February 14, 2018
Medical Product Safety
Acyclovir 400mg Tablets by Apace Packaging: Recall - Product Mix-up
Apace Packaging LLC is voluntarily recalling one lot of Acyclovir Tablet, USP, 400mg, 50ct Unit Dose, NDC# 50268-061-15, Lot Number 19900, to the retail level. These products have been recalled due to a product mix-up. A small number of blister cards containing Acyclovir Tablets, 400mg, UD Blister Cards may potentially also include Torsemide, 20mg Tablets. Missing a dose of Acyclovir Tablets could cause a reactivation of a virus being treated. Unintentional dosing of Torsemide, 20mg Tablets could cause excessive urination. Serious adverse events reported in the clinical studies, for which a drug relationship could not be excluded, were atrial fibrillation, chest pain, diarrhea, digitalis intoxication, gastrointestinal hemorrhage, hyperglycemia, hyperuricemia, hypokalemia, hypotension, hypovolemia, shunt thrombosis, rash, rectal bleeding, syncope, and ventricular tachycardia. More information
Gericare Eye Wash by Kareway Products: Recall - Potential Product Contamination
Kareway Products, Inc is voluntarily recalling 60,000 lots of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail or consumer level. The product has been found to have potential microbial contamination which compromises sterility. Use of the affected product could be calamitous for any population due to a probability of a potentially sight threatening eye infection or impairment. More information
Ocaliva (obeticholic acid): Drug Safety Communication - Boxed Warning Added To Highlight Correct Dosing
FDA is warning that the liver disease medicine Ocaliva (obeticholic acid) has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (PBC), a rare chronic liver disease, increasing the risk of serious liver injury. To ensure correct dosing and reduce the risk of liver problems, FDA is clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva. FDA is adding a new Boxed Warning, FDA’s most prominent warning, to highlight this information in the prescribing information of the drug label. FDA is also requiring a Medication Guide for patients to inform them about this issue. More information
Medical Product Approval
FDA Permits Marketing of Clinical Decision Support Software for Alerting Providers of a Potential Stroke in Patients
FDA permitted marketing of the Viz.AI Contact application, a type of clinical decision support software designed to analyze computed tomography (CT) results that may notify providers of a potential stroke in their patients. More information
FDA Approved SYMDEKO to Treat Patients with Cystic Fybrosis
SYMDEKO is a combination of tezacaftor and ivacaftor, indicated for the treatment of patients with cystic fibrosis aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence. The Prescribing Information will be available at DailyMed or Drugs@FDA
FDA Approved BIKTARVY fixed dose combination to treat HIV
FDA recently approved BIKTARVY (bictegravir, emtricitabine, and tenofovir alafenamide) which is a three drug fixed dose combination tablet indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 3 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of BIKTARVY. See thePrescribing Information
FDA Approved SYMFI LO fixed dose combination to treat HIV
FDA recently approved SYMFI LO Tablets which is a fixed dose combination product containing 400 mg efavirenz, 300 mg lamivudine and 300 mg tenofovir disoproxil fumarate (equivalent to 245 mg of tenofovir disoproxil) and is indicated as a complete regimen for the treatment of HIV-1 in adult and pediatric patients weighing at least 35 kg. The Prescribing Information will be available at DailyMed orDrugs@FDA
FDA and NRC Pave Way for the First Domestic Supply of the Most Commonly Used Medical Isotope in Diagnostic Imaging
FDA and the Nuclear Regulatory Commission (NRC) took steps to ensure a stable and secure supply of a critical radioactive imaging product used to detect potentially life-threatening diseases. The FDA approved the RadioGenix System, a unique system for producing Technetium-99m (Tc-99m), the most widely used radioisotope in medical imaging. The NRC is issuing guidance and will license the RadioGenix System to enable the Tc-99m it produces to be used for its medical purpose. More information
From the Commissioner
Statement on Administration’s Request for New FDA Funding to Promote Innovation and BBroaden Patient Access Through Competition
New scientific opportunities, as well as advances in manufacturing and commerce, give the U.S. Food and Drug Administration new ways to advance our mission to protect and promote public health. Leveraging these opportunities requires us to make investments in regulatory science that can reduce uncertainty for innovators, spur investment in new industries and provide principles for the safe and effective development of new technologies. These same advances also give us new ways to support greater availability and use of generic drugs as a way to promote price competition and patient access. More information
Statement on the Agency’s Scientific Evidence on the Presence of Opioid Compounds in Kratom, Underscoring its Potential for Abuse
Over the past several months, there have been many questions raised about the botanical substance known as kratom. Our concerns related to this product, and the actions we’ve taken, are rooted in sound science and are in the interest of protecting public health. However, we recognize that there is still much that is unknown about kratom, which is why we’ve taken some significant steps to advance the scientific understanding of this product and how it works in the body. Today, we’re providing details of some of the important scientific tools, data and research that have contributed to the FDA’s concerns about kratom’s potential for abuse, addiction, and serious health consequences; including death. More information
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.
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.
- Saquinavir Mesylate (Invirase) 200mg Capsules (Discontinuation)
- Simvastatin (Zocor) Tablets (Discontinuation)
- Simvastatin Tablets (Discontinuation)
- Nesiritide Powder (NATRECOR) for Injection (Discontinuation)
- Repaglinide Tablets (Discontinuation)
More information on drug shortages and discontinuations: Drug Shortage Database and Vaccines, Blood and Biologic Shortages.
For Women: The FDA Gives Tips to Prevent Heart Disease
More women die from heart disease than from any other cause—a staggering one in four American women, according to the Centers for Disease Control and Prevention. But you can take action now to help prevent problems. Resources from the FDA can help women of all ages learn how to use FDA-approved drugs and devices safely to prevent and treat heart disease. More information
Request a Meeting on Drugs with CDER
Meetings between stakeholders and the FDA’s Center for Drug Evaluation and Research (CDER) promote effective two-way communication to improve drug development and safety. You can request a meeting with Professional Affairs and Stakeholder Engagement (PASE). Once PASE receives a request, our staff will review it, contact you, and work with you to help facilitate your meeting. If you would like to meet with the FDA about other topics, please contact the FDA Office of Health and Constituent Affairs (OHCA) at (301) 796-8460. You can email Professional Affairs and Stakeholder Engagement: CDERPASE@fda.hhs.
CLIA-Waived Rapid Flu Test Facts
With higher performance standards, FDA helps lower misdiagnoses with antigen-based rapid flu tests during this year’s flu season: More information
Office of Generic Drugs (OGD) Annual Report for 2017
FDA’s Office of Generic Drugs has posted their annual report for calendar year 2017, noting that this year marked the highest number of generic drug approvals and tentative approvals ever awarded by the FDA–1,027. These generic drug products have the potential to provide more affordable care to thousands of patients with serious and life-threatening diseases.More information
How to Buy Medicines Safely From an Online Pharmacy
Ever been tempted to buy your medicines from an online pharmacy or another website? Protect yourself and your family by using caution when buying medicine online. There are many pharmacy websites that operate legally and offer convenience, privacy, and safeguards for purchasing medicines. More information