miércoles, 28 de febrero de 2018

FDA Patient Network News - February 28, 2018

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Medical Product Safety

Recall: Bella Diet Capsules by Bella All Natural - Presence of Sibutramine
This recall has been initiated due to presence of sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 due to safety concerns. N-Desmethyl sibutramine is an active metabolite of sibutramine. Sibutramine and its active metabolites substantially increase blood pressure and/or pulse rate in some patients and may present significant health risks including heart attack, arrhythmia, and stroke. More information

Class I Recall: Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs) by Medtronic
Manufacturing Error Preventing Electrical Shock Delivery Delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient’s heart whose heartbeat is too slow could result in serious injury and/or death. Medtronic is recalling certain ICDs and CRT-Ds due to a defect in the manufacturing process.  This defect causes an out of specification gas mixture inside the device and may prevent the device from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest. More information

Recall: FDA oversees destruction and recall of kratom products; and reiterates its concerns on risks associated with this opioid
The FDA announced the voluntary destruction and recall of a large volume of kratom-containing dietary supplements manufactured and distributed nationwide under the brand names Botany Bay, Enhance Your Life and Divinity by Divinity Products Distribution of Grain Valley, Missouri. In cooperation with the FDA, the company has also agreed to stop selling all products containing kratom. More information

FDA Drug Safety Communication: FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease
The FDA  is advising caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later. Our recommendation is based on our review of the results of a 10-year follow-up study1 of patients with coronary heart disease from a large clinical trial2 that first observed this safety issue. More information

Medical Product Approval

FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer progressing
The FDA approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation). More information

FDA expands treatment window for use of clot retrieval devices in certain stroke patients
The FDA cleared the use of the Trevo clot retrieval device to treat certain stroke patients up to 24 hours after symptom onset, expanding the device’s indication to a broader group of patients. More information

FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint
The FDA approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer. More information

FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults
The FDA permitted marketing of the first blood test to evaluate mild traumatic brain injury (mTBI), commonly referred to as concussion, in adults. The FDA reviewed and authorized for marketing the Banyan Brain Trauma Indicator in fewer than 6 months as part of its Breakthrough Devices Program. More information 

From the Commissioner

Ongoing efforts to help improve effectiveness of influenza vaccines
The current influenza season has been especially difficult, causing widespread illness that has affected all fifty states and resulted in a record number of hospitalizations. While healthcare professionals continue to combat this year’s flu – which may continue to affect Americans into April – we’re already partnering with other public health agencies to conduct essential work to produce next season’s influenza vaccines. More information

The efficacy of the 2017-2018 influenza vaccine
Seasonal flu has been widespread this year, impacting millions of people across the country. It has been an especially challenging season, with high rates of hospitalization for both influenza and its complications, which include pneumonia and the exacerbation of chronic conditions such as asthma and congestive heart failure. More information

Advancing the development of novel treatments for neurological conditions; part of broader effort on modernizing FDA’s new drug review programs
New medical breakthroughs are altering how diseases are treated in ways that seemed unimaginable just a decade ago. Perhaps one of the most significant developments is the advent of new gene therapies and drugs that boost the immune system’s ability to target tumor cells. More information

Upcoming Public Meetings

Most FDA 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 patients 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

Discovering New Voices for Novel Treatments: Rare Disease Day 2018
Scientists have identified nearly 7,000 rare diseases ranging from rare cancers to metabolic disease and in the United States alone, more than 30 million people—or 1 out of every 10 Americans—have at least one rare disease. Tragically, more than half of these people are children.

The United States observes the last day of February as Rare Disease Day to raise awareness among the public and decision-makers about rare diseases and their impact on patients’ lives. Here at FDA, the observance has been expanded to include a full week of activities to reflect on what progress we have made—and what more needs to be done.
More information

Celebratory Program on March 1, 2018
FDA will join the National Institutes of Health (NIH) to celebrate Rare Disease Day with a one-day program at NIH Masur Auditorium on March 1, 2018.  The FDA's Office of Orphan Products Development will present FDA rare disease highlights and its grants research collaboration with NIH for rare diseases. For more information about this event, see Rare Disease Day at NIH 2018.

Consumer Updates

Traumatic Brain Injury: FDA Actions and Research
A car accident. A football tackle. An unfortunate fall. These things—and more—can cause head injuries. Head injuries can happen to anyone, at any age, and they can damage the brain. Here’s how damage can happen: A sudden movement of the head and brain can cause the brain to bounce or twist in the skull, stretching and injuring brain cells and creating chemical changes. This damage is called a traumatic brain injury, or “TBI.” The FDA continues to research TBI—and encourage the development of new medical devices to help diagnose and treat it. More information 

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