The FDA Alert s below may be specifically about Singulair or relate to a group or class of drugs which include Singulair montelukast. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. March 4, -- The U. The boxed warning advises health care providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis.
The Drug Safety Communication includes recommendations for health care professionals and patients and a summary of the data that led to these warnings. Importantly, there are many other safe and effective medications to treat allergies with extensive history of use and safety, such that many products are available over the counter without a prescription.
The FDA updated the product labeling in to include information about neuropsychiatric events reported with use of montelukast. In response to continued reports of suicide and other adverse events, the FDA evaluated available data regarding the risk of neuropsychiatric events, including reports submitted through the FDA Adverse Event Reporting System FAERS and observational studies in the published literature.
As part of its review, the FDA re-evaluated the benefits and risks of montelukast as the treatment landscape has evolved since the drug was first approved in Based upon this assessment, the FDA determined the risks of montelukast may outweigh the benefits in some patients, particularly when the symptoms of the disease are mild and can be adequately treated with alternative therapies.
For allergic rhinitis in particular, the FDA has determined that montelukast should be reserved for patients who have not responded adequately to other therapies — or who cannot tolerate these therapies.
In addition to the boxed warning, the FDA is also requiring a new Medication Guide to be given to patients with each montelukast prescription. The FDA, an agency within the U. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
ISSUE: FDA is strengthening existing warnings about serious behavior and mood-related changes with montelukast Singulair and genericswhich is a prescription medicine for asthma and allergy. We decided a stronger warning is needed after conducting an extensive review of available information and convening a panel of outside experts, and therefore determined that a Boxed Warning was appropriate. It is a prescription medicine approved to prevent asthma attacks and for the long-term treatment of asthma in adults and children 1 year and older.
It is approved to prevent exercise-induced asthma in patients 6 years and older. Montelukast is also approved to control the symptoms of allergic rhinitis, also known as hay fever, such as sneezing, stuffy nose, runny nose, and itching of the nose. It is used to treat seasonal outdoor allergies in patients 2 years and older, and year-round indoor allergies in patients 6 months and older. Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:.
The U. Sealed bottles labeled as montelukast sodium tablets, 10 milligram, count bottle from Camber were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg. This tablet mix-up may pose a safety risk as taking losartan tablets when not prescribed has the potential to cause renal dysfunction, elevated potassium levels and low blood pressure. This risk is especially high for pregnant women taking the allergy and asthma medication montelukast because losartan, which is indicated to treat high blood pressure, could harm or kill the fetus.
The FDA recommends that consumers who have this recalled product should contact their health care provider or pharmacist immediately.FSIS has reason to believe that the retail locations listed received the recalled meat or poultry products described in the news release.
Lists may not include all retail locations that have received the recalled product or may include retail locations that did not actually receive the recalled product. Therefore, it is important that you use the product-specific identification information in the news release, in addition to this list of retail stores, to check meat or poultry products in your possession to see if they have been recalled.
For large volume recalls, it may take several days to assemble the initial list.
Lists may be updated as additional information becomes available. For example, the product may have gone exclusively to restaurants and institutions, and in this case there would be no retailers in the distribution chain. Topics Careers.
CVS Pharmacy Pulls Zantac from Shelves Due to Cancer Concerns
Data Collection and Reports. Fact Sheets. Food Defense and Emergency Response. Food Safety Education. FSIS Employees. International Affairs. Recalls and Public Health Alerts. Regulatory Compliance. Contact Centers. Cooperative Agreements. Email Subscription Service. Exporting Products. Federal Grant of Inspection Guide. Importing Products. Label Submission and Approval System. Codex Office. Newsroom News Releases, Statements, Transcripts. Feeds and Subscriptions.The author of this post has written an update, which you can read here.
If you or a family member take ranitidine Zantac to relieve heartburn, you may have heard that the FDA has found a probable human carcinogen a substance that could cause cancer in it. The story is unfolding quickly and many details remain murky. Here is what we know so far and what you should do. This week, the drug companies Novartis through its generic division, Sandoz and Apotex announced that they were recalling all of their generic ranitidine products sold in the US.
These announcements came after a Connecticut-based online pharmacy informed the FDA that it had detected NDMA in multiple ranitidine products under certain test conditions. Update, October 1, Major drugstore chains including CVS and Walgreens are pulling Zantac and other generic versions of the heartburn drug ranitidine from their shelves.
You can get FDA updates here. Ranitidine also known by its brand name, Zantac, which is sold by the drug company Sanofi is available both over the counter OTC and by prescription. It belongs to the class of drugs known as H2 or histamine-2 blockers. OTC ranitidine is commonly used to relieve and prevent heartburn. Prescription strengths are also used to treat and prevent more serious ulcers in the stomach and intestines.
Multiple companies sell generic versions of both the OTC and prescription products. Ranitidine distributed by other companies remains on store shelves. NDMA is an environmental contaminant that is found in water and foods, including dairy products, vegetables, and grilled meats. Its classification as a probable carcinogen is based on studies in animals; studies in humans are very limited. It is important to know that the NDMA in ranitidine products does not pose any immediate health risks.
Although classified as a probable carcinogen, NDMA may cause cancer only after exposure to high doses over a long period of time. NDMA is one of the same impurities that was found in certain heart medications beginning last year and that resulted in the recall of many products.
As the FDA and other agencies around the world continue to investigate ranitidine, more details will become available.
In the meantime, the FDA is not calling for individuals to stop taking the medication. However, for many conditions, ranitidine is only recommended for short-term use. If you have been using ranitidine for a while, now would be a good time to discuss with your physician whether you still need it, and whether you might benefit from alternative treatment options, including other drug classes or a different H2 blocker.
Based on what is known so far, there is no evidence that other H2 blockers or other heartburn medications are affected by NDMA impurities. Some people might find antacids useful for relieving heartburn.
Lifestyle changes, including avoiding certain foods and beverages, such as spicy foods, large or fatty meals, and alcohol, can also help prevent episodes of heartburn.
I have been taking ranitidine for a little over 3 years. What type of cancer is it known to cause. My Dr just changed my medication. Originally in 75mg doses once a day and then years later in mg doses once a day. It has never failed me especially since I travelled around the world for over 20 years and ate the spiciest of foods. It was the only medication that has consistently helped me. Several times I tried ALL the other alternatives for various periods of time bet never more that months and the acid reflux killed me.Risk news rating: Severe FDA provides consumer advice following recall of products for infants and children.
For a complete list of recalled products, please see the recall notice and list of products 1. Following McNeil? Hamburg, M. We are investigating the products and facilities associated with this recall and will provide updates as we learn more. What products are affected by this recall? The products include certain liquid infant? Why were these products recalled?
Recalls in April 2020
McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. As a precautionary measure, parents and caregivers should not administer these products to their children.
Some of the products included in the recall may contain a higher concentration of active ingredient than specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, FDA advises consumers who have purchased these recalled products to discontinue use. What can I use instead of the recalled products? There are a number of other products on the market, including generic versions of the recalled products, which are intended for use in infants and children and are not affected by the recall.
FDA recommends that you check the labeling of these products. If you have any questions, you should discuss this with your pharmacist or other health care professional.
FDA does not anticipate that there will be a shortage of alternative products. Can I give my child adult strength Tylenol or Motrin products that are not being recalled? Consumers should not give drug products to infants and children that are not intended for those age groups. This could result in serious harm.
What should I do if I have some of the medication at home? FDA recommends that consumers stop using these products. For further instructions, see McNeil? I gave my child some of the medication. What do I do? Is my child at risk? According to the information the FDA has received at this time, the potential for serious medical problems is remote.
If your child exhibits any unexpected symptoms after use of any of the recalled products, contact your health care professional.
If I think my child may be having an adverse reaction to one of the products involved in this recall, who should I notify? Adverse reactions or quality problems experienced with the use of these products may be reported to FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax, using the contact information at the bottom of this sheet.
The agency asks health care professionals and consumers to report any adverse reactions to the FDA? General News Home Page. Nationwide Recall Risk news rating: Severe FDA provides consumer advice following recall of products for infants and children FDA recommends that consumers stop using these products. Risk news rating: Severe FDA provides consumer advice following recall of products for infants and children FDA recommends that consumers stop using these products.
All Rights Reserved.Thank you, you have successfully subscribed to our newsletter! Enjoy reading our tips and recommendations. Y, is recalling aboutcommercial-grade tamper resistant duplex receptacles.
A manufacturing error within the recep. The support which holds the brake mechanism coul. Pusateri's Fine Foods is recalling spring rolls that may contain milk, an allergen not declared on the label. No adverse reactions have been reported. The rear part of the fender liner on the front ax. The headliners may have been improperly manufactured without a m. The product may be contaminated with Listeria m.
Y, is recalling about 56, Lenox 2. The tea kettles can expel hot water during u. The products may contain egg and milk, allergens not declared on the label. No adverse reactions ha. Indian Motorcycle Company is recalling model year Challenger motorcycles. The engine output shaft bearing may not have been sufficiently lubric. Joybird of Commerce, Calif. The dressers are unstable if not anchored to the wall, posing tip-over and entrapme.
An internal part of the heater fails to meet flammabi. Fuel may. The tires may not. High levels of histamine in fish can cause an allergic.
Vinh Fat Food Products is recalling its own brand of spring rolls. The products may contain milk, an allergen not declared on the label. No illnesses. A component within the door latches may break as a result of excess. The products may be contaminated with norovirus. There have been some repo. The spare tire label may indicate the maximum s.The FDA Alert s below may be specifically about Flonase or relate to a group or class of drugs which include Flonase fluticasone.
Following is a list of possible medication recalls, market withdrawals, alerts and warnings. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.
There is a potential for patients to be exposed to the glass particles and mechanical irritation cannot be ruled out. Local trauma to the nasal mucosa might occur with use of the defective product. To date, Apotex Corp. Healthcare Professionals in your organization should be informed of this recall. If you have further distributed the recalled product, to the wholesale or retail level, please notify any accounts or additional locations which may have received the recalled product from you.
Customers with questions regarding this recall can contact Apotex Corp. Customers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:. Complete and submit the report Online: www. Download form or call to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to FDA The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records.
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FDA alerts.Nitrosamine Impurities in Medications. The medicines are being recalled because they may contain unacceptable levels of N-nitrosodimethylamine NDMA. FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake 96 nanograms per day. The agency posted the results of its testing of ranitidine samples and has asked companies to conduct their own laboratory testing.
Patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine. FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake 96 nanograms per day or 0. Nizatidine is a commonly prescribed antacid. NDMA is a known environmental contaminant found in water and certain foods.
Genotoxic substances such as NDMA may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but a person taking a drug that contains NDMA at-or-below the acceptable daily intake limit every day for 70 years is not expected to have an increased risk of cancer.
In SeptemberFDA announced it had become aware of laboratory testing that found low levels of NDMA in the heartburn medicine, ranitidine, which is chemically similar to nizatidine. FDA has been testing samples of both ranitidine and nizatidine.
The agency has also asked manufacturers of the drugs to conduct their own laboratory testing to assess levels of NDMA in their products and to send samples to FDA to be tested by our scientists.
FDA will recommend recalls to manufacturers of ranitidine and nizatidine with NDMA levels above the acceptable daily intake limit 96 nanograms per day. There are multiple drugs that are approved for the same or similar uses as ranitidine and nizatidine. Patients taking prescription ranitidine or nizatidine who wish to stop use should talk to their health care professional about other treatment options.
If you are taking one of the recalled medicines, you should follow the recall instructions provided by the company.
FDA is committed to helping assure the medicines Americans take are safe and effective. When we identify lapses in the quality of drugs that pose potential risks for patients, FDA makes every effort to understand the issues and provide our best recommendation to the public as quickly and accurately as possible. FDA will continue to investigate and work to make certain these types of impurities do not exceed acceptable limits, so that patients can continue taking their medicines without concern.
The agency will provide timely updates throughout the investigation. We have launched an investigation to understand the cause of this impurity in these drugs and to provide information for patients and consumers who take them.
Today, we are announcing that we have asked manufacturers of ranitidine and nizatidine products to expand their testing for NDMA to include all lots of the medication before making them available to consumers.
If testing shows NDMA above the acceptable daily intake limit 96 nanograms per day or 0. Our scientists have determined ranitidine does not form NDMA in typical stomach conditions.
However, we need further investigation to fully test how ranitidine and nizatidine behave in the human body and have plans to study this. There is also some evidence that there may be a link between the presence of nitrites and the formation of NDMA in the body if ranitidine or nizatidine is also present.Blood pressure drug Losartan recalled
Because of this, consumers who wish to continue taking these drugs should consider limiting their intake of nitrite-containing foods, e. Consumers may also consider alternative treatments that are approved for the same or similar uses as ranitidine and nizatidine.
Consumers may not know if the OTC ranitidine in their homes contains NDMA above the acceptable daily intake level because these recalls have been to the retail level, meaning they were only removed from store shelves.
The NDMA levels FDA found are similar to the levels a consumer would expect to be exposed to when eating common foods like grilled and smoked meats.