The FDA has come up with a draft guidance list of labeling changes that they recommend be made by breast implant manufacturers to address the safety concerns threatening women all over the world. The recent October 2019 article from The New York Times, “Women Should Be Warned of Breast Implant Hazards, F.D.A. Says”, tells us that “Agency officials … [Read more...]
Breast Implants FDA March 2019 Meeting: Lymphoma Cancer Was A Main Topic
There was an FDA CDRH General and Plastic Surgery Devices Advisory Committee Meeting held on March 25-26, 2019. The first day was focused in large part on Breast Implant Associated Anaplastic Large-Cell Lymphoma (BIA-ALCL). This lymphoma cancer associated with breast implants is a rare type of blood cancer that is classified as a non-Hodgkin … [Read more...]
Will FDA Order Uloric Recall Requested In June 2018 By Public Citizen
The consumer advocacy group Public Citizen asserts that a FDA Uloric recall is necessary following results of a large postmarketing study that showed higher rates of fatal cardiovascular (CV) events and all-cause mortality in patients taking the drug. More exactly, it is the Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout … [Read more...]
Limbrel Medical Food Product for Osteoarthritis Removed from the Market
Background Limbrel (flavocoxid) is an anti-inflammatory agent comprised mostly of flavonoids such as baicalin and catechin that is prescribed to manage the metabolic processes associated with osteoarthritis. This supplement has traditionally been classified and marketed as a "medical food," which is defined by the Orphan Drug Act as: "a food … [Read more...]
New Data Released on Risk of Lymphoma Due to Breast Implants
Recent Study on BIA-ALCL RisksSince my last article on this topic, "What is the Risk of Death Due to Breast Implant-Associated Lymphoma?," additional information on the risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) has been released. The most recent study, titled "Breast Implants and the Risk of Anaplastic Large-Cell … [Read more...]
Expanding Treatment Options for Bleeds Related to Oral Anticoagulants
UPDATE: The FDA announced that it will push back its decision on whether to approve the reversal agent AndexXa to May 4, 2018. The original review date was set for February 3, 2018, but the FDA wanted to consider additional information it had requested from Portola, the drug's manufacturer. (12/28/17). Risk of Bleeding … [Read more...]
EU Calls for Strengthened and Revised Warnings for MS Drug Gilenya
UPDATE: On December 15, 2017, the FDA released an updated drug label for Gilenya with increased warnings. (12/27/17). Background After conducting a routine review of the immunosuppressive drug Gilenya (fingolimod), the Medicines and Healthcare Products Regulatory Agency (MHRA) recently suggested that the drug label for Gilenya be … [Read more...]
Osteoarthritis “Medical Food” Limbrel Tied to Life-Threatening Events
What is Limbrel? Limbrel is marketed by Primus Pharmaceuticals Inc., and is classified as a "medical food," which the FDA defines as: A food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive … [Read more...]
Breast Implant-Associated Lymphoma Diagnoses on the Rise
On October 18, 2017, the JAMA Surgery journal published an article titled "Breast Implant–Associated Anaplastic Large Cell Lymphoma A Systematic Review," in which they discuss the rate of occurrence of the condition. The article served as a review of 115 articles on the topic of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) … [Read more...]
FDA Warns of New Possible Side Effects for Nexium / Prilosec / Prevacid
The most recent report from the FDA Adverse Event Reporting System (FAERS) for April - June 2017 provides updates on adverse events experienced by those taking proton pump inhibitors (PPIs) such as Nexium, Prilosec, and Prevacid. The FDA provides the following list of PPIs: Nexium (esomeprazole magnesium) Nexium I.V. (esomeprazole … [Read more...]