Safety Alerts & Recalls

What does this mean?

Patients can continue to receive Iclusig under their authorized investigational new drug applications (IND) application, the method of obtaining Iclusig in the time since the marketing suspension in October 2013. The FDA is working closely with ARIAD, the manufacturer of Iclusig on these new safety measures The FDA expects that the new safety measures will be in place by the end of January 2014. Once that process is complete, it is expected that patients can receive the Iclusig product from their pharmacy as before.

If you are currently receiving Iclusig, please follow up with your healthcare provider if you have any questions about the risk of blood clots with Iclusig or your ability to obtain your Iclusig prescription.

Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:

--- Telephone: 1-800-332-1088

--- Fax: 1-800-332-0178

--- Mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

--- Website: www.fda.gov/medwatch

FDA Requires New Safety Measures for Iclusig (Ponatinib) Before It Can Return to Market

The Food and Drug Administration (FDA) has announced the new safety measures required before the leukemia medicine Iclusig (ponatinib) can return to the market. In October 2013, the FDA requested and the manufacturer agreed to stop advertising and selling Iclusig due to the safety concerns with the medicine. These included life-threatening blood clots and severe narrowing of blood vessels that can cause serious outcomes like heart attack or stroke.

The required safety measures involve the following changes to the prescribing information: --Limiting prescribing of Iclusig to patients with certain types of leukemia

--Providing additional warnings and precautions about the risk of blood clots and severe narrowing of blood vessel

--Revising recommendations about dosage and administration of Iclusig to state that the optimal dose of Iclusig has not been identified.

--Updating the patient Medication Guide to include this additional safety information

The FDA is also requiring the manufacturer to put additional safety monitoring into place, including a risk evaluation and mitigation strategy (REMS) and conducting additional research to better understand Iclusig’s safety and dosing.

For more information, please visit: more information here

Source: FDA
Publication Date: 2014-01-02
Last Updated: 2014-01-02

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