March 28, 2018
Medical Product Safety
Tamarack Inc. of Roy, Utah is voluntarily recalling Eclipse Kratom-containing powder products because it has the potential to be contaminated
The affected powder products are packaged in plastic heat sealed pouches or plastic sealed bottles sold in one gram capsules and powder. Distribution of an estimated 120 units were sold directly to five retailers in Utah.Tamarack article
PDX Aromatics Expands Recall of Kratom Products Because of Possible Health Risk
PDX Aromatics, DBA Kraken Kratom, Phytoextractum, and Soul Speciosa, is expanding the scope of their 3/9/2018 voluntary recall of certain kratom white vein powder and capsule products and red vein powder products because they have the potential to be contaminated with Salmonella. PDX article
FDA warns consumers not to use unapproved erectile dysfunction products advertised on the radio
The FDA is warning consumers not to purchase or use drugs advertised nationwide as a “healthy man alternative to the little blue pill” or “healthy man,” or “the power pill” for erectile dysfunction on broadcast and internet radio platforms such as iHeart Radio, as these drugs have not been approved by FDA. Erectile dysfunction article
Bayer Issues Voluntary Recall of Alka-Seltzer Plus® Products due to labeling errors
Bayer is voluntarily recalling Alka-Seltzer Plus® packages that were sold only in the U.S. at Walmart, CVS, Walgreens and Kroger (including Dillons Food Stores, Fred Meyer, Fry’s Food Stores, Ralphs, King Soopers and Smith’s Food and Drug) after February 9, 2018. Bayer article
FDA investigates two adverse events associated with United Pharmacy’s compounded glutamine, arginine, and carnitine product for injection
FDA laboratory analysis found the glutamine in United Pharmacy’s compounded glutamine, arginine, and carnitine (GAC) 10/100/200 mg/mL product for injection is degrading before the beyond-use date (BUD) of 6 months specified on the product label. United Pharmacy's article
Medical Product Safety
Tamarack Inc. of Roy, Utah is voluntarily recalling Eclipse Kratom-containing powder products because it has the potential to be contaminated
The affected powder products are packaged in plastic heat sealed pouches or plastic sealed bottles sold in one gram capsules and powder. Distribution of an estimated 120 units were sold directly to five retailers in Utah.Tamarack article
PDX Aromatics Expands Recall of Kratom Products Because of Possible Health RiskPDX Aromatics, DBA Kraken Kratom, Phytoextractum, and Soul Speciosa, is expanding the scope of their 3/9/2018 voluntary recall of certain kratom white vein powder and capsule products and red vein powder products because they have the potential to be contaminated with Salmonella. PDX article
FDA warns consumers not to use unapproved erectile dysfunction products advertised on the radio
The FDA is warning consumers not to purchase or use drugs advertised nationwide as a “healthy man alternative to the little blue pill” or “healthy man,” or “the power pill” for erectile dysfunction on broadcast and internet radio platforms such as iHeart Radio, as these drugs have not been approved by FDA. Erectile dysfunction article
Bayer Issues Voluntary Recall of Alka-Seltzer Plus® Products due to labeling errorsBayer is voluntarily recalling Alka-Seltzer Plus® packages that were sold only in the U.S. at Walmart, CVS, Walgreens and Kroger (including Dillons Food Stores, Fred Meyer, Fry’s Food Stores, Ralphs, King Soopers and Smith’s Food and Drug) after February 9, 2018. Bayer article
FDA investigates two adverse events associated with United Pharmacy’s compounded glutamine, arginine, and carnitine product for injection
FDA laboratory analysis found the glutamine in United Pharmacy’s compounded glutamine, arginine, and carnitine (GAC) 10/100/200 mg/mL product for injection is degrading before the beyond-use date (BUD) of 6 months specified on the product label. United Pharmacy's article
Medical Product Approval
FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices
The FDA permitted marketing of the Dexcom G6 integrated continuous glucose monitoring (iCGM) system for determining blood glucose (sugar) levels in children aged two and older and adults with diabetes. Glucose monitoring system article
FDA approves new indication for Adcetris (brentuximab vedotin)
The FDA approved Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy. Adcetris article
From the Commissioner
Efforts to reduce tobacco use, especially among youth, by exploring options to address the role of flavors ‒ including menthol ‒ in tobacco productsThe thought of any child starting down a path of a lifelong addiction to tobacco, which could ultimately lead to their death, is unacceptable. We need to take every effort to prevent kids from getting hooked on nicotine. To that end, the FDA's comprehensive plan we announced last summer to regulate tobacco and nicotine first-and-foremost seeks to better protect our nation’s youth, as well as future generations, from the disease and death caused by tobacco use
Tobacco products article
Pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels
When I returned to the FDA last year, it was immediately clear that tackling tobacco use – and cigarette smoking in particular – would be one of the most important actions I could take to advance public health. With that in mind, we’re taking a pivotal step today that could ultimately bring us closer to our vision of a world where combustible cigarettes would no longer create or sustain addiction – making it harder for future generations to become addicted in the first place and allowing more currently addicted smokers to quit or switch to potentially less harmful products. Lowering nicotine article
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 Seeks Information on Role of Flavors in Tobacco Products
FDA issued an advance notice of proposed rulemaking (ANPRM) seeking comments, data, research results, or other information related to the role that flavors, including menthol, play in tobacco product use and potential regulatory options the agency could take, such as tobacco product standards and measures related to the sale and distribution of flavored tobacco products. Comment here
FDA Seeks Public Comment on a Potential Product Standard to Lower Nicotine in Cigarettes to a Minimally or Non-Addictive Level
Food and Drug Administration (FDA) issued Tobacco Product Standard for Nicotine Level of Combusted Cigarettes, an advance notice of proposed rulemaking (ANPRM) seeking public comment for consideration in developing a potential nicotine product standard. Lowering nicotine to a minimally or non-addictive level could potentially save millions of lives, both in the near and long-terms.Comment here
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.
- Betaine Hydrochloride (Cystadane) for Oral Solution (Resolved)
- Cardene IV (nicardipine hydrochloride) 0.2 mg/mL in 5% Dextrose (Discontinuation)
- Ceftazidime (Fortaz) Injection (Discontinuation)
- Cefuroxime Sodium (Zinacef) Injection (Discontinuation)
- Montelukast Sodium Tablets (Discontinuation)
- Triamcinolone Acetonide Cream (Discontinuation)
- Lamivudine and Zidovudine Tablets (Discontinuation)
- Lamivudine Tablets (Discontinuation)
More information on drug shortages and discontinuations: Drug Shortage Database and Vaccines, Blood and Biologic Shortages.
FDA Announcements
FDA’s New Pilot Program Aims for More Transparency about New Drug Approvals By: Janet Woodcock, M.D., of FDA’s Center for Drug Evaluation and ResearchWhen FDA approves a new drug, it has been found safe and effective when used under the conditions described in the label. Although this concept seems simple, the execution can be complex. Many factors are involved in weighing the benefits a drug can provide against the risks associated with its use. To that end, after we approve a new drug, we also want to make sure the scientific community and the public can understand why we approved it. This can help inform future drug development and, in turn, may facilitate the approval of additional safe and effective medicines. FDA's Pilot Program article
FDA Blood Supply and Demand Simulation Model Could Help Nation Prepare for Emergencies By: Arianna Simonetti, Ph.D., Mathematical Statistician at FDA’s Office of Surveillance & Biometrics, Division of Biostatistics in CDRH and Richard Forshee, Ph.D., Associate Director for Research at FDA’s Office of Biostatistics and Epidemiology in CBERKeeping the nation’s blood supply and demand system working efficiently can be a matter of life and death. That often means moving blood to meet critical needs when an area of the country experiences shortages. In fact, ensuring that blood gets to where it is needed, when it is needed, during emergencies is an important part of national security preparedness, and part of FDA’s mission. FDA Blood Supply and Demand Simulation Model article
CDER and You: Keys to Effective Engagement
Center for Drug Evaluation and Research (CDER) is conducting a public workshop entitled “CDER and You: Keys to Effective Engagement.” This marks the third annual CDER public workshop for patient advocacy groups. It builds upon previous efforts to help advocates understand how they can engage with the FDA to enhance drug development and safety.
CDER seeks to share information on navigating CDER’s engagement resources with stakeholders including patients, patient advocates, academic and medical researchers, health care professionals, drug developers, and others.
The workshop equips stakeholders with knowledge they need to share their unique perspectives on drug development and safety. It will include educational presentations about the drug approval process, an interactive panel featuring patient advocates who will offer guidance on engaging with CDER, as well as an opportunity for questions and answers following many of the presentations. Finally, presenters will explain CDER’s new procedure for requesting drug-related meetings. Keys to effective engagement article
FDA In Brief: FDA launches mobile app to increase access to information about drugsFDA announced the availability of the Drugs@FDA Express mobile application. On this mobile app, the public can search for information about FDA-approved brand and generic prescription and over-the-counter human drugs and biological therapeutic products. The FDA currently operates the Drugs@FDA webpage, which includes information about drug products approved by the agency, including patient information, drug labeling, approval letters, reviews and other information. The Drugs@FDA Express mobile app is a streamlined version of Drugs@FDA, allowing users to search on their mobile devices for certain product information based on product name, active ingredient or application number using a single search box. Some information (like labeling supplements and approval letters) won’t be available on the app, but can be found on the Drugs@FDA webpage. Mobile App article
Consumer Updates
5 Things to Know About Breast ImplantsShould I get breast implants? Are there alternatives? Will they need to be replaced? And if I decide to get implants, which are medical devices, there are even more questions. Saline or silicone? Which style? How much monitoring is needed? These are common questions people have when considering breast implants. Breast implants article
Beware of Illegally Marketed Diabetes Treatments
As the number of people diagnosed with diabetes continues to grow, illegally marketed products promising to prevent, treat, and even cure diabetes are flooding the marketplace.The FDA is advising consumers not to use such products—for many reasons. For example, they may contain harmful ingredients or may improperly be marketed as over-the-counter (OTC) products when they should be marketed as prescription products. Illegally marketed products carry an additional risk if they cause people to delay or discontinue effective treatments for diabetes. Without proper disease management, people with diabetes are at a greater risk for developing serious health complications.Illegally Marketed Diabetes article
Tobacco Products
FDA seeks additional input, scientific data on public health impacts of “premium” cigarsTo further inform the regulation of “premium” cigars, FDA is requesting comments from the public. Specifically, the FDA is interested in new data, research, and information on the definition, usage patterns, and public health considerations of so-called “premium” cigars. More information.
Pet Health
Lovely Lilies and Curious Cats: A Dangerous Combination
Cats are curious creatures by nature. They love to play, jump, and roam around the house or yard, but sometimes their inquisitive personalities get the best of them. They’re just drawn to that beautiful bouquet of stargazer lilies on your kitchen table or the colorful cluster of daylilies in your garden.
Lilies are extremely popular around the world and are commonly seen in garden beds and borders and in bouquets. While their flowers are lovely to see and smell, lilies pose a significant safety threat for your cat. Lilies and cats article
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