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Batches of drugs for hypertension have been recalled in the past six months due to impurities causing cancer. The FDA has said that drugs at Valsartan are already in short supply and that others may be in short supply. ( pixabay )
The US Food and Drug Administration has warned of an impending shortage of drugs used by millions of people in the United States to treat high blood pressure.
Valsartan products out of stock
The agency said Friday that there was a national shortage of ARB, or angiotensin II receptor blockers, among them valsartan, irbesartan and losartan, prescribed by doctors to treat hypertension and heart failure.
The FDA has also warned of a new shortage of drugs for the treatment of high blood pressure, given that other drugs might also be lacking due to ongoing recalls.
"Valsartan's products are in short supply and we know that other types of products could be coming soon," said FDA Commissioner Scott Gottlieb and the Director of Assessment and Evaluation. from the FDA's drug research, Janet Woodbad.
NDMA-Contained Blood Pressure Medications Cause Cancer
In the past six months, the FDA has recalled dozens of lots of anti-hypertensive drugs, fearing that they have been contaminated with a carcinogen.
The drugs contain N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), two likely carcinogens for humans. These substances are an environmental contaminant and may be present in water and food products such as vegetables, dairy products and meat. The quantity of these substances in the affected pharmaceutical products was, however, unacceptable.
The long-term risk that these substances represent in medications for hypertension is not yet clear, but Erin Michos, of Johns Hopkins Medicine, said the amount consumed would play a role in the risks.
"The dose makes the poison," Michos told CNN. "It is a toxin that can affect the liver and cause liver fibrosis or scars and liver tumors in rats, so it is badumed that it is also toxic to humans."
The presence of impurities in drugs is probably due to manufacturing processes that reuse materials such as solvents. Solvent reuse is an accepted industry practice, although manufacturers must ensure that reused materials meet safety standards.
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