miércoles, 25 de abril de 2018

FDA Patient Network News - April 25, 2018

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Medical Product Safety

Rhino 69 Extreme 50000 by AMA Wholesale: Recall - Presence of Tadalafil
AMA Wholesal
e Inc. (Distributor/Re-seller), is voluntarily recalling Rhino 69 Extreme 50000 capsules to the consumer level. FDA analysis found the product to be tainted with undeclared tadalafil. Tadalafil is an active ingredient in a FDA-approved prescription drug that is used for erectile dysfunction. Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and PDE5 inhibitors can lead to fatal cardiovascular collapse.

Euphoric Capsules by Epic Products: Recall - Undeclared Sildenafil and Tadalafil
Overland Park, KS, Epic Products, LLC is voluntarily recalling all lots of Euphoric capsules, packaged in 1 count blister cards, 3 count bottles, and 12 count bottles to the consumer level. FDA analysis found samples of Euphoric to be tainted with undeclared sildenafil and tadalafil, active ingredients in two FDA-approved prescription drug products, also known as phosphodiesterase 5-inhibitors (PDE-5 inhibitors), used to treat male erectile dysfunction (ED). Consumers who take this product for ED could have underlying cardiovascular disease. Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and PDE-5 inhibitors can lead to fatal cardiovascular collapse.


Medical Product Approval

FDA authorizes new use of test, first to identify the emerging pathogen Candida auris
FDA has authorized the first test to identify the emerging pathogen Candida auris (C. auris), which can cause serious infections in hospitalized patients.

FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia
FDA has approved Crysvita (burosumab-twza), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets. XLH causes low levels of phosphorus in the blood. It leads to impaired bone growth and development in children and adolescents and problems with bone mineralization throughout a patient’s life.

FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems
FDA is permitting marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes.


From the Commissioner   

Statement from FDA Commissioner Scott Gottlieb, M.D., on new enforcement actions and a Youth Tobacco Prevention Plan to stop youth use of, and access to, JUUL and other e-cigarettes
Protecting our nation’s youth from the dangers of tobacco products is among the most important responsibilities of the U.S. Food and Drug Administration – and it’s an obligation I take personally. We recognize that if the FDA is to end the tragic cycle of successive generations of nicotine and tobacco addiction, we must take every opportunity to disrupt that process where it starts: youth access to and use of tobacco products.

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to encourage more widespread innovation and development of new treatments for opioid use disorder
Addressing the issue of opioid misuse and abuse remains one of my highest priorities. This is the most profound public health crisis facing the U.S. Food and Drug Administration and Americans. The FDA remains committed to take steps across all of its authorities to make significant inroads against this tragic epidemic. As part of this effort, we are committed to take steps to help those currently addicted to opioids, while taking steps to help prevent new cases of addiction.

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to enhance and modernize the FDA’s approach to medical device safety and innovation
Advances in material science, digital technology and advanced manufacturing are contributing to an unparalleled period of invention in medical devices. New devices offer more opportunities to improve health than at any time. Last year, the FDA approved a record number of novel devices. This reflects an advancing pace of innovation that’s resulting in many more potentially lifesaving new medical products. This includes the first artificial pancreas and the first blood test to evaluate traumatic brain injury.  


Upcoming Public Meetings

Most FD A meetings are free to the public and do not require the public to register.  Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee. Other types of meetings listed may require prior registration and fees.

View FDA Patient Network Calendar of FDA Sponsored Public Meetings for a list of meetings and workshops that may be of interest to pati ents and caregivers.

Opportunity to Comment

FDA rules have great impact on the nation’s health, these rules are formed with the public's help.  By law, anyone can participate in the rule-making process by commenting in writing.

View FDA Patient Network Opportunity to Comment on Current Draft Guidance page, for a list of current draft guidances and other topics of interest for patients and caregivers.


Drug Shortages

FDA knows the major public health consequences that can result from drug shortages. These shortages occur for many reasons including manufacturing and quality problems, delays and discontinuations. When issues are discovered, FDA works closely with the company to address risks involved to prevent harm to patients. FDA also considers the impact a shortage would have on patient care and access and works with the company to restore supplies while also ensuring safety for patients. The following list includes drugs currently in shortage, shortages recently resolved and drugs that have been discontinued.
More information on drug shortages and discontinuations: Drug Shortage Database and Vaccines, Blood and Biologic Shortages.

FDA Announcements

FDA takes new steps to advance the development of innovative products for treating opioid use disorder
FDA has announced today the latest action to encourage and support the development of treatment options for people with opioid use disorder (OUD). The agency has released the first of two new draft guidances intended to aid industry in developing new medications for use in medication-assisted treatment (MAT) for opioid dependence. The first guidance, released today, explains the FDA’s current thinking about drug development and clinical trial design issues relevant to the study of sustained-release “depot” buprenorphine products (i.e., modified-release products for injection or implantation).

FDA to offer a voluntary, more modern 510(k) pathway for enabling moderate risk devices to more efficiently demonstrate safety and effectiveness
The development of medical devices often includes iterative improvements over previous devices, and these small advances can enhance their overall safety and effectiveness. The aim of our review policies is to facilitate this sort of helpful evolution in product performance to benefit patients. As part of these efforts, we’ve proposed a new option for 510(k) clearance that will modernize the FDA’s approach to moderate risk devices by allowing manufacturers to use objective performance criteria to facilitate demonstration of substantial equivalence of their new products to legally marketed devices.

FDA finalizes guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests
FDA has finalized finalized two guidances to drive the efficient development of a novel technology that scans a person’s DNA to diagnose genetic diseases, which are usually hereditary, and guide medical treatments. The guidances provide recommendations for designing, developing, and validating tests that use the technology, called next generation sequencing (NGS), and will play an important role in the continued advancement of individualized, genetic-based medicine.

Guidance Documents:

Consumer Updates

FD A takes steps to protect consumers against dietary supplements containing dangerously high levels of extremely concentrated or pure caffeine
FDA has taken an im
portant step to better protect consumers from the dangers of highly concentrated and pure caffeine products. These products present a significant public health threat because of the high risk that they will be erroneously used at excessive, potentially dangerous doses. Highly concentrated and pure caffeine, often sold in bulk packages, have been linked to at least two deaths in otherwise healthy individuals.

Disposal of Unused Medicines: What You Should Know
When your medicines are no longer needed, they should be disposed of promptly. Consumers and caregivers should remove expired, unwanted, or unused medicines from their home as quickly as possible to help reduce the chance that others accidentally take or intentionally misuse the unneeded medicine, and to help reduce drugs from entering the environment. Below, we list some options and special instructions for you to consider when disposing of expired, unwanted, or unused medicines.


FDA on Social Media
Tweets you might have missed from FDA and the Commissioner!
  • DYK? #FDAORA Denver lab chemists have developed methods to analyze pet treats for illegal antibiotics and antivirals that can harm animals. https://go.usa.gov/xnued  #labweek
  • FDA & @CDCgov continue to warn consumers to NOT eat any #RomaineLettuce from Yuma, AZ, at this time. We are still investigating the source and will provide more information when it becomes available. https://go.usa.gov/xQbAz 
  • Did you know the FDA actively monitors levels of metals in food? See what our Toxic Elements Working Group of experts is doing to keep our food supply safe.https://go.usa.gov/xQjmM 
  • Are you a veteran and curious about clinical trials? Watch as U.S. Army Retired Staff Sergeant Quinyardo McClain shares his experience. https://youtu.be/zd4NAD9TsfY #NMHM18
Facebook posts you might have missed from FDA
  • Just in time for National Drug Take Back Day on Saturday, April 28th, check out FDA’s newly revised drug disposal page! This site contains information for patients and health care providers to help encourage patients to properly get rid of unused, unwanted, or expired prescription medications.www.fda.gov/drugdisposal
  • Kids are magnets for colds. But when the sniffles and sneezing won’t go away for weeks, the culprit may be allergies. Learn more about allergen triggers and what you can do to reduce exposure & treat symptoms. https://go.usa.gov/xQZ9K

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