DA limits packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use
To foster safe use of the over-the counter (OTC) anti-diarrhea drug loperamide, FDA is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package. FDA continues to receive reports of serious heart problems and deaths with much higher than the recommended doses of loperamide, primarily among people who are intentionally misusing or abusing the product, despite the addition of a warning to the medicine label and a previous communication. Loperamide is a safe drug when used as directed. More information
Primus Announces a Voluntary Nationwide Recall of All Lots Within Expiry of Prescription Medical Food Limbrel® Due to Rare But Serious and Reversible Adverse Events While Seeking FDA's Cooperation to Restore Access for Patients with Medical Necessity
Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA's request. FDA has requested a recall of Limbrel due to rare but serious and reversible side effects associated with Limbrel. More information
Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs
In accordance with a Consent Decree of Permanent Injunction ordered in the United States District Court for the District of New Jersey, Flawless Beauty, LLC is voluntarily recalling all lots of nineteen different products sold individually or as part of multi-unit kits alleged by the FDA to be misbranded or unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic Act. The FDA believes that these drugs present serious public health risks. To date, Flawless Beauty has not received any reports of adverse events related to this recall. More information
Break Ventures/California Basics Recalls "Zero For Him" 150ct Lot#1710-638 Because of Possible Health Risk
Break Ventures/California Basics is recalling its Dietary Supplement “Zero for Him 150ct” Lot#1710-638 (the “Product”) because it may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. More information
Basic Drugs Brand of Senna Laxative by Magno-Humphries Laboratories: Recall- Mislabeling
Magno-Humphries Laboratories, Inc., is voluntarily recalling one lot of Basic Drugs Brand of Senna Laxative tablets, 8.6mg Sennosides to the consumer level due to a customer complaint that their bottle labeled as Senna Laxative actually contained Basic Drugs Brand of Naproxen Sodium 220mg. Naproxen Sodium 220mg tablet is used as a pain reliever and is a nonsteroidal anti-inflammatory drug (NSAID). More information
Baxter Expands Voluntary Nationwide Recall to Include Second Lot of Nexterone Injection Due to Presence of Particulate Matter
Following the issuance of a voluntary recall dated November 10, 2017 of one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection, Baxter International Inc. announced today it is expanding the recall to include a second lot (NC109123) of NEXTERONE due to the potential presence of particulate matter. The affected lots were distributed between 7/21/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities. The particulate matter may have entered the solution during the manufacturing process. More information
FDA approves new treatment for certain digestive tract cancers
The FDA approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated for adult patients with somatostatin receptor-positive GEP-NETs. More information
New steps to help prevent new addiction, curb abuse and overdose related to opioid products
The issue of opioid misuse and abuse remains one of my highest priorities and we believe it’s going to take carefully developed, sustained, and coordinated action by everyone involved to reduce the tide of opioid addiction and death afflicting our communities; while maintaining appropriate prescribing for patients in medical need. We recognize both the urgency and complexity of this crisis and are taking several steps today toward these goals. More information
FDA’s strengthened commitments to humane and judicious animal research and the termination of a nicotine study
The FDA has a deep commitment to ensuring the responsible and humane care of animals when research involving animals is needed to fulfill the agency’s public health mission. The FDA also is fully committed to complying with the rules and guidance governing animal research. That’s why we acted quickly on concerns related to a study that was working with squirrel monkeys to investigate the role of exposure to various levels of nicotine on the onset of addiction in adolescence and young adults, and why we are announcing today that we are permanently ending this study and placing the animals in a permanent sanctuary home. More information
New policy steps for strengthening public warning and notification of recalls
Americans depend on the FDA to help ensure that the products they buy are safe. Last month, I committed the agency to further improve our recall processes because I believe that consumers should have actionable information for protecting themselves from any FDA-regulated, recalled product.
Recalls are an important safety tool. The FDA works with companies to get potentially unsafe products out of the marketplace as quickly and efficiently as possible. When we learn about a product in the marketplace that may be unsafe, the FDA must act quickly to keep people from getting sick or being harmed. More information
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.
To foster safe use of the over-the counter (OTC) anti-diarrhea drug loperamide, FDA is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package. FDA continues to receive reports of serious heart problems and deaths with much higher than the recommended doses of loperamide, primarily among people who are intentionally misusing or abusing the product, despite the addition of a warning to the medicine label and a previous communication. Loperamide is a safe drug when used as directed. More information
Primus Announces a Voluntary Nationwide Recall of All Lots Within Expiry of Prescription Medical Food Limbrel® Due to Rare But Serious and Reversible Adverse Events While Seeking FDA's Cooperation to Restore Access for Patients with Medical Necessity
Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA's request. FDA has requested a recall of Limbrel due to rare but serious and reversible side effects associated with Limbrel. More information
Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs
In accordance with a Consent Decree of Permanent Injunction ordered in the United States District Court for the District of New Jersey, Flawless Beauty, LLC is voluntarily recalling all lots of nineteen different products sold individually or as part of multi-unit kits alleged by the FDA to be misbranded or unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic Act. The FDA believes that these drugs present serious public health risks. To date, Flawless Beauty has not received any reports of adverse events related to this recall. More information
Break Ventures/California Basics Recalls "Zero For Him" 150ct Lot#1710-638 Because of Possible Health Risk
Break Ventures/California Basics is recalling its Dietary Supplement “Zero for Him 150ct” Lot#1710-638 (the “Product”) because it may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. More information
Basic Drugs Brand of Senna Laxative by Magno-Humphries Laboratories: Recall- Mislabeling
Magno-Humphries Laboratories, Inc., is voluntarily recalling one lot of Basic Drugs Brand of Senna Laxative tablets, 8.6mg Sennosides to the consumer level due to a customer complaint that their bottle labeled as Senna Laxative actually contained Basic Drugs Brand of Naproxen Sodium 220mg. Naproxen Sodium 220mg tablet is used as a pain reliever and is a nonsteroidal anti-inflammatory drug (NSAID). More information
Baxter Expands Voluntary Nationwide Recall to Include Second Lot of Nexterone Injection Due to Presence of Particulate Matter
Following the issuance of a voluntary recall dated November 10, 2017 of one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection, Baxter International Inc. announced today it is expanding the recall to include a second lot (NC109123) of NEXTERONE due to the potential presence of particulate matter. The affected lots were distributed between 7/21/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities. The particulate matter may have entered the solution during the manufacturing process. More information
FDA approves new treatment for certain digestive tract cancers
The FDA approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated for adult patients with somatostatin receptor-positive GEP-NETs. More information
New steps to help prevent new addiction, curb abuse and overdose related to opioid productsThe issue of opioid misuse and abuse remains one of my highest priorities and we believe it’s going to take carefully developed, sustained, and coordinated action by everyone involved to reduce the tide of opioid addiction and death afflicting our communities; while maintaining appropriate prescribing for patients in medical need. We recognize both the urgency and complexity of this crisis and are taking several steps today toward these goals. More information
FDA’s strengthened commitments to humane and judicious animal research and the termination of a nicotine study
The FDA has a deep commitment to ensuring the responsible and humane care of animals when research involving animals is needed to fulfill the agency’s public health mission. The FDA also is fully committed to complying with the rules and guidance governing animal research. That’s why we acted quickly on concerns related to a study that was working with squirrel monkeys to investigate the role of exposure to various levels of nicotine on the onset of addiction in adolescence and young adults, and why we are announcing today that we are permanently ending this study and placing the animals in a permanent sanctuary home. More information
New policy steps for strengthening public warning and notification of recalls
Americans depend on the FDA to help ensure that the products they buy are safe. Last month, I committed the agency to further improve our recall processes because I believe that consumers should have actionable information for protecting themselves from any FDA-regulated, recalled product.
Recalls are an important safety tool. The FDA works with companies to get potentially unsafe products out of the marketplace as quickly and efficiently as possible. When we learn about a product in the marketplace that may be unsafe, the FDA must act quickly to keep people from getting sick or being harmed. More information
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.
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.
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, USDA announce formal agreement to bolster coordination and collaboration
U.S. Agriculture Secretary Sonny Perdue and FDA Commissioner Scott Gottlieb, M.D. announced at the White House a formal agreement aimed at making the oversight of food more efficient and effective by bolstering coordination between the two agencies. The formal agreement outlines efforts to increase interagency collaboration, efficiency and effectiveness on produce safety and biotechnology activities, while providing clarity to manufacturers.
The FDA and the USDA have worked closely over the years to oversee the nation’s food supply. The USDA oversees the safety of most meat, poultry, catfish and certain egg products while the FDA has authority over all other foods such as dairy, seafood, produce and packaged foods. The USDA and the FDA are partnering in many key areas, including the implementation of produce safety measures and biotechnology efforts. More information
FDA, FTC warn companies for selling illegal, unapproved opioid cessation products using deceptive claims
The FDA and the Federal Trade Commission today posted joint warning letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal. More information
Shortages/discontinuations voluntarily reported by manufacturers during the past 2 weeks:
- Carboplatin Injection
- Cisplatin Injection
- Dorzolamide Hydrochloride Ophthalmic Solution
- Doxorubicin Injection
- Gemcitabine Injection
- Ifosfamide Injection
- Methotrexate 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
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
But the FDA warns that there are many rogue online pharmacies that claim to sell prescription medicines at deeply discounted prices, often without requiring a valid prescription. These Internet-based pharmacies often sell unapproved or counterfeit medicines outside the safeguards followed by licensed pharmacies.These rogue sites often prominently display a Canadian flag, but may actually be operated by criminals from the other side of the globe with no connection to Canada. Medicines bought from these websites can be dangerous and may put your health at risk.
The FDA’s BeSafeRx can help you identify and avoid fake online pharmacies. More information
Are You Ready to Tackle Food Safety on Game Day?
Remember to Clean, Separate, Cook and Chill to serve a safe buffet
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! More information
Are You Ready to Tackle Food Safety on Game Day?
Remember to Clean, Separate, Cook and Chill to serve a safe buffet
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! More information
Is My Dog or Cat a Healthy Weight? Important Questions to Ask the Vet
Your 8-year-old chocolate lab is putting on weight, and you know she should probably lose a pound or two. But when she looks at you pleadingly with those big brown eyes, how can you resist handing out just one more treat? It’s not easy. But it may be important.
“Just as obesity has become a serious problem in people, it’s also a growing problem in pets, one that can seriously harm your pet’s health,” says Carmela Stamper, a veterinarian in the Center for Veterinary Medicine (CVM) at the FDA. Among CVM’s responsibilities are making sure that food for animals—which includes animal feed, pet food, and pet treats—is properly labeled with truthful claims, and is safe for animals and the people who handle it. More malformation
Your 8-year-old chocolate lab is putting on weight, and you know she should probably lose a pound or two. But when she looks at you pleadingly with those big brown eyes, how can you resist handing out just one more treat? It’s not easy. But it may be important.
“Just as obesity has become a serious problem in people, it’s also a growing problem in pets, one that can seriously harm your pet’s health,” says Carmela Stamper, a veterinarian in the Center for Veterinary Medicine (CVM) at the FDA. Among CVM’s responsibilities are making sure that food for animals—which includes animal feed, pet food, and pet treats—is properly labeled with truthful claims, and is safe for animals and the people who handle it. More malformation
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