Medical Product Safety
Help FDA Improve FDA Form 3500, 3500A and 3500B
FDA is looking for comments to help improve the way we collect information about adverse events via the MedWatch program. Members of the public can use FDA's MedWatch system to report adverse events, product problems, errors with the use of a human medical product, or when evidence of therapeutic failure is suspected or identified in clinical use. Please review our Federal Register Notice and submit your comments here on regulations.gov
FDA Orders Mandatory Recall for Kratom Products Due to Risk of Salmonella
FDA announced it has issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several were found to contain salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall. This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products. Kratom recall on April 3, 2018 and MedWatch recall announcement
FDA Restricts Sale and Distribution of Essure to Protect Women and to Require that Patients Receive Risk Information
FDA issued an order to restrict the sale and distribution of the Essure device to ensure that all women considering use of the permanent contraception device are provided with adequate risk information so that they can make informed decisions. The FDA is taking this step after becoming aware that some women were not being adequately informed of Essure’s risks before getting the device implanted, despite previous significant efforts to educate patients and doctors about the risks associated with this device. The FDA is requiring a unique type of restriction, using its authority to restrict the sale and distribution of a device to impose additional requirements needed to provide a reasonable assurance of its safety and effectiveness. The FDA is committed to continuing to use its full authorities to ensure the post-market safety of medical products. Essure restriction and MedWatch restriction announcement
Recall - Potential Contamination - Pasta De Lassar Andromaco Skin Protectant 25 Percent Zinc Oxide by MarcasUSA
MarcasUSA, LLC and Industria Farmacéutica Andromaco, S.A. de C.V. voluntarily recalled four lots of Pasta De Lassar Andromaco Skin Protectant, 25% zinc oxide to the retail level. FDA analysis of this product confirmed that Pasta De Lassar Andromaco is contaminated with high levels of yeast, mold, and bacteria. The specific lot associated to the positive findings was never sold in the US. However, due to the amount and type of contamination the remaining four lots in the US market are being recalled out of an abundance of caution.
Use of the contaminated product could result in an increased risk of infection. Recall article
Recall - Dietary Supplements by Nutrizone, Recall Potential for Salmonella Contamination
NutriZone, LLC is recalling 4 different dietary supplements because it has the potential to be contaminated with Salmonella. The potential for contamination was noted after routine sampling and testing by the FDA revealed the presence of Salmonella. Nutrizone recall
Medical Product Approval
FDA Expands Approval of Blincyto for Treatment of a Type of Leukemia in Patients Who Have a Certain Risk Factor for Relapse
FDA granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). MRD refers to the presence of cancer cells below a level that can be seen under the microscope. In patients who have achieved remission after initial treatment for this type of ALL, the presence of MRD means they have an increased risk of relapse. Blincyto approval
FDA Approves New Use of Exparel for Nerve Block Pain Relief Following Shoulder Surgeries
FDA approved a new indication for Exparel (bupivacaine Liposome injectable suspension) for use as an interscalene brachial plexus nerve block to produce post-surgical regional analgesia following shoulder surgery in adults. Interscalene brachial plexus nerve block works by anesthetizing the body’s nerves nearest the shoulder in order to help curb pain. Exparel is intended for use as a nerve block to relieve pain associated with shoulder surgery for a period of 48 to 72 hours following administration. Exparel approval
FDA Clears First Contact Lens with Light-Adaptive Technology
FDA cleared the first contact lens to incorporate an additive that automatically darkens the lens when exposed to bright light. The Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology are soft contact lenses indicated for daily use to correct the vision of people with non-diseased eyes who are nearsighted (myopia) or farsighted (hyperopia). They can be used by people with certain degrees of astigmatism, an abnormal curvature of the eye. Light-Adaptive Contact Lens
First Generic Drug Approvals
“First generics” are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product in the United States. FDA considers first generics to be important to public health, and prioritizes review of these submissions. See a database with information onGeneric Drugs Approved in 2018
From the Commissioner
FDA’s Efforts to Enhance the Patient Perspective and Experience in Drug Development and Review
Benefit-risk assessment is at the heart of what we do to ensure that Americans have access to medical products that are safe, effective and meet their needs.
But we’re also deeply aware that serious chronic illnesses aren’t monolithic. Patient perception of the benefits and risks of different treatment options can vary based on the stage of the disease, the age of onset, alternative therapies available to treat the disease (if any) and whether a novel therapy improves a patient’s ability to function normally, slows the rate of disease progression or impacts other aspects of a patient’s quality of life. Commissioner's statement
Remarks by Scott Gottlieb, M.D. at the National Food Policy Conference
More than 630,000 Americans die every year from heart disease. It’s followed closely by cancer as the second leading cause of death in America, with another 600,000 Americans dying annually from cancer. While we’ve made progress in reducing deaths due to cancer and heart disease -- in part due to reductions in smoking -- some of that progress is now being offset by the increasing problem of obesity. We focus a lot of policy and resources on the development of innovative new treatments for these and other maladies. Medical innovation, and access to life-saving treatments, has the potential to remedy afflictions like cancer and heart disease. Read Dr. Gottlieb's full remarks as prepared for the National Food Policy Conference
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 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.
- Diclofenac Sodium Extended Release Tablets (Discontinuation)
- Exenatide (BYDUREON) Extended Release for Injectable Suspension (Discontinuation)
- Leucovorin Calcium Lyophilized Powder for Injection (Currently in Shortage)
- Ondansetron Hydrochloride Injection (Currently in Shortage)
More information on drug shortages and discontinuations: Drug Shortage Database and Vaccines, Blood and Biologic Shortages.
FDA on Social Media
Tweets you might have missed from FDA and the Commissioner!
@FDAOMH’s new PSA and learn how veterans can continue to serve their communities by participating in clinical trials. #NMHM18 and Watch PSA.
- FDA's Ask Me Anything about Biosimilar On April 12, 2018 ask Dr. Leah Christl from FDA Center for Drug Evaluation and Research about Biosimilars. The event will be held on April 12, 2018 from 2:00 pm ET to 3:30 pm ET.
- #PatientReportedOutcome measures to inform tolerability- PRO experts, international regulators, @theNCI & patients discuss uses of PRO in cancer trials- #FDAOncology @CPathInstitute workshop summary
- Emergency treatment of opioid overdose is an urgent public health priority.
#FDA supports efforts to increase use of naloxone and is exploring new options to make it more accessible to stop/reverse effects of an opioid overdose: #savealife #getnaloxone.
- April 10, 2018: Veterans have served their country and communities in many ways, and they can continue serving by participating in clinical research. Watch this new video from FDA's Office of Minority Health and the Veterans’ Affairs Office of Health Equity to learn about one veteran’s experience. #NMHM18 https://youtu.be/zd4NAD9TsfY
- April 10, 2018: The FDA, along with CDC and state partners, are investigating a multistate outbreak of E. coli. The CDC reports that there are 17 cases in 7 states: Connecticut (2), Idaho (4), Missouri, New Jersey (6), Ohio, Pennsylvania (2), and Washington. At this time no specific food item has been identified as a likely source of the infections, but we are working with our partners to trace the food eaten by those who became ill to a common source. People who think they might have symptoms of E. coli infection should consult their health care provider. https://go.usa.gov/xQTjr
- April 9, 2018: Children are at high risk for food poisoning because their immune systems are still developing. Parents, learn more about protecting your child from food poisoning here.See FoodSafety.Gov
- April 6, 2018: New Spotlight on CDER Science! CDER Scientists Use Modern Measurement Tools for Quality Assurance and Comparability of Complex Drugs: See CDER Spotlight
- April 5, 2018: Today, Vice Adm. Jerome M. Adams, M.D., M.P.H, U.S. Surgeon General, released an advisory on Naloxone, an opioid overdose-reversing drug. This Surgeon General advisory on naloxone is part of the administration’s ongoing effort to respond to the sharp increase in drug overdose deaths. With this advisory, the Surgeon General is urging more individuals, including family, friends and those who are personally at risk for an opioid overdose, to carry naloxone. See Surgeon General's Advisory
Seasonal Allergies: Which Medication is Right for You?
The pollen count is sky-high. You’re sneezing, your eyes are itching, and you feel miserable. Seasonal allergies are real diseases that can interfere with work, school or recreation. Allergies can also trigger or worsen asthma and lead to other health problems such as sinus infections (sinusitis) and ear infections in children. Seasonal Allergy Update
New York Raw Milk Cheese Company Ordered to Stop Sales for Food Safety Violations
A New York raw milk cheese company whose products were linked to a multi-state outbreak of Listeria monocytogenes (L. mono) has been ordered by a federal court not to manufacture its ready-to-eat aged soft, semi-soft and hard cheeses until it complies with food safety regulations. Raw milk safety
Every Try Counts Campaign
Cigarette smoking remains the leading cause of preventable disease and death in the United States, causing 480,000 deaths every single year. Approximately 2 out of 3 adult smokers, more than 22 million people, say they would like to quit. However, in 2015, of the 55% of adult smokers who made a quit attempt, only 7% were successful. FDA’s newest public education campaign, “Every Try Counts” is aimed at encouraging cigarette smokers to quit through messages of support that underscore the health benefits of quitting. Every Try Counts Campaign