"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 effec ..read more

March 2023 Miami Breast Cancer Conference: Updates on The Number of BIA-ALCL Deaths and Diagnoses   (Posted by Tom Lamb at Drug Injury Watch)   In late March 2023, the FDA issued an update that announced the launch of a new reporting system for cases of breast implant-associated lymphoma. Earlier in March 2023 we received updates on the number of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) deaths and diagnoses in the US and worldwide. From "UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants - FDA Safety Commun ..read more

Timeline for EzriCare Artificial Tears, Delsam Pharma’s Artificial Tears, Delsam Pharma’s Artificial Eye Ointment   (Posted by Tom Lamb at Drug Injury Watch)   During February 2023 there were recalls of Global Pharma eye products, specifically: EzriCare Artificial Tears Delsam Pharma’s Artificial Tears Delsam Pharma’s Artificial Eye Ointment Here is the most recent information from the US Centers for Disease Control and Prevention (CDC) about case reports associated with the bacterial contamination problem for these Global Pharma eye products: As of February 21, 202 ..read more

Updates About Bacterial Contamination Problem for These Over-The-Counter (OTC) Eye Products Given by FDA and CDC   (Posted by Tom Lamb at Drug Injury Watch)   On February 21, 2023, and February 22, 2023, there were updates to this FDA document, "FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination", which was initially issued on February 2, 2023. The first update was about a Delsam Pharma’s Artificial Eye Ointment warning not to purchase or use this OTC eye product. The second update, one day later, was about a Delsam Phar ..read more

Serious Infections Causing Vision Loss Have Been Linked to the Use of EzriCare Artificial Tears Lubricant Eye Drops   (Posted by Tom Lamb at Drug Injury Watch)   Today we pick up where our article from last week "EzriCare Artificial Tears Associated With Eye Infections: February 2023 CDC Warnings Issued" ended --  that is, we will be monitoring the CDC and FDA for further developments -- with news about an artificial tears eye drops recall involving EzriCare and Delsam Pharma’s Artificial Tears over-the-counter (OTC) products. From this February 2, 2023 document ..read more

Canadian Product Monograph for Valtrex Now Warns About Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)   (Posted by Tom Lamb at Drug Injury Watch)   Valtrex (valacyclovir) is a long-established treatment for cold sores, genital herpes, and herpes zoster, having been initially approved by the FDA in 1995. According to the Health Product InfoWatch December 2022 edition released by Health Canada on December 22, 2022, cases of Valtrex-associated DRESS have been reported as a drug side effect. In more detail, from the Valtrex part of the "New health pr ..read more

This Treatment for Thyroid Eye Disease Was Approved by FDA in 2020, With Hearing Problems Reported Soon Thereafter   (Posted by Tom Lamb at Drug Injury Watch)   We recently wrote about Tepezza hearing loss cases in this October 2022 article, "Tepezza Hearing Side Effects Include Deafness, Sound Sensitivity, and Tinnitus, Resulting in Tepezza Drug Injury Lawsuits".  Therein we noted that case reports in medical journal articles show that Tepezza (teprotumumab) has been linked to hypoacusis, hyperacusis, autophony, and other hearing problems, which sometimes may be ..read more

Issue: Whether Copiktra Risk-Benefit Profile is Still Favorable as a Third-Line CLL/SLL Cancer Treatment; Final Vote: "No"   (Posted by Tom Lamb at Drug Injury Watch)   We concluded our July 5, 2022 article, "Using Copiktra for Leukemia or Lymphoma May Increase Risks of Serious Side Effects and Death", stating that we would be watching a future FDA Advisory Committee Meeting that will discuss the safety of Copiktra and, in turn, for any significant developments about the Copiktra risk-benefit profile as regards it being prescribed for chronic lymphocytic leukemia (CLL ..read more

Other MS Treatments Such as Lemtrada and Mayzent May Have an Increased Risk of Basal Cell Carcinoma and Squamous Cell Carcinoma   (Posted by Tom Lamb at Drug Injury Watch)   An analysis of skin cancers reported to the FDA Adverse Event Reporting System (FAERS) has revealed the need for close skin cancer monitoring in patients receiving certain multiple sclerosis (MS) therapies, including the drugs Gilenya, Lemtrada, Mayzent, and Ocrevus. In particular, the findings showed the MS drugs Gilenya and Ocrevus linked to melanoma, with Gilenya linked to squamous cell carcinom ..read more

In a Long-Awaited Opinion, Federal Court Judge Wolfson Rules in Favor of Merck on Federal Preemption Legal Issue   (Posted by Tom Lamb at Drug Injury Watch)   On March 23, 2022, the federal court product liability lawsuits filed on behalf of women who used Fosamax and suffered femur fractures were dismissed by means of an opinion issued by Judge Freda Wolfson. These Fosamax femur fracture lawsuits had been remanded to the District of New Jersey in late 2019 by the U.S. Court of Appeals for the Third Circuit.  That happened after and because the U.S. Supreme Court ..read more