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U.S. Department of Health and Human Services

Safety

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Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets October 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Reproductive Risk Potential
  • Antiretroviral Pregnancy Registry
    • Efavirenz

ADVERSE REACTIONS

  • Postmarketing Experience
    • Efavirenz
      • Nervous System Disorders
        • Cerebellar coordination and balance disturbances (added)

PATIENT COUNSELING INFORMATION

  • Reproductive Risk Potential
    • ...Because of the long half-life of efavirenz, use of adequate contraceptive measures for 12 weeks after discontinuation of Atripla is recommended...

PATIENT PACKAGE INSERT

  • What should I avoid while taking Atripla?
    • Women should not become pregnant while taking Atripla and for 12 weeks after stopping it...
    • ...Efavirenz, a component of Atripla, may remain in your blood for a time after
      therapy is stopped. Therefore, you should continue to use contraceptive measures
      for 12 weeks after you stop taking Atripla.

WARNINGS AND PRECAUTIONS

Reproductive Risk Potential:

...Because of the long half-life of efavirenz, use of adequate contraceptive measures for 12 weeks after discontinuation of Atripla is recommended...

Antiretroviral Pregnancy Registry:

Efavirenz: As of July 2007, the Antiretroviral Pregnancy Registry has received prospective reports of 373 pregnancies exposed to efavirenz-containing regimens, nearly all of which were first-trimester exposures (359 pregnancies). Birth defects occurred in 7 of 295 live births (first-trimester exposure) and 1 of 26 live births (second/third-trimester exposure). None of these prospectively reported defects were neural tube defects. However, there have been five retrospective reports of findings consistent with neural tube defects, including meningomyelocele.

 

Label approved 10/18/2008 is not available on this site

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