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Black Box Warning – The Strongest Consumer Warning FDA Can Issue


A black box warning is the strongest consumer warning that the Food & Drug Administration (FDA) can issue for prescription drugs and medical devices. Most often caused by reports of severe health risks, the warning is designed to make consumers a Read More »

Invokana Risks Push Doctors to Switch Patients to Other Medications


The SGLT2 inhibitor Invokana has come under fire recently because of the increased risk of lower limb amputations caused by one of its key ingredients, canagliflozin. Physicians in California are hurrying to switch patients from Invokana to other dia Read More »

Intragastric Balloon System – FDA Issues Safety Alert


In the United States, an estimated 160 million Americans are overweight or obese, according to the Institute for Health Metrics and Evaluation. The statistics are not only overwhelming but an indication that obesity is a massive, worldwide problem. W Read More »

AstraZeneca’s Farxiga Safety Claims Contradict FDA Findings


Last month at the American Diabetes Association’s (ADA) 77th Scientific Sessions, AstraZeneca Plc. presented new data supporting the safety and effectiveness of their SLGT-2 inhibitor Farxiga. This data is in direct contention with the FDA̵ Read More »

Invokana Black Box Warning Issued by U.S. Food & Drug Administration


Invokana Black Box Warning Pharmaceutical manufacturer Johnson & Johnson’s Invokana (“the SGLT-2 canagliflozin pharmaceutical marketed to treat type 2 diabetes and off-label for type 1 diabetes”), along with related drugs Invoka Read More »

FDA Raises Concern About Breast Implants and Cancer


As of February 1st, 2017, the FDA has received 359 reports of a rare type of breast cancer linked to breast implants. The FDA has confirmed that a malignancy of the immune system associated with breast implants has resulted in 9 deaths. Read More »

FDA Warns Doctors About “Absorb” Dissolving Heart Stent


Absorb is a stent made of plastic that is designed to dissolve completely over a three-year period. Recent data from two-year clinical trials reveal a much higher rate of heart problems than initially expected once the stent begins to fully dissipate Read More »

Pfizer Finds New Ways to Squeeze Money Out of Lipitor


Pfizer is due to lose its patent protection in November for Lipitor, the world’s highest selling drug, but already has a plan to continue raking in money from the cholesterol lowering drug.  The drug company plans to market an over-the-cou Read More »

FDA Warns of Risk of Birth Defects With Chronic Diflucan Use


The FDA is warning the public that treatment with chronic, high doses (400-800mg/day) of Diflucan (fluconazole) during the first trimester of pregnancy may be associated with a rare and distinct set of birth defects in infants. The FDA noted that the Read More »

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