This holiday season, Lock up your medicines to protect children and teens

The holiday season brings guests of all ages into your home, so it’s an especially important time to make sure your medications are locked away safely in order to prevent accidental poisonings in children and misuse by teens. Hospitalizations and even deaths from medications meant for someone else are growing problems among kids and teens.

Children and teenagers can get into medications that can be dangerous and how to lock them up securely. Each year, thousands of children and teens are hospitalized because they've taken medications that have not been properly secured. 

A child may discover a pill box or a package of cold medicine on a bathroom counter, mistaking them for candies because of the attractive colors.

A teenager may take pills out of a medicine cabinet or a purse to experiment. Ever heard of "Pharm Parties" ? These are parties where in teens get together to share the prescribed medicines with their friends. Tragically, these scenarios are not uncommon, but they can be prevented.

Protect your loved ones this holiday season by locking away your prescription and over-the-counter medications before they wind up in the wrong hands. It’s a small step that can save a life.

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Improvements To The Medical Device Recalls Database

The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) recently announced improvements to several public databases that will increase access to safety information on marketed medical devices. The improvements include adding new fields to the Medical Device Recalls database disclaimer icon and providing links to the recall database from FDA’s 510(k) Premarket Notification disclaimer icon and Premarket Approval (PMA) disclaimer icon  databases.

Specifically:

• The 510(k) and PMA databases will have a CDRH Recalls hyperlink at the bottom of each record if there are recalls associated with that medical device.
• The recalls database has been expanded to include recall status (whether or not the recall has been terminated), product classification (product code), premarket submission numbers associated with the recall (510(k)s and PMAs only), and the root cause of the recall as determined by the FDA. Also, the previously available field "Reason for Recall" has been renamed "Manufacturer Reason for Recall" to better clarify the source of the information.
• In addition to the new and renamed fields, two new links are available at the bottom of recall records. The first will search the Total Product Lifecycle (TPLC) database for additional information regarding other devices with the same product code as the recalled device. The other will search the premarket databases for other premarket submissions of this type of product from the same applicant. This will provide information about submissions cleared or approved after the recall.

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Breast Cancer Screening - Nipple Aspirate Test Is Not An Alternative To Mammography

What is a nipple aspirate device ?

It is a type of pump used to collect fluid from a woman's breast. A nipple aspirate test can determine whether the fluid collected from the breast contains any abnormal cells.

Certain manufactures are promoting the use of nipple aspirate tests as a stand-alone evaluation tool for screening and diagnosing breast cancer, claiming they are an alternative to biopsy or mammography. They also claim that a nipple aspirate test can detect pre-cancerous abnormalities and diagnose breast cancer before mammography with just a sample of a few cells.  The FDA is concerned that women will believe these misleading claims about a nipple aspirate test and not get mammograms and/or other needed breast imaging tests or biopsies. This may lead to serious adverse health consequences.

Possible health consequences include false negative test results, indicating the absence of breast cancer when cancer exists, and false positive test results, indicating the presence of breast cancer when none exists.  False negative results may lead to delayed diagnosis and/or delayed treatment of breast cancer, with increased risk of serious illness or death.  False positive results may lead to needless patient anxiety, along with unnecessary additional testing and treatment.

The FDA is alerting the public, including women and health care providers, that a nipple aspirate test is not a replacement for mammography, other breast imaging tests, or breast biopsy, and should not be used by itself to screen for or diagnose breast cancer.  The FDA is not aware of any valid scientific data to show that a nipple aspirate test by itself is an effective screening tool for any medical condition including the early detection of breast cancer or other breast disease.

The FDA, other public health agencies, and national medical and professional societies agree that mammography is the most effective method for detecting breast cancer in its earliest, most treatable stages.  These organizations include the American Cancer Society, the American College of Radiology, the Centers for Disease Control and Prevention, the National Cancer Institute, and the Society for Breast Imaging. The National Comprehensive Cancer Network (NCCN) 2013 guidelines state that the clinical utility of nipple aspiration is still being evaluated and it should not be used as a breast cancer screening technique.

What Health Care Providers are recommended:

• Do not use a nipple aspirate test as a substitute for mammography or by itself for breast cancer screening or diagnosis.

What Patients are recommended:

• Remember that a nipple aspirate test, such as Atossa Genetics Inc.'s Mammary Aspiration Specimen Cytology Test (MASCT) and/or ForeCYTE Breast Health Test systems, or the HALO Breast Pap Test, is not a substitute for mammography, other breast imaging tests, or breast biopsy, and should not be used by itself for breast cancer screening or diagnosis.
• If you have had a nipple aspirate test as a stand-alone evaluation tool for screening and diagnosing breast cancer, you should request a mammogram from your health care provider to get accurate results.
• Undergo regular mammograms according to screening guidelines or as recommended by your health care provider.

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