Why would Multaq be pulled?

I do not claim to be an expert on the goings on at the FDA or EMA but why would they decide to pull Multaq off the market?

It has proven to be safe in the appropriate patient type (paroxysmal or persistent AF), there has been no causality established between the extremely rare incidence of Hepatic Toxicity and the drug. . . but they are going to pull the product off the market because of PALLAS? Why?

PALLAS was an attempt to expand the labeled indication and it backfired but the patient population that was studied is inappropriate for all AAD's, not just Multaq. Have you read the patient inclusion criteria? Permanent AF, most of which was for 2+ years, an EF of equal or less than 40, symptomatic HF. . . The exclusion criteria was no patients with paroxysmal or persistent AF. This was ANDROMEDA all over again, the only difference is that our company took this one on.

I could care less what the "sky is falling" crew has to say about this and I admit that this is another unforeseen challenge but to pull this product for doing a study on a patient population outside of our indication that our customers don't use AAD's for just doesn't make any sense.

 

Could anyone shed light on the difference between persistent and permanent AF?

 

Some good points, in fact if you take out the PI's of all the other options docs can use, starting with AMIO, there are some scary percentages there in terms of side effects and long term health issues. I think part of the issue is the perception thing now... when reps first started promoting it, many docs thought from a safety standpoint it was a less potent amio with NO baggage. Well now 2 years later as you'd expect shit happens. I dont think the FDA will make us pull it. In fact it will be a box warning, and then the question is will the docs buy what we are selling? The other huge question is many of them, ie: cardiologists are NOT sure when their patients are permanent or not for AFIB. So there might be doubt there to keep Multaq on board.

 

ummmmm, nothing about Pallas here:

Since its approval last year, the Sanofi-Aventis Multaq heart drug has been controversial. For instance, a study published last spring found the pill is only modestly effective and has no clear safety benefits (see this) and more recently, questions were raised about the study that led to FDA approval (look here).

Now, a new analysis of FDA adverse event reports indicate Multaq may cause or worsen heart failure, trigger potentially lethal irregular heartbeats and impair kidney function. There is also a glaring discrepancy between the language in the Med Guide given docs and patients, and the warning label about pregnant patients. And the findings led The Institute for Safe Medicine Practices, which conducted the analysis, to conclude that “we have seldom seen a drug with so many issues in so many areas of its safety profile.”

Why? The non-profit points out that development stopped several years ago after a study of patients with severe heart failure found the drug doubled the risk of death; other data found signals of cancer and birth defects in animals; there are potentially serious interactions with other drugs used to treat atrial fibrillation, and Multaq causes new heart rhythm disturbances in some patients.

In its analysis, ISMP found 387 domestic serious adverse events cited Multaq as he primary suspect in reports involving 24 deaths, two cases of disability, and 361 other serious reactions. Overall, 25.8 percent indicated new or worsened heart failure. “This was of concern given that worsened heart failure was identified as the reason for increased mortality in the company’s trial in heart failure patients; the current prescribing information cautions doctors to consider discontinuing or suspending the drug if heart failure develops,” ISMP writes.


Heart rhythm disturbances were also reported, including 18 potential cases of abnormally slow heartbeats, 47 cases of rapid heartbeats and 13 cases of ventricular tachycardia. ISMP says this was determined after noticing earlier this year that Multaq accounted for more reported cases of these kinds of rhythm disturbances than any other drug it monitors. There were also 15 cases of kidney failure or impairment, including four cases of acute kidney failure, but computer excerpts did not provide sufficient info to evaluate them, ISMP reports.

And so ISMP asked Sanofi-Aventis for a reply and this came back: “The company said it believed that some studies showed that the reporting rate for adverse drug events may be higher during the first two years after introduction.” In other words, wait a few years and adverse events may drop? The drugmaker acknowledged, though, that the FDA is evaluating “at least two signals” in the adverse event data - heart failure and Torsades de Points, a lethal form of ventricular tachycardia.

One final note: ISMP found the Medication Guide has a “serious lapse.” The non-profit notes the FDA classified Multaq is teratogenic, or a risk for pregnant women. The label says: Multaq may cause fetal harm when administered to a pregnant woman…(and) is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.”

Yet, the Med Guide says: “It is not known if Multaq will harm your unborn baby. Talk to your
doctor if you are pregnant or plan to become pregnant.” ISMP writes that “we raised this issue with Sanofi-Aventis, which told us the company believed the current wording was appropriate.”

 

Multaq is the skinniest fat chick at the dance. . . but its still a fat chick

It is not an easy drug to sell but it brings value to the class of AAD's especially early in the treatment spectrum. There will be a lot of disappointed physicians if it is pulled.

I believe the difference between permanent and persistent AF is persistent AF can have rhythm restored via CV while permanent cannot.

 

Since its approval last year, the Sanofi-Aventis Multaq heart drug has been controversial. For instance, a study published last spring found the pill is only modestly effective and has no clear safety benefits (see this) and more recently, questions were raised about the study that led to FDA approval (look here).

Now, a new analysis of FDA adverse event reports indicate Multaq may cause or worsen heart failure, trigger potentially lethal irregular heartbeats and impair kidney function. There is also a glaring discrepancy between the language in the Med Guide given docs and patients, and the warning label about pregnant patients. And the findings led The Institute for Safe Medicine Practices, which conducted the analysis, to conclude that “we have seldom seen a drug with so many issues in so many areas of its safety profile.”

Why? The non-profit points out that development stopped several years ago after a study of patients with severe heart failure found the drug doubled the risk of death; other data found signals of cancer and birth defects in animals; there are potentially serious interactions with other drugs used to treat atrial fibrillation, and Multaq causes new heart rhythm disturbances in some patients.

In its analysis, ISMP found 387 domestic serious adverse events cited Multaq as he primary suspect in reports involving 24 deaths, two cases of disability, and 361 other serious reactions. Overall, 25.8 percent indicated new or worsened heart failure. “This was of concern given that worsened heart failure was identified as the reason for increased mortality in the company’s trial in heart failure patients; the current prescribing information cautions doctors to consider discontinuing or suspending the drug if heart failure develops,” ISMP writes.


Heart rhythm disturbances were also reported, including 18 potential cases of abnormally slow heartbeats, 47 cases of rapid heartbeats and 13 cases of ventricular tachycardia. ISMP says this was determined after noticing earlier this year that Multaq accounted for more reported cases of these kinds of rhythm disturbances than any other drug it monitors. There were also 15 cases of kidney failure or impairment, including four cases of acute kidney failure, but computer excerpts did not provide sufficient info to evaluate them, ISMP reports.

And so ISMP asked Sanofi-Aventis for a reply and this came back: “The company said it believed that some studies showed that the reporting rate for adverse drug events may be higher during the first two years after introduction.” In other words, wait a few years and adverse events may drop? The drugmaker acknowledged, though, that the FDA is evaluating “at least two signals” in the adverse event data - heart failure and Torsades de Points, a lethal form of ventricular tachycardia.

One final note: ISMP found the Medication Guide has a “serious lapse.” The non-profit notes the FDA classified Multaq is teratogenic, or a risk for pregnant women. The label says: Multaq may cause fetal harm when administered to a pregnant woman…(and) is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.”

Yet, the Med Guide says: “It is not known if Multaq will harm your unborn baby. Talk to your
doctor if you are pregnant or plan to become pregnant.” ISMP writes that “we raised this issue with Sanofi-Aventis, which told us the company believed the current wording was appropriate.”

 

poa canclled the end is near

 

Maybe for the drug but they will keep some if not all of CV.... Plavix promotion thru first quarter of 012, if they dont have anything by then, I guess people will be looking for work.

 

Because it is unsafe, undefined and uncomfortable, that's why.

 

As compared to all of the other safe AAD's?

Please-

This is a flawed classification of drugs that all (except the unquestioned most toxic-amio) provide modest efficacy when using traditional endpoints-

There is no completely safe AAD- its just a matter of which combines the most of modest efficacy with the least of substantial side-effects-

How would the (non-profit) group evaluate Sotalol for Torsades? Flecanide or Propafanone for proarrythmia or in a patient with structural heart issues, or Amiodarone for, well for being Amiodarone?

Multaq has its place-

 

They are analyzing the data to see if where, and for what patient type these results might cross over. It then becomes risk/benefit ratio. If there weren't other similar options available, that would change the ratio, but there are. What Europe does will drive what happens here. However, "first and sooner" are dead marketing messages and NRX share increase will be a joke. Liability will be a factor for these doctors with all the lawyers licking their lips, eyeing their next kill. The ROI will just not be there to support a sales force with the new projected numbers with the small amount of time the have left branded....hence, they just might pull it or just pull the sales promotion behind it.

 

Does this alarm you at all that the non-profit group is not alarmed about the other AADs. Think about it.

 

yes, you do not seem to be an expert at all. No, the Pallas trial is not the reason why Multaq will be pulled, it just added more concern and doubt in the customer's minds. It will hurt sales more than you know. How are you so certain about no more liver issues? Proof please. The sky isnt falling, but Pallas raises serious doubts about the persistent afib patient (that's right, not permanent) and any CHF patient. So, to conclude, you sound like a shallow, uneducated used car salesman.

 

ISMP's feedback is not what prompted the FDA alert and the EMA review. . . ISMP's information has been out there for months, as has the liver enzyme issue and the recent heart failure information and yet they did not prompt this recent FDA inquiry. . . PALLAS did.

I realize this is anecdotal evidence but I have yet to discuss this issue with a PRESCRIBER who translates the risks shown in PALLAS to the appropriate patient population that they are using Multaq in.

Yes, this will make it more difficult to promote Multaq to those who have waited to Rx or those who are skeptical but I still don't see how this warrants its removal from the market.

 

Remember in Athena 7% of the pts had perm AF and had the SAME reduction in cv hospitalization as the rest of the patients but now the Pallas trial with the same end points were the inverse.
As forISMP, their data is somewhat sued but still the new onset chf is real and has been an issue at FDA. This is above and beyond Pallas.
Last of all Chris V has told his leadership no more spend on Multaq.
I'm on the inside and know.....

 

The drug should be prescribed with much more caution in individuals with even mild, stable forms of heart failure based on findings from the study, according to cardiologists interviewed. They also questioned the overlap between “persistent” and “permanent” AF designations and indicated that Multaq should perhaps be contraindicated for both groups of patients based on the study’s findings.

 

Heard they also fired whoever was the lead on the inside to authorize the Pallas trial.

 

BINGO !

 

Really for crumbs sake who the heck would do a study like pallas Stupid.

 

Greed... looking for an indication that medically they should have known was risky, pure french greed.