Drug Injury Watch

Trulicity Recall Due to Dose Labeling Error Back in 2021 May Still be Drug Safety Issue Today

Thousands of Trulicity Autoinjector Devices Labeled as 0.75 mg Might Contain 1.5 mg (i.e., a "double-dose")

 

(Posted by Tom Lamb at Drug Injury Watch)

 

A Trulicity recall back in August - September 2021 by Eli Lilly & Company was due to a dose labeling error involving a single lot of Trulicity (dulaglutide). That does not sound too alarming at first glance, but this incident becomes more concerning as a Trulicity drug safety issue when one takes a closer look.

First, some Trulicity autoinjector devices labeled as 0.75 mg/0.5 mL, in fact, contain 1.5 mg/0.5 mL of product.  As such, those Trulicity products can be viewed as "defective".

Second, this 2021 Trulicity recall affects 119,539 boxes of Trulicity 0.75 mg/0.5 mL single-dose pens, four pens per box (NDC 0002-1433-80), from lot D396436C.

Third, when the FDA issued its Enforcement Report for that Trulicity recall, the document did not include the lot’s expiration date or where the defective Trulicity products were manufactured.

Fourth, it was announced later that the expiration date for this batch of double-dose Trulicity was January 27, 2023.

Fifth, while the mislabeled Trulicity autoinjector devices were distributed throughout the United States, it appears that the associated Trulicity recall was only down to the retail level.

Sixth, it apparently took Eli Lilly at least two months, from mid-June 2021 to mid-August 2021 -- to realize that this double-dose lot of Trulicity had been shipped to US pharmacies to dispense for use by patients.

Lastly, even though the FDA designated this 2021 Trulicity recall as "Class II" -- by definition, meaning that use of this product could cause temporary or medically reversible adverse health consequences -- that FDA Class II designation also indicates there is a remote possibility of serious harm.

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For more details, see these two source documents:

1.  Recall Enforcement Report for FDA recall D-0773-2021, which starts as follows:

Drug Recall Enforcement Report Class II voluntary initiated by Eli Lilly & Company, originally initiated on 08-19-2021 for the product Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80 The product was recalled due to labeling: label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 ml actually contain 1.5 mg / 0.5 ml of product. The product was distributed nationwide and the recall is currently ongoing.

2.  California State Board of Pharmacy Trulicity recall alert, which provides an important update:

The Board of Pharmacy has received notice of the following product recall. The Board strongly encourages pharmacies to immediately review their quality assurance and recall policies and procedures to determine if any corrective action is required.

NOTE: UPDATED EXPIRATION DATE

Description: TRULICITY 0.75MG/0.5ML PEN 4

Lot #: D396436C

Exp Date: 01/27/2023

NDC: 00002143380

UPC: 30002143380

Eli Lilly is recalling the above item/lot due to a dose labeling error. This recall is to the retail level. Affected product started shipping June 14, 2021.

Significantly, neither of those two source documents tells us how many of the double-dose Trulicity boxes were dispensed by pharmacies to patients rather than returned by pharmacies to Eli Lilly.

In addition, even though the expiration date for this recalled double-dose Trulicity is stated as "01/27/2023", patients often overlook this type of preventive information.

For example, we were contacted by a woman who reportedly used one of these recalled Trulicity products in mid-February 2023 and was subsequently hospitalized for three days for seizures that may have been related to using twice the amount of Trulicity that had been prescribed by her doctor.

Given that this 2021 Eli Lilly / FDA Trulicity recall was rather "low-profile", and because there may still be thousands of double-dose Trulicity injectors in patients' homes, we are concerned that this is an ongoing Trulicity drug safety issue.

If you or someone you know may have suffered an adverse reaction as a result of using a Trulicity autoinjector device which was labeled as 0.75 mg but, later, it was determined the product contained 1.5 mg of Trulicity (a "double-dose"), we would be interested in hearing more about that event. It is possible that a Trulicity drug injury case could be filed against Eli Lilly, depending on the circumstances. For that purpose, one can submit a Case Evaluation Form to us for review.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

Prolia - Hypocalcemia Side Effect Safety Signal May Draw Regulatory Action by FDA

"Risk of severe hypocalcemia" in Patients on Dialysis Receiving Osteoporosis Drug Prolia (denosumab)

 

(Posted by Tom Lamb at Drug Injury Watch)

 

The FDA is in the process of evaluating the osteoporosis drug Prolia (denosumab) to determine the need for regulatory action as regards a Prolia - hypocalcemia side effect safety signal according to this recent FDA information, "October - December 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)".

This relatively new Prolia - hypocalcemia side effect issue first came to our attention late last year with the release of this November 22, 2022 document, "FDA Drug Safety Communication: FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)".

For some background and context, we refer you to this November 2022 Medscape article, "FDA Alert: 'Substantial' Hypocalcemia Risk with Prolia Use in Dialysis Patients":

The FDA explained it issued the alert because of "the frequency and seriousness" of the risk for hypocalcemia and resulting complications. The agency noted that the risk seems most acute for people on dialysis who also receive Prolia, but the risk may also extend to people with advanced kidney disease who are not being treated with hemodialysis.

The alert stemmed from "interim results" in an ongoing safety study of Prolia that the FDA required the agent's manufacturer, Amgen, to run when the agency first approved denosumab for US marketing in 2010. The FDA said its review of these interim results suggested an increased risk of hypocalcemia with Prolia in patients with advanced kidney disease.

In addition, adverse event reports submitted to the FDA suggested in a separate, internal study that patients on dialysis treated with Prolia are at "substantial risk for severe and symptomatic hypocalcemia, including hospitalization and death."

Returning to the November 2022 FDA Drug Safety Communication about the Prolia - hypocalcemia side effect safety signal, we point out this FDA statement: "We will communicate our final conclusions and recommendations when we have completed our review or have more information to share."

Of course, we will watch for the FDA's determination on possible regulatory action as regards this Prolia - hypocalcemia side effect -- for example, stronger drug safety warnings in a revised Prolia drug label -- and report on any such developments here on Drug Injury Watch.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)