One of the least-known facts in medicine is the amount of leeway a doctor has when it comes to prescribing medicine. They are essentially on their own; the final authority in determining the drugs their patients will take while under their care. So, while the FDA may have approved a drug to treat X condition, biology dictates that it might also have a positive effect on Y condition, and your ...
Bristol-Myers Squibb Settles Off-Label Marketing Suit
Posted January 10, 2017 in Product News and Recalls
New Concerns Raised Over Dangers of Off-Label Drug Use
Posted November 19, 2015 in Drug and Medical Device Lawsuits | Product News and Recalls
Few topics in healthcare are as contentious as that of off-label drug use. And now, a new study published in the Journal of the American Medical Association’s Internal Medicine edition adds new fuel to the fire.
Off-label drug use is nothing new. Based on the pretense that a prescription drug could be useful in circumstances other than the specific uses approved by the US Food and Drug Administration, doctors may ...
continue reading...Consumer Advocates Speak Out against Off-Label SGLT2 Inhibitor Promotion
Posted July 24, 2015 in Product News and Recalls
In a recent letter to the U.S. Food and Drug Administration (FDA), Public Citizen, a 350,000-member consumer advocacy group, spoke out against the apparent off-label promotion of certain sodium-glucose cotransporter 2 (SGLT2) inhibitors. The group takes issue with direct-to-consumer advertisements for five different drugs: Farxiga (dapagliflozin), Jardiance (empagliflozin), Invokana (canagliflozin), Victoza (liraglutide), and Bydureon (extended-release exenatide). According to Public Citizen, ads in print magazines and online are inappropriately ...
Getting Sued for Doing Your Job: Amarin Pharma and the FDA
Posted June 24, 2015 in Drug and Medical Device Lawsuits | Product News and Recalls
The job of a regulatory agency is to define, for those under its regulation, what is permissible behavior and what is not. It is tasked with laying down the ground rules: corporations can play on its field but they have to play by its rules. If they don’t, they get fined or they lose their right to play.
Regulation is a part ...
continue reading...What Everybody Ought to Know about Zofran
Posted March 23, 2015 in Product News and Recalls | zofran
Nausea is one of the worst feelings in the world; there is no easier or cleaner way to say it. When patients experiencing nausea have the chance to make it go away, they generally will jump at the chance.
Zofran has been a popular antiemetic (nausea treatment) since its approval in 1991 with sales routinely over $1 billion per year. Produced by drug manufacturer GlaxoSmithKline, it is intended to help with ...
continue reading...GlaxoSmithKline to Pay $105 Million Settlement
Posted June 16, 2014 in Product News and Recalls | Verdicts & Settlements
GlaxoSmithKline, a London-based pharmaceutical company, agreed to pay a $105 million settlement to 44 states and the District of Columbia. The company was allegedly unlawfully marketing Advair, its asthma drug, and two popular antidepressants.
The lawsuits claimed that GlaxoSmithKline was using off-label marketing and violated state consumer protection laws. Off-label marketing is when a company markets a drug for uses that are not approved by ...
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