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https://api.fda.gov/drug/event.json?search=safetyreportid:"4990905-5"

In this adverse event report, three drugs are listed in patient.drug.medicinalproduct. The first is marked as the suspect drug (FOSAMAX). The second (CALCIUM CARBONATE AND CHOLECALCIFEROL) and third (DROSPIRENONE AND ETHINYL ESTRADIOL) are marked as concomitant drugs.

The third drug (DROSPIRENONE AND ETHINYL ESTRADIOL) has an openfda section, which has many different spl_id, product_ndc, and brand_name items. For example, the brand names include:

"GIANVI", "SYEDA", "YAZ", "OCELLA", "LORYNA", "YASMIN", "VESTURA", "ZARAH", "DROSPIRENONE AND ETHINYL ESTRADIOL"
  1. Why are there so many brand names listed when the drug in the original report was DROSPIRENONE AND ETHINYL ESTRADIOL?
  2. If I search for one of the names in brand_name, like YAZ, why does this report show up?

I've noticed there's been some confusion about this, including in these posts about openFDA in "IBM Data Magazine" Part 1 Part 2 Part 3

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What's in a drug name?

It turns out that drug names are a complicated business. Drugs are known by a generic name (usually the name of the active ingredient)—like IBUPROFEN, and often multiple brand names—like ADVIL, or MOTRIN; even IBUPROFEN itself can be a brand name, like NIGHTTIME IBUPROFEN. Drugs may also have multiple ingredients, so the generic name may describe all of those ingredients—like ACETAMINOPHEN/CODEINE.

It’s important to note the difference between two “drug name” fields in openFDA’s drug adverse events API—medicinalproduct and openfda.brand_name.

medicinalproduct

This is imported from the original FDA adverse drug event report. It notes the drug name as reported, and even for a single “drug” there can be wide variation among records. For instance:

  • Generic or brand. Sometimes reporters write ACETAMINOPHEN, and sometimes TYLENOL.
  • Format. For the same drug, you might see ACETAMINOPHEN/CODEINE or CODEINE/ACETAMINOPHEN or ACETAMINOPHEN + CODEINE or CODEINE WITH ACETAMINOPHEN or ACETAMINOPHEN AND CODEINE.
  • Misspellings. IBUPROFEN appears in about 40,000 reports but even IBUPROPHEN (a misspelling) appears in almost 60! It’s not possible to know a priori all the ways that humans might have misspelled drug names when reporting.

Because of all this variation, you can imagine that it might be difficult to find ALL the records for a particular drug. It’s not even easy to capture all the variation in correctly spelled drug names, never mind the misspelled ones.

openfda annotations, which are added to the original record (like a sticky note), help by listing other known names and codes for the drug that was written in medicinalproduct. If the openFDA system was able to match a correctly spelled drug product name, it’ll add an openfda section for each drug; this section sits alongside medicinalproduct, and doesn't replace it. This is called “harmonization” in openFDA.

This section makes it easier to search for reports by those names and identifiers—no matter what name someone used in the original report. However, when you search in openfda fields, you’re distinctly NOT searching for the name used in the original report. You’re casting a wider net.

openfda.brand_name

This is a list of brand names that a drug may be known by. If you search in medicinalproduct for IBUPROFEN, a record may be returned with a long openfda.brand_name list including dozens of possible names that IBUPROFEN is marketed under, including:

"PAIN RELIEF ANTI INFLAMMATORY", "ADVIL", "HEALTH SENSE INFANTS IBUPROFEN ORAL SUSPENSION", "DOVER ADDAPRIN", "HEALTHY ACCENTS IBUPROFEN CHILDRENS", "PROFEN IB", "SHOPRITE IBUPROPHEN", "JUNIOR STRENGTH ADVIL", "PEDIACARE CHILDRENS", "GOOD NEIGHBOR PHARMACY IBUPROFEN CHILDRENS" …

This list isn’t doesn’t necessarily tell you what drug brand the patient was taking, but it gives you an idea of all the products you might want to search for if you want a complete count of adverse events for a particular drug (if you think of the drug as its ingredient, i.e. its generic name).

So, now it’s possible to answer the question…

1. Why are there so many brand names listed in patient.drug.openfda.brand_name, when the original report listed DROSPIRENONE AND ETHINYL ESTRADIOL?

DROSPIRENONE AND ETHINYL ESTRADIOL is the generic name of the drug YAZ. Although the original report listed DROSPIRENONE AND ETHINYL ESTRADIOL as the medicinal product being taken, the openfda section shows possible brand names (and other information) for the the drug. This particular drug, a combination of two hormones, is marketed under many brand names, all with the same ingredients (but sometimes in different dosage forms and strengths, meant to be taken on different schedules). Those brand names include, but are not limited to:

`GIANVI, SYEDA, YAZ, OCELLA, LORYNA, YASMIN, VESTURA, ZARAH`

This Mayo Clinic article lists _even more names that this drug (DROSPIRENONE AND ETHINYL ESTRADIOL) goes by. What’s important to understand is that the openfda annotation is additional information that can be used to learn more about the drug listed in the report—it does not necessarily list the name of the drug the patient was taking.

2. Why does a search in patient.drug.openfda.brand_namefor one of the brand names—YAZ—include reports listing a generic drug (DROSPIRENONE AND ETHINYL ESTRADIOL)?

Searching in openfda.brand_name tells the API to look in the annotated list of possible brand names for a drug, not in the original report’s medicinalproduct field. The results include all the records that have an openfda.brand_name list that contains YAZ.

Here’s why a record would have YAZ in openfda.brand_name:

  • The patient.drug.medicinalproduct contained YAZ.
  • The patient.drug.medicinalproduct contained DROSPIRENONE AND ETHINYL ESTRADIOL, which is marketed under many brand names, including YAZ.

https://api.fda.gov/drug/event.json?search=safetyreportid:"4990905-5"

For this report, the original medicinalproduct contains DROSPIRENONE AND ETHINYL ESTRADIOL—the generic name of YAZ. So, openFDA matched the generic name and made an openfda section that lists the known possible brand names for DROSPIRENONE AND ETHINYL ESTRADIOL—including YAZ. That’s why it showed up in a search for YAZ in patient.drug.openfda.brand_name.

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