[ad_1]
April 5, 2019 – The FDA released Thursday a list of 40 non-nitrosamine-mediated hypertension medications, a recurring problem that has triggered several drug recalls since last summer.
The list is meant to help physicians make therapeutic decisions, but a cardiologist who was not involved in its creation believes that patients should be encouraged to act and that their doctors and pharmacies still do not administer any contaminated drugs to them.
The medications involved are drugs that lower blood pressure in a family of medications called ARAs (angiotensin II receptor blockers), which block the effect of angiotensin, a protein hormone that contracts the blood vessels and increases the pressure. Medications are also used to treat heart failure and other problems.
Nitrosamines are environmental contaminants also present in water and food. they are classified as substances that can cause cancer. In its review of ongoing problems, the FDA has stated that "the maximum possible exposure to nitrosamines … in ARB containing drugs appears to be small", but that their presence in drugs n & # 39; 39 is not acceptable.
The problem appeared last July, when the FDA announced the voluntary recall of several drugs containing valsartan when the impurities had been found.
The first 40 nitrosamine-free drugs will be added to the list of "safe" drugs, says the FDA. The list is intended for health professionals to consider when they are considering treatments. "We are also working with manufacturers to quickly eliminate drugs from the market if they contain an impurity of nitrosamine at levels above the temporary intake limits," the FDA release said.
The disposal of contaminated products has resulted in shortages, and the agency says working to help solve them. One solution proposed by the authorities is to temporarily authorize the distribution of specific batches of losartan, a drug also affected by the contamination. "Our scientists believe that the risk of cancer will not be significantly increased in the time it takes for unfiltered losartan to be on the market," the statement said. The FDA predicts that this will happen within 6 months.
Continued
View of the cardiologist
While the list should help doctors and pharmacies focus on approved drugs, Dr. Guy L. Mintz, Director of Cardiovascular Health and Lipidology at Sandra Atlas Bass Heart Hospital in Manhasset, New York , is not certain.
"I do not have much confidence in pharmacies to store their tablets [only] "It is good that the FDA has done due diligence and examined 40 drugs," he says. But "now you have to depend on the pharmacy".
Many patients use mail order pharmacies and drug manufacturers can be changed without alerting them, he says.
He contests the FDA claiming that people using the contaminated losartan could continue to take it until a supply of this drug free of any contaminant is available. Although the risk of cancer is considered low, many patients, especially those who have already survived cancer, find this risk unacceptable.
These patients could ask their doctors to switch to other types of ARBs, he says. "There are two other members of the ARB class who have a long span of action," he says. These include telmisartan (Micardis) and olmesartan (Benicar). "To my knowledge, these two have never been contaminated."
His advice for those who take blood pressure medications: "Do not stop your medications.You could do more harm in stopping you."
For those who take contaminated medication, he says, "Call your doctor, make an appointment to discuss alternative medicine for your high blood pressure."
"I would also like to tell patients to contact their pharmacies," he says, "to be sure that they carry an FDA-approved mark and that they have been proven safe."
[ad_2]
Source link