Agency seeking alternatives, extending 'shelf life' for meds like epinephrine
By Margaret Farley Steele
FRIDAY, June 16, 2017 (HealthDay News) -- The U.S. Food and Drug Administration said Friday that it's working with the drug company Pfizer to remedy a shortage of important injectable medications, including emergency syringes of epinephrine.
Epinephrine treats anaphylaxis, a severe allergic reaction to bee stings and foods such as peanuts.
The drugs in short supply are made by the Pfizer company Hospira. In some cases, the FDA is extending expiration dates.
"These are all critically important drugs for treating patients with life-threatening conditions," said Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York City.
The conditions these drugs treat include cardiac arrest (when the heart suddenly stops); a chemical imbalance in the blood called metabolic acidosis; and abnormal heart rhythms, Glatter said.
"The reality is this: There is no substitute for medications such as epinephrine in the setting of anaphylaxis, angioedema, and patients in cardiac arrest," Glatter said. "The end result may be death." Angioedema is swelling that can occur as part of a serious allergic reaction.
Besides epinephrine, the drugs include vials and syringes of sodium bicarbonate and dextrose 50 percent injections, as well as emergency syringes of calcium chloride and atropine sulfate.
Pfizer blames the shortage on manufacturing, distribution and third-party delays, the FDA said.
"We are working closely with Pfizer to resolve these critical shortages by addressing the underlying causes," the agency said in a news release.
The FDA said it's seeking alternative manufacturers, and weighing whether to expedite review of new applications.
The FDA has also extended expiration dates on certain lots of emergency syringes, so that health care professionals can continue using them during the shortage.
If replacement syringes become available during the extension period, the FDA said the older lots should be disposed of as soon as possible.
"We will update the public as the situation changes. Continue to visit the drug shortages webpage for more information on approved sources of these drug products," the agency said.
According to Glatter, the FDA's steps are just a temporary fix.
The "shelf life" and potency of these drugs may extend well beyond their intended expiration dates. However, he said it's never ideal to risk a patient's life with a medication that has expired.
"It is imperative that we develop real-world solutions to the dangerous dilemma of critical drug shortages that threaten patients' lives and safety," Glatter added.
To see which syringe lots have extensions, check the FDA's Drug Shortages webpage. Doctors and other health care professionals can also contact Pfizer directly.
For more about anaphylaxis, see the American Academy of Allergy, Asthma, and Immunology.
SOURCES: U.S. Food and Drug Administration, news release, June 16, 2017; Robert Glatter, M.D., emergency physician, Lenox Hill Hospital, New York City
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