FDA warning to be aware of

Hi Guys,

The FDA released this statement on the 18th of December about anti-seiazure meds:

[size=150]FDA: Antiepileptics Linked to Increased Risk of Suicidal Thoughts, Behaviour[/size]

“Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviour, or any unusual changes in mood or behaviour,” said Russell Katz, MD, Division of Neurology Products.

The FDA’s actions are based on the agency’s review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behaviour or thoughts (0.43%) compared with patients receiving a placebo (0.24%). This difference was about 1 additional case of suicidal thoughts or behaviours for every 500 patients treated with antiepileptic drugs instead of placebo.

The following antiepileptic drugs are required to add warnings about the risk of suicidality: carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol XR); clonazepam (Klonopin); clorazepate (Tranxene); divalproex sodium (Depakote, Depakote ER, Depakene); ethosuximide (Zarontin); ethotoin (Peganone); felbamate (Felbatol); gabapentin (Neurontin); lamotrigine (Lamictal); lacosamide (Vimpat); levetiracetam (Keppra); mephenytoin (Mesantoin); methosuximide (Celontin); oxcarbazepine (Trileptal); phenytoin (Dilantin Suspension); [size=120]pregabalin (Lyrica)[/size]; primidone (Mysoline); tiagabine (Gabitril); [size=120]topiramate (Topamax)[/size]; trimethadione (Tridione); and zonisamide (Zonegran). Some of these medications are also available as generics.

And this:

[size=150]Bradycardia (low heart rate) not synonymous with cardioprotection in hypertension – atenolol[/size]

In the new review, nine randomized controlled trials evaluated beta blockers for hypertension that also reported heart-rate data, including 34 096 patients taking beta blockers, 30 139 taking other antihypertensives, and 3987 receiving placebo. Of the patients in the beta-blocker arms, [size=120]78% received atenolol[/size], 9% took oxprenolol, 1% propranolol, and 12% received atenolol/metoprolol/pindolol or hydrochlorothiazide.

Paradoxically, a lower heart rate (as attained in the beta-blocker group at study end) was associated with a greater risk for all-cause mortality (p < 0.0001), cardiovascular mortality (p < 0.0001), heart attack (p < 0.0001), stroke (p = 0.06), or heart failure (p < 0.0001).

Cockcroft contends that because this new review contains studies almost exclusively using atenolol, “this doesn’t move the argument forward very much.” Atenolol, he says, “has been tried and found guilty, and yet around 40% of prescriptions for beta blockers in the UK and in the US are still for atenolol. Atenolol should not be given to anybody. Nobody disagrees that atenolol is guilty, and yet we are still using it.”

Scott 8)

Thank you Scott.

Thanks Scott for that information.

Joe