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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 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 »

U.S. Food & Drug Administration Warns About Multaq Safety

 

The F.D.A. recently issued a warning for Multaq, which is a drug used to treat abnormal heart rhythms. The drug is used by people who suffer from atrial fibrillation that lasts less than six months. The drug was approved in 2009 and approximately 241 Read More »

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