U.S. Food and Drug Administration
FDA Consumer magazine
January-February 2002
Table
of Contents
The FDA has cleared for marketing a first-of-its-kind pacemaker capable of transmitting data on a patient's heart condition to the doctor between office visits.
The Biotronik Home Monitoring System combines a pacemaker already on the market, a short-range radio frequency transmitter, and a cell phone-like device carried by the patient in a pocket or handbag. The transmitter relays data from the patient's heart to the phone, which transmits it to the company's service center, where it is processed or tabulated and forwarded via fax to the physician. The device can be programmed by the physician to collect data as frequently as needed, from once a month to once a day.
The information, which can be transmitted from any location served by the manufacturer's digital cell phone provider, tells the physician how the electrical system of the heart is working and how much the pacemaker needs to work to help the heart function normally. The data is intended to supplement information gathered during the patient's regular office visits.
As with all pacemaker manufacturers, Biotronik Inc., of Lake Oswego, Ore., will be required to track the new pacemaker for the life of the product and file annual adverse event reports with the FDA.
The FDA has approved a new type of soft contact lenses, safe enough to wear continuously for up to 30 nights. Prior to its approval in October, contact lenses were approved only for up to seven days of extended wear.
Focus Night and Day lenses may be worn for up to a month without removal because they allow six times more oxygen to reach the eye than current lenses.
All extended-wear contact lenses carry a greater risk of serious eye infections than lenses that are removed before retiring for the day.
The new lenses should be replaced every month, as recommended by eye-care providers, and should never be worn longer than the recommended time. When removed in between replacement times, the lenses should be cleaned and disinfected before reinsertion, or disposed of. Once lenses are removed, eyes should have a rest without lens wear for at least one night. (For more information on contact lenses, see "Vision Correction: Taking a Look at What's New" in the September-October 2001 issue of FDA Consumer.)
Focus Night and Day lenses are made by CIBA Vision Corp., of Duluth, Ga.
The FDA has approved the first biologic treatment for the most serious forms of sepsis, a life-threatening illness caused by severe infection. The new treatment, called Xigris, is a genetically engineered version of a naturally occurring human protein, Activated Protein C. It interferes with some of the body's responses to severe infection, including the formation of blood clots that can lead to organ failure and death.
"Xigris is a new treatment that helps to save the lives of patients with the most severe forms of sepsis," says the FDA's Acting Principal Deputy Commissioner Bernard A. Schwetz, D.V.M., Ph.D. "While not everyone will benefit from this treatment, we believe the approval of Xigris is an important advance for the treatment of this often deadly disease."
Of about 750,000 people who get sepsis in the United States each year, an estimated 30 percent will die from it, despite treatment with intravenous antibiotics and supportive care. Patients with severe sepsis often experience failures of various systems in the body, including the circulatory system, as well as kidney failure, bleeding, and clotting.
Xigris was approved by the FDA for the treatment of adult patients with severe sepsis who have an especially high risk of dying from sepsis, as measured by a scoring system based on their general health and the severity of their illness.
In a placebo-controlled, multi-center, randomized clinical trial of nearly 1,700 patients, the overall mortality rate was reduced by 6 percent during the 28-day study period of the trial. Among patients at higher risk of dying, the group for whom Xigris is now indicated, mortality was reduced 13 percent. The treatment did not lower mortality rates of those in the study who were less severely ill.
Because Activated Protein C interferes with blood clotting, the most serious side effect associated with Xigris therapy is bleeding, including bleeding that causes stroke. Patients at high risk of bleeding were excluded from the trial, as were severely ill patients with pre-existing conditions not related to sepsis that made them likely to die within the study period.
Xigris should not be used for patients who have active internal bleeding, or who are more likely to bleed because of certain medical conditions including recent strokes, recent head or spinal surgery, or severe head trauma.
Because sepsis is a life-threatening condition and because treatment with Xigris comes with potentially serious risks, the benefits and risks of treatment with Xigris must be carefully weighed for each individual patient.
Eli Lilly and Co., Indianapolis, will market the treatment.
The FDA has approved Ortho Evra, the first skin patch for birth control. The prescription patch works by releasing hormones through the skin into the bloodstream to prevent pregnancy.
The square patch, just under two inches wide, consists of three layers. The hormones norelgestromin and ethinyl estradiol are embedded in the adhesive layer and are slowly released when the patch is applied to the skin.
Women using the product should apply it to the lower abdomen, buttocks or upper body, but not to the breasts. The patch is worn continuously for one week and then replaced with a new patch, for a total of three weeks of patch wear. During the fourth week, no patch is used, allowing the woman to have her menstrual period.
Like birth control pills, Ortho Evra is effective for pregnancy prevention when used as directed. The risks of using this product include an increased risk of blood clots, heart attack, and stroke. The product's warning label also notes that cigarette smoking increases the risk of serious cardiovascular side effects.
The FDA approved Ortho Evra following three worldwide clinical trials involving 4,578 women, of whom 3,319 used Ortho Evra. The other women in the trials used birth control pills. The trials demonstrated that that women were able to follow the weekly patch application and changing regimen. About 5 percent of the women had at least one patch that did not stay attached to their skin. About 2 percent withdrew from the trial due to skin irritation from the patch. The product appeared to be less effective in women weighing more than 198 pounds.
Ortho Evra was developed by R. W. Johnson Pharmaceutical Research Institute and is marketed by Ortho-McNeil Pharmaceutical Inc., Raritan, N.J. The product is sold in packages of three patches for the monthly cycle of use.
The FDA has notified Internet vendors of foreign-made ciprofloxacin that it is taking actions to halt potentially illicit sales of the antibiotic, which has been in increased demand since recent bioterrorist attacks in the United States. Ciprofloxacin is the generic name for Cipro.
The FDA is unable to determine whether these products were made in accordance with U.S. specifications, and their sale and distribution in the United States may be illegal. Foreign-manufactured ciprofloxacin has not been approved or evaluated by the FDA, and the manufacturing practices for production of these drugs have not been regulated by the agency.
The FDA encourages consumers to be aware that several risks exist with obtaining a prescription drug over the Internet. For example, the product could be contaminated and harmful, or it could be counterfeit and not contain the drug's active ingredient. There is also the risk that foreign drugs promoted on the Internet may not be approved for marketing in this country and may not be legally imported.
Ciprofloxacin is a powerful antibiotic that should only be taken after consultation with a health-care provider. The drug is associated with side effects--some of which may be serious--and may interact with other drugs. Ciprofloxacin should not be administered to treat anthrax unless exposure to the bacterium that causes anthrax (Bacillus anthracis) is suspected or confirmed. Its use in the absence of suspected or confirmed anthrax exposure could result in the development of antibiotic resistance, a serious public health risk.
For more information on ciprofloxacin, visit the FDA's Web site at www.fda.gov/cder/drug/infopage/cipro/. For more information on buying drugs over the Internet or to view the cyber letters, visit the FDA's Web sites at www.fda.gov/cder/drug/consumer/buyonline/guide.htm and www.fda.gov/cder/warn/cyber/cyber2001.htm.
For additional tips on buying products online from sellers who claim their products will protect you from biological threats, see the Federal Trade Commission's consumer alert at www.ftc.gov.
The FDA has established an office to help ensure that research studies involving humans are conducted according to good clinical practice.
Good clinical practice (GCP) is a standard for the total research process: designing studies, conducting and monitoring them, recording data, analyzing results, and reporting and submitting these results to support product applications to the FDA.
The FDA's newly established office for good clinical practice (OGCP) requires that FDA-regulated medical research conform to the GCP standard. Compliance with this standard assures that the data and reported results are credible and accurate and that the rights, safety, and well-being of people in studies are protected. "Poor quality data has an impact on the accuracy of product labels and advertising that will be used by the public--and may lead to inappropriate decision-making on product approvals," says David Lepay, M.D., Ph.D., director of the OGCP. "Our office is out to ensure FDA's broad public protection role of high-quality decision-making on product approvals and labeling. We also want to protect subjects participating in clinical research that is critical to FDA decision-making."
To help make sure that the GCP standard is followed, the FDA conducts more than 1,000 inspections of clinical trials each year.
The OGCP, established in October and located within the office of the FDA commissioner, works closely with the FDA centers, the FDA's office of regulatory affairs, and the Department of Health and Human Services' office for human research protections. The OGCP staff also works with international colleagues to implement GCP standards globally.
If you have a question about the FDA's good clinical practice regulations and policy, call 301-827-4000 or 301-827-3340.
The FDA has approved Viread (tenofovir disoproxil fumarate), a new antiviral drug for the treatment of HIV-1 infection in combination with other antiretroviral medicines.
The introduction of potent antiviral drugs and the combined used of these drugs, often called "cocktails," has markedly reduced replication of HIV in many infected people and has improved survival rates. But because HIV mutates rapidly, resistance to one or more of these potent drugs may develop over time, necessitating the development of new drugs to treat these resistant virus strains.
The FDA based its approval of Viread on two clinical studies involving more than 700 patients who had previously been treated with antiretroviral agents, but showed signs of continued HIV replication despite drug therapy.
There are no study results to show long-term inhibition of the clinical progression of HIV by Viread. In addition, the risk-benefit ratio for people who have never been treated with antiretrovirals is unknown since the studies only included people previously treated with the drugs.
Viread is available as a 300-milligram tablet to be taken orally, with a meal. Use of the drug should be considered for adult patients with HIV strains that are expected to respond to Viread as assessed by laboratory testing or treatment history.
The most frequently reported adverse events among patients in the clinical trials were mild to moderate gastrointestinal problems, including diarrhea, nausea, vomiting and gas. Severe liver enlargement and excess fat in the liver have also occurred among patients treated with drugs similar to Viread, alone or in combination with antiretrovirals. These are severe and potentially fatal conditions.
Viread is marketed by Gilead Sciences Inc. of Foster City, Calif.
Two drugs already on the market to treat breast cancer have been approved by the FDA to be used in combination for an even greater effect in treating advanced cases of the disease.
Xeloda (capecitabine), an oral cancer therapy, and Taxotere (docetaxel), an intravenous drug, can now be used together to treat advanced cancer that has progressed after being treated with an anthracycline-containing therapy, such as Adriamycin (doxorubicin). Doctors limit anthracycline-containing treatments to life-threatening situations.
The FDA approved the drug combination in September after a study of 511 cancer patients demonstrated improvements in overall response rates, lengths of time before the disease worsened, and survival rates.
Xeloda and Taxotere individually are associated with side effects such as gastrointestinal symptoms, nausea, vomiting, and painful inflammation of the mouth. People with breast cancer also should be aware of these side effects when taking the newly approved drug combination. If side effects occur, it may be necessary to reduce the dose, or to interrupt or discontinue treatment.
In addition, Xeloda has a significant drug interaction with oral coumarin-derivative anticoagulant therapy, which can cause serious bleeding complications. The FDA urges people receiving Xeloda and a coumarin-derivative, such as Coumadin, to have their anticoagulant response monitored frequently. The agency also says that dosages of the drugs may have to be modified for people who have impaired kidney function.
Xeloda is manufactured by Roche Laboratories Inc., Nutley, N.J. Taxotere is marketed by Aventis Pharmaceuticals Inc., Bridgewater, N.J.
The first male infertility home test kit available without a prescription has been cleared for marketing by the FDA. The test indicates when sperm cell counts fall below a certain level--a potential indicator for male infertility.
The FertilMARQ Home Diagnostic Screening Test for Male Infertility stains cells in the sperm sample to produce a color. The color is then compared to a reference (chart/guide) on the test kit. The color comparison tells the user whether the sperm cells in the sample are positive--above 20 million per milliliter (/mL) or negative--below 20 million/mL. However, because this is a screening test, a positive test is no guarantee of infertility, meaning that other factors may be involved. Users should confirm test results with their physicians.
Embryotech Laboratories Inc., of Wilmington, Mass., makes the FertilMARQ test kit, which was cleared for marketing in August.
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2001-DEC-19.