Three Vermont lawmakers sent a letter to the FDA Oct. 18 accusing the agency of failing to be transparent about Takeda Pharmaceutical's recall of the lifesaving drug Natpara. The lawmakers also called on the agency to quickly resolve the shortage of the recalled drug.
Takeda recalled Natpara, a treatment for a rare, but potentially fatal calcium-depleting disease, Sept. 5 after it discovered rubber particles in the vials that could clog the needles used to deliver the drug. Natpara was approved four years ago to treat the disease, called hypoparathyroidism.
The recall left about 2,700 patients with no alternative treatment.
Takeda has not provided patients or physicians any information about why the rubber particles suddenly appeared or how long the problem may last, according to STAT.
"The main frustration is not that the product is recalled. I understand there's an issue and they’re trying to fix it. But nobody is giving us information. We don’t know if it’s going to be three months or a year before it comes back," Ryan Polly, 40, a patient who had taken Natpara since 2015, told STAT.
Sens. Bernie Sanders (I-Vt.) and Patrick Leahy (D-Vt.) and Rep. Peter Welch (D-Vt.) signed the letter, requesting the FDA provide as much information as possible on when the issue will be resolved and clear guidance on alternative treatments for affected patients.
"We urge the FDA to take all steps within your administration's authority to aid patients impacted by the recall and ensure that Natpara, or any safe and effective alternative, is made available as soon as possible," the lawmakers wrote.
Takeda told STAT in a statement that it can't yet predict a timeline of when Natpara will be available.
The FDA told STAT, "we acknowledge the current challenges around accessing Natpara Injection. The agency is working with Takeda to increase product availability. Takeda can be contacted for more information … Additionally, the FDA has no information to provide regarding specific manufacturing and supplier information or about products approved overseas."
Since the recall began, there have been 174 emergency room visits because patients were unable to get the drug, according to Mr. Polly, who provided STAT the figures from two Natpara support groups on Facebook. Sixty-seven patients were admitted to the hospital, some more than once, and six patients went to intensive care units.
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