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食品和药物管理局FDA(Food and Drug Administration)

     FDA 是美国政府在健康与人类服务部 (DHHS) 和公共卫生部 (PHS) 中设立的执行机构之一。
　 作为一家科学管理机构，FDA 的职责是确保美国本国生产或进口的食品、化妆品、药物、生物制剂、医疗设备和放射产品的安全。它是最早以保护消费者为主要职能的联邦机构之一。该机构与每一位美国公民的生活都息息相关。在国际上，FDA 被公认为是世界上最大的食品与药物管理机构之一。其它许多国家都通过寻求和接收 FDA 的帮助来促进并监控其本国产品的安全。
　 食品和药物管理局（FDA）主管：食品、药品（包括兽药）、医疗器械、食品添加剂、化妆品、动物食品及药品、酒精含量低于7％的葡萄酒饮料以及电子产品的监督检验；产品在使用或消费过程中产生的离子、非离子辐射影响人类健康和安全项目的测试、检验和出证。根据规定，上述产品必须经过FDA检验证明安全后，方可在市场上销售。FDA有权对生产厂家进行视察、有权对违法者提出起诉。

在热心会员shaobei的支持下，特开此转贴，报道最新FDA相关新闻，欢迎关注！

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FDA Advises Consumers to Avoid Toothpaste From China Containing Harmful Chemical

FDA Detains One Contaminated Shipment, Issues Import Alert
The U.S. Food and Drug Administration (FDA) today warned consumers to avoid using tubes of toothpaste labeled as made in China, and issued an import alert to prevent toothpaste containing the poisonous chemical diethylene glycol (DEG) from entering the United States.

DEG is used in antifreeze and as a solvent.

Consumers should examine toothpaste products for labeling that says the product is made in China. Out of an abundance of caution, FDA suggests that consumers throw away toothpaste with that labeling. FDA is concerned that these products may contain "diethylene glycol," also known as "diglycol" or "diglycol stearate."

FDA is not aware of any U.S. reports of poisonings from toothpaste containing DEG. However, the agency is concerned about potential risks from chronic exposure to DEG and exposure to DEG in certain populations, such as children and individuals with kidney or liver disease. DEG in toothpaste has a low but meaningful risk of toxicity and injury to these populations. Toothpaste is not intended to be swallowed, but FDA is concerned about unintentional swallowing or ingestion of toothpaste containing DEG.

FDA has identified the following brands of toothpaste from China that contain DEG and are included in the import alert: Cooldent Fluoride; Cooldent Spearmint; Cooldent ICE; Dr. Cool, Everfresh Toothpaste; Superdent Toothpaste; Clean Rite Toothpaste; Oralmax Extreme; Oral Bright Fresh Spearmint Flavor; Bright Max Peppermint Flavor; ShiR Fresh Mint Fluoride Paste; DentaPro; DentaKleen; and DentaKleen Junior. Manufacturers of these products are: Goldcredit International Enterprises Limited; Goldcredit International Trading Company Limited; and Suzhou City Jinmao Daily Chemicals Company Limited. The products typically are sold at low-cost, “bargain” retail outlets.

Based on reports of contaminated toothpaste from China found in several countries, including Panama, FDA increased its scrutiny and began sampling toothpaste and other dental products manufactured in China that were imported into the United States.

FDA inspectors identified and detained one shipment of toothpaste at the U.S. border, containing about 3 percent DEG by weight. In addition, FDA inspectors found and tested toothpaste products from China located at a distribution center and a retail store. The highest level found was between 3-4 percent by weight. The product at the retail store was not labeled as containing DEG but was found to contain the substance.

DEG poisoning is an important public safety issue. The agency is aware of reports of patient deaths and injuries in other countries over the past several years from ingesting DEG-contaminated pharmaceutical preparations, such as cough syrups and acetaminophen syrup. FDA recently issued a guidance document to urge U.S. pharmaceutical manufacturers to be vigilant in assuring that glycerin, a sweetener commonly used worldwide in liquid over-the-counter and prescription drug products, is not contaminated with DEG.

FDA continues to investigate this problem. If FDA identifies other brands of toothpaste products containing DEG, FDA will take appropriate actions, including adding products and their manufacturers to the import alert to prevent them from entering the United States.

[ 本帖最后由 sally208 于 2007-9-22 13:51 编辑 ]

FDA Approves First Drug for Treating Fibromyalgia
The U.S. Food and Drug Administration today approved Lyrica (pregabalin), the first drug to treat fibromyalgia, a disorder characterized by pain, fatigue and sleep problems.

Lyrica reduces pain and improves daily functions for some patients with fibromyalgia.

"Today's new approval marks an important advance, and provides a reason for optimism for the many patients who will receive pain relief with Lyrica," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "However, consumers should understand that some patients did not experience benefit in clinical trials. We still have more progress to make for treatment of this disorder."

Persons with fibromyalgia typically experience long-lasting or chronic pain, as well as muscle stiffness and tenderness. Fibromyalgia affects about 3 million to 6 million people in the United States each year. The disorder mostly affects women and typically develops in early-to-middle adulthood.

There is no test for the diagnosis of fibromyalgia. Doctors make a diagnosis by conducting physical examinations, evaluating symptoms, and ruling out other conditions.

Individuals with fibromyalgia have been shown to experience pain differently from other people. Studies have shown that such patients have decreased pain after taking Lyrica, but, the mechanism by which Lyrica produces such an effect is unknown.

Two double-blind, controlled clinical trials, involving about 1,800 patients, support approval for use in treating fibromyalgia with doses of 300 milligrams or 450 milligrams per day.

The most common side effects of Lyrica include mild-to-moderate dizziness and sleepiness. Blurred vision, weight gain, dry mouth, and swelling of the hands and feet also were reported in clinical trials. The side effects appeared to be dose-related. Lyrica can impair motor function and cause problems with concentration and attention. FDA advises that patients talk to their doctor or other health care professional about whether use of Lyrica may impair their ability to drive.

Lyrica already is approved for treating partial seizures, pain following the rash of shingles and pain associated with diabetes nerve damage (diabetic neuropathy).

Lyrica is manufactured by New York-based Pfizer Inc. Pfizer has agreed to perform a study of the drug in children with fibromyalgia and a study in breastfeeding women.

http://www.fda.gov/consumer/updates/fibromyalgia062107.html

[ 本帖最后由 shaobei 于 2007-6-22 14:13 编辑 ]

FDA Approves New Orphan Drug for Treatment of Pulmonary Arterial Hypertension
The U.S. Food and Drug Administration (FDA) today approved Letairis (ambrisentan) for the treatment of pulmonary arterial hypertension, a rare, life-threatening condition characterized by continuous high blood pressure within the arteries of the lungs.

"Letairis represents a valuable addition to the treatment alternatives for this orphan disease," said John Jenkins, M.D., director of FDA's Office of New Drugs. "Letairis is similar to an existing drug, but offers the potential for fewer drug interactions."

In pulmonary arterial hypertension, the small arteries in the lungs become narrowed or blocked, and the heart must work harder to pump the blood through them. Over time, the overworked heart muscle may become weak and lose its ability to pump enough blood through the lungs. Symptoms include shortness of breath, fatigue, chest pain, dizzy spells and fainting. About 100,000 people in the United States have pulmonary arterial hypertension.

Letairis, a new drug not previously approved in the United States, was granted a priority review by FDA. A priority review designation is intended for those products that address unmet medical needs. For priority drug applications, FDA sets a target date of six months after the date of receipt for the agency to complete all aspects of a review and to take action.

The safety and effectiveness of Letairis were demonstrated in two international clinical trials involving 393 patients. Letairis significantly improved physical activity capacity compared with a placebo, as shown by a six-minute walk, a standard test. Letairis also delayed the worsening of the pulmonary hypertension.

The most common side effects in patients using Letairis included swelling of legs and ankles, nasal congestion, sinusitis, and getting red in the face (flushing).

Letairis should not be used by women who are pregnant or may become pregnant because the drug may cause birth defects. Patients taking Letairis must have monthly blood tests to check for potential liver injury.

Letairis will be available in five-milligram and 10-milligram once-daily tablets.

Letairis was granted orphan drug status by FDA because it treats a rare disease and meets other criteria. Orphan designation qualifies the drug's sponsor for a tax credit and marketing incentives.

Letairis is manufactured by Gilead Sciences, Inc., Foster City, Calif. Gilead acquired the U.S. rights to ambrisentan when it acquired Myogen, Inc. in 2006. GlaxoSmithKline holds rights to ambrisentan outside of the United States.

The Orphan Drug Act
www.fda.gov/orphan/

National Heart Lung and Blood Institute – What is Pulmonary Arterial Hypertension?
www.nhlbi.nih.gov/health/dci/Diseases/pah/pah_what.html

[ 本帖最后由 shaobei 于 2007-6-22 14:15 编辑 ]

FDA Detains Imports of Farm-Raised Chinese Seafood
Products Have Repeatedly Contained Potentially Harmful Residues
The Food and Drug Administration (FDA) today announced a broader import control of all farm-raised catfish, basa, shrimp, dace (related to carp), and eel from China. FDA will start to detain these products at the border until the shipments are proven to be free of residues from drugs that are not approved in the United States for use in farm-raised aquatic animals.

This action by FDA, a part of the U.S. Department of Health and Human Services, will protect American consumers from unsafe residues that have been detected in these products. There have been no reports of illnesses to date.

"We're taking this strong step because of current and continuing evidence that certain Chinese aquaculture products imported into the United States contain illegal substances that are not permitted in seafood sold in the United States," said Dr. David Acheson, FDA's assistant commissioner for food protection. "We will accept entries of these products from Chinese firms that demonstrate compliance with our requirements and safety standards."

During targeted sampling from October 2006 through May 2007, FDA repeatedly found that farm-raised seafood imported from China were contaminated with antimicrobial agents that are not approved for this use in the United States.

The contaminants were the antimicrobials nitrofuran, malachite green, gentian violet, and fluoroquinolone. Nitrofuran, malachite green, and gentian violet have been shown to be carcinogenic with long-term exposure in lab animals. The use of fluoroquinolones in food animals may increase antibiotic resistance to this critically important class of antibiotics.

None of these substances is approved for use in farm-raised seafood in the United States, and the use of nitrofurans and malachite green in aquaculture is also prohibited by Chinese authorities. Chinese officials have acknowledged that fluoroquinolones are used in Chinese aquaculture and are permitted for use in China.

The levels of the drug residues that have been found in seafood are very low, most often at or near the minimum level of detection. FDA is not seeking recall of products already in U.S. commerce and is not advising consumers to destroy or return imported farm-raised seafood they may already have in their homes FDA is concerned about long term exposure as well as the possible development of antibiotic resistance.

The FDA action includes conditions under which an exporter can be exempted from FDA's detention action by providing specified information to the agency This information must demonstrate the exporter has implemented steps to ensure its products do not contain these substances and that preventive controls are in place. The additional import controls placed on seafood from China will last as long as needed.

FDA may allow the entry into the United States and subsequent distribution into the marketplace of individual shipments of the Chinese farm-raised seafood products if the company provides documentation to confirm the products are free of residues of these drugs.

FDA Warns Consumers Not to Eat Veggie Booty Snack Food
Risk of Salmonella Contamination
The U.S. Food and Drug Administration is warning consumers not to eat Veggie Booty snack food, marketed by Robert's American Gourmet, due to possible contamination with Salmonella Wandsworth, bacteria that cause gastrointestinal illness.

FDA advises consumers to throw away any Robert's American Gourmet brand Veggie Booty they have in their home. Veggie Booty is sold in a flexible plastic foil bag in four ounce, one ounce, and one-half ounce packages.

Veggie Booty is often consumed by children, so parents are encouraged to watch their children, and seek medical care if they observe signs of illness.

Individuals who have recently eaten Veggie Booty and who have experienced any of the symptoms described below should contact a doctor or other health care provider immediately. Any such illnesses in persons with a recent history of eating Veggie Booty should be reported to state or local health authorities.

This warning is based on 52 reports of illness across 17 states, beginning in March 2007. Almost all the illnesses have occurred in children under 10 years old, with the most cases in toddlers. Most persons had reported bloody diarrhea; four were hospitalized. FDA learned of the illnesses on June 27 from the Centers for Disease Control and Prevention, which conducted an investigation of the illnesses with state and local health officials. The outbreak is considered likely to be ongoing.

Salmonella typically causes diarrhea (may be bloody); the diarrhea is often accompanied by abdominal cramps and fever. Symptoms typically begin within one to four days after exposure to the bacteria. In infants, persons with poor underlying health and those with weakened immune systems, Salmonella can invade the bloodstream and cause life-threatening infections.

States reporting illnesses include: California (seven cases), Colorado (five cases), Connecticut (one case), Georgia (one case), Indiana (one case), Massachusetts (three cases), Minnesota (two cases), New Hampshire (two cases), New Jersey (two cases), New York (13 cases), Oregon (one case), Pennsylvania (three cases), Tennessee (one), Texas (one), Vermont (three cases), Washington (four cases), and Wisconsin (two cases).

Robert's American Gourmet, of Sea Cliff, N.Y., which markets Veggie Booty, and its contract manufacturer, are fully cooperating with FDA's investigation into the cause of the contamination. Manufacturing and distribution of this product has ceased, and Robert's American Gourmet is recalling all potentially contaminated product, including all expiration dates and lot codes. The product is sold in all 50 states and Canada at retail locations and over the Internet.

FDA will provide updates as the investigation progresses and more information becomes available.

FDA Approves First Generic Versions of Lamisil Tablets
Agency also approves over-the-counter terbinafine cream to treat athlete’s foot
The U.S. Food and Drug Administration today approved the first generic versions of prescription Lamisil (terbinafine hydrochloride) tablets, used to treat nail fungus infection (onychomycosis). Such infections occur when fungi invade a fingernail or toenail or the skin underneath the nail.

"This approval offers Americans additional alternatives when choosing medications to treat nail fungus infections," said Gary J. Buehler, R.Ph., director of FDA's Office of Generic Drugs.

FDA approved applications from multiple generic drug manufacturers for terbinafine hydrochloride tablets in 250-milligram formulations. Manufacturers include: Amneal Pharmaceuticals, Apotex Corp., Aurobindo Pharma USA Inc., Dr. Reddy's Laboratories Ltd., Gedeon Richter USA Inc., Genpharm Inc., Glenmark Pharmaceuticals Inc., InvaGen Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Orgenus Pharma Inc., Roxane Laboratories Inc., TEVA Pharmaceuticals USA, Watson Laboratories Inc., Wockhardt USA Inc.

The remaining patent or exclusivity for Lamisil expired on June 30, 2007.

According to the online trade magazine, Drug Topics, Lamisil tablets are the 57th highest selling brand-name prescription drug by retail dollars in the United States.

In addition to terbinafine tablets, FDA also approved an application for a generic version of over-the-counter Lamisil cream (terbinafine hydrochloride,1 percent) to treat athlete's foot, a skin disease caused by a fungus that usually occurs between the toes. The cream is manufactured by Taro Pharmaceuticals U.S.A. Inc.

The FDA's Office of Generic Drugs ensures that generic drugs are safe and effective through a thorough scientific and regulatory process.

For more information:
Office of Generic Drugs
www.fda.gov/cder/consumerinfo/generic_equivalence.htm.

Generic Drugs: What You Need to Know
www.fda.gov/fdac/features/2002/502_generic.html.

FDA monthly reports for first-time generics
www.fda.gov/cder/ogd/approvals/

FDA Approves First Molecular-Based Lab Test to Detect Metastatic Breast Cancer
The U.S. Food and Drug Administration today approved the first molecular-based laboratory test for detecting whether breast cancer has spread (metastasized) to nearby lymph nodes. The GeneSearch BLN Assay detects molecules that are abundant in breast tissue but scarce in a normal lymph node.

The presence or absence of breast cancer cells in underarm lymph nodes is a powerful predictor of whether the cancer has spread and is used to help decide appropriate therapy for a woman with metastatic breast cancer.

Lymph nodes are part of the system that helps protect the body against infection. The first lymph node that filters fluid from the breast is called the "sentinel node," because that is where breast cancer cells are likely to spread first.

During a lumpectomy or mastectomy to remove a breast tumor, surgeons commonly remove the sentinel node for examination under a microscope. Sometimes the sentinel node is examined immediately and if tumor cells are found, additional lymph nodes are removed. A more extensive microscopic examination, requiring one to two days for results, is almost always performed. If tumor cells are only found with the later microscopic examination, the patient may require a second surgery to remove the remaining lymph nodes.

"The GeneSearch BLN Assay offers a new approach to sentinel node testing," said Daniel Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health. "Results of this rapid test are available while patients are on the operating table, providing a way for some women to avoid a second operation."

In a clinical trial, the GeneSearch BLN Assay showed strong agreement with results from extensive microscopic examination of the lymph nodes of 416 patients. The test accurately predicted that breast cancer had spread nearly 88 percent of the time in women with metastasis. Patients without metastasis were identified accurately 94 percent of the time.

Most of the women were also studied to compare the BLN Assay with immediate microscopic examination during surgery. The test gave fewer false negative results, but slightly more false positive results. A false negative test result, when the cancer has actually spread, may delay the needed removal of additional lymph nodes. A false positive test, indicating metastasis when there is none, may result in a more extensive surgery and puts the women at risk of  unnecessary lymphedema (swelling due to fluid build-up following lymph node removal) and other side effects.

The GeneSearch BLN Assay is manufactured by Veridex, a Johnson & Johnson Company, of Warren, N.J.

FDA Approves CustomVue Monovision LASIK

The U.S. Food and Drug Administration approved for marketing the first LASIK device designed for treating one eye to see far away objects and the other eye for close-up vision.

“The approval of the CustomVue Monovision LASIK expands permanent vision correction options for nearsighted adults who also have trouble focusing on objects close-up,” said Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “Unlike traditional LASIK, Monovision LASIK may reduce the need for reading glasses in some people over 40.”

LASIK, or laser in-situ keratomileusis, is a procedure in which the surgeon cuts a flap in the outer layers of the cornea, removes a small amount of the tissue beneath it with the laser, and then replaces the flap. CustomVue Monovision LASIK produces monovision correction in nearsighted (myopic) adults, with or without astigmatism, ages 40 years or older with normal age-related loss of ability to focus on near objects (presbyopia).

The CustomVue device is designed to correct all nearsightedness in the patient’s dominant eye and only part of the nearsightedness in the non-dominant eye. This allows the patient to use the fully corrected eye for distance vision and the under-corrected eye for seeing close up. After a period of time, the brain adjusts to the difference in perception between the two eyes.

People considering CustomVue monovision LASIK should first wear monovision contact lenses for at least a week to determine if they can tolerate having one eye under-corrected. Following monovision surgery, the two eyes may not work together as well as they did before in some patients, especially in dim light or when performing tasks requiring very sharp vision or fine depth perception. Patients may need to wear glasses or contact lenses for some activities such as night driving or reading small type.

CustomVue Monovision LASIK is a permanent operation to the cornea. Side effects may include glare from bright lights, rings around lights (halos), light sensitivity, night driving glare, ghost images, double vision and visual fluctuation.

CustomVue Monovision LASIK is manufactured by AMO/VISX Inc., based in Santa Clara, Calif. The new approval is for the monovision correction, which uses the previously approved wavefront-guided treatments—an eye-mapping system that guides the laser—for myopia and astigmatism. FDA based its approval on the review of a clinical study of safety and effectiveness outcomes submitted by the company.

At FDA’s request, AMO/VISX will conduct a post-approval study following 500 patients for six months after surgery to characterize quality of vision and quality of life issues associated with permanent LASIK monovision correction. The objective of the study is to estimate the proportion of monovision LASIK patients who experience visual disturbances that are severe enough to limit activities or adversely affect a patient’s quality of life.


####

To see a consumer article called "First LASIK Device for Monovision," visit http://www.fda.gov/consumer/updates/lasik071207.html.

FDA Finds Consumers Continue to Buy Potentially Risky Drugs Over the Internet
Practice Puts Consumers at Risk and May Be More Expensive than Domestic Purchasing
The U.S. Food and Drug Administration continues to warn the American public about the dangers of buying medications over the Internet.

New data collected by the FDA show that consumers who are trying to save money on prescription drugs don’t need to take chances by buying prescription drugs from foreign Internet sites, because low-cost generic versions are available in the United States. This finding also may be an indication that some consumers are likely buying foreign drugs this way to avoid getting a prescription from their doctor or health care professional, since many Web sites do not require a prescription.

Safety Concerns
The use of prescription drugs without a prescription is an intrinsically unsafe practice. FDA urges consumers to have a prescription from their doctor or other health care professional before using prescription drugs. The agency also urges consumers to review www.fda.gov for important information before making such purchases.

Consumers should be aware of safety concerns of drugs purchased from unregulated Internet sellers since some of these drugs might:

require careful dosing and monitoring;
not have adequate labeling for safe use;
be inappropriately packaged, therefore product integrity is uncertain;
have been withdrawn from the U.S. market for safety or efficacy reasons;
may carry risks that require initial screening and/or periodic patient monitoring;
cause harm—such as a controlled substance (narcotic), whose use should be supervised by a doctor or health care professional due to abuse potential; and
have clinically significant drug-drug interactions.
Recent examinations of a sample of drugs shipped to U.S. consumers found several drugs are associated with higher risks and are more dangerous to the consumer if used without the supervision of a doctor or health care professional. For example, warfarin (an anticoagulant or blood thinner) is a medication that requires very close monitoring to prevent stroke or death. Another example is amoxicillin and other antibiotics that should not be used for self treatment to reduce the risk of antibiotic-resistant infections. Levothyroxine, a thyroid replacement hormone, also requires close monitoring to ensure effective treatment. Another blood thinner, clopidogrel, may pose increased risk of cardiac events, such as heart attack if used in sub-optimal doses, which might be found in imported tablets. (See more examples in Table 2).

Consumers are also at risk if the drugs are not properly labeled for safe and effective use. For example, alendronate sodium, which is used to treat and prevent osteoporosis, should include information warning patients of significant side effects if it is not taken appropriately. Imported eye drop preparations may not have been manufactured under proper conditions to ensure sterility, leaving patients susceptible to contamination that may result in serious infections. These are only a few examples demonstrating the importance of obtaining FDA-approved drugs and health care provider monitoring.

Cost Concerns
The examination of foreign mail shipments also found that about 45 percent of the imported products already are available in the United States as an FDA-approved generic drug (see Table 1). About half of these generic drugs are available through national pharmacy chain programs that offer generic prescriptions at a cost of $4 each. This cost is usually significantly less than the cost of drugs charged by Internet sellers.

FDA has documented problems with imported drug products and has taken action when possible against foreign Web sites selling counterfeit products. Some examples follow.

FDA Updates its Nationwide Alert on Counterfeit Blood Glucose Test Strips (October 23, 2006)
www.fda.gov/bbs/topics/NEWS/2006/NEW01497.html
FDA Warns Consumers Not to Buy or Use Prescription Drugs from Various Canadian Websites that Apparently Sell Counterfeit Products (August 30, 2006)
www.fda.gov/bbs/topics/NEWS/2006/NEW01441.html
Federal Authorities Cease Sale and Distribution of Counterfeit Lipitor (August 31, 2005)
www.fda.gov/bbs/topics/news/2005/new01228.html
FDA Takes Action Against Company for Illegal Importation of Unapproved, Potentially Unsafe Drugs (December 01, 2004)
www.fda.gov/bbs/topics/news/2004/NEW01142.html
FDA Warns Consumers About Counterfeit Drugs Purchased in Mexico (July 30, 2004)
www.fda.gov/bbs/topics/ANSWERS/2004/ANS01303.html
FDA Test Results of Prescription Drugs from Bogus Canadian Website Show All Products Are Fake and Substandard (July 13, 2004)
www.fda.gov/bbs/topics/news/2004/NEW01087.html
FDA Takes Action Against Foreign Websites Selling Counterfeit Contraceptive Patches (February 12, 2004)
www.fda.gov/bbs/topics/NEWS/2004/NEW01023.html
FDA and Johnson & Johnson Warn Public About Counterfeit Contraceptive Patches Sold Through Foreign Internet Site (February 04, 2004)
www.fda.gov/bbs/topics/NEWS/2004/NEW01017.html
FDA/U.S. Customs Import Blitz Exams Reveal Hundreds of Potentially Dangerous Imported Drug Shipments (September 29, 2003)
www.fda.gov/bbs/topics/NEWS/2003/NEW00948.html

TABLE 1:  Examples of intercepted drugs available as
low-cost generic products in the U.S.

Drug Product
Common Intended Medical Use

Amoxicillin Capsules
Antibiotic

Atenolol Tablets
High blood pressure

Fluoxetine Capsule
Depression

Hydrochlorothiazide (HCTZ) Tablets
High blood pressure (diuretic)

Isotretinoin Capsules
Oral anti-acne

Levothyroxine Tablets
Thyroid hormone replacement

Lisinopril Tablets
High blood pressure

Meloxicam Tablets
Inflammation

Metformin Tablets
Diabetes (blood sugar levels)

Metoprolol Tartrate Tablets
High blood pressure

Methotrexate Tablets
Anti-cancer

Nifedipine ER (extended release) Tablets
High blood pressure

Paroxetine Tablets
Depression

Phenytoin Capsules
Anti-seizure

Prednisone Tablets
Inflammation (steroid)

Simvastatin Tablets
High cholesterol

Tamoxifen Tablets
Anti-cancer

Warfarin Tablets
Blood thinner




TABLE 2:  Examples of intercepted drugs with particular associated risks

Drug Product
Common Intended Medical Use

Alendronate sodium Tablets
Osteoporosis

Amoxicillin Capsules
Antibiotic

Celecoxib Capsules
Osteo- and Rheumatoid Arthritis

Clopidogrel Tablets
Blood thinner

Isotretinoin Capsules
Oral anti-acne

Levothyroxine Tablets
Thyroid hormone replacement

Methotrexate Tablets
Anti-cancer

Prednisone Tablets
Inflammation (steroid)

Phenytoin Capsules
Anti-seizure

Warfarin Tablets
Blood thinner

Zolpidem Tablets
Insomnia


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To see a consumer article called The Possible Dangers of Buying Medicine Online, visit www.fda.gov/consumer/features/drugsonline0707.html.

FDA Approves First of a Kind Medical Device to Treat Cervical Degenerative Disc Disease
The U.S. Food and Drug Administration (FDA) approved for marketing the Prestige Cervical Disc, made by Medtronic Sofamor Danek of Memphis—the first artificial cervical (neck) disc for the treatment of cervical degenerative disc disease, one of the most common causes of neck and arm pain.

"The approval of this artificial disc means that people with cervical degenerative disc disease now will have another surgical option for treating this condition," said Daniel Schultz, M.D., director, Center for Devices and Radiological Health, FDA. "This device will help relieve pain and restore function."

The cervical spine (neck region) consists of seven bones (called the vertebrae), which are separated from one another by intervertebral discs. These discs allow the neck to bend and rotate.

The current surgical treatment involves removing a diseased or bulging disc in a patient's neck and fusing two or more bony vertebrae. The Prestige Cervical Disc would instead replace the impaired natural disc.

The PRESTIGE Cervical Disc consists of two main pieces of stainless steel that articulate against one another with a ball and trough (groove) . After a doctor removes the impaired natural disc, the artificial disc is attached to the adjacent vertebrae with bone screws.

FDA based approval on the company's laboratory and animal testing, and on its clinical study of 541 patients. The clinical study showed that the device improved neck and/or arm pain, and was as safe and effective as cervical fusion, a common treatment for degenerative disc disease. The approval decision also took into account the recommendations of the Orthopedic and Rehabilitation Devices Panel of FDA's Medical Devices Advisory Committee, which reviewed the product in September.

As a condition of approval, the company will conduct a post-approval study over the next seven years to evaluate the longer term safety and effectiveness of the device. FDA will continue to monitor the device as part of the agency's overall effort to ensure that products remain safe and effective once they reach the marketplace.

FDA approved the PRESTIGE Cervical Disc as a class III device under the pre-market approval process. FDA's regulation of medical devices is risk-based, with devices classified into low-risk (class I), moderate-risk (class II), or high-risk (class III) categories. The FDA regulatory program includes requirements for registration and listing of products, for high-quality production using good manufacturing practices and for post-market reporting of adverse events.