If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.
Ringers Side Effects Reported to FDA
Ringers Side Effect Report#9057810 Chest Pain, Feeling Abnormal
This is a report of a 41-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Ringers (dosage: NA, start time:
Dec 26, 2012), combined with:
and developed a serious reaction and side effect(s): Chest Pain, Feeling Abnormal after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ringers treatment in female patients, resulting in Chest Pain side effect. The patient was hospitalized.
Ringers Side Effect Report#7729707-5 Neonatal Respiratory Distress Syndrome, Premature Baby, Maternal Exposure During Pregnancy
This report suggests a potential Ringers Injection In Plastic ContainerNeonatal Respiratory Distress Syndrome side effect(s) that can have serious consequences. A patient (weight: NA) from Austria was diagnosed with the following symptoms/conditions: maternal exposure during pregnancy and used Ringers Injection In Plastic Container (dosage: NA) starting NS. After starting Ringers Injection In Plastic Container the patient began experiencing various side effects, including: Neonatal Respiratory Distress Syndrome, Premature Baby, Maternal Exposure During PregnancyAdditional drugs used concurrently:
Thiopental Sodium (teva)
Although Ringers Injection In Plastic Container demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Neonatal Respiratory Distress Syndrome, may still occur.
Ringers Side Effect Report#7368593-2 Arthralgia, Mobility Decreased, Condition Aggravated, Dysphagia, Muscle Rigidity, Pain In Extremity, Myotonia
This Arthralgia problem was reported by a consumer or non-health professional from Japan. A 24-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Ringers Acetate (dosage: NA). The following drugs were being taken at the same time:
When using Ringers Acetate, the patient experienced the following unwanted symptoms/side effects: Arthralgia, Mobility Decreased, Condition Aggravated, Dysphagia, Muscle Rigidity, Pain In Extremity, MyotoniaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Arthralgia, may become evident only after a product is in use by the general population.
Ringers Side Effect Report#5664731-8 Blood Pressure Increased, Chills, Pyrexia
This Blood Pressure Increased side effect was reported by a physician from Poland. A 68-year-old male patient (weight:NA) experienced the following symptoms/conditions: hypokalaemia.The patient was prescribed Ringers Injection In Plastic Container (drug dosage: NA), which was initiated on
Mar 03, 2008. Concurrently used drugs:
.After starting to take Ringers Injection In Plastic Container the consumer reported adverse symptoms, such as: Blood Pressure Increased, Chills, PyrexiaThese side effects may potentially be related to Ringers Injection In Plastic Container.
The appearance of Ringers on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.
Why Your Notes are Important
Your notes could be helpful in several ways:
You can use them to remind you of details that may alert your health care professional(s) to a problem
You will have a record to refer to in the future, in case you are ever prescribed the same medicine again
You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.
Medicine Name and Dosage:
Date & Time
Other Medicine(s) or Treatment(s)
Scale: 1 = very mild to 10 = very bad
Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Ringers reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.
Lactated Ringers and 5 Percent Dextrose Injection, USP, 1000 ML, Flexible Containers: Recall - Due to Non-Sterility
AUDIENCE: Pharmacy, Patient, Health Professional
ISSUE: Hospira, Inc. is initiating a voluntary nationwide user-level recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC 0409-7929-09. This action is due to one confirmed customer report where a spore-like structured particulate, consistent with mold, was noted in the solution. Hospira has not received reports of any adverse events associated with this issue for this lot, and has not identified any quality issues with retention samples for this lot. If contaminated solution is used on a patient, this may cause thrombosis, phlebitis, bacteremia, sepsis, septic shock and/or endocarditis, or result in a fatal infection in a broad array of patients.
BACKGROUND: The product is used as a source of water, electrolytes and calories or as an alkalizing agent and is packaged in a 1000 mL flexible container, lot number 05-019-JT, with an expiration date of May 1, 2013. The affected lot was distributed nationwide between June 2011 and January 2012 to wholesalers/distributors, hospitals and pharmacies.
RECOMMENDATION: Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-965-5798 between the hours of 8am to 5pm EST, Monday through Friday, to arrange for the return of the product. Replacement product from other lots is available. For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187.
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: