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FDA urges patients to continue taking blood pressure medications despite cancer risk, despite global shortage
- Drugs containing valsartan, losartan and irbesartan are among the most commonly prescribed medications for hypertension.
- One in three Americans may need treatment for high blood pressure to avoid a heart attack or stroke
- The pills of nearly 30 manufacturers contained more carcinogens than the FDA judged safe and were recalled
- The recalls led to shortages. The FDA has temporarily raised the limit of the carcinogen and urged patients to continue taking contaminated medications for the time being.
By Natalie Rahhal Assistant Health Editor for Dailymil.com
published: 6:25 pm EDT, April 4, 2019 | Update: 6:25 pm EDT, April 4, 2019
The US Food and Drug Administration urges patients to continue taking blood pressure medications despite the shortage of drugs.
In July, the FDA began recalling some drugs for valsartan blood pressure after discovering they had a chemical impurity that could lead to cancer risk.
As the list of contaminated versions of drugs increased, an alarming number of Americans found themselves without access to life-saving drugs.
Now, the FDA has reiterated its warnings, advising Americans to continue to take blood pressure medications to a minimum, until manufacturers have the opportunity to replenish this unclean drug supply.
Many blood pressure medications containing valsartan have been recalled for being contaminated with a possible carcinogen, resulting in a shortage. On Thursday, the FDA said that taking contaminated drugs was safer than the lack of drugs
It is estimated that one in three Americans may need to take medication for high blood pressure.
But since July, a series of drugs containing valsartan, irbesartan and losartan have been recalled after the FDA had discovered that they were contaminated with a chemical called NMBA.
Animal studies suggest that NMBA could be carcinogenic.
The FDA limits to 0.96 the amount of NMBA that can be present in the drug without causing harm.
The drugs manufactured by the companies were recalled while the drug manufacturers were striving to fill the gaps in the supply.
The manufacturers concerned should increase their production sufficiently to replenish their stocks in pharmacies within six months.
But patients still have a lot of time to do without drugs – and this would increase their risk of heart attack and stroke.
Thus, the FDA has temporarily increased the amount of NMBA that it would tolerate in drugs at 9.82 parts per million (parts per million) after determining that six months of this low exposure would not increase cancer risk in a significative way.
"The risk badociated with abrupt cessation of the use of these important drugs far outweighs the low risk that our scientists feel is badociated with continued treatment until the doctor or pharmacist of the drug patient provides a safe replacement or a different treatment option, "said the FDA in a statement Thursday.
At present, the agency has identified 40 drugs that contain no contaminants.
But even if your medications are on the list of contaminated products, you must continue to take them, says the FDA.
Of course, it is important to avoid carcinogens, but not taking antihypertensive drugs is a more immediate danger.
"The FDA reminds patients taking losartan recalled to continue taking their current medication until their pharmacist gives them a replacement or their doctor prescribes a different medication that addresses the same problem," said Dr. 39, agency in a statement.
"Untreated hypertension (high blood pressure) causes an increased risk of heart attack and stroke.
"Untreated heart failure increases the risk of hospitalization and death. Untreated diabetic nephropathy (kidney disease) leads to worsening of kidney disease. "
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