Media
raises the alarm, but based on what?
By
Will Collette
Last
week, many network news shows featured stories about the Food and Drug
Administration’s discovery of a cancer-causing chemical called NDMA in some
batches of Zantac and its generic versions.
Since
millions of Americans – including me – take ranitidine to control heartburn and
acid reflux, the news caused quite a stir even though the news reports were
very sparse on details.
The
reason for the sparse details stem from the statements from the FDA and its
European counterpart, the European Medicines Agency that did not contain a lot
of crucial information. I have reprinted both agencies’ statements below.
We
don’t know exactly how the NDMA got there, though I have seen some accounts
that say a chemical reaction between ranitidine’s ingredients could cause its
formation.
We
don’t know if all, most or only a few batches of ranitidine contain NDMA.
We
also don’t know what levels of NDMA are present, though we do have this observation
in the FDA statement:
Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.
We
don’t know if there’s a technological “fix,” such as a reformulation that
eliminates NDMA from the medication. We DO know there will be further, deeper
study of this issue by the FDA and the EMA.
We
don’t really know why the FDA and its European colleagues decided to issue
their statements.
Under Trump, we have rarely seen federal regulatory agencies put a lot of zeal into protecting public health over corporate profits. That makes the FDA statement, amplified by the European’s parallel statement, all the more concerning.
Under Trump, we have rarely seen federal regulatory agencies put a lot of zeal into protecting public health over corporate profits. That makes the FDA statement, amplified by the European’s parallel statement, all the more concerning.
Despite
that inference, neither agency is telling patients to stop taking ranitidine.
Instead, you are told to keep taking the medication if you need it or talk to
your doctor about treatment alternatives.
Except
your doctor probably doesn’t know more about this issue that what’s been
published. Further, treatment alternatives are limited since the entire class
of “sartan” stomach acid inhibitors have this same issue. Last June, we went
through a similar
health scare with Prilosec® and its generics.
So what do you do? Personally, I do plan to discuss this with my doctor when I see her later this month. She also takes ranitidine so I plan to follow her lead.
We live in a world full of risks. We have to make daily choices about such risks versus whatever benefits those risks deliver. Not to minimize the Zantac alarm, I personally don't see enough information yet to make an intelligent decision about ranitidine's risks versus its benefits.
Here
are the complete statements issued by the FDA and EMA.
Janet
Woodcock M.D., Director, Center for Drug Evaluation and Research
September
13, 2019 - The U.S. Food and Drug Administration has learned that some
ranitidine medicines, including some products commonly known as the brand-name
drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine
(NDMA) at low levels. NDMA is classified as a probable human carcinogen (a
substance that could cause cancer) based on results from laboratory tests. NDMA
is a known environmental contaminant and found in water and foods, including
meats, dairy products, and vegetables.
The
FDA has been investigating NDMA and other nitrosamine impurities in blood
pressure and heart failure medicines called Angiotensin II Receptor Blockers
(ARBs) since last year. In the case of ARBs, the FDA has recommended numerous
recalls as it discovered unacceptable levels of nitrosamines.
When
the agency identifies a problem, it takes appropriate action quickly to protect
patients. The FDA is evaluating whether the low levels of NDMA in ranitidine
pose a risk to patients. FDA will post that information when it is available.
Patients
should be able to trust that their medicines are as safe as they can be and
that the benefits of taking them outweigh any risk to their health. Although
NDMA may cause harm in large amounts, the levels the FDA is finding in
ranitidine from preliminary tests barely exceed amounts you might expect to
find in common foods.
Ranitidine
is an over-the-counter (OTC) and prescription drug. Ranitidine is an H2
(histamine-2) blocker, which decreases the amount of acid created by the
stomach. Over-the-counter ranitidine is approved to prevent and relieve
heartburn associated with acid ingestion and sour stomach.
Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
The
agency is working with international regulators and industry partners to
determine the source of this impurity in ranitidine. The agency is examining
levels of NDMA in ranitidine and evaluating any possible risk to patients. The
FDA will take appropriate measures based on the results of the ongoing
investigation. The agency will provide more information as it becomes
available.
The
FDA is not calling for individuals to stop taking ranitidine at this time;
however, patients taking prescription ranitidine who wish to discontinue use
should talk to their health care professional about other treatment options.
People taking OTC ranitidine could consider using other OTC medicines approved
for their condition. There are multiple drugs on the market that are approved
for the same or similar uses as ranitidine.
Consumers
and health care professionals should report any adverse reactions with
ranitidine to the FDA’s MedWatch
program to help the agency better understand the scope of the
problem:
Download
and complete the appropriate form, then submit it via fax at 1-800-FDA-0178
The
FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and security
of human and veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the safety and
security of our nation’s food supply, cosmetics, dietary supplements, products
that give off electronic radiation, and for regulating tobacco products.
EMA to review ranitidine medicines following detection of NDMA
Press
release 13/09/2019
At the request
of the European Commission, EMA is to start a review of ranitidine medicines
after tests showed that some of these products contained an impurity called
N-nitrosodimethylamine (NDMA).
NDMA is
classified as a probable human carcinogen (a substance that could cause cancer)
on the basis of animal studies. It is present in some foods and in water
supplies but is not expected to cause harm when ingested in very low levels.
EMA is
evaluating the data to assess whether patients using ranitidine are at any risk
from NDMA and will provide information about this as soon as it is available.
Ranitidine
medicines are used widely to reduce the production of stomach acid in patients
with conditions such as heartburn and stomach ulcers. They are available over-the-counter
and on prescription.
Patients who
have any questions about their current treatment can speak to their doctor or
pharmacist. There are several other medicines used for the same conditions as
ranitidine that could be used as an alternative.
In 2018, NDMA
and similar compounds known as nitrosamines were found in a number of blood
pressure medicines known as ‘sartans’, leading to some recalls and to an EU review,
which set strict new manufacturing requirements for these medicines.
EMA is currently working on
guidance for avoiding nitrosamines in other classes of
medicines. EMA will continue to cooperate with national authorities, EDQM and
international partners to protect patients and ensure that effective measures
are taken to prevent these impurities from being present in medicines.
More about the
medicine
Ranitidine
belongs to a class of medicines known as H2 (histsamine-2) blockers, which work
by blocking histamine receptors in the stomach and reducing the production of
stomach acid.
It is used to treat and prevent conditions caused by excess acid in the stomach such as heartburn and stomach ulcers. Ranitidine-containing medicines are authorised by national authorities and are available as tablets and injectable formulations.
More about the
procedure
The review of
ranitidine medicines was initiated on 12 September 2019 at the request of the
European Commission, under Article 31 of Directive
2001/83/EC.
The review will
be carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning
medicines for human use, which will adopt an opinion.
The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.
The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.