Antinausea Drug Withdrawn From US Market

The FDA announced that the 32 mg dose of Zofran (ondansetron), an anti-nausea medication, will no longer be marketed in the US due to the potential the risk of Torsades de pointes, a serious cardiac rhythm abnormality.  The event occurs when there is a prolongation in the QTc interval, an important part of the electrical activity of the heart.  Prolongation of the QTc can be fatal.  Information from the FDA can be found here.

Adverse Event Reporting of Lipitor, Lyrica, Viagra and Chantix

In May 2010, the FDA sent a letter to Pfizer's CEO, Jeffrey Kindler, warning the company that it had failed to report serious and unexpected adverse reactions to many of its widely known medications including Viagra (sildenafil), Lipitor (atorvastatin) and Lyrica (pregabalin) in a manner consistent with regulations.

The late reporting of adverse events was found to go back as far as 2004 and was noted to have increased over the six year period.  The FDA found that Pfizer did not report important cases within its 15-day period as a result of "misclassifying and/or downgrading reports to non-serious without reasonable justification."

In the past Pfizer had blamed issues with reporting on the lack of proper training of its employees with a new computerized adverse event reporting system.  Pfizer subsequently informed the FDA that this had been addressed, but the FDA called Pfizer's changes "inadequate" and "ineffective."  The FDA called for a revised "corrective action plan," also known as a CAP at the time.

A year later, in May 2011, the Institute for Safe Medication Practices (ISMP), a nonprofit organization, reported that "the risks of varenicline (CHANTIX) were underestimated in prior adverse event reporting." They outlined how Pfizer had failed to provide hundreds of reports through "the usual channels."  The ISMP noted that of the serious adverse event (SAE) reports, there were 150 patients who had completed suicides dating back to 2007.  As a result of the lapse in Pfizer's pharmacovigilance, more than half of the cases involving suicide were not sent to the FDA.  This meant that FDA analysts could not properly monitor this serious psychiatric issue.

Statins may help reduce bad memories

For a number of years there have been reports concerning the loss of memory, as well as muscle pains associated with the use of a group of medications called statins.  These drugs have been well known and widely prescribed to millions of people to help reduce cholesterol.  At least 32 million people in the US take these medications in the hopes that they will ward off a multitude of illnesses.  In the UK it is estimated that 5 million people take statins.

Cholesterol is associated with cardiovascular disease and can lead to myocardial infarctions, commonly called heart attacks.  Another risk associated with the build up of cholesterol in plaques is that of stroke.

In March of 2012 the U.S. Food and Drug Association (FDA) alerted the public that the entire class of statin drugs would be receiving new warnings in its labeling. The new label will warn that memory loss and confusion is associated with use of statins.  Additionally the labels will be updated to inform the public that statins can cause an increase in blood sugars called hyperglycemia and an increase in the risk of Type 2 diabetes.

With the above changes, the FDA is also removing its recommendation for routine and periodic monitoring of liver functioning.  Before patients start treatment with statins it is still recommended to get   liver enzyme tests (LFTs).

Cholesterol, however, is not all bad.  It is also not only from food; only 25% comes from diet.  The liver and other cells create approximately 75% of blood cholesterol.  There is good cholesterol, which is HDL and then bad cholesterol, also known as LDL.

Cholesterol is an important substance for normal functioning in the body.  Some people, however, have an increased risk of elevated cholesterol associated with genes that are inherited.  Others may have the ability to moderate their cholesterol through diet and exercise.

According to some investigators, a large number of patients do not achieve the desired goal of reduction in cholesterol levels after six months of treatment.

Effect of a Pharmacist Intervention on Clinically Important Medication Errors After Hospital Discharge: A Randomized Trial

This article from the Ann Intern Med. 3 July 2012;157(1):1-10 shows that half of all cardiac patients had clinically important medication errors after having an explanation of their medications and how to take them by a pharmacist.  Could it be that the patient wasn't able to process the information after having been hospitalized with a heart condition?

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