional protection for people undergoing surgery. The SurgiChip Tag Surgical Marker system is the first to use radio frequency identification (RFID) technology to mark parts of the body for surgery. It aims to minimize the likelihood of wrong-site, wrong-procedure, and wrong-patient surgeries.
The patient's name and the site of the surgery are printed on a SurgiChip tag. The inside of the tag is encoded with the date of surgery, type of procedure, and the name of the surgeon. The tag is scanned with a desktop RFID reader for confirmation by the patient and is then placed in the patient's hospital file.
On the day of the surgery, the tag is removed from the file and scanned again, and the encoded information is verified by the patient. The tag, which has an adhesive backing, is then placed on the patient's body near the surgical site. In the operating room, the tag is scanned again and the encoded information is verified with the patient's chart. The tag is removed just before surgery and returned to the patient's hospital file. The device is manufactured by SurgiChip Inc. of Palm Beach Gardens, Fla.
The FDA also has stepped up its efforts to use RFID to improve the safety and security of the nation's drug supply. In this case, RFID uses electronic tags on product packaging to allow manufacturers and distributors to more precisely track drug products as they move through the supply chain.
For the first time, the FDA has granted clearance for the over-the-counter (OTC) sale of an automated external defibrillator (AED) designed specifically for use by the general public. The HeartStart Home Defibrillator shocks the heart to restore rhythm in people who are experiencing cardiac arrest. The device is already available for home use with a prescription.
AEDs are used to treat someone with cardiac arrest whose heart is beating irregularly (fibrillating). If the heart does not return to a regular rhythm within five minutes, the fibrillation could be more difficult to treat or be fatal. The defibrillator administers an external electric shock through the chest wall to the heart with the use of conductive adhesive pads. Built-in computers analyze the person's heart rhythm and interpret the rhythms that require defibrillation shocks. Voice and visual prompts guide the user.
The HeartStart Home Defibrillator, manufactured by Philips Medical Systems of Andover, Mass., is cleared for use on adults or on children who are 8 years old or older or who weigh at least 55 pounds. Special small pads are available by prescription for use on infants and young children. The device is intended for use when a person is believed to be in sudden cardiac arrest, does not respond when shaken, and is not breathing properly. It should not be used if the person is responsive when shaken or breathing normally.
The AED comes with a training video and also instructs users that they should obtain training in cardiopulmonary resuscitation (CPR) in case that is needed instead of a shock. The instructions remind users that, in the event of a possible cardiac arrest, they should also call 911 immediately. Philips plans to conduct a postmarket study to further determine the device's performance when used in the general population without physician oversight.
Nutrition experts and health care providers emphasize the importance of fresh produce in a healthy diet. The FDA has developed an action plan to minimize the risk of foodborne illness from these products.
"Produce Safety From Production to Consumption: 2004 Action Plan to Minimize Foodborne Illness Associated With Fresh Produce Consumption" focuses on the major points from farm to table where contamination of produce could occur. It covers fresh fruits and vegetables in their unpeeled natural form and raw minimally processed products such as fresh-cut produce. The plan's four objectives are:
The action plan expands on a 1998 FDA guidance document. That guide provided an overview of the microbial food safety hazards and good agricultural and management practices common to the growing, harvesting, washing, sorting, packing, and transporting of most fruits and vegetables sold to consumers in an unprocessed or raw (minimally processed) form to reduce the risk of foodborne illness from fresh produce. Both domestic and foreign fresh fruit and vegetable producers are encouraged to use this voluntary, science-based guidance to help ensure the safety of their produce.
To view the new action plan, visit www.cfsan.fda.gov/~dms/prodpla2.html.
People with the most common form of lung cancer that has continued to progress despite using other medications have a new treatment option--a drug that received expedited, or "fast-track," review from the FDA during its development.
The drug, Tarceva (erlotinib), was approved in November 2004 for treating people with locally advanced or metastatic non-small cell lung cancer (NSCLC). The FDA reviewed the drug application under "rolling review" procedures that are available to new fast-track drug applications. In rolling review, the FDA starts reviewing specific parts of a drug approval application even before all the application information has been submitted to the agency.
In clinical trials, the drug has shown improved survival in people with NSCLC. The average survival time was about seven months for those taking Tarceva, compared with about five months in the group taking an inactive pill (placebo). The most common side effects reported in the trials were diarrhea, rash, nausea, and vomiting. Tarceva may cause fetal harm if taken by pregnant women.
Tarceva is manufactured by OSI Pharmaceuticals Inc. of Melville, N.Y., and distributed by Genentech Inc. of South San Francisco, Calif.
The FDA has approved a new medical device that targets and destroys uterine fibroids, noncancerous masses in the uterus. The FDA expedited review of the device, the ExAblate 2000 System, because it offers significant advantages over existing treatments.
The ExAblate 2000 combines two systems: a magnetic resonance imaging (MRI) machine and an ultrasound beam. The MRI is used to visualize patient anatomy, map the fibroid tissue to be treated, and monitor the temperature of the uterine tissue after heating. The ultrasound beam heats and destroys the fibroid tissue using high frequency, high-energy sound waves. This is the first time these two systems have been combined and the first time magnetic resonance has been used to monitor tissue temperature.
The treatment requires repeated targeting and heating of fibroid tissue while the woman lies inside the MRI machine. The procedure can last as long as three hours. The new device can be used to treat some--but not all--fibroids. Fibroids close to sensitive organs such as the bowel or bladder and those outside the image area cannot be treated.
About 20 percent to 40 percent of women age 35 and older have fibroids. Although many of these women do not experience any symptoms, in others the location and size of the fibroids can cause heavy and prolonged menstrual periods, pressure on the bladder or bowels, pain during sexual intercourse, and pain in the back, legs, or pelvis.
Women who experience problems from uterine fibroids are currently treated with hormone therapy, myomectomy (removal of the fibroids while leaving the uterus intact), or by hysterectomy (removal of the uterus). ExAblate provides a uterine-sparing, noninvasive treatment.
The manufacturer, InSightec Ltd. of Haifa, Israel, studied the use of the ExAblate System to treat 109 women with uterine fibroids at seven medical centers around the world. The study compared the results with those of 82 women who had hysterectomies. When the ExAblate-treated women were followed up six months later, the study showed that the new device had successfully reduced fibroid-related problems in 71 percent. However, 21 percent of the women needed an alternative surgical treatment for fibroids within a year. This means that, while the ExAblate treatment may succeed in reducing the symptoms from the treated fibroids, symptoms may return at a later time in some women and require additional treatment, either with ExAblate or another method. Labeling for the device indicates that no more than two treatments should be performed in a two-week period.
The device is intended to treat women who have completed childbearing or do not intend to become pregnant. The procedure could alter the composition and strength of the uterine tissue, and the effects of the treatment on the ability to become pregnant and carry a fetus to term or on the development of the fetus have not been determined.
The FDA is requiring InSightec to conduct a three-year postmarket study to better assess the long-term safety and effectiveness of the ExAblate System. The study will include additional numbers of black women because, as a group, these women have a greater incidence of uterine fibroids, but were underrepresented in the original study.
Helping Americans quit smoking is the focus of a series of initiatives announced recently by Health and Human Services Secretary Tommy G. Thompson.
The initiatives include the opening of a national "quitline" number that puts callers in touch with programs that can help them give up tobacco. In addition, an HHS Web site offers online advice and downloadable information to make quitting easier.
"What starts as a single puff can become a death sentence for millions of Americans," says Thompson. "These initiatives will help Americans kick the habit and save their own lives." Cigarette smoking is the nation's leading preventable cause of death and disease, causing about 440,000 premature deaths each year.
The toll-free number, (800) QUIT-NOW (784-8669), is a single access point to the National Network of Tobacco Cessation Quitlines. Callers are automatically routed to a state-run quitline, if one exists in their area, or the National Cancer Institute (NCI) quitline.
Quitlines offer advice, support, and referrals to local cessation services. Scientific evidence shows that quitlines are effective tools to help smokers quit.
The Web site, www.smokefree.gov, includes the NCI's direct quitline number and an interactive map with toll-free state quitline numbers. The site also offers instant messaging text chat with an NCI specialist in tobacco cessation during specified hours of operation. Among the other information available is a step-by-step guide to managing the process of quitting.
The last of three FDA rules to make human cells and tissues intended for transplant even safer was finalized in November 2004. The rule on current good tissue practice (GTP) covers the methods, facilities, and controls used to manufacture products to prevent them from introducing, transmitting, and spreading communicable diseases. The broad range of products affected includes musculoskeletal tissue such as bone and tendons, corneas, human heart valves, lining of the brain (dura mater), and cellular therapies.
The first rule, which requires tissue facilities to register with the FDA and list all their products, became effective in January 2004. The second focuses on donor screening and testing measures to prevent the unwitting use of contaminated tissues that are potentially able to transmit infectious diseases. The rule on donor screening and testing and the GTP rule both will become effective on May 25, 2005.
"Together, these three rules will improve public health and, equally important, increase confidence in these new technologies that hold such great promise for medical practice," says Acting FDA Commissioner Dr. Lester M. Crawford. "In finalizing these rules, FDA considered comments from a broad range of groups, including those representing consumers, health professionals, and industry. The breadth and complexity of the products being regulated required nothing less than our most serious deliberation."
The new GTP rule includes a requirement for manufacturers to report certain adverse reactions and product deviations, to have labeling that contains accurate and complete information, and to allow FDA inspections to ensure compliance with regulations.
The FDA has announced safety-related changes to the labeling of Mifeprex (mifepristone), also known as RU-486, distributed by Danco Laboratories LLC of New York. The FDA and Danco have received reports of serious bacterial infection, including sepsis, severe bleeding, ectopic pregnancies, and death in women using mifepristone.
Sepsis is an overwhelming infection that has spread to the bloodstream. An ectopic pregnancy occurs when a fertilized egg develops outside of the uterus, usually in a fallopian tube, which can rupture and bleed if the pregnancy is not discovered early.
These reports led to the FDA's revision of the black box labeling on the product in November 2004. The new information reminds health care providers that serious bacterial infection and sepsis may occur without the usual signs of infection, such as fever and pelvic tenderness on examination. Health care providers should be aware that prolonged, heavy bleeding may warrant surgical interventions.
The label also warns that health care providers should be vigilant for patients with undiagnosed ectopic pregnancies, as this condition may be missed by physical examination and ultrasound. Some of the symptoms of an ectopic pregnancy may mimic the expected symptoms of a medical termination of pregnancy. Mifepristone is not effective for termination of ectopic pregnancies.
The medication guide for consumers states that they should contact their health care provider immediately if they have severe abdominal pain or fever of 100.4 F or higher for four hours. These may be signs of an infection or ectopic pregnancy. Patients who soak through two full-size sanitary pads per hour for two consecutive hours also should contact their health care provider, as surgery may be needed to stop the bleeding.
Mifeprex was approved in 2000 for the termination of early pregnancy, defined as 49 days or less.
Christopher Wayne Lamoreaux, 38, of Anaheim, Calif., was sentenced to 21 months in federal prison, followed by three years of supervised probation, for two counts of mail fraud for his role in a kickback scheme involving counterfeit and diverted prescription drugs. U.S. District Court Judge Howard F. Sachs also ordered Lamoreaux to pay $115,278.54 in restitution to NuCare Pharmaceuticals Inc., the firm that he defrauded. Lamoreaux was convicted of these charges in July 2004.
Todd P. Graves, United States Attorney for the Western District of Missouri, successfully prosecuted Lamoreaux following an investigation conducted by the FDA's Office of Criminal Investigations. Lamoreaux, the former president and CEO of NuCare, defrauded his employer by accepting secret kickbacks for negotiating a contract for the company to purchase counterfeit and diverted prescription drugs from a Missouri pharmaceutical firm and repack these drugs for further sale.
"The FDA's Office of Criminal Investigations and U.S. Attorney's office are to be commended for their work in exposing and pursuing those who deal in drug counterfeiting," says Acting FDA Commissioner Dr. Lester M. Crawford. "Those who attempt to peddle counterfeit drugs endanger lives and the integrity of our country's drug supply. This sentence sends the appropriate message to those who would consider such a dangerous and illegal activity."
NuCare, a licensed repackager of prescription drugs, also supplies drugs to urgent care facilities, indigent patient clinics, and occupational health clinics.
In late 2002, Lamoreaux negotiated a contract with Albers Medical Inc. of Kansas City, Mo., on behalf of NuCare. Graves said that under the agreement, NuCare purchased Lipitor and Bextra on consignment from Albers, repackaged the drugs at its facility, and then shipped the repacked drugs to Med-Pro, another repackaging company located in Lexington, Neb. NuCare paid Lamoreaux a commission of $1,692 for bringing in the business from Albers, unaware that Lamoreaux had received the more than $115,000 in kickbacks from Albers and others involved in the transactions. On March 11, 2003, Lamoreaux abruptly resigned from NuCare; shortly thereafter, the company learned of the fraud scheme from FDA investigators.
The drugs NuCare repackaged were ultimately distributed by Albers throughout the United States. Much of the Lipitor involved in the repackaging was later determined by the FDA to be counterfeit.
People should not use or purchase two products promoted and offered for sale on Web sites as "dietary supplements" for treating erectile dysfunction and enhancing sexual performance for men.
The FDA says that Actra-Rx and Yilishen both contain the active prescription drug ingredient sildenafil, which can be dangerous to people's health, and even life-threatening. Sildenafil is the active ingredient in Viagra, a Pfizer prescription drug product approved in the United States for the treatment of erectile dysfunction. Unlike new drugs, however, dietary supplements don't generally have to go through review by the FDA for safety and effectiveness or be "approved" before they can be marketed, which means that people might not know what's actually contained in these supplements.
A research letter published in the Journal of the American Medical Association described the results of a chemical analysis of Actra-Rx, which found that each capsule analyzed contained prescription-strength quantities of sildenafil. The FDA's own testing of Actra-Rx found that the product contained prescription-strength sildenafil.
An interaction between sildenafil and certain prescription drugs containing nitrates such as nitroglycerin, or those found in illicit substances such as amyl nitrate, may cause a significant and unsafe lowering of blood pressure. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
People taking either Actra-Rx or Yilishen should stop taking these products and consult their health care providers regarding legitimate erectile dysfunction treatments.
The FDA also issued an import alert instructing field personnel to stop the importation of Actra-Rx and Yilishen.
The FDA has licensed a new approach to treat people with relapsing forms of multiple sclerosis (MS) to reduce the frequency of symptom flare-ups or relapses. MS is a chronic, often disabling disease of the brain and spinal cord.
The product, Tysabri (natalizumab), is given intravenously once a month in a physician's office. Tysabri is the first monoclonal antibody approved to treat MS. Monoclonal antibodies are produced in manufacturing plants and act similarly to the antibodies in the immune system that fight infection. They are designed to be able to identify and bind to single, specific disease-related cells or other problem-causing proteins wherever they are in the body.
Although the cause of MS is unknown, it is widely considered to be an autoimmune disease in which the person's immune system attacks the brain or spinal cord. Tysabri appears to work by binding to the immune system cells, preventing them from traveling to the brain.
Tysabri received accelerated approval because it appears to provide substantial benefit for patients with a serious disease. As part of the approval, the manufacturer has committed to continuing its trials of this product for another year.
In a yearlong clinical trial, Tysabri reduced the frequency of MS relapses by 66 percent compared with an inactive substance (placebo). Common, non-serious adverse reactions included infections in the urinary tract, lower respiratory tract, GI system, and vaginal infections; as well as headache, depression, joint pains, and menstrual disorders. Serious adverse reactions were uncommon, but those reported most frequently were infections, including pneumonia; temporary hypersensitivity reactions such as rash, fever, low blood pressure, and chest pain; depression; and gallstones.
Tysabri is manufactured by Biogen Idec Inc. of Cambridge, Mass., and distributed by Elan Pharmaceuticals Inc. of San Diego.