This Drug Could Cause Liver Damage

WASHINGTON — Federal health officials are warning doctors and patients that a recently-launched heart drug from Sanofi-Aventis SA has been linked to liver damage in a handful of patients.

The Food and Drug Administration said Friday it has received several reports of liver damage with Multaq tablets, including two cases in which patients had to have their livers removed. Both patients were women and roughly 70 years old. They had been taking the drug for 4.5 months and 6 months, respectively.

The FDA approved Multaq in July 2009 to treat atrial flutter and atrial fibrillation which are irregular heart rhythms that can reduce blood flow and lead to stroke. More than a half-million prescriptions for Multaq have been written since the drug was approved.

In an online notice, the FDA said it would add a new warning about the risk for liver damage to the label of Multaq. The agency said patients should contact their doctor if they experience signs of liver injury, including nausea, vomiting and fever. If doctors suspect a toxicity issue they should discontinue use of the drug and test the patient's liver enzymes.

Liver toxicity is among the most common drug-related side effects across a number of medication classes.

Multaq already carries a black box warning, the most severe type, stating the drug can cause severe complications, including death, in people with recent severe heart failure and should not be used in those patients. Common side effects of the twice-a-day tablets include fatigue, loss of strength, diarrhea, nausea and vomiting.

Paris-based Sanofi reported $84 million in sales for Multaq in the first-half of 2009.

Leerink Swann analyst Seamus Fernandez said the safety warning is unlikely to hurt U.S. sales of drug, which he estimates at $128 million for 2010 and $521 million by 2016.

Sanofi said in a statement it has already issued a letter about the liver injuries to doctors and other health care professionals who prescribe Multaq. The letter recommends prescribers consider giving liver enzyme tests during the first six months of treatment.

"Sanofi-Aventis will continue to be in communication with the FDA and this issue will be closely reviewed and monitored," the company stated.

Comments

[dlo2]

12:03 PM on 01/22/2011

Liver damage is also a genuine concern in the case of tylenol overdose or in tylenol intake that follows hangovers. One of our fellow ACLS instructors that I was working with one day mentioned that her liver transplant unit was seeing a surge of young 20s who needed liver transplants after suffering liver failure from taking tylenol following an alcohol binge.

All medications, OTC NSAIDs/tylenol as well as prescription meds, can create hazards depending on pharmacogenomic/genetic issues. After the human genome was mapped successfully in 2000, pharmacogenomics became the first science to use this critical information that has enormous applications in avoiding the pharmaceutical toxicities in human populations.

[farmilyman]

05:38 AM on 01/19/2011

Never take any medicine that has not been on the market for at least 7 years. Drug companies fudge data to get their drugs quickly approved.

[CynWaveRider]

01:42 PM on 01/18/2011

Another drug that is dangerous for the liver is Acetaminophen; should never be used by those who drink alcohol

[GreenKate]

12:53 PM on 01/18/2011

Not to worry Sanofi-Aventis SA: The crown jewel in the GOP's health care alternative is to end "junk lawsuits." They think having one's liver removed after taking a pill for a few months is no big deal. Tell that lady to just suck it up.

[drricklippin]

08:08 PM on 01/15/2011

Aren't you tired of reading these stories?

Trust in Big PhRMA has been seriously eroded especially in recent decades

This was a truly miraculous industry which out of excess and greed has gone very sour

Proceed to take especially new meds with caution,

Dr. Rick Lippin
Southampton,Pa

[farmilyman]

05:44 AM on 01/19/2011

Yep, you can't trust drug companies:

http://articles.mercola.com/sites/articles/archive/2011/01/18/sixty-minutes-exposes-why-you-cant-trust-drug-companies.aspx

[ddanimal]

10:28 PM on 01/14/2011

Its absolutely nonsensical to use a drug like this for treating heart problems. heart problems are effectively and safely treated with nutrients like taurine, coenzyme Q10, magnesium, carnitine, etc.

[JSDKoeln]

04:55 AM on 01/15/2011

Where there's an uneducated assumption. I take Multaq and was taking all the "nutrients" prior to my almost dying last summer... and I'm an avid exerciser. These drugs can save lives. Arrhythmia's are an odd occurrence and a very difficult condition to treat. that being said, I have been on Multaq for 9 months and have perfect liver values. I am wondering just what else the patients were taking that were hard on the liver.

[SitandStay]

10:49 PM on 01/15/2011

food and water

[silverhair01]

12:49 PM on 01/14/2011

My plan is the paleo diet. It fits my lifestyle perfectly. I prefer to call it the paleo lifestyle though...

[sabelmouse]

12:46 PM on 01/14/2011

i expect every drug to be a burden on the liver [ as are many other things in our modern lives ]but this is indeed extreme. all the more reason to do without if at all possible.

[JSDKoeln]

04:57 AM on 01/15/2011

arrhythmia's are difficult to treat. And these drugs help a LOT of people who have some odd biological condition, including myself. My liver values were off until I ended my statins. Then my liver values went to normal. I am wondering what other drugs, or what combination could have caused this...

[sabelmouse]

07:13 AM on 01/15/2011

we are very burdened with environmental poisons . as someone with a liver problem i feel like a canary. there are so many things that make me ill that people don't normally notice.
i bet they have an adverse effect on them over time nevertheless.