CIENCIASMEDICASNEWS: FDA Patient Network Newsletter

Safe medicine disposal options
Last year Americans filled 4.3 billion prescriptions. It is clear that prescription drugs play an important role in managing a range of medical conditions and are widely used in homes across the United States.. But the drug life-cycle is not complete until the medicine has been consumed in its entirety or eventually discarded properly. However, little attention is given to the potential risks, such as accidental exposure or intentional misuse, related to improper medicine disposal. Where should unused and expired medicines go? Let’s look at drug disposal and get a better understanding of why it’s important to safeguard medicines in the home and how to properly dispose them when no longer needed. More information

MedWatch Safety Alert: Sterile Compounded Products by US Compounding, Inc: Recall - Lack of Sterility Assurance
US Compounding, Inc. is voluntarily recalling all lots of sterile products aseptically compounded and packaged by USC and that remain within expiry due to FDA concern over a lack of sterility assurance. The sterile products were distributed nationwide to patients, providers, hospitals, or clinics between March 14, 2015 and September 9, 2015. If the sterility of a compounded preparation intended to be sterile is compromised, patients may be at risk.

Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Providers who have dispensed any sterile product distributed by USC to a patient(s) for use outside of the provider's office should contact the patient(s) to whom product was dispensed and advise the patient(s) of this recall. More information

WARNING: Dose Confusion and medication with antibacterial drug Avycaz (ceftazidime and avibactam)
Warning issued to health care professionals about the risk for dosing errors with the intravenous antibacterial drug Avycaz (ceftazidime and avibactam) due to confusion about the drug strength displayed on the vial and carton labels. Avycaz was initially approved with the vial and carton labels displaying the individual strengths of the two active ingredients (i.e., 2 gram/0.5 gram); however, the product is dosed based on the sum of the active ingredients (i.e., 2.5 gram). To prevent medication errors, we have revised the labels to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram (see Photos).

Avycaz is approved for intravenous administration to treat complicated infections in the urinary tract, or in combination with the antibacterial drug metronidazole to treat complicated infections in the abdomen in patients with limited or no alternative treatment options. Antibacterial drugs work by killing or stopping the growth of bacteria that can cause illness. More Information

Comunicaciones de la FDA sobre la seguridad de los medicamentos en español
Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información importante sobre seguridad de los medicamentos en idiomas distintos al inglés. Hacemos lo mejor posible para proporcionar versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en inglés y la de español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information endruginfo@fda.hhs.gov. Comunicaciones de la FDA

Empty Medicine Cabinet with Empty Medicine Bottle

FDA recognizes the significant public health consequences that can result from drug shortages and takes tremendous efforts within its legal authority to address and prevent drug shortages. These shortages occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. When issues are discovered by the company or the public and reported to FDA or are found by FDA upon inspection, FDA works closely with the firm 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 firm to restore supplies while also ensuring safety for patients. More information

Drug Shortages Voluntarily Reported by Manufacturers During the Past 2 Weeks:

Drugs Reported to be Discontinued by Manufacturers During the Past 2 Weeks:

More information about drug shortages, drug shortages resolved, and drugs to be discontinued

Information about blood and biologic shortages, resolved shortages, and discontinuations

La FDA reconoce las consecuencias significativas para la salud pública que pueden resultar de la escasez de medicamentos y hace un gran esfuerzo dentro de sus facultades legales para abordar yprevenir la escasez de medicamentos. La escasez se produce por muchas razones, incluyendoproblemas de fabricación y calidad, retrasos y discontinuación del producto. Cuando los problemas son descubiertos por la empresa o el público y reportados a la FDA o se descubren por inspecciones de la FDA, la FDA trabaja en estrecha colaboración con la empresa para hacer frente a los riesgosinvolucrados y evitar daños a los pacientes. La FDA también considera el impacto que una escaseztendría en la atención médica del paciente y al acceso del producto y trabaja con la empresa pararestablecer el suministro al tiempo que garantiza la seguridad de los pacientes. Más información

FDA permits marketing of new laser-based hearing aid with potential for broad sound amplification
The FDA allowed marketing of a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound. The combination of laser light pulses and a custom-fit device component that comes in direct contact with the eardrum is designed to use the patient’s own eardrum as a speaker and enables amplification over a wider range of frequencies for some hearing impaired persons. The EarLens Contact Hearing Device (CHD) is indicated for use by adults with mild to severe sensorineural hearing impairment. More information

New oral medication to treat patients with advanced Colorectal cancer approved
Lonsurf (a pill that combines two drugs, trifluridine and tipiracil) for patients with an advanced form of colorectal cancer who are no longer responding to other therapies is now FDA approved.

“The past decade has brought a new understanding around colorectal cancer, in how we can both detect and treat this often devastating disease,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “But there are many patients who still need additional options, and today’s approval is a testament to the FDA’s commitment to work with companies to develop new drugs in disease areas where unmet needs remain.”More information

Two new drug treatments for diabetes mellitus approved
Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus are now FDA approved.

According to the Centers for Disease Control and Prevention, approximately 21 million people in the United States have been diagnosed with diabetes. Over time, diabetes increases the risk of serious health complications, including heart disease, blindness, nerveand kidney damage. Improvement in blood sugar control can reduce the risk of some of these long-term complications. More information

New drug to treat schizophrenia and bipolar disorder approved
The FDA approved Vraylar (cariprazine) capsules to treat schizophrenia and bipolar disorder in adults.

“Schizophrenia and bipolar disorder can be disabling and can greatly interfere with day-to-day activities,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “It is important to have a variety of treatment options available to patients with mental illnesses so that treatment plans can be tailored to meet a patient’s individual needs. More information

For information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed.

View FDA's Comments on Current Draft Guidance page, for a list of current draft guidances and other topics of interest for patients and caregivers.

FDA Awards 18 grants to stimulate product development for rare diseasesFDA announced it has awarded 18 new research grants totaling more than $19 million to boost the development of products for patients with rare diseases, which affect the lives of nearly 30 million Americans. These new grants were awarded to principal investigators in ten states, with research spanning clinical sites domestically and internationally. More Information

First- Ever Patient Engagement Advisory Committee Created at FDA, by Nina L. Hunter, Ph. D, Regulatory Scientist, CDRH; and Robert F. Califf, M.D, Deputy Commissioner for Medical Products and Tobacco
Although it may seem odd in retrospect, the development of new technologies intended to improve patients’ lives has largely relied upon expert opinions rather than asking patients and families directly what they consider most important.

But that’s changing. We are entering an era of “patient-centered” medicine in which patients and their care partners participate actively in decision-making and priority-setting about all aspects of health care. Americans are becoming increasingly active consumers of health care, making choices about their doctors, diagnostics, treatments, and healthcare experiences rather than simply allowing health care providers to make the decisions for them. Moreover, FDA believes that patients can and should bring their own experiences to bear in helping the Agency define meaningful benefits or unreasonable risks for certain new devices.

To read the rest of this post, see FDA Voice Blog, September 18, 2015.

Federal judge enters permanent injunction against Florida dietary supplements maker, Sunset Natural Products Inc.
U.S. Magistrate Judge Edwin G. Torres for the U.S. District Court for the Southern District of Florida entered a consent decree of permanent injunction on Sept. 25, 2015, against Sunset Natural Products Inc. and its two owners, Teresa Martinez (a.k.a. Teresa Martinez-Arroyo) and Elsy Cruz, for manufacturing and distributing adulterated dietary supplements at its facility located in Miami, Florida.

The complaint filed by the U.S. Department of Justice sought the permanent injunction against the company and its owners for manufacturing dietary supplements under conditions that do not meet the U.S. Food and Drug Administration’s current Good Manufacturing Practice (cGMP) requirements. Under the terms of the consent decree, the company will not be allowed to manufacture or sell dietary supplement products until the FDA has determined that the business is in compliance with the Federal Food, Drug, and Cosmetic Act. More information

FDA advisory committee meetings are free and open to the public. No prior registration is required to attend. 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's Calendar of Public Meetings page for a complete list of meetings and workshops.

Please visit FDA’s Advisory Committee page to obtain advisory committee meeting agendas, briefing materials, and meeting rosters prior to the meetings. You may also visit this page after meetings to obtain transcripts, presentations, and voting results. For additional information on other agency meetings please visit Meetings, Conferences, & Workshops.

When Sun and Medicines don't mix
Fun in the sun can be had all year long -- hiking, winter skiing, swimming, or just enjoying the warmth of the sun. However, when taking certain medicines, life in the sun can sometimes be less than fun.

Some medicines contain ingredients that may cause photosensitivity -- a chemically induced change in the skin. Photosensitivity makes a person sensitive to sunlight and can cause sunburn-like symptoms, a rash or other unwanted side effects. It can be triggered by products applied to the skin or medicines taken by mouth or injected. More information

More Consumer Updates
For previously published Consumer Update articles that are timely and easy-to-read and cover all FDA activities and regulated products. More information

En Español
La información en esta página es para el público en general, y para profesionales y educadores de salud. Esta información puede ser distribuida y publicada sin previa autorización. En Español

Information about Expanded Access
Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA). FDA is committed to increasing awareness of and knowledge about its expanded access programs and the procedures for obtaining access to human investigational drugs (including biologics) and medical devices. General information

Learn about what your physician should do before submitting a request for individual patient expanded access use of an investigational medical product, who may be eligible for expanded access, associated costs, FDA contacts and more. Information for Patients

Learn about your responsibilities under the expanded access pathway, how to submit a request for expanded access for an individual patient (including for emergency use), which forms to use, FDA contacts and more. Information for Physicians

Farmer's Markets are a Resource to Add Fruits and Vegetables to Your Diet.Fruits and vegetables are an important part of a healthy diet. Your local markets carry an amazing variety of fresh fruits and vegetables that are both nutritious and delicious. However, harmful bacteria that may be in the soil or water where produce grows may come in contact with fruits and vegetables and contaminate them. Fresh produce may also become contaminated after it is harvested, such as during preparation or storage. Eating contaminated produce (or fruit and vegetable juices made from contaminated produce) can lead to food-borne illness, often called “food poisoning.” As you enjoy fresh produce and fresh-squeezed fruit and vegetable juices, follow these safe handling tips to help protect yourself and your family. More Information

Center for Food Safety and Applied Nutrition
The Center for Food Safety and Applied Nutrition, known as CFSAN, carries out the mission of FDA. The Center provides services to consumers, domestic and foreign industry and other outside groups regarding field programs; agency administrative tasks; scientific analysis and support; and policy, planning and handling of critical issues related to food and cosmetics. More information

Food Facts for You
The Center for Food Safety and Applied Nutrition, known as CFSAN, issues food facts for consumers to keep you and your family safe. More information

Animal Health Literacy
Animal Health Literacy means timely information for the benefit of all animals and their humans. With continuous communication and outreach, the Center for Veterinary Medicine (CVM) strives to enhance the public trust, promote safe and effective use of the animal health products we regulate, and share our scientific endeavors. CVM provides reliable, science-based information to promote animal and human health. More information and Publicaciones en Español del

Animal and Veterinary Updates
Animal and veterinary updates provide information to keep your pets healthy and safe. More information

How to Report a Pet Food Complaint
You can report complaints about a pet food product electronically through the Safety Reporting Portal or you can call your state’s FDA Consumer Complaint Coordinators.

Please have as much of the following information available when submitting your complaint: Consumers often transfer dry pet food into other containers for easier handling. If possible, please save the original packaging until the pet food has been consumed. The packaging contains IMPORTANT information often needed to identify the variety of pet food, the manufacturing plant, and the production date. More information

FDA and the Department of Defense: A Joint Force to Reduce Tobacco Use in the Military, by Kathy Crosby, FDA’s Director, Office of Health Communication and Education, Center for Tobacco Products
Tobacco use continues to be a serious problem, particularly in the military community. So when I presented FDA’s award-winning The Real Cost ads at the Interagency Committee on Smoking and Health earlier this year, they caught the eye of Public Health Service Capt. Kimberly Elenberg, a program manager from the Department of Defense’s Defense Health Agency (DHA). She was looking for a way that FDA and DHA could work together to reduce smoking rates among the military community, especially youth.

To read the rest of this post, see FDA Voice Blog, September 22, 2015.

Public Health Education
Tobacco products are harmful, yet widely used, consumer products that are responsible for severe health problems in both users and non-users. These health problems include cancer, lung disease, and heart disease, which often lead to death.

Access the latest Health Information available from our Federal partners.
Learn about Tobacco-Related Health Fraud.

Public Education Campaigns
We are investing in a number of public education campaigns, such as The Real Cost, to help educate the public – especially youth – about the dangers of regulated tobacco products. Rooted in science, these efforts are directly linked to our authority to regulate the marketing and sales of tobacco products. More information

Youth and Tobacco
We are working to protect the health of America’s children and ultimately reduce the burden of illness and death caused by tobacco use. More information

FDA Basics
Each month, different centers and offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA. More information

Patient Network Webinars
Through our webinars and presentations, the Office of Health and Constituent Affairs brings information to you on many topics related to patient engagement, medical product (Drugs, Biologics, Devices) approval and medical product safety updates. More information

Educational Videos
FDA Food Safety and Modernization Act: An FDA Primer The Rulemaking Process: An FDA Primer
What is Regulatory Science
Taking Acetaminophen Safely

healthfinder.gov
Welcome to healthfinder.gov, a government Web site where you will find information and tools to help you and those you care about stay healthy.More information and más información

FDA E-list
Sign up for one of the FDA disease specific e-mail list that delivers updates, including product approvals, safety warnings, notices of upcoming meetings, and notices on proposed regulatory guidances.

You may wish to sign up for other email updates from the FDA - see other email updates.

Patient Network - Bring Your Voice to FDA
An interactive tool for educating patients, patient advocates, and consumers on how their medications - both prescription and over-the-counter - and medical devices move from the realm of idea to the realm of the marketplace. More information