Side Effects Blog

As background, an Ozempic gallbladder disease warning was the subject of a March 2022 Ozempic drug label change by Novo Nordisk.

While this March 2022 Ozempic gallbladder label change is a significant part of the legal analysis for a possible Ozempic gallbladder injury case, there are other important factors also. Figuring out if there might be a drug injury lawsuit to file against Novo Nordisk for your gallbladder disease is not as simple as whether your gallbladder diagnosis was made before or after that March 2022 “line-in-the-sand” date.

Two important factors — having to do with things other than when your gallbladder disease was first diagnosed or when you had gallbladder removal surgery — are:

1. What is the date (month/year) when your doctor prescribed Ozempic?
2. Was that Ozempic prescription for one month, a few months, or one year?

Of course, there are additional facts we would consider when investigating these Ozempic gallbladder cases as possible drug injury cases.

Generally, the legal basis for these Ozempic gallbladder cases is that Novo Nordisk failed to warn doctors and patients about the risks of gallbladder diseases in a timely manner. The contention is that, when one views the March 2022 Ozempic drug label change in the context of what they knew and when they knew it, this Ozempic gallbladder disease warning should have been added earlier. For example, there are several medical journal articles published before 2022 that report the use of GLP-1 receptor agonists like Ozempic has been associated with an increased risk of bile duct and gallbladder diseases such as gallstones.

If we can be of assistance to you or someone you know, we encourage you to submit a Case Evaluation Form online. Attorney Tom Lamb will do your Ozempic gallbladder case review and get back to you no later than the next business day.

Or call us toll-free at (800) 426-9535 to speak directly to attorney Tom Lamb about a possible Ozempic gallbladder case.

Either way, you will get Mr. Lamb’s impressions about your Ozempic case based on his more than 20 years of experience handling drug injury lawsuits.

1. 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”.
2. This 2021 Trulicity double-dose 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.
3. When the FDA issued its Enforcement Report for that Trulicity double-dose recall, the document did not include the lot’s expiration date or where the defective Trulicity products were manufactured.
4. It was announced later that the expiration date for this batch of double-dose Trulicity was January 27, 2023.
5. 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.
6. 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.
7. Even though the FDA designated this 2021 Trulicity double-dose 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.

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.

As of now, it appears the FDA is still in the process of evaluating the osteoporosis drug Prolia (denosumab) to determine the need for regulatory action as regards this Prolia side effect hypocalcemia safety signal. This is 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)” — which was labeled “Content current as of: 04/05/2023” when viewed earlier today, May 9, 2023.

We are waiting for the FDA’s determination on possible regulatory action as regards this Prolia side effect of hypocalcemia. Perhaps there will be stronger drug safety warnings in a revised Prolia drug label, for example.

This March 22, 2023, MedPage Today news item, “Case Reports Detail Vision Loss Linked to Recalled Artificial Tears”, points out these observations found in the March 2023 JAMA Ophthalmology medical journal edition with the articles about these serious eye infections due to the use of EzriCare Artificial Tears eye drops:

The current outbreak of MDR P. aeruginosa “associated with the use of carboxymethylcellulose sodium (EzriCare) multidose preservative-free artificial tears may be a wake-up call for the field,” the editorialists wrote, and “is a harsh reminder that all eye drops, including artificial tears, are medications with potential adverse effects, most commonly ocular but potentially systemic.”…

We have been following EzriCare Artificial Tears case reports since early February 2023, when the FDA issued its first warning about Global Pharma eye products. Since then, this drug safety issue has expanded to include:

1. Delsam Pharma’s Artificial Eye Ointment;
2. Delsam Pharma’s Artificial Tears; and,
3. EzriCare Artificial Tears.

Let us know if we can be of assistance to you or someone you know by submitting an online Case Evaluation Form or calling us at 800-426-9535.

During February 2023 there were recalls of Global Pharma eye products, specifically:

1. EzriCare Artificial Tears
2. Delsam Pharma’s Artificial Tears
3. Delsam Pharma’s Artificial Eye Ointment

Timeline for Global Pharma Eye Products Recall

• 2/1/2023: The CDC issued a warning about this Global Pharma eye product, EzriCare Artificial Tears, associated with serious eye infections in patients from various states during recent months.
• 2/2/2023: Global Pharma initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears as well as a second Global Pharma eye product, Delsam Pharma’s Artificial Tears.
• 2/21/2023: First announcement by the FDA about Delsam Pharma’s Artificial Eye Ointment is a warning not to purchase or use this different type of Global Pharma eye product.
• 2/22/2023: Second announcement by the FDA, one day later, is about a Delsam Pharma’s Artificial Eye Ointment recall by Global Pharma.

For more information, see our earlier articles about this Global Pharma eye products recall:

Delsam Pharma’s Artificial Eye Ointment Recall February 2023 (2/23/23)

EzriCare and Delsam Pharma’s Eye Drops Products Recall (2/8/23)

EzriCare Artificial Tears Eye Infections Warnings (2/7/23)

We are investigating cases involving hospitalization, death, or permanent vision loss from an infection due to bacterial contamination in connection with this Global Pharma eye products recall.

Let us know if we can be of assistance to you or someone you know by submitting an online Case Evaluation Form or calling us at 800-426-9535.

Here are two earlier articles we posted about a similar bacterial contamination problem for two other OTC eye products from Global Pharma, EzriCare Artificial Tears and EzriCare Artificial Tears lubricant eye drops.

“EzriCare and Delsam Pharma’s Eye Drops Products Recall” (2/8/23)

“EzriCare Artificial Tears Eye Infections Warnings” (2/7/23)

Let us know if we can be of assistance concerning the recent Delsam Pharma’s Artificial Eye Ointment recall or with a possible drug injury lawsuit arising out of the Artificial Eye Ointment contamination problem.

Importantly, this Global Pharma Healthcare recall announcement includes a “Product Photos” part at the end which will help people figure out if they should be concerned about this artificial tears eye drops products recall involving EzriCare and Delsam Pharma’s Artificial Tears products.

We are investigating cases involving hospitalization, death, or permanent vision loss related to these eye drops products recall as possible drug injury lawsuits that would be filed against Global Pharma Healthcare, the company which is responsible for EzriCare and Delsam Pharma’s Artificial Tears.

1. Discontinue using EzriCare Artificial Tears pending additional guidance from CDC and FDA.
2. If patients were advised to use EzriCare Artificial Tears by their healthcare provider, they should follow up with their healthcare provider for an alternative artificial tears product to use.
3. Patients who used EzriCare Artificial Tears and who have signs or symptoms of an eye infection, such as discharge from the eye, eye pain or discomfort, redness of the eye or eyelid, feeling of something in the eye, increased sensitivity to light, or blurry vision, should seek timely medical care. At this time, CDC does not recommend testing of patients who have used this product and who are not experiencing any signs or symptoms of infection.

Those were taken from this February 1, 2023, CDC document, “Health Alert Network (HAN) No. 485 – Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa associated with Artificial Tears”, which provides a quick overview of these EzriCare Artificial Tears eye infections.

We are investigating cases of EzriCare Artificial Tears eye infections as possible drug injury lawsuits that would be filed against Global Pharma Healthcare, the company responsible for this lubricant eye drops product.

Valtrex (valacyclovir) is a long-established treatment for cold sores, genital herpes, and herpes zoster, having been initially approved by the FDA in 1995. The Full Prescribing Information document for Valtrex in the United States does not currently have any discussion of or warning about Valtrex-associated DRESS as a possible Valtrex drug side effect. We will watch to see whether the FDA follows the lead of Health Canada and require a Valtrex drug label change to add information about drug reaction with eosinophilia and systemic symptoms (DRESS).

1. “Hearing Loss and [Tepezza (teprotumumab)]“
2. “Hearing Dysfunction After Treatment With [Tepezza (teprotumumab)] for Thyroid Eye Disease“
3. “Sensorineural Hearing Loss After [Tepezza (teprotumumab)] Therapy for Thyroid Eye Disease: A Case Report“
4. “[Tepezza (teprotumumab)] and Hearing Loss: Case Series and Proposal for Audiologic Monitoring“

For those people experiencing Tepezza drug side effects that involve hearing, we encourage you to submit a Drug Injury Case Evaluation Form — it is free, confidential, and there is no obligation.