By Jen Christensen, CNN |
Posted: Tue 4:32 PM, Nov 13, 2018
The US Food and Drug Administration says another
heart medicine is being voluntarily recalled after tests showed that it was
tainted with a potential cancer-causing chemical.
The new recall of losartan potassium
hydrochlorothiazide is sold by the company Sandoz. The voluntary recall only
involves the 100 milligram/25 milligram tablets, it does not involve the other
versions of the drug, sometimes sold under the brand names Hyzaar. If you take
Sandoz's losartan potassium, look on the bottle for the lot number. If it has
the lot number JB8912, then you have the recalled pills. Patients use these
drugs to keep their high blood pressure in check.
The drug is being recalled because the active
ingredient has tested positive for N-Nitrosodiethylamine or
NDEA, a suspected human and animal carcinogen that is used in gasoline as a
stabilizer for industry materials and as a lubricant additive, according to
the National Institutes of Health.
The ingredient was made by Zhejiang Huahai
Pharmaceutical Company Co. Ltd. The FDA placed the Chinese company on an import alert at the
end of September, meaning all of its active pharmaceutical products and
finished products will not be permitted to enter the United States. The FDA
made that decision after an inspection of the facility.
Several pills that contain valsartan, another drug
used by heart patients, have been under a recall since July. The drugs were
tainted with NDEA or NDMA, N-nitrosodimethylamine, an impurity that is also
considered a possible carcinogen by the US Environmental Protection Agency.
NDMA is an organic chemical used to make
liquid rocket fuel and is a byproduct of manufacturing some pesticides and
processing fish. It can be unintentionally introduced into manufacturing
through certain chemical reactions.
The FDA is testing all heart drugs known as
ARBs for these impurities.
Not all medicine containing valsartan is
recalled. The FDA keeps an ongoing list of products that are recalled and
a list of the valsartan products that are not recalled.
The latest recall impacts less than 1% of the
total losartan drug products in the US market, according to the FDA.
If your drug is on the recall list, the FDA
suggests taking it until your doctor or pharmacist provides a replacement.
Because not all valsartan and irbesartan drugs are involved in the recall, you
might be able to switch to a version by another company.
It's unclear exactly what the cancer risk is
if you take the contaminated valsartan pills; the FDA believed that
the risk was low with the valsartan recall.
It estimated that if 8,000 people took the
highest dose of valsartan (320 milligrams) containing NDMA from these recalled
batches daily for four years, there may be one additional case of cancer over
the lifetimes of 8,000 people. Many patients take a much lower dose of
valsartan, and therefore their risks are theoretically much lower.
The FDA said it will continue to test all
products containing valsartan and similar drugs for the presence of impurities.
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