Sodium polystyrene sulfonate FDA Alerts
The FDA Alerts below may be specifically about sodium polystyrene sulfonate or relate to a group or class of drugs which include sodium polystyrene sulfonate.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for sodium polystyrene sulfonate
Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Recommends Separating Dosing
ISSUE: FDA is recommending that patients avoid taking the potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) at the same time as other medicines taken by mouth. A study found that sodium polystyrene sulfonate binds to many commonly prescribed oral medicines, decreasing the absorption and therefore effectiveness of those oral medicines. To reduce this likelihood, we recommend separating the dosing of sodium polystyrene sulfonate from other orally administered medicines by at least 3 hours. We are updating the sodium polystyrene sulfonate drug labels to include information about this dosing separation.
BACKGROUND: Sodium polystyrene sulfonate is used to treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high. It works by binding with potassium in the intestines so it can be removed from the body. Potassium is a mineral that helps the body function properly. Too much potassium in the blood can cause problems with heart rhythm, which in rare cases can be fatal. Sodium polystyrene sulfonate is available as the brand name Kayexalate, as generic brands, and also as non-branded generics.
RECOMMENDATION: Patients should take orally administered prescription and over-the-counter (OTC) medicines at least 3 hours before or 3 hours after taking sodium polystyrene sulfonate. Patients should not stop taking their potassium-lowering medicines without talking to their health care professional first. If you have questions or concerns, including about how to take sodium polystyrene sulfonate with other medicines, talk to a pharmacist or other health care professional.
When prescribing sodium polystyrene sulfonate, health care professionals should advise patients to separate dosing from other orally administered medicines by at least 3 hours. That time should be increased to 6 hours for patients with gastroparesis or other conditions resulting in delayed emptying of food from the stomach into the small intestine.
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.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[09/06/2017- Drug Safety Communication - FDA]
Sodium Polystyrene Sulfonate Suspension[Posted 07/16/2008] Roxane Laboratories, Inc. informed healthcare professionals of the recall of two lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; lot 856396A Exp April 2010, and lot 856693A Exp May 2010), a product used to treat hyperkalemia. A sample of one of the affected lots tested positive for a strain of yeast, which could potentially affect immunocompromised patients. Symptoms of a yeast infection range from thrush, skin rash, and blood infections. If patients develop an infection they should consult their physician. Pharmacists should determine if any of the referenced product has been dispensed and retrieve it. Additionally, pharmacists and wholesalers of the product should discontinue distribution and use of the referenced lots immediately and contact the manufacturer regarding returning the product.
More sodium polystyrene sulfonate Resources
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- Sodium Polystyrene Sulfonate AHFS DI Monograph
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