Earlier this week John's Hopkins TB clinic director Maunank Shah told us a shortage of isoniazid had forced some US state health departments to ration tuberculosis (TB) drugs and restrict treatment to only the most seriously ill patients.
The US Food and Drug Administration (FDA) added isoniazid to its list of drugs in short supply in December, attributing the problems to the combined impact of shortages of the API and high demand being experienced by manufacturers Teva, Sandoz and VersaPharm.
The situation has now eased somewhat according to Sandoz spokeswoman Alanna Jamieson who told in-Pharmatechnologist.com the firm is "currently supplying its isoniazid product at all strengths without interruption.”
The FDA has updated its website on the shortage to acknowledge this, noting that Sandoz’s various isoniazid products are ‘now available’. Similarly, the agency said that Teva “has established an emergency reserve to be disbursed in compliance with published CDC guidelines.”
Nevertheless, the drug has yet to be included on the FDA’s list of resolved drug shortages and Dr Shah’s comments suggest that supplies have not yet normalized.
Dr Shah told in-Pharmatechnologist.com that while he heard the shortage was resolved late last week “to date we haven't heard of any changes in terms of our ability to order the drugs.”
"We get our drugs through the State office, and I've emailed them to see if they are able to access the drug any better than before," Shah continued, adding that "so far, we have not received any official word from State, CDC, or others that there is normalization of INH availability, so we are continuing to operate under our 'rationing' guidelines.”
Salina Smith, a CDC (Centers for Disease Control and Prevention) spokeswoman, was of a similar opinion telling us the shortage has not eased. She added that the lack of isoniazid has worsened TB patient outcomes, increased treatment duration to at least 18 months – instead of the usual six – and increased toxicities.
Both Smith and Shah's comments suggest that, while the situation at Sandoz and Teva may have improved, the other key supplier named by the FDA on its shortage list - VersaPharm - still does not have adequate supplies of isoniazid.
Carl Meredith, VP of VersaPharm, told us that “VersaPharm is working on the shortage," explaining that first the company had an API issue and then an unspecified manufacturing issue.
Meredith added that VersaPharm has not “had people calling in panic,” although he has heard the shortage has caused changes to treatment plans.
Meredith also noted that although VersaPharm has been producing isoniazid for years, the company is “essentially not making any money” on its production and only continues to make it for mostly altruistic reasons.
Some experts also contend that the shortage is only due to the profitability of the drug because isoniazid is relatively easy to produce.
“Since the number of patients has dropped in the US, it is expensive to import,” Girish Malhotra, president of the manufacturing consulting firm EPCOT International, told us. “Based on Isoniazid prices in India, the transportation cost [to the] US would be more than the drug cost.”
Malhorta added that isoniazid is so easy to produce, the world’s supply of it could all be made at one manufacturing site.