We are investigating possible Tepezza drug injury cases where the patient, while using Tepezza, started to experience hearing loss or other hearing problems. Specifically, those Tepezza hearing issues include: Hearing loss, ranging from impairment to deafness (Hypoacusis and Sensorineural Hearing Loss) Sound or noise sensitivity that makes … [Read more...]
Tepezza Hearing Loss, Other Tepezza Hearing Problems May be Irreversible and Permanent
Tepezza hearing loss and other Tepezza hearing problems have been reported by medical doctors and patients since this treatment for Thyroid Eye Disease was approved by the FDA in 2020. Those Tepezza hearing problems have involved various medical diagnosis types, including: Hypoacusis: hearing loss ranging from impairment to … [Read more...]
FDA AdComm: Copiktra Risk-Benefit Profile No Longer Favorable as a Third-Line CLL/SLL Treatment
The FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted 8-4 against the Copiktra risk-benefit profile, as reported in this September 23, 2022, Endpoint News article, “FDA adcomm takes down Secura Bio’s leukemia drug after final trial results show potential OS detriment”. From that recent news report about the safety of Copiktra … [Read more...]
Gallbladder Side Effects Related to Byetta and Other GLP-1 Receptor Agonists
Cases of gallbladder side effects related to Byetta, Trulicity, Ozempic, and Adlyxin were reported in this August 2022 medical journal JAMA Internal Medicine article, “Acute cholecystitis associated with the use of glucagon-like peptide-1 receptor agonists reported to the US Food and Drug Administration”, which starts with the following: The … [Read more...]
Copiktra May Increase Risks of Death and Serious Side Effects
From this June 30, 2022, FDA Drug Safety Communication, “FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)”, we get the following: To evaluate the long-term safety of Copiktra, we required the drug manufacturer, Secura Bio, to submit the final 5-year survival results from the clinical … [Read more...]
Xalkori Side Effects: Children Suffering Ocular Toxicity and Severe Visual Loss
A June 14, 2022, European Pharmaceutical Review (EPR) article about the most recent meeting of EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) reports a new drug safety issue involving Xalkori and vision loss found in clinical trials for pediatric patients treated with Xalkori. In relevant part from this EPR article about the EMA’s PRAC … [Read more...]
Ukoniq Death Risk is Reason for Ukoniq Drug Recall Says FDA
This June 1, 2022 document, “Drug Safety Communication: FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns”, makes clear it is the Ukoniq death risk that was behind the recent Ukoniq drug recall: Due to safety concerns, the U.S. Food and Drug Administration (FDA) has withdrawn its approval for the cancer … [Read more...]
Drug Injury Research: FDA Resources Online Available for Patients
In order to make sure that you are using credible sources if and when you want to do some drug injury research, there is an FDA information site and an FDA database that is searchable which we want you to know are available online. (1) Drug Safety Communications This webpage was developed to provide the public with easy access to important drug … [Read more...]
Ukoniq Withdrawn From Market Due to Increased Risk of Patient Deaths
The drug company responsible for the lymphoma medicine Ukoniq (umbralisib), TG Therapeutics, indicated in April 2022 that Ukoniq was withdrawn from the market due to an increased risk of death in patients using Ukoniq. This April 15, 2022 Dow Jones piece, “TG Therapeutics Pulls Sole Product Ukoniq Amid Increased Death Risk”, summarizes why … [Read more...]
MS Drugs Ocrevus and Gilenya Linked to Melanoma, Other Skin Cancers
Multiple sclerosis (MS) drugs Ocrevus and Gilenya have been linked to melanoma, with Gilenya linked to squamous cell carcinoma and basal cell carcinoma, also. These new drug safety findings come from an analysis of skin cancer cases reported to the FDA Adverse Event Reporting System (FAERS) for patients receiving certain multiple sclerosis (MS) … [Read more...]
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