Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication - FDA Evaluating Potential Risk of Serious Side Effects
FDA is investigating the safety of using codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for serious side effects, including slowed or difficult breathing.
Children, especially those who already have breathing problems, may be more susceptible to these serious side effects. In 2013, FDA warned against using codeine in children who recently had surgery to remove their tonsils and/or adenoids. More information
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Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication - Permanent Skin Color Changes
FDA is warning that permanent loss of skin color may occur with use of the Daytrana patch (methylphenidate transdermal system) for Attention Deficit Hyperactivity Disorder (ADHD). FDA added a new warning to the drug label to describe this skin condition, which is known as chemical leukoderma. See the FDA Drug Safety Communication for photos of chemical leukoderma.
Chemical leukoderma is a skin condition that causes the skin to lose color due to repeated exposure to specific chemical compounds. The condition is not physically harmful, but it is disfiguring. The areas of skin color loss described with the Daytrana patch ranged up to 8 inches in diameter. This condition is not thought to be reversible, which may cause emotional distress. More information
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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 |
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
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Drug Shortages Voluntarily Reported by Manufacturers During the Past 2 Weeks:
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
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New Drug to Treat Heart Failure Approved
FDA approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure.
Heart failure is a common condition affecting about 5.1 million people in the United States. It is a condition in which the heart can't pump enough blood to meet the body's needs. Heart failure generally worsens over time as the heart's pumping action grows weaker. The leading causes of heart failure are diseases that damage the heart, such as heart attacks and high blood pressure.
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New Treatment for Cystic Fibrosis approved
FDA approved the first drug for cystic fibrosis directed at treating the cause of the disease in people who have two copies of a specific mutation.
Orkambi (lumacaftor 200 mg/ivacaftor 125 mg) is now approved to treat cystic fibrosis (CF) in patients 12 years and older, who have the F508del mutation, which causes the production of an abnormal protein that disrupts how water and chloride are transported in the body. Having two copies of this mutation (one inherited from each parent) is the leading cause of CF. More information
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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.
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- Request for comment by July 13, 2015: Draft Guidance - Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
FDA announced the availability of a revised draft guidance for industry entitled “Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.” This draft guidance provides answers to common questions from sponsors interested in developing proposed biosimilar products, BLA holders, and other interested parties regarding FDA's interpretation of the BPCI Act. This guidance revises the draft guidance entitled “Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009,” issued February 15, 2012, to provide new and revised Q&As. It also includes certain original Q&As that have not yet been finalized. To read the entire Federal Register Notice and to
make comments electronically.
- Request for comment by July 13, 2015: Public Meeting- Patient-Focused Drug Development for Functional Gastrointestinal Disorders
FDA is holding public meeting and an opportunity for public comment on Patient-Focused Drug Development for functional gastrointestinal (GI) disorders, including irritable bowel syndrome, gastroparesis, chronic persistent symptomatic gastroesophageal reflux despite standard therapeutic interventions, and chronic idiopathic constipation. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). To read the entire Federal Register Notice and to make comments electronically.
- Request for comment by July 14, 2015: Draft Guidance- Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products
FDA announced the availability of a draft document entitled “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry.” The draft guidance document provides blood establishments that collect blood or blood components, including Source Plasma, with revised donor deferral recommendations for individuals at increased risk for transmitting human immunodeficiency virus (HIV) infection. The draft guidance document recommends corresponding revisions to donor education materials, donor history questionnaires and accompanying materials, along with revisions to donor requalification and product management procedures. To read the entire Federal Register Notice and to
make comments electronically.
Federal judge enters permanent injunction against Acino Products, LLC
A federal judge for the District of New Jersey has entered a consent decree of permanent injunction between the United States and Acino Products LLC (Acino), of Hamilton, New Jersey, and the company’s president, Ravi Deshpande, for marketing unapproved and misbranded prescription drugs.
The U.S. Department of Justice brought the action on behalf of the U.S. Food and Drug Administration.
According to the complaint, Acino marketed unapproved prescription drugs, hydrocortisone acetate 25 mg suppositories under the brand names Rectacort-HC and GRx HiCort 25, for treatment of medical conditions including inflamed hemorrhoids, chronic ulcerative colitis, and other inflammatory conditions.More information
OtisMed Corporation former CEO sentenced for shipping adulterated knee replacement cutting guides
The U.S. District Court of the District of New Jersey sentenced the OtisMed Corporation’s (OtisMed) former chief executive officer, Charlie Chi, to 24 months in prison and also ordered him to serve one year of supervised release and to pay a $75,000 fine.
In December 2014, OtisMed agreed to pay more than $80 million to resolve related criminal and civil liability related to charges of distributing adulterated medical devices with intent to defraud and mislead. At that same time, Chi pleaded guilty to introducing adulterated medical devices into interstate commerce. More information
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Salon Professionals: Fact Sheet
FDA often gets questions from both salon professionals and their clients about the safety of cosmetic products used in hair, nail, skin care, and spray tanning salons. We have compiled a list of resources people often ask for when they’re concerned about salon safety. More information
FDA often gets questions from both salon professionals and their clients about the safety of cosmetic products used in hair, nail, skin care, and spray tanning salons. We have compiled a list of resources people often ask for when they’re concerned about salon safety. 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.
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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.
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FDA: Use Only Approved Prescription Ear Drops
FDA wants to make sure that the next time your child has ear pain requiring a prescription drug, the product has been approved by FDA as safe and effective.
That’s why FDA is notifying companies to stop marketing 16 unapproved prescription drugs labeled to relieve ear pain and swelling. These ear drops contain active ingredients such as benzocaine and hydrocortisone but have not been evaluated by FDA for safety, effectiveness and quality.
For years, health care providers have prescribed—and pharmacies have sold—these drug products whose labels did not disclose that they weren’t approved by FDA. More information and to read the FDA News Release
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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
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
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
Eating Outdoors, Handling Food Safely
Picnic and barbecue season offers lots of opportunities for outdoor fun with family and friends. But these warm weather events also present opportunities for foodborne bacteria to thrive. As food heats up in summer temperatures, bacteria multiply rapidly.
To protect yourself, your family, and friends from foodborne illness during warm-weather months, safe food handling when eating outdoors is critical. Read on for simple food safety guidelines for transportingyour food to the picnic site, and preparing and serving it safely once you've arrived. More information
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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
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FDA Issues Nicotine Exposure Warnings and Child-Resistant Packaging ANPRM
FDA issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking comments, data, research, and/or other information related to nicotine exposure warnings and child-resistant packaging for liquid nicotine, nicotine-containing e-liquid(s), and potentially for other tobacco products including, but not limited to novel tobacco products such as dissolvables, lotions, gels, and drinks.
FDA has evaluated data and science related to the risks, especially to infants and children, from accidental exposure to nicotine, including exposure to liquid nicotine and nicotine-containing e-liquid(s).More information
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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.
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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
Educational Videos
FDA Food Safety and Modernization Act: An FDA PrimerThe Rulemaking Process: An FDA Primer What is Regulatory Science Taking Acetaminophen Safely
Director's Corner Podcasts
The Director’s Corner is a quarterly audio podcast series featuring the director of FDA’s Center for Drug Evaluation and Research and produced by CDER’s Office of Communications. As 2015 begins, Dr. Woodcock discusses major events of 2014 and priorities for 2015. |
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 /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.
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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 |
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