Thanks to all of our readers for a great 2015. Below is a top 10 countdown of Advera Health's most downloaded reports of the year with links to access the free downloads.
10.) Special Report: Rheumatoid Arthritis Medications - An Analysis Utilizing Adverse Events Explorer
Using the methods outlined here we were able to detail real-world side effect data across RA medications. Our review suggests disproportionately elevated reporting of many AEs that can adversely affect patient safety.
9.) Special Report: The Comparative Safety of Cholesterol Lowering (Statin) Medications
In general, our analyses of post-marketing adverse event data regarding statins suggest disproportionally elevated reporting for a number of adverse events (AEs) that can adversely affect treatment adherence and quality of life for patients.
8.) Special Report: The Comparative Safety of Multiple Sclerosis Medications
In general, the older-generation drugs, particularly the interferons (Rebif, Avonex, Betaseron), have inferior safety profiles when compared to newer drug regimens
7.) White Paper: Post FDA-approval drug safety data - why they are vital and how they can be made accessible, actionable, and predictable
Side effects from drugs, vaccines, and devices approved by the Food and Drug Administration (FDA) are a major public safety concern.
Due to financial and logistical hurdles, no pre-approval clinical trial can ever be large enough, or long enough, to identify and properly characterize all side effects that may occur once a drug is introduced to large consumer populations.
All FDA approved drugs have the potential to trigger various side effects not revealed during pre-approval investigations. Careful and continuous post-approval monitoring is therefore vital to the evaluation of a drug's safety profile.
6.) White Paper - RxCost
Assessing real world drug safety by calculating the costs of side effects and poor patient outocmes after FDA approval
Introducing RxCost: the first methodology to identify the total costs of adverse drug reactions (ADRs) associated with FDA-approved drugs.
RxCost provides the most complete representation of a drug’s true cost by analyzing real-world data and presenting the costs of actual adverse side effects of specific drugs (e.g., injury, hospital admission/readmission, disability and/or death). This rapid and meaningful analysis results in improved prescribing, formulary, and coverage decisions.
5.) Special Report: Asthma Medications - A Comparative Safety Analysis
In general, Asmanex, Singular, and Dulera appeared to have lower ROR results for the individual AEs and AE groups that we analyzed, while Xolair, Advair, Flovent, and Decadron had more instances of elevated RORs.
4.) Special Report: GLP-1, DPP-4, adn SGLT2 Drugs for Type 2 Diabetes- An Analysis Utilizing Adverse Events Explorer
While all three classes had members with elevated reporting for diabetic ketoacidosis, the SGLT2 inhibitors had much higher RORs than the other two classes of medications with a 63.77 for Invokana and a 19.61 for Farxiga. Indeed, after this report had already been drafted, FDA issued a warning regarding SGLT2 inhibitors and ketoacidosis.Download Now
3.) Special Report: Examing the Comparative Safety of Blood Thinners: An Analysis Utilizing Adverse Events Explorer
The results from our analyses all point to the same general conclusions: 1) apixaban may be a safer choice within the anticoagulant class and 2) prasugrel may have higher safety risks than the other two medications.Download Now
2.) Special Report: Comparative Analysis of the Newly Approved Obesity Drug, Contrave
On September 10th, the FDA granted approval of a new chronic weight-loss drug, Contrave (naltrexone and bupropion extended-release). Contrave is formulated as a combination product consisting of an opioid antagonist (naltrexone) and an antidepressant (bupropion), both of which are FDA-approved drugs indicated for treating different conditions as individual agents. Several issues pertaining to Contrave’s safety profile raise significant concerns.
This report serves to highlight some of the safety considerations for currently approved obesity treatments as well as compare the safety profiles of Contrave and Qsymia.
1.) Drug Safety Monitor: Safety Comparison of Viekira Pak, Harvoni, and Sovaldi
This report compares the prescribing information of Viekira Pak and Harvoni, and on-label adverse events of Viekira Pak to the post-marketing case reports of Sovaldi. We employed our proprietary RxFilter to determine Sovaldi’s ROR values for on-label Sovaldi adverse events (AEs), discussed off-label AEs for Sovaldi that may trigger future pharmacovigilance signals via RxSignal, and compared RxScores among Chronic Hepatitis C treatments.