Arthritis related pain and safety concerns of NSAIDs

This month, the December 2012 issue of the Open Rheumatology Journal published an online article from a group that was brought together for a meeting in Aachen, Germany by Grünenthal GmbH, a pharmaceutical company.  The authors were compensated for their time and had assistance in the writing of the publication, which was funded by Grünenthal.

The article describes osteoarthritis and rheumatoid arthritis, as well as multiple therapies.  It concludes that the use of combinations of medications, as well as a multimechanistic approach are what is needed to help avoid the long-term potential safety concerns associated with NSAIDs. 

Inconsistency seen in safety labeling for generic drugs

An article published in  Pharmacoepidemiology and Drug Safety notes that over two-thirds of generic drugs in the U.S. have safety warning labels that differ from the equivalent brand-name medications.

According to the lead author, Jon Duke, "generic drug labels may contain incomplete or incorrect safety information."  This becomes problematic when the generic label is used by the physician to make prescribing decisions. If side effects, information on durg interactions or other safety issues are not in the label, then the patient may be at an increased risk for adverse events.

Out of more than 1,000 generic drugs, nearly 70% had some discrepancies in their safety labeling. Strikingly,  9% had differences of more than 10 side effects.

FDA Gives Alert That Ampyra Has Seizure Risk for Multiple Sclerosis Patients

Today, July 23, 2012, the FDA warned that there is a risk of seizures in patients with multiple sclerosis (MS) who start treatment with Ampyra (dalfampridine).

This is based on data that the FDA reviewed from post-marketing reports.  Most of the seizures reported took place within days to weeks after patients with MS started Ampyra at the recommended dose.  The patients did not have a history of previous seizures.

The FDA also updated the drug label for Ampyra to clarify rcommendations that kidney function should be monitored in individuals before they begin treatment with Ampyra.  Patients should be monitored at least once a year.

More information can be found on the FDA website.

Patient safety education for undergraduate medical students

The authors of an article published in BMC Medical Education conducted a survey of the medical literature related to patient safety education in the medical curriculum of medical schools.


The article notes that there are only a few relevant published studies on the inclusion of patient safety education in the undergraduate curriculum in medical schools either as a selective course, a lecture program, or by being integrated into the existing curriculum.  The search included developed countries with advanced health and education systems. 


It is clear that the integration of patient safety education into the existing curriculum in medical schools internationally, provides significant challenges and needs.

Reporting A Safety Issue in the US

The U.S. Food and Drug Administration (FDA) is the agency that is accountable for protecting and promoting public heath in the United States. It does this by setting regulations, conducting inspections and analyzing adverse events (AEs). The FDA maintains a computerized database where information related to AEs is stored and then analyzed. This database is called the Adverse Event Reporting System (AERS). The FDA monitors the AEs in the database to determine if there are signals that could represent a health risk to the patients and public. The reporting of AEs is done on a voluntary basis by healthcare providers, patients and the public. Manufacturers of medications are required to report information related to AEs that they become aware of either through the conduct of clinical trials or that occur spontaneously in patients taking medicines that are marketed by the company. Reporting of Adverse Events can be done as follows: Consumers and Healthcare Providers can report Adverse Events online or using a form available through the FDA by clicking here or pasting the following URL into their web browser: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm