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Population Exposure to Phthalate-containing Drugs
Anne Broe1,2, Zandra Nymand Ennis1,2, Anton Pottegård1
1Clinical Pharmacology and Pharmacy, Department of Public Health, University of Southern Denmark, Odense, Denmark.
Basic & Clinical Pharmacology & Toxicology
|April 4, 2017
Summary
Phthalates are common excipients in drugs. From 2004-2015, Danish drug sales revealed significant phthalate exposure, with some products exceeding regulatory limits for dibutyl phthalate (DBP).
Area of Science:
- Environmental Health
- Pharmaceutical Sciences
- Toxicology
Background:
- Phthalates are recognized endocrine disruptors.
- Their use as pharmaceutical excipients is not widely known.
- This study investigates phthalate exposure from medications in Denmark.
Purpose of the Study:
- To quantify the sales of phthalate-containing drugs in Denmark between 2004 and 2015.
- To assess phthalate exposure levels from these medications.
- To compare exposure to regulatory limits for specific phthalates.
Main Methods:
- Utilized national sales data for medications (tablets only) from medstat.dk (2004-2015).
- Integrated Danish Medicines Agency data on phthalate content per tablet with sales data.
- Calculated phthalate amounts (mg) per 1000 inhabitants using Defined Daily Doses (DDD).
Main Results:
- 154 drug products containing five different phthalates were identified.
- Significant sales of low- and high-molecular-weight phthalates were observed.
- Several drugs, including budesonide, lithium, and bisacodyl, exceeded the dibutyl phthalate (DBP) exposure limit.
Conclusions:
- Phthalate-containing drugs are widely used in Denmark.
- Exposure from certain medications significantly exceeded regulatory limits, particularly for DBP.
- This highlights a potential public health concern requiring further attention.