FDA statement from Douglas Throckmorton, M.D.,

FDA statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs, Center for Drug Evaluation and Research, on new warnings about the use of codeine and tramadol in children & nursing mothers.

The health and safety of children is a top priority at the FDA, which is why today we are requiring a series of changes to the labeling of two types of opioid medications in order to help better protect children from serious risks associated with these medicines – codeine (found in some prescription pain and cough medicines and some over-the-counter cough medicines) and tramadol (found in some prescription pain medicines).

We are requiring these changes because we know that some children who received codeine or tramadol have experienced life-threatening respiratory depression and death because they metabolize (or break down) these medicines much faster than usual (called ultra-rapid metabolism), causing dangerously high levels of active drug in their bodies. This is especially concerning in children under 12 years of age and adolescents who are obese or have conditions that may increase the risk of breathing problems, like obstructive sleep apnea or lung disease. Respiratory depression can also occur in nursing babies, when mothers who are ultra-rapid metabolizers take these types of medicines and pass it along to their children through their breast milk.

This isn’t the first time we have taken action on codeine to better ensure the safety of our children. Since 2013, prescription codeine labeling has contained a Boxed Warning and Contraindication for children up to age 18 years of age regarding the risk of life-threatening respiratory depression following the use of codeine for pain management after the removal of the tonsils (tonsillectomy) and/or adenoids (adenoidectomy). Now, labels for both codeine and tramadol are being updated to include additional Contraindications and Warnings; among the updates are Contraindications for use of codeine or tramadol in all children younger than 12 years of age, warnings about their use in children 12-18 years of age with certain medical conditions, and a stronger warning recommending against their use in nursing mothers. In addition to these labeling changes, labeling for tramadol-containing products will also get a Contraindication for post-operative pain management in children up to age 18 years of age who have undergone tonsillectomy and/or adenoidectomy, which is already in labeling for codeine products.

We urge health care providers, stakeholders and the public to read the Drug Safety Communication that we issued today, which provides more detailed information regarding the new Warnings and Contraindications, and the data that informed them. We also encourage parents to review the ingredients of pain medicines to see whether they include codeine or tramadol, and cough medicines to see if they contain codeine. It’s also important to check non-prescription cough and cold medicines that may be sold over the counter, as some of these medicines also include codeine. In all cases, if the medicine contains codeine or tramadol, parents should consult a health care provider before giving their children the medicines or taking them when nursing.

We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for health care providers and parents. However, please know that our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm553285.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

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As you enjoy fresh produce this summer, please remember these safe handling tips.

Produce: Selecting and Serving it Safely

As you enjoy fresh produce, follow these safe handling tips to help protect yourself and your family.

Fruits and vegetables are an important part of a healthy diet. Your local markets carry a wide variety of nutritious fresh fruits and vegetables. However, harmful bacteria that may be in the soil or water where produce grows can come in contact with fruits and vegetables and contaminate them. Fresh produce may also become contaminated after it is harvested, such as during storage or preparation.

Eating contaminated produce can lead to foodborne illness, often called “food poisoning.” So as you enjoy fresh produce, follow these safe handling tips to help protect you and your family. 

Buy Right

You can help keep produce safe by making wise buying decisions.

• Choose produce that is not bruised or damaged.
• When buying pre-cut, bagged or packaged produce — such as half of a watermelon or bagged salad greens — choose only those items that are refrigerated or surrounded by ice.
• Bag fresh fruits and vegetables separately from raw meat, poultry, and seafood when packing them to take home from the market

Store Properly

Proper storage of fresh produce can affect both quality and safety.

• Store perishable fresh fruits and vegetables (like strawberries, lettuce, herbs, and mushrooms) in a clean refrigerator at a temperature of 40° F or below. Use a refrigerator thermometer to check! If you’re not sure whether an item should be refrigerated to keep its quality, ask your grocer.
• Refrigerate all produce that is purchased pre-cut or packaged .

Separate for Safety

Keep fruits and vegetables that will be eaten raw separate from raw meat, poultry, and seafood — and from kitchen utensils used for those products.

• Wash cutting boards, dishes, utensils, and countertops with soap and hot water between preparing raw meat, poultry, and seafood and preparing produce that will not be cooked.
• If possible, use one cutting board for fresh produce and a separate one for raw meat, poultry, and seafood.
• If you use plastic or other non-porous cutting boards, run them through the dishwasher after use

Prepare Safely

When preparing any fresh produce, begin with clean hands. Wash your hands for at least 20 seconds with soap and warm water before and after preparation.

• Cut away any damaged or bruised areas on fresh fruits and vegetables before preparing and/or eating. Throw away any produce that looks rotten.
• Wash all produce thoroughly under running water before preparing and/or eating, including produce grown at home or bought from a grocery store or farmers’ market. Washing fruits and vegetables with soap, detergent, or commercial produce wash is not recommended.
• Even if you do not plan to eat the skin, it is still important to wash produce first so dirt and bacteria are not transferred from the surface when peeling or cutting produce.
• Scrub firm produce, such as melons and cucumbers, with a clean produce brush.
• After washing, dry produce with a clean cloth towel or paper towel to further reduce bacteria that may be present on the surface

What About Pre-Washed Produce?

Many pre-cut, bagged, or packaged produce items are pre-washed and ready-to-eat. If so, it will be stated on the packaging, and you can use the produce without further washing.

If you choose to wash produce marked as “pre-washed” or “ready-to-eat,” be sure that it does not come in contact with unclean surfaces or utensils. This will help to avoid cross contamination.

About Foodborne Illness

Know the Symptoms

Consuming dangerous foodborne bacteria will usually cause illness within 1 to 3 days of eating the contaminated food. However, sickness can also occur within 20 minutes or up to 6 weeks later. Although most people will recover from a foodborne illness within a short period of time, some can develop chronic, severe, or even life-threatening health problems.

Foodborne illness can sometimes be confused with other illnesses that have similar symptoms. The symptoms of foodborne illness can include:

• Vomiting, diarrhea, and abdominal pain
• Flu-like symptoms, such as fever, headache, and body ache

Take Action

If you think that you or a family member has a foodborne illness, contact your healthcare provider immediately. Also, report the suspected foodborne illness to

• Contact the Consumer Complaint Coordinator in your area.
• Contact MedWatch, FDA’s Safety Information and Adverse Event Reporting Program: By Phone: 1-800-FDA-1088 Online: File a voluntary report at http://www.fda.gov/medwatch

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Medical researchers have long studied the ability of stem cells, which can regenerate and form almost any cell type in the body, to treat numerous chronic diseases. So if you find the way to appropriately activate your Stem Cells, you can reduce wrinkles, scarfs and many others effects of time on the skin or any other tissue.

Stem cells contain two key components: growth factors, which play a role in cell division, the growth of new cells, and the production of collagen and elastin; and proteins, which regulate that stem-cell division. When applied to your skin, these two components help firm wrinkles and slow the development of new lines.

The activation of the Stem Cells to Regenerate and heal, it is made by the Growth Factors.

Growth factors are vital to maintaining a youthful appearance. The skin contain multiple growth factors that regulate natural cellular renewal and damage repair processes to keep skin healthy. These growth factors are responsible for helping to reverse the visible effects of chronological aging and premature aging due to environmental factors. The consequences of environmental exposure and the normal processes of aging lead to excessive free radical damage of skin and scalp cellular components, resulting in the breakdown of collagen and elastin networks in the dermis and producing the effect of visible facial aging. This same type of damage eventually impairs growth factor function, so they are less able to repair oxidative damage, and the damage becomes permanent.

There is a new technology in the market called GF-technology developed by Dr. Ahmed Al-Qahtani, with cutting edge methods of producing human growth factors and utilizing them in topical skin care products. Growth factors (GF) are found in many different cell types in the human body. They are a group of specialized proteins with many functions, the most important being the activation of cellular proliferation and differentiation. Growth factors turn essential cellular activities “on” and “off,” and they play a role in increasing cell production, cell division, blood vessel production, and collagen and elastin production. In recent decades, scientific research into GF biological functions has shown that medical GF-technology is related to resolving many cell developmental diseases.

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FDA approves first leadless pacemaker to treat heart rhythm disorders.

The U.S. Food and Drug Administration today approved the first pacemaker that does not require the use of wired leads to provide an electrical connection between the pulse-generating device and the heart. While the Micra Transcatheter Pacing System works like other pacemakers to regulate heart rate, the self-contained, inch-long device is implanted directly in the right ventricle chamber of the heart.

Pacemakers are surgically implanted medical devices that generate electrical impulses to treat irregular or stalled heart beats, and nearly 1 million people worldwide are implanted with pacemakers each year. The leads in a traditional single chamber pacemaker run from the pacemaker, implanted under the skin near the collarbone, through a vein directly into the heart’s right ventricle; the leads deliver electric pulses from the generator to the right ventricle and help coordinate timing of the chamber’s contractions. Micra eliminates these leads, which can sometimes malfunction or cause problems when infections develop in the surrounding tissue, requiring a surgical procedure to replace the device.  

“As the first leadless pacemaker, Micra offers a new option for patients considering a single chamber pacemaker device, which may help prevent problems associated with the wired leads,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. Micra is intended for patients with a heart arrhythmia called atrial fibrillation or those who have other dangerous arrhythmias, such as bradycardia-tachycardia syndrome.

The FDA evaluated data from a clinical trial of 719 patients implanted with the Micra device, which found that 98 percent of patients in the trial had adequate heart pacing (known as pacing capture threshold) six months after the device was implanted. Complications occurred in fewer than 7 percent of participants in the clinical trials and included prolonged hospitalizations, blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism), heart injury, device dislocation and heart attacks. 

Micra is contraindicated for patients who have implanted devices that would interfere with the pacemaker, who are severely obese, or who have an intolerance to materials in the device or the blood thinner heparin. It is also contraindicated for patients with veins that are unable to accommodate the 7.8 millimeter introducer sheath or pacemaker implant.

The Micra device is manufactured by Medtronic, located in Mounds View, Minnesota.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494417.htm

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