Regulatory Focus™ > News Articles > 2019 > 10 > Lawmakers Seek Clarity From FDA on Recall of Lifesaving Drug

Lawmakers Seek Clarity From FDA on Recall of Lifesaving Drug

Posted 18 October 2019 | By Zachary Brennan 

Lawmakers Seek Clarity From FDA on Recall of Lifesaving Drug

Following Takeda Pharmaceuticals’ recall of its hypoparathyroidism drug Natpara (parathyroid hormone) early last month, people who need the drug to stay alive are struggling to find it and ending up in the hospital.

Vermont Democrat Senators Bernie Sanders, Patrick Leahy and Rep. Peter Welch sent a letter to the US Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless on Friday seeking more information on how long the recall might last, what short- and long-term actions are being taken and any other guidance for patients.

“Patients across the country have already been hospitalized due to an inability to get Natpara, and we fear that as more patients run out of Natpara, the number of avoidable hospitalizations — or worse — may increase,” the letter says.

A Takeda spokesperson told Focus via email that “it is aware that some patients have been hospitalized after discontinuing” Natpara. And while noting that the recall is specific only to the US, the spokesperson added: “We are working closely with the FDA, and we have submitted short- and longer-term proposals for bringing NATPARA back to the market – and we are awaiting their response.”

Takeda and FDA created a special use program for Natpara in late September for those “with life-threatening health complications,” but the company noted, “It is anticipated that an extremely small number of patients prescribed NATPARA will qualify for this very limited program.”

And the senators and representative said that only about 1% of patients will be helped while more than 2,500 others may be unaffected by the program.

The Takeda spokesperson added: "For the Special Use Program, we are talking about patients who were previously prescribed NATPARA and are at extreme risk of life-threatening complications as a result of discontinuation of NATPARA per their prescribing physician. The program relies on the physician’s determination that without continued access to NATPARA their patient would face life-threatening health consequences. Again, we recognize and regret that the program will not address the needs of the vast majority of patients. We’re working diligently with the FDA on short- and long-term solutions to bring NATPARA back to the broader patient community, and this remains our highest priority."

An FDA spokesperson told Focus: “Takeda is actively working to resolve the issue and resume supply. As FDA receives updates the agency will continue to ensure our communications are updated with the latest information posted to our CDER Drug Shortage website.” 

On the website, the listed reason for the Natpara shortage is: “Requirements related to complying with good manufacturing processes.” Estimated shortage duration is listed as “to be determined.”

The initial recall, which was upgraded to a Class I recall earlier this month, was due to the potential for rubber particulates to detach into the Natpara cartridge. "I can confirm that 'Requirements related to complying with good manufacturing processes' refer to the same rubber particulate issue that led to the recall," the spokesperson said.

Takeda also has warned those taking Natpara and prescribers that discontinuing the injection “abruptly can cause a sharp decrease in blood calcium levels (severe hypocalcemia) which can result in serious health consequences. It is critically important that patients contact their prescribing healthcare provider to discuss their individual treatment transition plan and ensure close supervision, including frequent monitoring of blood calcium levels and close titration of active vitamin D and calcium supplements upon stopping NATPARA to avoid low blood calcium (hypocalcemia).”

In the fiscal year that ended 31 March, Takeda said in an SEC filing that it brought in ¥7.1 billion (about $65 million) in revenue from Natpara.

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