Valsartan,
Losartan & Other BP Med Recalls 2018-19
Note: This story was updated on March 18, 2019 with the
recall of 43 lots of Losartan.
Dozens
of medications used to treat high blood pressure have been recalled
over the past several months as federal investigators discover potentially
cancer-causing impurities in them. When American Health Packaging recalled one
lot of valsartan pills on March 7, the Public Interest Research Group said it
was the 75th recall of blood pressure medications since the problem first
appeared.
These
common prescription drugs include valsartan, losartan, and irbesartan in different
combinations and from different manufacturers.
The
problems have become so widespread that on March 12 the FDA prioritized
approval of a new generic of valsartan to help relieve shortages of
the drug.
“We
know that the ongoing recalls to prevent certain lots of valsartan that contain
unacceptable limits of impurities from reaching patients has resulted in a
shortage of these important medicines,” said FDA Commissioner Scott Gottlieb,
MD. Gottlieb said the agency will continue to work with drug manufacturers so
that more medicines like valsartan can be approved.
The
FDA is also working to determine what exactly has caused the impurities and
what changes need to be made in the manufacturing process to prevent
it. The Public Interest Research Group said in March that the FDA needs to
step up the pace.
"After
75 recalls it is clear more aggressive action is needed," PIRG consumer
watchdog Adam Garber said in a release. "Americans expect their blood
pressure medicadtion to treat their conditions, not cause cancer. The FDA needs
to finish its investigation and develop a plan to prevent further
contamination."
Almost
60 million prescriptions were written for losartan drugs in 2016 and 14 million
for valsartan or a drug that includes it. An additional 3.6 million
prescriptions were written for irbesartan that year. Here’s what you need to
know.
What blood pressure drugs have been recalled?
Valsartan. There have been so many types of valsartan
recalled this year that the FDA has created a website listing just
for them.
The latest is American Health Packaging's 160 mg valsartan tablets, lot number
179791 that expire on March 31, 2020. The pills come in 100-count blister packs
with NDC number 60687-139-01.
Losartan. In December, the FDA announced a voluntary
recall of losartan potassium tablets USP. An addition eight lots of
Torrent Pharmaceuticals' losartan tablets were added to a previous recall in
January. See which products
were affected by the recall.
In
November, the FDA announced a voluntary recall of losartan
potassium/hydrochlorothiazide, 100 mg/25 mg tablets in 1,000-count plastic
bottles, NDC 0781-5207-10, Lot number JB8912, Exp. Date 06/2020.
Torrent's
recall was expanded on Jan. 22 to include 10 additional lots of losartan
potassium tablets, and six lots of losartan potassium and hydrochlorothiazide
tablets. See the full list
here.
Macleods
Pharmaceuticals Limited on Feb. 25 recalled one lot of losartan
potassium/hydrochlorothiazide combination tablets 100mg/25mg, with a July 2019
expiration date.
Camber
Pharmaceuticals on Feb. 28 recalled 87 lots of losartan tablets USP 25mg, 50 mg
and 100 mg. See the affected
products and what the label looks like.
Legacy
Pharmaceutical Packaging, LLC on March 15 recalled 43 lots of losartan tablets.
See a list of affected products here and here.
Irbesartan. In July, the FDA announced a voluntary recall
of irbesartan tablets. See which products
were affected by the recall. In January 2019, Prinston
Pharmaceutical Inc., doing business as Solco Healthcare LLC, voluntarily
recalled eight llots of irbersartan-based drugs. These are not yet listed on
the FDA's website of all recalled ibersartan products. The recall involves
irbersartan and irbersartan HCTZ tabletes manufactured in China.
Why are the drugs being recalled?
In
each case, a recalled drug was contaminated with N-nitrosodimethylamine
(NDMA), N-nitrosodiethylamine (NDEA) or N-Nitroso N-Methyl 4-amino butyric
acid (NMBA).
Thosechemicals
are believed to cause cancer in humans. Research
also suggests NDEA can cause liver and blood cell damage.
NDEA
is used to make rocket fuel and can also be found in some food and drinking
water, but at low levels. It can also be a created through certain chemical
reactions and as a byproduct of industrial processes.
What is the risk of getting cancer from one of these drugs?
The
FDA says it is very small. The amount of NDMA found in the recalled valsartan
drugs exceeds acceptable levels. Records from drug manufacturers show the
impurity may have been in the valsartan products for up to 4 years. The FDA
estimates that if 8,000 people took the highest valsartan dose, which is 320
milligrams, from recalled batches every day for 4 years, there would likely
only be one additional case of cancer over the life of those 8,000 people.
For
context, 1 in 3 people in the United States will be diagnosed with cancer in
their lifetime.
What’s driving the spike in recalls?
A
common thread among all of these recalls is that the drugs, or ingredients in
the drugs, were all made in China or India.
American
drug companies since the 1990s have increasingly used factories in other
countries to manufacture their products. About 40% of finished medications are
made overseas, the Government Accountability Office says. Nearly 8 out of 10
active pharmaceutical ingredients, which are made into pills at other plants,
are, too.
This
globalization of the nation’s drug supply helps keep prices down, as it is
cheaper to have them made in other countries. But with lower costs sometimes
comes lower quality control.
What’s being done about products made in other countries?
An
FDA spokesman says the agency is still investigating how these drugs became
contaminated. Inspectors believe contaminated compounds were unintentionally
created through a chemical reaction.
What should people who rely on these medicines do?
Experts
say anyone taking a recalled drug should continue to do so, but contact your
doctor or pharmacist immediately. The
threat from the contamination may be less than the threat of not taking the
drug.
Your
doctor or pharmacist can help you find an alternative. But at least one expert
says the recalls are making it more difficult to find valsartan drugs that have
not been recalled. And, he says, some blood pressure drugs not on the recall
list have seen price increases as demand spikes.
...
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