Central PA Medicine Summer2020 - 34

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Features

Contaminated
Drugs
By ROBERT ETTLINGER, MD

T

his past year, a couple of common medicaWhile most American medications are made Labeling drug labels must include the
tions were recalled by the Food and Drug domestically, 85% of the facilities manufacturing drugmaker, the labeler, or the distributor, but
Administration, due to contaminants that the ingredients used to make these drugs are not all three.
posed potential dangers to consumers if located overseas, primarily in China and India.
their use were continued. Incidents like this are Production costs there are low, and local gov- At hospitals drug buyers don't always
relatively uncommon, with most cases getting ernment oversight is less stringent. Although have full information about where a particular
caught by the quality control programs of the the FDA does have jurisdiction to inspect medication comes from, which could potentially
companies, or by the FDA inspection teams. these foreign plants if the drugs or ingredients be from facilities with spotty inspection records.
On the other hand, they are far from being are bound for the United States, it is easier for
rare, to the chagrin of doctors and patients alike. those plants to have poorer quality control than
When the medication is taken by patients,
ones located domestically. As the inspectors can't and if they get ill from the drug, physicians
The first of the recent incidents involved possibly check every lot produced, they can will not suspect a drug contamination comvalsartan, an angiotensin II receptor blocker only get a snapshot of production standards monly, because the patent is already ill from
(ARB) used for hypertension and heart failure, and daily quality control. In foreign plants, the something else.
and commonly used in diabetics for kidney inspectors also only have limited legal powers
function protection. The drugs were found to force a problem resolution. Unfortunately,
By all means, one should take action if a
to contain a cancer-causing impurity called some violators get cited repeatedly.
medication you're taking is recalled by the
N-nitrosodimethylamine (NDMA), and, later,
FDA. First, check your lot number to see if it
N-nitrosodiethylamine (NDEA). In June of
Although relatively uncommon, these is involved. Like food recalls, most of a med
last year, an independent testing lab found a contaminated drugs are found and intercepted supply will not be tainted, and its use can be
third carcinogenic impurity, dimethylformide many hundreds of times in U.S. plants as continued. If yours is one of the problematic
(DMF). These impurities were also found in well. In addition to chemical impurities, supply, the pharmacist can exchange your pills
manufactured lots of two other ARBs, namely items such as glass fragments and bacteria with a non-involved supply or your physician
losartan and irbesartan. Quantitatively, over a are periodically discovered.
can facilitate prescription of a similar medicathousand lots of these tainted ARBs from over
tion. An OTC drug might also have similarly
20 drugmakers were recalled. The undesired
Tracking these tainted medications, while acting substitutes that will often have relatively
chemicals were produced as a result of chemical overwhelmingly successful, is difficult on equivalent activity and tolerance. Ranitidine
reactions during processing.
several levels:
(mentioned above) can serve as an example of
this, as several other acid blockers are available
The second contaminated drug to cause Ingredients because the active ones can on the market. Contaminated medications
headlines due to an FDA mandated recall be a trade secret, due to patent laws, this can should not be flushed down the toilet, as this
was ranitidine. In the H2 blocker class, this be a stumbling block for the FDA inspectors. gets the contaminant into groundwater. Dispose
medication is used to decrease excessive stomach
of them in the recommended avenues available
acid, in patients with ulcers or other forms of Production also involves trade secrets, so in your community. Lastly, do not always stop
indigestion. In this case, the NDMA was either the FDA can't provide full information about a recalled drug abruptly. Using the example of
formed during medication production like production in public records. Unfortunately, in valsartan, the dangers of sudden blood pressure
the ARBs or occurred in patients' bodies after one recent period, about half of all drug recalls elevation might greatly outweigh the theoretic
ingestion due to metabolic reactions.
came from factories that had been previously danger of cancer risk from a minute amount
cited by FDA inspectors, or that had not been of a contaminant.
recently inspected at all.
Information about drug recalls can be found at fda.gov/Drugs/DrugSafety/DrugRecalls,
or by calling the FDA at 888-INFO-FDA (888-463-6332). To proactively sign up for alerts about future
recalls, go to fda.gov/SubscriptionManagement.
34 Summer 2020 Central PA Medicine


http://www.dauphincms.org http://www.fda.gov/Drugs/DrugSafety/DrugRecalls http://www.fda.gov/SubscriptionManagement

Central PA Medicine Summer2020

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https://www.nxtbook.com/hoffmann/CPAMed/CPMWinter18
https://www.nxtbook.com/hoffmann/CPAMed/Fall2017
https://www.nxtbook.com/hoffmann/CPAMed/CentralPAMedicine_Summer17
https://www.nxtbook.com/hoffmann/CPAMed/CentralPAMedicine_Spring17
https://www.nxtbook.com/hoffmann/CPAMed/CentralPAMedicine_Feb2017
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