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FDA
FDA Consumer
magazine
September-October Issue
Topics in This Issue:
A new, lower-cost heart device implanted into the chest of people at risk of dying from sudden cardiac arrest has been approved by the FDA. The Cardiac Airbag implantable cardioverter defibrillator (ICD) system from Biotronik of Lake Oswego, Ore., monitors the heart's function and automatically delivers an electrical shock when needed to restore normal heart rhythms.
The Biotronik defibrillator has fewer features than other ICDs on the market. It is priced at $10,000--about half the price of standard ICDs--and is easier to program and use than standard models. The device provides high-energy shock therapy, but does not use lower-energy pacing therapies, which are sometimes used to bring the heart back into normal rhythm. The FDA approved the Cardiac Airbag ICD in May, about two months after the firm submitted its marketing application. The agency is requiring that Biotronik conduct a two-year post-approval study of the 370 people in whom the device is implanted.
Health and Human Services Secretary Tommy G. Thompson has ordered a halt to the importation of all rodents from Africa due to their potential to spread monkeypox to other animals and humans. Monkeypox is a rare viral disease found mainly in central and western Africa. June 2003 marked the first monkeypox outbreak in the United States, according to the Centers for Disease Control and Prevention (CDC). Most of the people got sick after having contact with pet prairie dogs that had monkeypox.
In addition to the ban, announced June 11, 2003, Thompson also stopped the distribution, sale, and transport within the United States of prairie dogs and six specific African rodent species implicated in the monkeypox outbreak: tree squirrels, rope squirrels, dormice, Gambian giant pouched rats, brush-tailed porcupines, and striped mice.
The ban does not apply to people who transport the listed animals to veterinarians, animal control officials, or other entities recommended by federal, state, or local government authorities.
HHS also is advising that people who acquired an animal named in the ban since April 15 should carefully monitor their health and the health of the animal. People showing symptoms such as a rash with a fever, cough, or aches should immediately contact a physician. If an animal becomes ill, immediately contact a veterinarian, contain the animal in an appropriate carrier, and transport it to the veterinarian without other people or pets in the vehicle. Under no circumstances should such animals be intentionally released into the wild.
More information on monkeypox is available from the CDC.
AstraZeneca Pharmaceuticals LP of Wilmington, Del., has agreed to pay a $355 million fine to resolve criminal charges and civil liabilities stemming from an illegal marketing and pricing scheme involving a drug to treat prostate cancer. The massive conspiracy involving the drug Zoladex (goserelin acetate) caused multimillion-dollar losses for federally and state-funded insurance programs and patients.
The FDA's Office of Criminal Investigations (OCI) discovered that AstraZeneca employees were using illegal methods to stimulate the demand for Zoladex by enabling physicians to reap illicit profits.
In one of these schemes, AstraZeneca provided thousands of free samples to physicians, knowing they would charge their patients and insurance programs for them. Another illegal inducement used by the firm involved inflating the price of Zoladex reported to Medicare as the basis for reimbursement, while deeply discounting the actual price charged to physicians. AstraZeneca also misreported and underpaid the Medicaid rebates it owed to the states for the use of Zoladex.
"FDA will not tolerate criminal conduct that exploits patients, plunders the national treasury, and adds to the cost of health care," says FDA Commissioner Mark B. McClellan, M.D., Ph.D. The FDA's OCI was joined by representatives of the U.S. Attorney's Office for the District of Delaware, the Department of Health and Human Services, and the Defense Criminal Investigative Service in announcing the guilty plea in June. The Federal Bureau of Investigation was also involved with the case.
The investigation resulted in charges against three physicians of conspiring with AstraZeneca to bill patients and third-party payers for free Zoladex samples.
After reviewing reports of a possible increased risk of suicidal thinking in children being treated with the antidepressant Paxil (paroxetine), the FDA is recommending that Paxil not be used in children and adolescents for the treatment of major depressive disorder (MDD). Currently, there is no evidence that Paxil is effective in children or adolescents with MDD, and the antidepressant is not approved for such use.
Paxil is approved for use in adults for the treatment of obsessive-compulsive disorder, MDD, panic disorder, social anxiety disorder, generalized anxiety disorder, and post-traumatic stress disorder. There is no evidence that Paxil is associated with an increased risk of suicidal thinking in adults.
Despite the new possible safety concerns about children and Paxil, the FDA advises that caretakers of children already receiving treatment with Paxil for MDD talk to their doctors before stopping use of the drug. Patients should not discontinue using Paxil without first consulting their physicians, and it is important that Paxil not be abruptly discontinued.
More information about these concerns is available on this Web site.
The Federal Trade Commission (FTC) has charged two dietary supplement marketers and their companies with making false and unsubstantiated health and medical claims. This enforcement action is part of a series of initiatives by the FDA and the FTC to cut down on deceptive marketing.
Kevin Trudeau and Robert Barefoot, the marketers of Coral Calcium Supreme Dietary Supplement, violated the FTC Act by claiming, falsely and without substantiation, that the supplement can treat or cure cancer and other diseases, investigators say. In a separate action, the FTC charged Trudeau with violating a previous court order by claiming that a pain-relief product called Biotape provides significant or permanent relief from severe pain.
The FDA and the FTC are sending strong warning letters to Web site operators who are marketing coral calcium products and claiming it is an effective treatment or cure, notifying them that they will take legal action against violators. Neither agency is aware of any reliable scientific evidence supporting the marketers' claims.
A protease inhibitor formulated to be taken once a day has been approved by the FDA. Reyataz (atazanavir sulfate) is to be used in combination with other anti-retroviral agents for the treatment of patients with HIV infection. As with other anti-retroviral agents, Reyataz does not cure and does not prevent transmission of HIV infection or AIDS.
Protease inhibitors work at the final stages of viral replication and attempt to prevent HIV from making new copies of itself by interfering with the HIV protease enzyme. Currently there are six other protease inhibitors approved by the FDA for the treatment of HIV infection.
Reyataz is manufactured by Bristol-Myers Squibb Co. of Princeton, N.J.
People with allergy-related asthma now have a bioengineered treatment option.
Asthma caused by allergies results from the immune system's over-reaction to inhaled allergens such as dust mites or animal dander. The body forms antibodies in response to the allergen, and this immune system reaction prompts inflammation that causes airway narrowing and other symptoms. Xolair (omalizumab) is a genetically engineered protein that blocks this immune response. The treatment, given as an injection under the skin, gained FDA approval in June.
Only people who have asthma caused by allergies can benefit from this treatment. The product's labeling indicates that this type of asthma should be established by skin or blood test before treatment. Xolair has been shown to be safe and effective in people ages 12 and older who have moderate to severe allergy-related asthma that hasn't been adequately controlled with inhaled steroid treatments. Xolair is a second-line treatment, recommended only after the first-line treatments have failed. The drug has been shown to decrease the number of episodes of airway narrowing that result in wheezing, breathlessness, and coughing.
In clinical trials of more than 1,000 adolescents and adults, about 85 percent of patients had no exacerbation of their symptoms, compared with about 75 percent of patients treated with a placebo. More patients treated with Xolair developed a new or recurrent cancer (0.5 percent) compared to control patients (0.2 percent). Long-term studies will investigate whether there is a relationship between Xolair treatment and cancer. The other major safety concern identified in clinical trials was severe allergic reaction (anaphylaxis).
Xolair is manufactured by Genentech Inc. of South San Francisco, Calif. Genentech will jointly market the product with Novartis Pharmaceuticals Corp. of East Hanover, N.J.
A new device for diabetes that combines a glucose meter and an insulin pump with a dose calculator could be the first step in the development of a fully automated glucose monitoring and insulin delivery system. The device, which is made by Medtronic MiniMed Inc. of Northridge, Calif., and Becton, Dickinson, and Co. (BD) of Franklin Lakes, N.J., was cleared by the FDA in July.
The product combines the Medtronic MiniMed Paradigm insulin pump with a BD glucose monitor. It has circuitry and software modifications that allow it to transmit glucose values to the insulin pump and to transfer data between the insulin pump and a personal computer running the appropriate Medtronic MiniMed communications software.
Because the glucose meter calculates and transmits information to the insulin pump automatically, it prevents the errors that sometimes can result when people input this data manually. Use of the integrated system is expected to make it more convenient for people to manage their diabetes.
Barr Laboratories voluntarily has recalled three lots of its Nortrel 7/7/7-28 day oral contraceptive (norethindrone and ethinyl estradiol tablets, USP) due to packaging errors that could lead to increased pregnancy risk. The recall involves lot numbers 290122001, 290122002, and 290122003, distributed between January and April 2003. Nortrel is a generic form of Ortho-Novum 7/7/7.
Nortrel 7/7/7-28 is packaged in a blister card containing four horizontal rows of seven tablets each. Colored tablets, which contain the active hormonal ingredients, should be in the first three rows. The fourth (bottom) row should contain the white tablets--placebos that contain no active ingredient. Barr Laboratories reported that out of about 470,000 packages that are subject to the recall, it has received two reports in which tablets in the blister pack are reversed, causing the white placebo to be in the first row (for the first week) labeled "start" rather than in the last row labeled "Week 4." Also, the lot number and expiration date were not visible on the back of these two blister cards.
Any woman who has taken pills from a blister card with tablets in the wrong color sequence could be at increased risk of pregnancy, and changes to the menstrual cycle may occur. These could include delayed bleeding, irregular bleeding, or spotting.
For more information, call the Barr Laboratories Inc. drug information line at (800) 222-0190. Report any adverse reactions experienced with the use of this product to the FDA's MedWatch program by phone at (800) FDA-1088, by fax at (800) FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site.
The FDA has announced a major new initiative to more aggressively protect consumers from counterfeit drugs. An internal task force will be created to explore the use of technologies, stronger enforcement, and other measures that will make counterfeiting more difficult. The FDA also plans to coordinate more closely with other federal agencies, state and local governments, and members of Congress.
Commissioner of Food and Drugs Mark B. McClellan, M.D., Ph.D., says, "At the forefront of this effort will be the special agents of our Office of Criminal Investigations. Their record and dedication are impressive. Working together, I am confident we will defeat the criminal element engaged in counterfeit drug activity."
Although drug counterfeiting in the United States is relatively rare, the agency has recently seen an increase in counterfeiting activities. The FDA's counterfeit drug investigations have increased to more than 20 per year since 2000, after averaging only about 5 per year through the late 1990s.
The FDA believes the increase has occurred for a number of reasons, including more sophisticated counterfeiting technology, better organized criminal groups, the online sale of prescription drugs by unlicensed pharmacies and foreign Web sites, and weak spots in the domestic wholesale distribution chain.
Consumers can protect themselves from counterfeit drugs by purchasing medications from licensed domestic pharmacies, and by contacting their pharmacist or doctor if they notice anything unusual about their medication such as with packaging, taste, or unfamiliar side effects.
A new blood test will help doctors predict the risk of coronary heart disease (CHD), the No. 1 killer of men and women in the United States.
The FDA has cleared PLAC, a lab test that measures an enzyme called lipoprotein-associated phospholipase A2. This enzyme is made by a type of white blood cell called a macrophage. Macrophages make more of this enzyme and release it into the blood when a person has CHD.
The FDA cleared the test based on results of a study of more than 1,348 people. They were free of CHD at the start of the study and were followed for the development of disease for nine years. The greatest increased risk was found in subjects with the highest PLAC test results and LDL cholesterol levels lower than 130 mg/dL. The study was part of a large multi-center study sponsored by the National Heart, Lung, and Blood Institute.
The PLAC test is not a stand-alone test for predicting CHD. An elevated PLAC test result with an LDL cholesterol level of less than 130 mg/dL gives doctors increased confidence that patients have two to three times the risk of having CHD, compared with patients having lower PLAC test results. CHD, the most common form of heart disease, is caused by a narrowing of the coronary arteries that feed the heart. Each year, more than 500,000 Americans die of heart attacks caused by CHD.
The PLAC test is manufactured by diaDexus Inc. of San Francisco.
A new medication guide provides better information to consumers about the risks and benefits of Lariam (mefloquine hydrochloride), a drug that helps to prevent malaria.
Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, says, "Lariam can work in certain areas where malaria is resistant to other drugs, and it offers several other advantages, including its once weekly dosing, the ability to use it in children, and the fact that it does not sensitize people to sunlight."
But in rare instances, Lariam has been associated with serious psychiatric problems. The Lariam medication guide instructs people who experience a sudden onset of certain adverse events--anxiety, depression, restlessness, or confusion--to contact a doctor or other health care provider because it may be necessary to stop taking Lariam and use another malaria prevention medicine. Sometimes these adverse events may persist even after stopping the medication. Rare reports have claimed that some Lariam users think about killing themselves. There have been rarer reports of suicides, but the FDA does not know if Lariam use was related to these suicides.
The medication guide highlights the risks of malaria and provides information on how to recognize psychiatric risks. It also gives other important facts, including how the drug should be taken and a list of the most common side effects, such as bad dreams, difficulty sleeping, nausea, and vomiting.
The FDA and Lariam's manufacturer, Roche Pharmaceuticals of Nutley, N.J., developed the medication guide, which should be given with each Lariam prescription filled.
A second oral medication to treat impotence in men (erectile dysfunction) has been approved by the FDA. The drug, Levitra (vardenafil) acts by relaxing blood vessels and muscles in the penis, allowing increased blood flow into the penis to produce an erection.
Erectile dysfunction affects millions of men in the United States.
Levitra was evaluated in randomized, placebo-controlled trials involving more than 2,000 men with erectile dysfunction. In two of the trials, men had erectile dysfunction associated with diabetes mellitus or following radical prostatectomy for prostate cancer.
The drug's effectiveness was assessed using a sexual function questionnaire. In addition, patients were asked to report if they were able to achieve an erection adequate for intercourse and whether the erection was maintained to allow completion of intercourse. In all of the trials, Levitra improved patients' ability to achieve and maintain a penile erection.
The recommended dose is 10 milligrams taken 1 hour before sexual activity. A higher dose of 20 milligrams is available for patients whose response to the 10-milligram dose is not adequate. Two lower doses (2.5 mg and 5 mg) are also available and may be necessary for patients who are taking other medicines or have medical conditions that may decrease the body's ability to metabolize vardenafil. Levitra should not be used more than once a day.
Levitra should not be used with nitrates (such as nitroglycerin tablets or patches) or with alpha-blockers (medicines used to treat benign prostatic hyperplasia and/or high blood pressure such as tamsulosin, terazosin, doxazosin, and alfuzosin) because the combination may significantly lower blood pressure and lead to fainting in some men. Currently there is no information available to support the safety of even the lower doses of Levitra taken together with alpha-blockers. In addition, Levitra should not be used in patients who have a rare heart condition known as "prolongation of the QT interval" because of the possibility of producing abnormal heart rhythm.
Because some drugs may affect the metabolism of Levitra, patients should inform their doctors that they are taking Levitra and they should not begin taking new medicines without informing their doctor. For example, patients taking erythromycin should not take more than a 5-milligram dose of Levitra. The maximum recommended dose for patients who are taking ritonavir is 2.5 milligrams of Levitra once every 72 hours.
Levitra should not be taken by men in whom sexual activity is inadvisable because of their underlying cardiovascular status (heart condition). Patients should inform their doctor about any heart problems they have experienced before taking Levitra.
Levitra is not recommended in patients who have suffered a heart attack or stroke within the last six months, or patients who have significantly low blood pressure, uncontrolled high blood pressure, unstable angina, severe liver impairment, end-stage renal disease requiring dialysis, or retinitis pigmentosa (an eye disorder).
The most common side effects reported in clinical trials included headache, flushing, rhinitis, and indigestion. Dizziness was reported in about 2 percent of patients. A small number of patients taking Levitra also reported abnormal vision.
Levitra is manufactured by Bayer Corporation in Germany and will be distributed by GlaxoSmithKline of Research Triangle Park, N.C. The drug is currently available in Europe.
The chart on page 32 of the July-August issue contained erroneous information concerning when problems with medical devices need to be reported. Here is the corrected version.
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Within 5 days |
Within 10 days |
Within 30 days |
Annually |
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|---|---|---|---|---|
|
User Facility |
|
Deaths (also report to Manufacturer) Serious injuries (report to manufacturer or FDA if manufacturer unknown) |
Summary of reported deaths and serious injuries to FDA (January 1) |
|
|
Importer |
Deaths and serious injuries to FDA and manufacturer Malfunctions (report to manufacturer or FDA if manufacturer unknown) |
|||
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Manufacturer |
5-day report on events requiring immediate remedial action and other designated events |
30-day report of deaths, serious injuries and malfunctions Baseline report to provide specific data on each reported device |
Certification of compliance with regulation |
Source: FDA Center for Devices and Radiological Health