AdverseEvents, Inc. conducted a survey of marketed drugs suspected of causing brain-related side effects in recognition of Brain Awareness Week, March 12-18, 2012. AdverseEvents used RxFilter™, its proprietary data aggregation and refinement process, to gather data from the FDA Adverse Event Reporting System (AERS) database. The Company found over fifty thousand (50,000) individual adverse event case reports linked to common brain-related side effect categories: memory loss (amnesia), inhibition of libido, and compulsive behaviors (such as uncontrolled gambling, compulsive hoarding, binge eating, hair pulling or nail biting).

The top drug linked to memory loss (amnesia) side effects was Ambien CR (an insomnia medication). Others in the top 25 included Neurontin, Lyrica, and Topamax (medicines used for epilepsy, pain and bipolar disorder), Xyrem (narcolepsy medicine), Tysabri and Avonex (multiple sclerosis treatments), Lipitor (a cholesterol medicine), Xanax and Klonopin (anxiolytics), Chantix (smoking cessation) and Detrol (incontinence medicine). Among the statins, Lipitor, Mevacor, Zocor, and Pravachol all had elevated signals for reports of memory loss with over 900 such cases for Lipitor alone since 2004.

The top drug linked to inhibition of libido side effects was Propecia (a hair loss medication that is also used to treat prostate enlargement). Four other drugs used to treat prostate problems (Jalyn, Proscar, Avodart and Lupron) also made the list. Other drugs in the top 25 included commonly used antidepressants, such as Paxil, Effexor, Pristiq, Lexapro and Celexa, and the birth control medicine Beyaz.

The top drug linked to compulsive behavior side effects was Mirapex (a Parkinson’s medication). Another medicine used for Parkinson’s disease (Requip) also made the list.

See the appendix below for the top ten drugs in each category.

P. Murali Doraiswamy, M.D., a professor and leading neuropsychiatric drug safety researcher at Duke University Medical Center, commented, “This is a very timely and insightful report. While the warning signals in this report don’t necessarily prove a causal relationship, they are often the first sign of such a link. Therefore, it is critical for consumers and prescribers to be aware of such potentially adverse effects. Some of these side effects, such as loss of libido or amnesia, can have a devastating impact on a person’s quality of life.”

Dr Doraiswamy cautioned, “The numbers are still preliminary since most adverse reactions are not reported to the FDA and we don’t know exactly how many people have actually received these drugs.” He added, “The intent of this report is not to deny the benefits of these drugs, but to provide the information needed to help consumers and doctors avoid unnecessary harm. No single doctor can keep up with all the adverse effects of the thousands of drugs, and modern data analytic techniques can supplement traditional clinical trials. This is going to be a high priority for future research.”

As is the case for any information regarding side effects and adverse events, patients should never discontinue, or alter in any way, the drugs or dosages prescribed by their physician until after consultation with their doctor. Patients should discuss these findings directly with their doctors before making any changes whatsoever to their medicines or prescribed medication regimen.

Brian Overstreet, president of AdverseEvents said, “The AERS database is a significant repository of important and potentially life-saving information. And while the data does have limitations, the ability to easily and quickly mine this plethora of data using our proprietary RxFilter™ provides a significant step forward to a better understanding of real-world side-effect risks, the enabling of more accurate safety signaling, and the propelling of further clinical evaluation of potential problems.”

AdverseEvents used the Proportional Reporting Ratio and the Reporting Odds Ratio calculations to determine the top drugs in each side-effect category. Both are common methods of disproportionality analysis and signal detection used with AERS data. Case reports from 1/1/04 - 9/30/2011 were studied and drugs with limited case reports were excluded from the final list.

Top Drugs Linked to Amnesia:

Top Drugs Linked To Inhibition of Libido:

Top Drugs Linked to Compulsive Behaviors:

About Brain Awareness Week (BAW)
Brain Awareness Week, celebrated from March 12-18, 2012, is the global campaign to increase public awareness about the progress and benefits of brain research. Each year, Brain Awareness Week unites partner organizations worldwide in celebration of the brain through events and outreach to people of all ages. The campaign combines the efforts of universities, hospitals, government agencies, schools, and professional associations in a week-long celebration of the brain. For more information, visit http://www.dana.org/brainweek/

About AdverseEvents, Inc.
AdverseEvents, Inc. (AEI) is the first service provider to deliver accurate, real-time information on adverse drug events reported to the FDA. AEI utilizes a unique data sourcing method called RxFilter™, a proprietary 17-step data refinement process that standardizes and normalizes the data from the FDA’s Adverse Event Reporting System (AERS) into a user-friendly, fully-searchable database of all FDA approved medications. As a leading resource for the pharmaceutical industry, AEI supports companies with competitive intelligence and data to inform drug marketing decisions and business development strategies. With AEI, the healthcare industry is able to quantify the benefit-risk assessments of FDA approved drugs to fully understand the scope of safety issues, based on accurate rates of side effects from such medications.

Limitations of this Study
RxFilter™ and this study make use of AERS data. The AERS database is only as accurate as the information inputted into it from various sources. The FDA estimates that only approximately 10% of all adverse events that are potentially triggered by postmarketed drugs are recorded into AERS. Reporting rates regarding a given adverse event can be influenced by publicity and marketing campaigns. Accordingly, while the RxFilter™ process used by AdverseEvents, Inc. represents an exceptionally useful tool for searching and analyzing AERS data, the output is constrained by the raw data that can be obtained from AERS.

For more information about AdverseEvents, Inc., please visit www.adverseevents.com.

Dr. Doraiswamy is an advisor to and equity holder in AdverseEvents, Inc. He has also received research grants and advisory fees from several pharmaceutical companies and advocacy groups. In 1993, Dr. Doraiswamy was part of a group that reported the association between atypical antipsychotics and diabetes. In 2003, he was also part of a group that reported on a series of 60 cases of memory loss with statins.

This message is sent from AdverseEvents, Inc., an independent company not associated with the manufacturing of the aforementioned drugs. AdverseEvents, Inc. has not been compensated, directly or indirectly, by any third party for the preparation of this report.