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Blood Pressure Medication Recalled — Here’s What You Need to Know
Numerous blood pressure drugs are now involved in the
recall that began in late July over a suspected cancer-causing compound.
For
the second time in the past week, a pharmaceutical firm has joined a long list
of companies announcing voluntary recalls of a blood pressure medication due to
contamination concerns.
Camber
Pharmaceuticals informed the Food and Drug Administration
(FDA) on Thursday that it is recalling 87 lots of 25mg, 50mg and 100mg Losartan
tablets because the company has detected in the products trace amounts
of N-Nitroso N-Methyl 4-amino butyric acid (NMBA), which has been
classified as a potential cancer-causing substance.
The
Losartan tablets are used to treat high blood pressure and congestive heart
failure.
Late
last week, Macleods Pharmaceuticals Limited informed the FDA that it is
voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide
100mg/25mg combination tablets.
Macleods
officials said they detected trace amounts of an impurity
called N-nitrosodiethylamine (NDEA), another pharmaceutical ingredient the
FDA has classified as a "probable human carcinogen."
For
the second time in the past week, a pharmaceutical firm has joined a long list
of companies announcing voluntary recalls of a blood pressure medication due to
contamination concerns.
Camber
Pharmaceuticals informed the Food and Drug
Administration (FDA) on Thursday that it is recalling 87 lots of 25mg, 50mg and
100mg Losartan tablets because the company has detected in the products trace
amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA), which has been
classified as a potential cancer-causing substance.
The
Losartan tablets are used to treat high blood pressure and congestive heart
failure.
Late
last week, Macleods Pharmaceuticals Limited informed the FDA that it is
voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide
100mg/25mg combination tablets.
Macleods
officials said they detected trace amounts of an impurity
called N-nitrosodiethylamine (NDEA), another pharmaceutical ingredient the
FDA has classified as a "probable human carcinogen."
The
Losartan tablets are used to treat hypertension and hypertensive patients with
left ventricular hypertrophy.
Macleods
officials said they have had no reports of anyone with adverse effects from the
recalled products.
This
is similar to the message that has been delivered the past seven months from
other companies that distribute blood pressure medications.
In
early February, the Japanese subsidiary of Pfizer Inc. announced it was
recalling a drug for high blood pressure due to NDEA found in the medicatiion's
active ingredient valsartan.
The
company told
Reuters
that more than 763,000 tablets of Amvalo manufactured between April and July in
Mylan Laboratories Limited in India will be removed from store shelves.
Company
officials said there have been no reports of any damage to anyone's health, but
they're still proceeding with the recall out of caution.
In
an announcement in January, FDA
officials said Solco Healthcare LLC has initiated a voluntary recall of one lot
of Irbesartan and seven lots of Irbesartan HCTZ tablets.
The
recall was also due to the discovery of trace amounts of NDEA. Company
officials said there have been no adverse effects reported from people taking
these pills.
In
late December, Aurobindo Pharma USA Inc. announced it is taking off
store shelves 80 lots of its Amlodipine Valsartan, Valsartan HCTZ, and
Valsartan tablets.
The
company also said it hasn't received any reports yet of adverse patient
reactions to their products.
Their
tablets also contained the NDEA chemical.
In
December, officials at Mylan said the pharmaceutical company would recall all lots of its blood
pressure medication valsartan.
The
additional 104 lots were being taken off shelves "out of an
abundance" of caution, company officials said, because of reports that
valsartan products may contain traces of the potential cancer-causing impurity.
The
previous week, Teva Pharmaceuticals announced they were
voluntarily recalling two blood pressure medications due to the impurity that
was detected above "specification limits."
The
Teva products are Amlodipine/Valsartan combination tablets and
Amlodipiine/Valsartan/Hydrochlorothiazide tablets.
Company
officials urged people who use the tablets to continue taking the medication
and consult with their doctor about potential alternative treatments. They said
the potential harm of stopping their medication was higher than the potential
risk from the tablets.
In
late October, officials at the FDA announced
they
were adding a brand of drugs sold under the RemedyRepack to the list of
medications recalled due to the ingredient in question.
In
late August, Accord Healthcare Inc. announced it was
voluntarily recalling a specific lot of blood pressure medication after
discovering a bottle had the wrong pills in it.
The
100-pill bottle was supposed to have Hydrochlorothiazide Tablets USP 12.5 mg.
Instead, it was filled with Spironolactone Tablets USP 25 mg. That medication
is used to treat congestive heart failure and cirrhosis of the liver, among
other ailments.
FDA
officials told USA
Today
that the effects of taking this incorrect medication range from
"limited" to "life threatening," depending on the
individual.
That
news came just a few weeks after the FDA expanded an initial recall involving
drugs containing valsartan, which is used to
treat high blood pressure and heart failure.
In
early August, FDA officials announced they had updated the list
of drugs
affected by the recall, which was originally announced in July. They also noted
the recall is now a worldwide recommendation.
Multiple
companies voluntarily recalled their medications, including valsartan from
Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries
Ltd., as well as valsartan/hydrochlorothiazide from Solco and Teva.
The
FDA said in a statement that “the presence
of NDMA was unexpected and is thought to be related to changes in the way the
active substance was manufactured.”
These
affected drugs are all generic versions of brand name Diovan, which is made by
Novartis International AG. Diovan and generic versions made by other companies
are not included in the recall.
“It’s
not the drug valsartan that’s the problem. It’s a contaminant that was included
in the manufacturing process that’s the problem. Patients shouldn’t lose faith
in the drug itself,” said Dr. Victoria Shin, a cardiologist with Torrance
Memorial Medical Center in California.
She
added that she doesn’t expect the recalls to affect patient care because of the
availability of other valsartan products.
The
FDA said in the statement that it’s “working with the affected companies to
reduce or eliminate the valsartan API impurity from future products.” It’s also
working on ensuring that the United States has an “adequate supply of
unaffected medications.”
CNN
reported that the
external supplier linked to the NDMA impurity in the recalled products has
stopped distributing its valsartan ingredient.
What should patients do?
The
FDA lists recall instructions provided by the
specific companies, including the drug lot numbers included in the recall and
how to return or dispose of the affected medicines.
It
noted that patients should look at the name of the drug and company listed on
the prescription label to determine if their medication has been recalled. They
can also contact the pharmacy where they picked it up.
These
medications are used to treat serious medical conditions — high blood pressure
and heart failure.
So
“patients should not stop their medication on their own without consulting a
physician,” said Shin. “This can cause elevated and uncontrolled blood pressure
which can potentially have severe health consequences.”
A
doctor or pharmacist can also help patients find an alternative medication.
This may be another valsartan product or a different medication from the same
class of drugs, known as angiotensin
receptor blockers.
These
blockers include losartan, olmesartan, irbesartan, and others.
Patients
should monitor their blood pressure closely after switching medicines. People
may respond differently to the new medication. The dose may also need to be
adjusted under the guidance of a healthcare provider.
Whether
patients end up paying more for their new medication depends on which product
they switch to. GoodRx lists the retail
price
of brand-name Diovan as around $250, with generic versions of valsartan as low
as $11.32. Health insurance plans may also often have lower copays for certain
medicines.
According
to the U.S.
Environmental Protection Agency (EPA), NDMA forms during both industrial and
natural processes. It was formerly used in the production of liquid rocket
fuel, antioxidants, and lubricant additives.
The
EPA notes that what’s known about the dangers of this chemical comes mainly
from laboratory studies. Exposure to high levels of NDMA may cause liver damage
in people.
The
long-term cancer risks of the levels of NDMA found in recalled valsartan
products is unknown.
FDA
officials said in a statement that it’s investigating how much NDMA was present
in the recalled products and is assessing what effect this might have on
patients who had been taking the medications.
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