Other safety alerts
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| The United States: Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA requires drug interaction studies |
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FDA is requiring the Kayexalate manufacturer to conduct studies to investigate Kayexalate's potential to bind to other medications administered by mouth – drug interactions that could affect how well the other medications work.
Kayexalate (sodium polystyrene sulfonate) and generic brands Kionex and SPS are used to treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high. They work by binding potassium in the large intestine so it can be removed from the body.
The approved labeling for Kayexalate in the US describes its potential to decrease absorption of lithium and thyroxine; however, extensive drug-drug interaction studies with Kayexalate have not been performed. During FDA’s review of another potassium-lowering drug, Veltassa (patiromer), FDA found that Veltassa bound to about half of the medications tested, some of which are commonly used in patients who require potassium-lowering drugs. Such binding could decrease the effects of these medications. The label for Veltassa contains a warning not to take other orally administered medications within 6 hours of taking Veltassa.
Similar to Veltassa, Kayexalate may also bind to other medications administered by mouth. To reduce this potential risk, prescribers and patients should consider separating Kayexalate dosing from other medications taken by mouth by at least 6 hours. This includes both prescription medications, such as antibiotics, blood pressure lowering agents and blood thinners, and those purchased over-the-counter without a prescription, such as antacids and laxatives. Health care professionals should monitor blood levels or clinical response to the other medications when appropriate.
If the studies conducted by the Kayexalate manufacturer, Concordia Pharmaceuticals, confirm significant interactions with other medications, FDA will require all manufacturers of sodium polystyrene sulfonate products to update the drug labels to include information about these drug interactions.
Prescribers and patients should consider separating Kayexalate dosing from other medications taken by mouth by at least 6 hours. Health care professionals should monitor blood levels or clinical response to the other medications when appropriate. Patients should not stop taking their potassium-lowering drugs without talking to their health care professional.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm468720.htm
In Hong Kong, there are two registered pharmaceutical product containing sodium polystyrene sulfonate, namely Resonium A Powder (HK-42418) and PMS-Sodium Polystyrene Sulfonate Powder (HK-44860); while there is no registered pharmaceutical product containing patiromer. In view of the possible drug interaction between sodium polystyrene sulfonate and other drugs, letters to inform local healthcare professionals of the risk will be issued. As the US FDA is requiring the brand product's manufacturer to conduct studies to confirm whether there will be significant drug interaction, and labels will be updated if the result is affirmative, DH will remain vigilant on the US FDA's conclusion and safety updates by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/ Friday, October 23, 2015
Issued at HKT 15:00
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