OLYMPUS DIGITAL CAMERAA Boston University School of Medicine researcher, Clifford Knapp, PhD, associate professor of psychiatry, got some press recently by claiming that Potiga, a GlaxoSmithKline drug used as an anti-convulsant to suppress partial epileptic seizures in patients, might be given to alcoholics to reduce their alcohol consumption.

Potiga was the first neuronal potassium channel opener developed for the treatment of epilepsy. This drug is not available as a generic.

Dr. Knapp said “This finding is of importance because Ezogabine (Potiga) acts by opening a particular type of potassium channel in the brain, called the Kv7 channel, which regulates activity in areas of the brain that are believed to regulate the rewarding effects of alcohol.”
He added that,” This research indicates that drugs that open Kv7 channels might be of value in the treatment of alcoholism.”

He tested this idea on laboratory rats and concluded that the drug “…may produce a decrease in ethanol consumption by rats at doses that do not significantly reduce the drinking of either water or a sucrose solution. These findings are consistent with the hypothesis that activation of Kv7 channels facilitates the reduction of alcohol consumption in the rat.”

He admitted much more research needs to be done as too much of the drug caused motor impairment in the rats – something a human alcoholic is already having trouble with.
Aside from whether or not reactions in a human being have anything to do with those of a rat, Potiga should be shunned as it’s a drug with a laundry list of dangerous side effects.

GlaxoSmithKline’s own website page for Potiga offers these warnings on what the drug can do:
•    POTIGA can cause retinal abnormalities which are known to result in damage to the photoreceptors and vision loss

•    POTIGA caused urinary retention in clinical trials – in 17% of the people it required catheterization in order to relieve urine retention.

•    POTIGA can cause skin discoloration. The skin discoloration is generally described as blue, but has also been described as grey-blue or brown. It is predominantly on or around the lips or in the nail beds of the fingers or toes, but more widespread involvement of the face and legs has also been reported.

•    POTIGA can cause neuro-Psychiatric Symptoms – Confusion, psychotic symptoms, and hallucinations were reported Half of the patients in the controlled trials who discontinued POTIGA due to hallucinations or psychosis required hospitalization.

•    POTIGA causes dose-related increases in dizziness and somnolence

•    POTIGA causes an increase in suicidal thoughts or behavior in patients who should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

GSK adds their comments to this issue of suicide.

“There were 4 suicides in drug-treated patients in the trials and
none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.”

“The increased risk of suicidal thoughts or behavior with AEDs (Antiepileptic Drugs) was observed as early as 1 week after starting treatment. Anyone considering prescribing POTIGA or any other AED must balance this risk with the risk of untreated illness.”

Other Potiga side effects include drowsiness, dizziness and vertigo, confusion, fatigue, problems paying attention, memory impairment, lack of strength and slurred speech. Less common side effects include tremor, memory loss, gait disturbances, and double vision.

An alcoholic might be familiar with these effects already without resorting to taking Potiga.

An additional warning is that Ezogabine (Potiga) may be habit-forming and one should not stop using the drug without first talking to his or her doctor. Even if they feel fine they may have increased seizures if they stop using Ezogabine suddenly.

To top off the list there is evidence that Potiga can cause certain cancers and that it can cause adverse genetic mutation to occur in the body.

Before we get too excited with the prospect that GlaxoSmithKline is about to offer a drug that cures alcoholism, we should look at that drug company’s record for safety and the care of those who swallow their pills.

It has been less than two years since The NY Times reported that GSK had agreed to plead guilty to criminal charges and pay $3 billion dollars in a fraud settlement for promoting its best-selling antidepressants for unapproved uses and failing to report safety data about a top diabetes drug. It also included civil penalties for improper marketing of a half-dozen other drugs.

Interestingly one of GSK’s drugs involved in these lawsuits was Avandia which turned out to almost triple the risk of a specific condition that caused loss of vision in diabetic patients taking that drug. The FDA had warned about it in 2006 but the drug company downplayed the risk – until it was sued by patients who had suffered vision loss.

Now Potiga faces future lawsuits over loss of vision. In October 2013 the FDA ordered GSK to add a black box warning label to Potiga for the risk of retina abnormalities that can lead to blindness. The label also highlighted the risk of skin discoloration. The FDA offered no data as to whether these Potiga side effects were reversible or not.

Law firms dedicated to patient’s rights and litigation against drug companies who knowingly hide the dangerous side effects of their products are reaching out to Potiga users now suffering with skin and vision problems.

What kind of potential volume of drug sales is luring GSK to risk another huge settlement by peddling this pill as a cure for alcoholics?

The CDC estimates some 2.3 million adults and some 460,000+ children have some form of “epilepsy”. But they admit that in 2/3rds of these cases, the cause of the symptom cannot be identified. In contrast, there are some 17 million Americans with an “alcohol disorder” – a large and easily diagnosed group of potential Potiga users.

The irony is that both the National Institute of Health and the FDA warn to, “Ask your doctor about the safe use of alcoholic beverages while you are taking Ezogabine. Alcohol can make the dizziness and drowsiness caused by Ezogabine worse.”

And GlaxoSmithKline tells us on their website, “Patients taking Potiga should be advised of possible worsening of Ezogabine’s general dose-related adverse reactions if they take POTIGA with alcohol.”

Hopefully this idea for treating alcoholics will never go further than a few boozed up rats in a lab.



http://www.nlm.nih.gov/medlineplus/druginfo/meds/a612028.html  .


https://www.gsksource.com/gskprm/htdocs/documents/POTIGA-PI-MG.PDF gsk’s