ATTENTION: Newsletter Update
Subscribers have probably noticed changes to the FDA Patient Network Newsletter over the past several months. The Office of Health and Constituent Affairs' staff is continuing to look into how to improve and streamline FDA's communications to you in the near future.
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The FDA Patient Network Newsletter Team
Medical Product Safety
Lamictal (lamotrigine): Drug Safety Communication - Serious Immune System Reaction
FDA is warning that the medicine Lamictal (lamotrigine) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. As a result, we are requiring a new warning about this risk be added to the prescribing information in the lamotrigine drug labels.
Medical Product Approval
FDA approves new uses for two drugs administered together for the treatment of BRAF-positive anaplastic thyroid cancer
FDA has approved Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body (metastatic), and has a type of abnormal gene, BRAF V600E (BRAF V600E mutation-positive).
From the Commissioner
Statement from FDA Commissioner Scott Gottlieb, M.D., on the public health benefits from enactment of menu labeling
Science tells us that improvements in diet and nutrition offer one of our greatest opportunities to have a profound and generational impact on human health, reducing the burden of chronic disease, from diabetes to cancer to heart disease. We know that many Americans both want and use nutritional information on food package labels to make decisions about what to eat to help improve their health. But consumers can’t always access similar information at their favorite restaurant chains. Or there is little consistency in the information that they receive. Yet more Americans are eating meals away from home.
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. Please visit the following FDA pages to see up-to-date information on upcoming public meetings.
- FDA - Advisory Committee Section
- FDA - Workshops, Meetings, and Conferences (non-advisory committee)
- CBER (Biologics) - Workshops, Meetings and Conferences
- CDER (Drugs) - Workshops, Meetings and Conferences
- CDRH (Medical Devices) - Workshops, Meetings and Conferences
- CFSAN (Food Safety) - Workshops, Meetings and Conferences
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.
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 over the past two weeks.
- Pentoxifylline Extended-Release Tablets (Discontinued)
- Penicillin G Benzathine (Bicillin L-A) Injection (Shortage Resolved)
- Morphine Sulfate Extended-Release Tablets (Discontinued)
- Indomethacin Capsules (Discontinued)
- Disulfiram Tablets (Discontinued)
- Dextroamphetamine Sulfate Extended-Release Capsules (Discontinued)
- Clonazepam Tablets (Discontinued)
- Gabapentin Capsules (Discontinued)
- Lorazepam Injection, USP (Currently in Shortage)
- Sodium Iodide I 131 Capsules (Discontinued)
- Sodium Iodide I 131 Solution (Discontinued)
- Hepatitis B Vaccine (Recombinant) (Currently in Shortage)
- Isoniazid Oral Tablets (Discontinued)
- Stavudine Capsules (Discontinued)
- Magnesium Sulfate Injection (Currently in Shortage)
- Methadone Hydrochloride Injection (Currently in Shortage)
- Lidocaine HCl Topical Jelly (Discontinued)
More information on drug shortages and discontinuations: Drug Shortage Database and Vaccines, Blood and Biologic Shortages.
FDA, FTC take action against companies misleading kids with e-liquids that resemble children’s juice boxes, candies and cookies
As part of ongoing efforts to protect youth from the dangers of nicotine and tobacco products, today the U.S. Food and Drug Administration and the Federal Trade Commission (FTC) issued 13 warning letters to manufacturers, distributors, and retailers for selling e-liquids used in e-cigarettes with labeling and/or advertising that cause them to resemble kid-friendly food products, such as juice boxes, candy or cookies, some of them with cartoon-like imagery. Several of the companies receiving warning letters were also cited for illegally selling the products to minors.
FDA In Brief: FDA brings additional efficiency and modernization to regulation of digital health, as part of the Digital Health Innovation Action Plan
FDA recognizes that it can help encourage digital health innovation by making its policies and processes more efficient and modernizing its regulatory tools. As part of the FDA’s Digital Health Innovation Action Plan issued in 2017, the agency committed to developing a new regulatory framework for reviewing software as a medical device and issuing a suite of guidances to provide transparency and clarity to product developers about the agency’s regulatory process.
Advancing the Development of Treatments for Neurological Disorders
FDA recently published five guidances for industry related to neurological conditions. The release of these guidances was noteworthy for many reasons and reflects a renewed commitment to describing the agency’s thinking and providing advice on conducting clinical studies in specific neurological indications. Billy Dunn, who is the director of CDER’s Division of Neurology Products, discusses the guidances and why they are significant.
Overall, five guidances were released. Two of the guidances are final versions. These are:
- Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment
- Migraine: Developing Drugs for Acute Treatment
- Early Alzheimer’s Disease: Developing Drugs for Treatment
- Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment
- Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 4 Years of Age and Older
What FDA is Doing to Protect Consumers from Toxic Metals in Foods
A reality about our food supply is that metals, such as arsenic, lead, cadmium, mercury and others - are present in certain foods. These elements occur naturally and as environmental pollutants in air, water and soil and they enter the food supply when plants take them up as they grow. FDA actively monitors the levels of these metals because at high levels they can be toxic and present a unique danger to those who are the most vulnerable: our children. The agency is working to reduce the health risks that these elements present and last year established a work group of food safety experts to help shape what FDA will do to protect consumers of all ages from these metals when present in foods.
FDA on Social Media
Tweets you might have missed from NIH, FDA, and the Commissioner!
@NIHDirector, Dr. Francis Collins, use his musical talent to thank HHS employees for the work they do every day to help the American public: https://youtu.be/u5Ez-tUEcaU #PSRW #HHSPSRW
- Sign up for FDA’s Predictive
#Toxicology Roadmap: Implications & Opportunities for Stakeholders webcast #FDAGrandRounds May 10 presentation by Dr. Suzanne Fitzpatrick. #Organs-on-a-Chiphttps://go.usa.gov/xQ8Ze
- Visit our Flickr album for examples of signage consumers can expect to see at restaurants as FDA’s new menu labeling rule is implemented: https://www.flickr.com/photos/
- On May 16, 2018 from 1:00 pm - 2:30 pm ET, join the FDA Office of Women’s Health for The Great Debate! The debate centers on cardiovascular disease clinical trials and the challenges and complexity of the question “What is enough?” when determining participation of women in these trials. FDA Commissioner Scott Gottlieb, M.D. will provide the keynote in celebration of National Women’s Health Week. http://go.usa.gov/xQ9Xq
- Are you pregnant and taking medication? Participate in a pregnancy registry to help improve safety info for future moms! https://go.usa.gov/xQNcw
- FDA makes sure medical countermeasures (MCMs) are safe and effective. Our work to support MCM availability includes: reviewing evidence for approval, conducting regulatory science, ensuring policy and legal support, and working with many partners.https://go.usa.gov/xQDuM