CIENCIASMEDICASNEWS: FDA Patient Network News

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Medical Product Safety

Limbrel Capsules by Primus Pharmaceuticals: Linked to Potentially Life-Threatening Health Problems
FDA is investigating serious adverse events involving Limbrel, a product in capsule form currently being marketed as a medical food to manage the metabolic processes associated with osteoarthritis. While a range of adverse events have been reported, two serious and potentially life-threatening medical conditions are among them: drug-induced liver injury and hypersensitivity pneumonitis. In total, the FDA has received 194 adverse event reports regarding Limbrel, of those, 57 of the cases contained sufficient information to analyze in detail whether Limbrel was associated with an adverse event; 30 of these contained sufficient information to use the Council for International Organizations of Medical Sciences (CIOMS) causality assessment method to determine the likelihood that an association between the consumption of Limbrel and the adverse events reported exists. More information

Recall -Diphenoxylate Hydrochloride and Atropine Sulfate Tablets by Greenstone: - Possible Sub Potent and Super Potent Tablets
Greenstone, a wholly owned subsidiary of Pfizer, is voluntarily recalling multiple lots of diphenoxylate hydrochloride and atropine sulfate tablets, USP to the consumer level. Greenstone initiated this recall because product from these lots has the potential to be super potent or sub potent. Products were distributed nationwide to wholesalers/retailers from November 2016 through June 2017 in the United States. See the recall notice for affected lot numbers. More information

Drug Safety Communication: Uloric (Febuxostat): FDA to Evaluate Increased Risk of Heart-related Death
FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. FDA required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when the medicine was approved in 2009. Once the final results from the manufacturer are received, FDA will conduct a comprehensive review and will update the public with any new information. More information

Medical Product Approval

FDA approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1)
FDA approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment. Juluca is a fixed-dose tablet containing two previously approved drugs (dolutegravir and rilpivirine) to treat adults with HIV-1 infections whose virus is currently suppressed on a stable regimen for at least six months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca. More information

FDA expands approval of Sutent to reduce the risk of kidney cancer returning
FDA approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of kidney cancer (renal cell carcinoma) returning after a kidney has been removed (nephrectomy). Adjuvant treatment is a form of therapy that is taken after an initial surgical removal to lower the risk of the cancer coming back. More information

New treatment to prevent bleeding in certain patients with hemophilia A approved
FDA approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors. “Reducing the frequency or preventing bleeding episodes is an important part of disease management for patients with hemophilia. More information

First telehealth option to program cochlear implants remotely approved
FDA approved a remote feature for follow-up programming sessions for the Nucleus Cochlear Implant System through a telemedicine platform. The remote programming feature is indicated for patients who have had six months of experience with their cochlear implant sound processor and are comfortable with the programming process. More information

FDA approves pill with sensor that digitally tracks if patients have ingested their medication is approved
FDA approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults. More information

Marketing authorization of the first device for use in helping to reduce the symptoms of opioid withdrawal is granted
FDA granted a new indication to an electric stimulation device for use in helping to reduce the symptoms of opioid withdrawal.
“Given the scope of the epidemic of opioid addiction, we need to find innovative new ways to help those currently addicted live lives of sobriety with the assistance of medically assisted treatment. There are three approved drugs for helping treat opioid addiction. More information

Treatment for rare genetic enzyme disorder approved
FDA approved Mepsevii (vestronidase alfa-vjbk) to treat pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome. MPS VII is an extremely rare, progressive condition that affects most tissues and organs. More information

From the Commissioner

Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA advisory about deadly risks associated with kratom
FDA is concerned about harmful unapproved products that have been crossing our borders in increasing numbers. The agency has a public health obligation to act when we see people being harmed by unapproved products passed off as treatments and cures for serious conditions. More information

Efforts to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls
It’s been nine weeks since Hurricane Maria made landfall on Puerto Rico and the island continues to struggle to recover from the devastation brought by this storm, as well as Hurricane Irma. As I’ve commented on previously, the medical products industry has a significant presence in Puerto Rico, and the disruption to this industry has had ramifications for patients both on the island and throughout the U.S. More information

FDA’s comprehensive new policy approach to facilitating the development of innovative regenerative medicine products to improve human health
One of the most promising fields of science is the area of cell-based therapies and their use in regenerative medicine. These new technologies, most of which are in early stages of development, hold transformative promise for patients. Given this area’s rapid growth, dynamism and complexity, this field has also presented unique challenges to researchers, health care providers and the FDA.More information

FDA Takes Steps to Build a Stronger Workforce, by: Scott Gottlieb, M.D., Commissioner of FDA
FDA faces challenges related to building and maintaining a diverse, talented, and dedicated professional workforce. The agency’s responsibilities increasingly demand a staff with specialized skills; and our own process sometimes doesn’t fully support our ability to recruit and retain the people we need. Congress has given FDA new resources and authorities to build and maintain our talented workforce. But the agency still needs to do more to expand on these opportunities and solidify our workforce. To read this entire post, see FDA Voice on November 15, 2017

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

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

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

Drug Shortages Resolved by Manufacturers During the Past 2 Weeks:

Bleomycin Sulfate for Injection

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.

More information on drug shortages and discontinuations: Drug Shortage Database and Vaccines, Blood and Biologic Shortages

FDA Announcements

FDA issues guidance on development of generic abuse-deterrent opioids
FDA issued a final guidance to assist industry in their development of generic versions of approved ADF opioids. This guidance includes new recommendations about the type of studies companies should conduct to demonstrate that the generic drug is no less abuse-deterrent than its brand-name counterpart. More information

FDA unveils a streamlined path for the authorization of tumor profiling tests alongside its latest product action
FDA authorized Memorial Sloan Kettering Cancer Center’s (MSK) IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) tumor profiling test (assay), an in-vitro diagnostic test that can identify a higher number of genetic mutations (biomarkers) that may be found in various cancers than any test previously reviewed by the agency. The IMPACT test uses next-generation sequencing (NGS) to rapidly identify the presence of mutations in 468 unique genes, as well as other molecular changes in the genomic makeup of a person’s tumor. More information

Consumer Updates

FDA Warns About Stem Cell Therapies
Stem cells have been called everything from cure-alls to miracle treatments. But don’t believe the hype. Some unscrupulous providers offer stem cell products that are both unapproved and unproven. So beware of potentially dangerous procedures—and confirm what’s really being offered before you consider any treatment. More information

The FDA Warns Against Injectable Silicone for Body Contouring and Enhancement
Are you considering a procedure to shape or increase the size of certain parts of your body? Beware of using injectable silicone for body contouring, or any other unapproved products to achieve your goals. Injectable dermal fillers are medical devices regulated by the U.S. Food and Drug Administration. Although the FDA has approved certain injectable dermal fillers for use in the face (for example, to enhance lips and cheeks) and hands, no injectable filler is FDA-approved for large-scale body contouring or body enhancement. More information and FDA Press Announcement

Tobacco Products

The Real Cost Now Informs Youth: Vaping, Too, Can Rewire Your Brain
Did you know FDA is expanding “The Real Cost” public education campaign to include advertising about e-cigarettes and other electronic nicotine delivery systems? New messages focus specifically on how nicotine can rewire the developing brain to crave more nicotine. Read more about “The Real Cost.”

More Data from Philip Morris MRTP Applications Now Online
FDA recently posted some additional study reports and datasets from modified risk tobacco product (MRTP) applications submitted by Philip Morris Products S.A. These materials add to the information previously made public after FDA filed the applications for substantive scientific review on May 24. FDA plans to post the remaining documents of the originally submitted applications by Nov. 24. View the application on our website.

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Pet Health

No Bones (or Bone Treats) About It: Reasons Not to Give Your Dog Bones
Many dog owners know not to toss a turkey or chicken bone to their dog; those bones are just too brittle. But the FDA says the risk goes beyond that, especially when it comes to the “bone treats” you may see at the store. FDA has received about 68 reports of pet illnesses related to "bone treats,” which differ from uncooked butcher-type bones because they are processed and packaged for sale as dog treats. More information

Food Safety

Serving Up Safe Buffets
Plan a “bacteria-free buffet” with these easy tips for food safety when entertaining. Bon appétit! Entertaining is one of the mainstays of the holiday season — and helps commemorate milestone events throughout the year, too. With proper preparation, you can be creative and tempt your party guests with an array of fun platters while still keeping food safety in mind! If you’re planning a buffet at home and are not sure how quickly the food will be eaten, keep buffet serving portions small. More information

The FDA Patient Network Newsletter is provided to you by the FDA Office of Health and Constituent Affairs. If you have questions about the newsletter, email us at PatientNetwork@FDA.HHS.GOV