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BIA-ALCL Current Recommendations and Potential Future FDA Guidance Changes

April 21, 2021 By Law Offices of Thomas J. Lamb, P.A.

History of BIA-ALCL In 2011, the Food and Drug Administration (FDA) reported 34 cases worldwide of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), bringing this unique disease into the public eye for the first time. Since then, BIA-ALCL has been recognized internationally as a distinct type of cancer, and prompted the 2019 … [Read more...]

Filed Under: Unsafe Medical Devices Tagged With: allergan breast implants, breast implant-associated anaplastic large cell lymphoma, breast implants, breast implants BIA-ALCL, breast implants cancers, breast implants lawsuits, breast implants lymphoma cancers, breast implants side effects, FDA, textured breast implants

FDA Proposes New Recommendations for Breast Implant Labels

December 3, 2019 By Law Offices of Thomas J. Lamb, P.A.

The FDA has come up with a draft guidance list of labeling changes that they recommend be made by breast implant manufacturers to address the safety concerns threatening women all over the world.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...]

Filed Under: Unsafe Medical Devices Tagged With: breast implant-associated anaplastic large cell lymphoma, breast implants, breast implants lymphoma cancers, FDA

Breast Implants FDA March 2019 Meeting: Lymphoma Cancer Was A Main Topic

March 26, 2019 By Law Offices of Thomas J. Lamb, P.A.

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...]

Filed Under: Unsafe Medical Devices Tagged With: breast implant-associated anaplastic large cell lymphoma, breast implants, FDA

Will FDA Order Uloric Recall Requested In June 2018 By Public Citizen

July 13, 2018 By Law Offices of Thomas J. Lamb, P.A.

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...]

Filed Under: Unsafe Drugs Tagged With: card, Cardiovascular death, drug side effects, FDA, Uloric

Limbrel Medical Food Product for Osteoarthritis Removed from the Market

January 12, 2018 By Law Offices of Thomas J. Lamb, P.A.

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...]

Filed Under: Unsafe Drugs Tagged With: DILI, drug-induced liver injury, FDA, flavocoxid, hypersensitivity pneumonitis, limbrel, medical food, Pancreatitis, recall, side effects

New Data Released on Risk of Lymphoma Due to Breast Implants

January 9, 2018 By Law Offices of Thomas J. Lamb, P.A.

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...]

Filed Under: Unsafe Medical Devices Tagged With: ALCL, anaplastic large cell lymphoma, BIA-ALCL, blood cancer, breast implant-associated anaplastic large cell lymphoma, breast implants, cancer, FDA, JAMA, JAMA oncology journal, lawsuits, lymphoma, non-hodgkin lymphoma, smooth breast implants, T-cell lymphoma, textured breast implants

Expanding Treatment Options for Bleeds Related to Oral Anticoagulants

December 20, 2017 By Law Offices of Thomas J. Lamb, P.A.

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...]

Filed Under: Unsafe Drugs Tagged With: ACC, American College of Cardiology, andexxa, antidotes, apixaban, bleeding reversal agents, dabigatran, direct oral anticoagulants, DOACs, edoxaban, Eliquis, FDA, major bleeding events, oral anticoagulants side effects, Pradaxa, Praxbind, rivaroxaban, Savaysa, Xarelto

EU Calls for Strengthened and Revised Warnings for MS Drug Gilenya

December 19, 2017 By Law Offices of Thomas J. Lamb, P.A.

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...]

Filed Under: Unsafe Drugs Tagged With: cardiovascular events, drug label warnings, EMA, EU, European Medicines Agency, FDA, fingolimod, food and drug administration, Gilenya, gilenya side effects, immunosuppressive drugs, lymphoma, MHRA, MS drugs, multiple sclerosis drugs, pml, serious infections, skin cancers

Osteoarthritis “Medical Food” Limbrel Tied to Life-Threatening Events

November 28, 2017 By Law Offices of Thomas J. Lamb, P.A.

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...]

Filed Under: Unsafe Drugs Tagged With: baicalin, catechin, drug safety communication, FDA, FDA investigation, FDA MedWatch reporting system, flavonoid capsule, limbrel, medical food, osteoarthritis, osteoarthritis drugs, Primus Pharmaceuticals

Breast Implant-Associated Lymphoma Diagnoses on the Rise

October 19, 2017 By Law Offices of Thomas J. Lamb, P.A.

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...]

Filed Under: Unsafe Medical Devices Tagged With: ALCL, anaplastic large cell lymphoma, BIA-ALCL, blood cancer, breast implant-associated anaplastic large cell lymphoma, breast implants, cancer, FDA, JAMA, JAMA surgery journal, lawsuits, lymphoma, non-hodgkin lymphoma, smooth breast implants, T-cell lymphoma, textured breast implants

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