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Washington - In February, after the carcinogen nitrosamine led to the recall of several common blood pressure medicines known as sartans, the U.S. Food & Drug Administration (FDA) temporarily increased the allowable level of the chemical. The FDA based the higher interim level on the additional likelihood a patient would develop cancer from taking the drug for six months with that level of contamination versus a lifetime at the original level. The Administration worried removing the drug completely from the market could potentially endanger 15 million Americans who take the tainted blood pressure medications.
The FDA said the six months would allow it to assess the problem and help drug manufacturers resolve their nitrosamine contamination. However, a new analysis of publicly available information from the FDA by U.S. Public Interest Research Group Education Fund finds that the Administration has only assessed the risk of 26 percent of these medications -- and found nitrosamine levels even higher than the interim level in 61 percent of some lots of those assessed medications.
“Americans expect their blood pressure medication to treat their conditions, not cause cancer,” said Adam Garber, U.S. PIRG Education Fund’s Consumer Watchdog. “The FDA has an obligation to meet its own self-imposed safety timeline to ensure that the millions of patients who need these drugs aren’t exposed to carcinogens.”
The FDA is allowing companies to continue distributing drugs in the United States even if it’s unclear if those medications are contaminated with the toxin. The hope is spot inspections will catch any tainted batches before they reach pharmacies.
But that preventative measure is not working well. The FDA has issued 14 recalls since March.
“Clinicians need transparency from the FDA about the planned investigations and the interventions so that we can keep our patients safe,” said Jodi Segal MD, MPH, the Co-Director of Johns Hopkins University’s Center for Drug Safety and Evaluation.
High blood pressure is a chronic condition usually requiring constant treatment. Many patients use these medications for years or even decades, increasing the chance that nitrosamine contamination could lead to cancer.
Public health advocates and doctors stress that patients should continue taking the medication unless their doctor prescribes an effective alternative. Patients also can discuss with their pharmacist which drug manufacturers have the best track records for nitrosamine-free blood pressure pills or alternative medications, as the FDA advises. But these conversations may be of limited futility without the FDA constantly updating their assessment list.
“This should have never happened,” said Patrick Devereux, PharmD, a pharmacist from Alabama. “I can’t provide safe medicine to my customers when the system fails to remove a known hazard in a major medication for this long. We need the FDA to announce a clear plan and timeline to remove these carcinogens from our drug supply completely.”
U.S. PIRG Education Fund and public health advocates recommend the Food & Drug Administration take the following immediate actions:
Provide resources and tools to increase production from companies whose drugs have not contained the carcinogen.
Set a clear public timeline for assessing all manufacturers to ensure their drugs are nitrosamine free. Regularly update doctors and the public on which manufacturers have been approved.
Help pharmacists and doctors suggest alternative, uncontaminated medication or ensure safe supply for patients.
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