Drug Safety Warnings and Updates: January-March 2018

Shannon Thor, PharmD, MS

Disclosures

May 23, 2018

Editorial Collaboration

Medscape &

In This Article

The FDA's MedWatch program compiles a quarterly report of important changes to safety labeling for boxed warnings for drugs and therapeutic biologics.

Boxed warnings highlight:

  • Adverse reactions so serious in proportion to the potential benefit from the drug that it is essential that it be considered in assessing the risks and benefits of using the drug; OR

  • Serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; OR

  • FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted.

Label changes are searchable in the Drug Safety Labeling Changes (SLC) database.

Didanosine (Videx; Videx EC)

For more on this Drug Safety Labeling Change, click here and here.

For full prescribing information, click here.

Updated Boxed Warning

WARNING: PANCREATITIS, LACTIC ACIDOSIS, and HEPATOMEGALY with STEATOSIS

Coadministration of VIDEX or VIDEX EC and stavudine is contraindicated because of increased risk for serious and/or life-threatening events. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.

Comments

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