CDC Recommendations for Isoniazid Shortages

The continuous shortage of isoniazid has prompted the CDC to release recommendations on how to adjust tuberculosis treatment and prevention practices in response to the shortage. Isoniazid is an isonicotinic acid indicated for the prophylaxis and treatment of susceptible tuberculosis.

A critical shortage of isoniazid 300mg tablets was initially reported on November 2012 by the Illinois State tuberculosis (TB) program. Other state TB programs reported difficulty obtaining isoniazid 300mg tablets as well. Recent reports stated that the stocks of the 100mg tablets are being depleted.  According to the FDA, the three U.S. suppliers of isoniazid are Teva, Sandoz, and VersaPharm. Teva has reported low inventory and possible backorder due to delayed shipment. Sandoz has reported a shortage of the active ingredient from its supplier. VersaPharm has notified public health officials that it is cancelling all isoniazid backorders and is not accepting new orders.

The CDC is recommending the following prioritization:

  • Treating patients who have TB disease,
  • Treating latent TB patients who are diagnosed during contact tracing of contagious TB, and
  • Treating latent TB patients who face the greatest likelihood of TB disease (eg, HIV) or the hazard of severe illness (eg, children <5 years old)

The WHO is recommending that a full treatment course of drugs should be secured before starting treatment with one of the fixed-dose combinations.

An initial forecast date for restoring isoniazid production has been extended from late January 2013 to as late as March 2013. The CDC is working to determine current isoniazid stocks, jurisdictions with urgent needs, and options for restoring supplies as soon as can be safely done.

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