Farxiga Bladder Cancer Warning In PI

[Anonymous]

You can find the full PI on astrazeneca.com Oh well, what's a little cancer as long as my A1C is good!


http://packageinserts.bms.com/pi/pi_farxiga.pdf

 

[Anonymous]

You can find the full PI on astrazeneca.com Oh well, what's a little cancer as long as my A1C is good!


http://packageinserts.bms.com/pi/pi_farxiga.pdf

Neither the advisory committee nor the FDA believes dapa caused those cancers, which is partly why the committee voted overwhelmingly to recommend approval. It appears the cancers were found after the subjects had been taking dapa only for a short time, which means they originated prior to the start of the trial.

 

[Anonymous]

Neither the advisory committee nor the FDA believes dapa caused those cancers, which is partly why the committee voted overwhelmingly to recommend approval. It appears the cancers were found after the subjects had been taking dapa only for a short time, which means they originated prior to the start of the trial.

Read the financials fools because these guys rarely get it wrong. Worst in class efficacy results, including future new releases and add in any cancer warnings that the competition doesn't have and (Holy Shit Batman) I can hear the dogs barking from here. Projections are 1/3 of 1 percent market share, max $280 Million.

 

[Anonymous]

Neither the advisory committee nor the FDA believes dapa caused those cancers, which is partly why the committee voted overwhelmingly to recommend approval. It appears the cancers were found after the subjects had been taking dapa only for a short time, which means they originated prior to the start of the trial.

Well, good luck trying to twist that with our docs. The competition is already planting this in their minds.

 

[Anonymous]

Neither the advisory committee nor the FDA believes dapa caused those cancers, which is partly why the committee voted overwhelmingly to recommend approval. It appears the cancers were found after the subjects had been taking dapa only for a short time, which means they originated prior to the start of the trial.

which is why the FDA is requiring postmarketing studies "to ascertain whether dapagliflozin is associated with increased risks for cardiovascular events, liver problems, or malignancies."

 

[Anonymous]

which is why the FDA is requiring postmarketing studies "to ascertain whether dapagliflozin is associated with increased risks for cardiovascular events, liver problems, or malignancies."

Yeah but even so it is all but impossible to retract those warnings. The best you can usually hope for is no additional causative effect.

 

[Anonymous]

Yeah but even so it is all but impossible to retract those warnings. The best you can usually hope for is no additional causative effect.

HaHa!!!! Thanks for coming to our site and welcome to our Invokana friend. What a shame that we've nearly taken 25% of your market share in a eight week period. Just wait-there is more fun coming. Once our combo comes out with MetXR in about five months, you're in for some more fun. Best wishes and thanks for all of your effort with launching the SGLT2 class and making it easy for us.

 

[Anonymous]

HaHa!!!! Thanks for coming to our site and welcome to our Invokana friend. What a shame that we've nearly taken 25% of your market share in a eight week period. Just wait-there is more fun coming. Once our combo comes out with MetXR in about five months, you're in for some more fun. Best wishes and thanks for all of your effort with launching the SGLT2 class and making it easy for us.

Good guess, but no, I work for AZ.

Am thinking of the formation of cataracts in beagle dogs, which became a concern with Seroquel and put additional labeling in the prescribing information. Even with, for example, additional studies from the Am J of Opthalmol., which recommends twice yearly eye exams as unnecessary, I believe the warning still exists.