A review of Medwatch data from the period of 11/03/97 to 4/27/07 reveals 408 case reports of amnesia associated with Lipitor use.
Prior to this time Wagstaff and others had reviewed available Medwatch data from November 1997 to September 2002. They gleaned 60 cases of transient global amnesia associated with the use of Lipitor, Zocor and Pravachol and reported their findings in Pharmacotherapy in August of 2003. Pravachol contributed only one case to this total; the remaining cases were equally divided between Lipitor and Zocor.
Subtracting Wagstaff's 60 cases from the 408 obtained from my recent Medwatch review gives 348 new cases of Lipitor associated amnesia reported to Medwatch since September 2002. A very rough estimate of total statin associated amnesia cases could be obtained by doubling this figure, based upon Wagstaff's original data about Zocor and additional cases from other statins (Mevacor, Lescol, Crestor, Pravachol and Vytorin and Zocor). So 700 would be a very conservative estimate of all statin associated amnesia reports at this time.
Many researchers feel that less than 1% of statin side effects are reported. Others feel the figure is closer to 10%. At 1% our 700 becomes 70,000 and at 10% our 700 becomes 7,000 - either figure entirely adequate to get some sort of response from FDA.
We are not talking urinary retention or anxiety here; we are talking amnesia; eradication, more or less, of your mind. Shouldn't this get greater consideration in our society, like a black box warning so that doctors will understand what we are dealing with? Or is there some other factor here, related to the fact that since 2004, the drug companies are paying for their own drug safety monitoring?
This is Medwatch, our government's protective umbrella, supposedly shielding us from adverse post-marketing drug events.
And to think about how little of this information is known to the practicing physicians. Not a day goes by that I do not get a report or two from doctors saying, "I didn't know statins could do that." And this is seven years after my own experience with Lipitor associated amnesia. "Statins don't do that" was a refrain I heard over and over again from both doctors and pharmacists as I sought answers to my two statin associated amnesias. During the first episode at 10 mg daily, I retrograded back ten years and, for six hours, knew neither my new wife nor my new home. In my second case at 5 mg daily, I was 13 years of age for 12 terrifying hours and laughed hysterically when they told me I was married with children and a family doctor. I was 13!
And what about huge clinical studies wherein thousands of participants are placed on today's heroic doses of statins with nary a problem according to the investigators. Pfizer's own statistics tell us to expect five cases of amnesia for every one thousand statin users. Who is doing the monitoring of these studies for side effects? What questions are being asked? If neither doctor nor patient knows that memory lapses are possible in statin users how often will it be reported? I can only surmise that cognitive side effects from statin drug use are not being seen because they are not being looked for.
Duane Graveline MD MPH
Former USAF Flight Surgeon
Former NASA Astronaut
Retired Family Doctor
Other trade / brand names for Atorvastatin: Atorlip, Lipvas, Sortis, Torvacard, Torvast, Totalip, Tulip.
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