U.S. FDA Releases Statement Regarding Shortages
June 19, 2018 – According to a statement from Dr. Douglas Throckmorton of the U.S. FDA, the Center for Drug Evaluation and Research has been working with manufacturers to prevent and resolve medication shortages. In particular, Dr. Throckmorton addressed the issues of short supplies of EpiPen, intravenous (IV) fluids, and injectable opioid analgesics.
EpiPen availability has been affected by multiple factors, including regional disruptions that interrupt the supply in some areas of the country. Dr. Throckmorton reminds prescribers, pharmacists, and patients that alternatives to the EpiPen are available and can be used safely and effectively. The FDA predicts the EpiPen shortage will present a short-term difficulty only, and is working with Mylan to restore regular access to the brand product.
In the case of IV fluids, hurricane damage has impacted manufacturers and interfered with FDA and manufacturer efforts to resolve an already existing shortage. A severe flu season placed additional strain on the supply. The FDA reports that IV fluid supplies have begun to improve, and temporary imports of saline will provide additional resources while the FDA and manufacturers work to address the issue.
Injectable opioid analgesics, such as hydromorphone, morphine and fentanyl, faced a shortage in 2017 due to manufacturing issues. These products are often used to provide palliative care for cancer patients. The current shortage is due in part to changes and upgrades being made to a Pfizer production facility based in Kansas. The company anticipates these delays to last until 2019. The FDA is currently working with Pfizer and other manufacturers to improve supplies.
More information on drug shortages can be found at the FDA’s recently redesigned drug shortages website: https://www.fda.gov/drugs/drugsafety/drugshortages/default.htm.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.