FDA to Address Challenges of Using Complex Medical Devices in the Home

/PRNewswire/ -- The U.S. Food and Drug Administration today announced a new initiative to ensure that caregivers and patients safely use complex medical devices in the home.

Hemodialysis equipment to treat kidney failure, wound therapy care, intravenous therapy devices, and ventilators are among the medical products that have migrated to the home in recent years. And more hospital patients of all ages are being discharged to continue their medical treatment at home.

"Using complex medical devices at home carries unique challenges," said Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological Health. "Caregivers may lack sufficient training, product instructions may be inadequate or overly technical, and the home environment itself may pose environmental or safety hazards that can affect the product's functioning."

According to an FDA white paper, the initiative will develop guidance for manufacturers who intend to market a device for home use, provide for postmarket surveillance, and put in place other measures to encourage safe use of these products. In addition, the FDA is developing educational materials on home use of medical devices.

"The FDA's Home Use Initiative will help address the potential challenges, providing greater protection and awareness for patients who are being cared for in the home," Shuren said.

Currently, the FDA does not have a clear regulatory pathway for devices intended for home use that describes the unique factors that manufacturers should take into consideration when designing, testing, and labeling such products. The new home use guidance document that FDA intends to develop will:

-- make recommendations for actions manufacturers should take to support
premarket approval or clearance of these devices, including device
testing with at-home caregivers and patients in a non-clinical
setting,
-- define circumstances under which the FDA may exercise its authority to
require that certain devices cleared for marketing carry a statement
in the labeling that the device has not been cleared for use in the
home,
-- recommend postmarket surveillance to identify and address adverse
events that may occur in the home.


In addition to developing the guidance document, the FDA will launch a 10-month pilot program beginning in the summer of 2010 in which manufacturers of home use devices may voluntarily submit their labeling to the agency for posting on a central Web site repository. Posting medical device labeling in the repository will help home care patients and caregivers to quickly and conveniently access important information about the safe use of their devices.

The Home Use Initiative also contains measures for enhanced postmarket surveillance through HomeNet, a subnetwork of the FDA's Medical Device Surveillance Network, an adverse event reporting program that includes more than 350 health care facilities nationwide.

Understanding issues experienced by home users will help the FDA develop appropriate actions to address those issues in the future. It may also identify cases in which devices intended solely for use in a health care facility are being used at home. The FDA already has collected information on safety concerns related to home hemodialysis and is now collecting similar information on the use of some wound therapy devices.

The FDA is partnering with the Community Health Accreditation Program and the Joint Commission, which evaluates and accredits 17,000 U.S. health care organizations and programs, to strengthen home health agency accreditation criteria that relate to medical device safe use practices.

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FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers to Help Consumers Use Products Safely

The Food and Drug Administration issued a final rule today that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs.

Products covered by the FDA action include acetaminophen, and a class of drugs known as the nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs include aspirin, ibuprofen, naproxen, and ketoprofen. Acetaminophen is in a class by itself. The revised labeling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines containing pain relievers or fever reducers.

“Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches, “ said Charles Ganley, M.D., director, FDA’s Office of Nonprescription Drugs in the Center for Drug Evaluation and Research. “However, the risks associated with their use, need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk.”

Under the final rule, manufacturers must ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.

Since 2006, some manufacturers have voluntarily revised their product labeling to identify these potential safety concerns. However, the voluntary changes to labeling do not address all of the labeling requirements in the new rule. For example, the new rule includes a warning on products containing acetaminophen that instructs consumers to ask a doctor before they are taking the blood thinning drug warfarin. The new rule requires all manufacturers to relabel their products within one year of today’s date.

Safety data reported in medical literature indicate that people sometimes take more acetaminophen than the labeling recommends. Others unknowingly take multiple products containing acetaminophen at the same time. Exceeding the recommended dosage of acetaminophen may increase the risks for severe liver damage. Alcohol use can also increase the risk of liver damage with acetaminophen.

The risk for stomach bleeding may increase in people who use NSAIDs and who are taking blood-thinning drugs (anticoagulants) or steroids. Stomach bleeding risks also increase for people who take multiple NSAIDs at the same time, or in people who take them longer than directed. Alcohol use can increase the risk for stomach bleeding with NSAIDs use.

An FDA Advisory Committee meeting will be convened on June 29 & 30, 2009, to discuss further steps the FDA could take to reduce the risk of liver damage associated with acetaminophen overdoses.

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FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications

The U.S. Food and Drug Administration today announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.

The FDA is also requiring the manufacturers to submit for each of these products a Risk Evaluation and Mitigation Strategy, including a Medication Guide for patients. Medication Guides are manufacturer-developed handouts that are given to patients, their families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information about the risks of suicidal thoughts and behaviors associated with the class of antiepileptic medications.

"Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. “ Patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional.”

The FDA today also disseminated information to the public about the risks associated with antiepileptic medications by issuing a public health advisory and an information alert to health care professionals. Health care professionals should notify patients, their families, and caregivers of the potential for an increase in the risk of suicidal thoughts or behaviors so that patients may be closely observed.

The FDA's actions are based on the agency's review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent). This difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo.

Four of the patients who were randomized to receive one of the antiepileptic drugs committed suicide, whereas none of the patients in the placebo group did. Results were insufficient for any conclusion to be drawn about the drugs' effects on completed suicides. The biological reasons for the increase in the risk for suicidal thoughts and behavior observed in patients being treated with antiepileptic drugs are unknown.

The FDA alerted health care professionals in January 2008 that clinical trials of drugs to treat epilepsy showed increased risk of suicidal thoughts and actions. In July 2008, the FDA held a public meeting to discuss the data with a committee of independent advisors. At that meeting the committee agreed with the FDA's findings that there is an increased risk of suicidality with the analyzed antiepileptic drugs, and that appropriate warnings should extend to the whole class of medications. The panel also considered whether the drugs should be labeled with a boxed warning, the FDA's strongest warning. The advisers recommended against a boxed warning and instead recommended that a warning of a different type be added to the labeling and that a Medication Guide be developed.

Acting under the authorities of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA is requiring manufacturers of antiepileptic drugs to submit to the agency new labeling within 30 days, or provide a reason why they do not believe such labeling changes are necessary. In cases of non-compliance, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.

The following antiepileptic drugs are required to add warnings about the risk of suicidality:

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Clonazepam (marketed as Klonopin)
Clorazepate (marketed as Tranxene)
Divalproex sodium (marketed as Depakote, Depakote ER, Depakene)
Ethosuximide (marketed as Zarontin)
Ethotoin (marketed as Peganone)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Lacosamide (marketed as Vimpat)
Levetiracetam (marketed as Keppra)
Mephenytoin (marketed as Mesantoin)
Methosuximide (marketed as Celontin)
Oxcarbazepine (marketed as Trileptal) Phenytoin (marketed as Dilantin Suspension)
Pregabalin (marketed as Lyrica)
Primidone (marketed as Mysoline)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Trimethadione (marketed as Tridione)
Zonisamide (marketed as Zonegran)
Some of these medications are also available as generics.

Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.



-- Online : www.fda.gov/MedWatch/report.htm

-- Regular Mail : use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
and mail to MedWatch, 5600 Fishers Lane , Rockville , MD 20852-9787

-- Fax: (800) FDA-0178

-- Phone: (800) FDA-1088

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Hospira Issues Voluntary Recall of One Lot of 20meq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP

Hospira Issues Voluntary Recall of One Lot of 20meq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Due to Incorrect Bar Code Label

Hospira, Inc., a global specialty pharmaceutical and medication delivery company, is following up on a nationwide voluntary recall issued Sept. 18 of one lot (lot number 65-620-FW, expiration date May 1, 2010, NDC 0409-7902-09) of 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP in 1000 mL flexible plastic containers because a small number of the containers may be incorrectly labeled with a bar code for 5% Dextrose Injection, USP (NDC 0409-7922-09). The incorrect bar code could lead to a medication error resulting in the wrong drug being delivered to a patient if a bar code system is used to confirm the medication. Potential adverse events related to an error of this type include electrolyte imbalance, cardiac dysfunction, gastrointestinal disturbances, paresthesia and mental confusion.

The product contains 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride. The product name and National Drug Code (NDC) number printed on the container are correct. The affected lot was shipped to U.S. customers between July 2008 and September 2008. No other lots are affected by this recall.

Hospira has not received any reports of adverse health events in connection with the recalled lot. Hospira has identified the root cause of the error and taken action to prevent its recurrence.

Anyone with an existing inventory should quarantine the product immediately and call Hospira Customer Care at 1-877-946-7747 for instructions on how to return it. Customers who have medical questions should contact Hospira Medical Communications at 1-800-615-0187. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Any adverse reactions experienced with the use of these products, and/or quality problems may also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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FDA Approves Updated Labeling for Psoriasis Drug Raptiva

The U.S. Food and Drug Administration today announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS.

Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy to control their psoriasis.

The FDA's Office of Surveillance and Epidemiology, charged by the Agency with monitoring drugs once approved for the marketplace, has received reports of serious infections leading to hospitalizations, and deaths in some cases, in patients using Raptiva.

The now-required Boxed Warning will highlight the risk of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections.

Additionally, Raptiva's label will be updated to include data from juvenile animal studies in mice (age equivalent to a 1-14 year old human). These data indicate a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in this age group. Raptiva is not approved for children under 18 years of age.

"As part of FDA's monitoring of the life-cycle of approved products, the agency received reports of serious infections in some patients taking Raptiva. These reports led to our decision to highlight these risks in the drugs labeling," said Janet Woodcock, the FDA's director of the Center for Drug Evaluation and Research. "Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks."

Raptiva works by suppressing the immune system to reduce psoriasis flare-ups, however by suppressing the body's natural defense system, it can also increase the risk of serious infections and malignancies in patients.

Patients identified to begin therapy with Raptiva should have received all their age-appropriate vaccinations before starting the drug. Vaccinations should not be administered to patients taking Raptiva because immunity to the vaccination virus may not be conferred.

Patients taking Raptiva should be educated about recognizing the signs and symptoms of infection, PML (confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems), anemia (dizziness upon standing, weakness or jaundice), thrombocytopenia (bruising, bleeding gums, pin-point sized red or purple dots under the skin), or the worsening of their psoriasis or arthritis. Signs of a nervous system disorder include sudden onset of numbness, tingling or weakness in the arms, legs or face.

If any of these signs appear, Raptiva patients should seek immediate medical attention. Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva.

Because reports of these adverse events were received voluntarily from populations of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug's use.

One report of PML in a Raptiva-treated patient came from an ongoing post-marketing epidemiological study of patients with psoriasis.

Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay.

Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.

Raptiva was approved in 2003. It is manufactured by Genentech, Inc. of San Francisco, Calif.

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FDA Creates Web Page with Drug Safety Information for Patients, Health Care Professionals

Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs. The Web page, http://www.fda.gov/cder/drugSafety.htm, provides links to information in these categories:

* Drug labeling, including patient labeling, professional labeling, and patient package inserts;
* Drugs that have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that their benefits outweigh their risks;
* A searchable database of postmarket studies that are required from, or agreed to by, drug companies to provide the FDA with additional information about a drug's safety, efficacy, or optimal use;
* Clinicaltrials.gov, a searchable database of clinical trials, including information about each trial's purpose, who may participate, locations, and useful phone numbers;
* Drug-specific safety information, including safety sheets with the latest information about the drug as well as related FDA press announcements, fact sheets, and drug safety podcasts;
* Quarterly reports that list certain drugs that are being evaluated for potential safety issues, based on a review of information in the FDA's Adverse Event Reporting System (AERS);
* Warning Letters, Import Alerts, Recalls, Market Withdrawals, and Safety Alerts;
* Regulations and guidance documents;
* Consumer information about using medications safely and disposing of unused medicines;
* Instructions how to report problems to the FDA through its MedWatch program;
* Consumer articles on drug safety; and
* The FDA's response to the Institute of Medicine's 2006 report on the future of drug safety.

"By placing Web links to these up-to-date resources on a single page, we're helping consumers and health care professionals find drug safety information faster and easier," said Paul Seligman, M.D., M.P.H., associate director of Safety Policy and Communication in the FDA's Center for Drug Evaluation and Research. "This type of communication is aimed at helping consumers and health care professionals make well-informed decisions about medication use."

Establishing such a Web page is one of the requirements of the Food and Drug Administration Amendments Act of 2007, and is among FDA's many efforts to address the safe use of drugs throughout their lifecycle.

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FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children

Background: The Consumer Healthcare Products Association (CHPA), an association that represents most of the makers of nonprescription over-the-counter (OTC) cough and cold medicines in children, recently announced that its members are voluntarily modifying the product labels for consumers of OTC cough and cold medicines to state "do not use" in children under 4 years of age. Additionally, the manufacturers are introducing new child-resistant packaging and new measuring devices for use with the products.

The U.S. Food and Drug Administration supports the voluntary actions by CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. The FDA continues to assess the safety and efficacy of these products and to revise its OTC monograph (list of approved ingredients and amounts) for these medicines. Although this new labeling is inconsistent with the current monograph, FDA will not object, under the circumstances presented here, to the new label modification stating "do not use in children under 4," which reflects a more restrictive use of the drugs in children.

The steps that are being taken by CHPA will not affect the availability of the medicines, but this voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others. FDA does not typically request removal of OTC products with previous labeling from the shelves during a voluntary label change such as this one. Therefore, some medicines will have the new recommendation "do not use" for children under 4 years of age, while others will instruct that they not be used for children under 2 years of age. If parents or caregivers have or purchase a product that does not have the voluntarily-modified labeling, FDA recommends that they should adhere to the dosage instructions and warnings on the label that accompanies the medication. They should not, under any circumstances, give adult medications to children. If parents or caregivers have questions or are just not sure about how to use a product, they should consult with their doctor or pharmacist.

Over the last year, FDA has been working on several fronts to address the safe use of nonprescription OTC cough and cold medicines in children.

FDA has held two public meetings to hear from stakeholders and consumers on the issue, most recently, a public hearing that focused on labeling of these products on Oct. 2, 2008. In January of this year, FDA issued a nationwide Public Health Advisory recommending that these products not be used in children under the age of two because of the risk of serious and potentially life-threatening side effects.

Another part of the agency's work includes outreach to other public health agencies, consumer and patient groups companies that manufacture these products, and CHPA.

FDA will continue to work with the Centers for Disease Control and Prevention to monitor the ongoing use of these products and to develop educational materials for parents and consumers. The Agency will also continue to reach out to the scientific community to obtain more up-to-date information and scientific data about the effects of these products in children so that it can take the appropriate regulatory steps moving forward.

All these areas are vital to support the development and review of data regarding the safe and effective use of these products.

FDA is proceeding with its rulemaking process to update the existing OTC monograph for cough and cold products for children, and will consider input from the recent hearing of Oct. 2. The rulemaking process affords additional opportunity for the submission of data and public comment.

Until all these issues are resolved, FDA continues to recommend to parents and caregivers the following:

• Do not give children medications labeled only for adults.
• Talk to your healthcare professional if you have any questions about using cough or cold medicines in children.
• Choose OTC cough and cold medicines with child-resistant safety caps, when available. After each use, make sure to close the cap tightly and store the medicines out of the sight and reach of children.
• Check the "active ingredients" section of the DRUG FACTS label of the medicines that you choose. This will help you understand what symptoms the "active ingredients" in the medicine are intended to treat. Cough and cold medicines often have more than one active ingredient (such as an antihistamine, a decongestant, a cough suppressant, an expectorant, or a pain reliever/fever reducer).
• Be very careful if you are giving more than one medicine to a child. If you are giving more than one medicine to a child make sure that they do not have the same type of "active ingredients." If you use two medicines that have the same or similar active ingredients, a child could get too much of an ingredient and that may hurt your child. For example, do not give a child more than one medicine that has a decongestant.
• Carefully follow the directions for how to use the medicine in the DRUG FACTS part of the label. These directions tell you how much medicine to give and how often you can give it. If you have a question about how to use the medicine, ask your pharmacist or your doctor. Overuse or misuse of these products can lead to serious and potentially life threatening side effects such as rapid heartbeat, drowsiness, suppression of the respiratory system, seizures and other adverse events.
• Only use measuring devices that come with the medicine or those specially made for measuring drugs. Do not use common household spoons to measure medicines for children because household spoons come in different sizes and are not meant for measuring medicines.
• Understand that using OTC cough and cold medicines does not cure the cold or cough. These medicines only treat your child’s symptom(s) such as runny nose, congestion, fever and aches and do not shorten the length of time your child is sick.

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Vitamin D Added to FDA Osteoporosis Risk-Reduction Health Claim

PRNewswire/ -- As a result of a 2004 petition from the Beverage Institute for Health & Wellness (hereafter the Institute) of The Coca-Cola Company (NYSE:KO) , the US Food and Drug Administration (FDA) announced today that it has amended its osteoporosis risk reduction health claim to reflect the importance of vitamin D, in combination with calcium, in promoting long-term bone health. The amended rule also includes a broader definition of the populations that could benefit from consuming calcium and vitamin D to include both men and women of all ages and races.

The amended labeling regulation explains that vitamin D is required for the normal absorption of calcium, and authorizes the health claim: "Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis."

"Osteoporosis is a growing public health crisis, and all Americans, men and women alike, will benefit from knowing that vitamin D along with calcium can help delay or prevent the onset of this disease," said Robert P. Heaney MD, FACP, John A. Creighton University Professor and Professor of Medicine at Creighton University in Omaha, Nebraska. "Along with weight-bearing exercise, the most valuable intervention for maintaining bone health is an overall healthful diet that supplies adequate amounts of all nutrients such as vitamin D."

The US National Osteoporosis Foundation predicts that by 2010, about 12 million people over the age of 50 will have osteoporosis and another 40 million will have low bone mass. These numbers are expected to continue climbing. To help address this significant public health issue, the FDA developed this health claim for manufacturers to include on labels of appropriate foods and dietary supplements. The new labeling can help consumers identify products with adequate calcium and Vitamin D that can help to reduce their risk of osteoporosis.

Increasing Awareness and Consumption of Vitamin D

"We initiated this petition because we believe consumers will benefit from efforts to increase awareness of the link between calcium and vitamin D and bone health," said Dr. Rhona Applebaum, Vice President and Chief Scientific and Regulatory Officer for The Coca-Cola Company. "Revising the osteoporosis risk reduction health claim to include both vitamin D and calcium will help the food industry communicate the importance of these nutrients to consumers."

According to Carolyn E. Moore, PhD, RD, Principal Scientist with The Coca- Cola Company's Institute, studies sponsored by the Institute at the Boston University Medical Center and ENVIRON Health Sciences, demonstrated that many consumers are not getting enough Vitamin D from food and dietary supplements. The groups at greatest risk in the US include teenage girls, women, the elderly, and African-American and Mexican-American adults.

It was The Coca-Cola Company who sought approval to add vitamin D to calcium-fortified juices and juice drinks from the FDA, through research the Company sponsored at the Vitamin D and Bone Health Research Laboratory at Boston University Medical School. Results from this research demonstrated that vitamin D is readily absorbed by the body when added to skim milk and

orange juice. The FDA approved the addition of vitamin D to calcium-fortified juices in 2003.

The Importance of Vitamin D for Strong Bones

Vitamin D requirements of all age groups can be met under conditions of adequate exposure to sunlight. However, several factors can reduce the production of vitamin D from the skin including the use of sunscreens, increased skin pigmentation, normal aging, and insufficient exposure to sunlight.

The primary function of Vitamin D is to aid in the body's absorption of calcium, helping to form and maintain strong bones. Without Vitamin D, the body absorbs 10 - 15 percent of calcium consumed in the diet. With Vitamin D, the absorption level increases to 30 - 50 percent.

Emerging Research on Vitamin D

Vitamin D has been the subject of extensive basic and clinical research in the past several years, which has generated valuable insights about this vital nutrient.

-- In a recent study supported in part by the Institute, researchers from Boston University School of Medicine found that vitamin D2 (found naturally in plants) is equally as effective as vitamin D3 (produced as a result of sun exposure and found in some food sources such as cod liver oil and oily fish) in maintaining circulating blood levels of vitamin D.

-- With support from the National Institutes of Health and the Institute, the United States Department of Agriculture's Nutrient Data Laboratory is in the process of conducting an updated analysis of vitamin D content in a wide range of whole and processed foods, including, for the first time, specific forms of vitamin D, i.e., D2 and D3.

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