Patients with a rare, but potentially fatal calcium-depleting disease are left in limbo with the recall of a critical medicine, according to NBC 5.
Patients with the condition, known as hypoparathyroidism, don't make enough human parathyroid hormone, which helps the body absorb calcium. Calcium is needed for a healthy heart, working nervous system and proper bone and muscle function.
To treat the disease, patients use Natpara, a bioengineered replica of human parathyroid hormone to help them properly absorb calcium.
Natpara was recalled this month because tiny pieces of rubber from the injector were found in some vials of the drug, which could contaminate the drug solution.
"It's really scary," Ryan Polly, a patient in Vermont who uses the drug, told NBC 5. "Without this medication, I could be sitting at work, and the next thing I know, I could be having a seizure or my heart could stop."
Patients were told to talk to their physicians before stopping use of the drug, because it could lead to health emergencies. Although many patients have the drug stockpiled, it is unclear when new supplies will be available, according to the report.
Natpara's maker, Takeda, said in a written statement on its website that it recognizes the recall has been hard for patients and their loved ones.
"Since the recall began on Sept. 5, 2019, our dedicated OnePath team has reached out to more than 2,000 Natpara patients in the U.S. with information and support," the statement reads. "Our commitment to patients remains our highest priority. We are working urgently with the FDA on a number of potential solutions to bring this critical medicine back to patients as quickly as possible and will continue to keep patients and healthcare providers informed."
The recall illustrates one of the paradoxes in modern medicine. The FDA created the Orphan Drug Act to persuade drugmakers to develop medications for rare, often fatal diseases that were once overlooked by pharma companies because they aren't profitable. The program offers financial incentives and patent protection on the drugs.
But when manufacturing problems or recalls disrupt the supply, the consequences for patients may be debilitating because there is typically only one supplier of these drugs.
Read the full report here.