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.

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.

It's not all bad news!

North Fulton Hospital in Atlanta Georgia has been given an "A" Hospital Safety Score by The Leapfrog Group, which is an independent, national nonprofit leader and advocate in hospital transparency. 

The Hospital Safety Score was calculated based on the guidance of The Leapfrog Group's Blue Ribbon Expert Panel using publicly available data regarding patient injuries, medical and medication errors, as well as infections. Hospitals are assigned an A, B, C, D, or F for their safety.

"Patient safety and quality are central to everything we do at North Fulton Hospital," said Deborah C. Keel, CEO of the hospital. "The Leapfrog Group's recognition publicly acknowledges the commitment of both medical staff and all hospital staff who 'blow the whistle' for patient safety each and every day."


Jennifer Green won a patient safety award for her as an infection preventionist and safety practitoner at Fort Hamilton Hospital in Cincinnati.  This award is given to those individuals who exemplify dedication and commitment to patient safety, work to communicate the importance of patient safety as an organizational priority and who serve as an outstanding role model to those other people working to further the safety of patients everywhere.

OxyContin formula change has many abusers switching to heroin

Researchers at the Washington University in St. Louis have found that the frequently abused prescription medication, OxyContin, is now leading drug abusers to switch from OxyContin to heroin as a result of a recent change in the drug's formulation.  An abuse-deterrent formulation was introduced in August 2010.  The researchers at Washington University examined the effect of the change in formulation with regard to the abuse of OxyContin and other opioids.

The painkiller's new formula makes inhaling or injecting the drug more difficult. This has led to a switch to heroin.  So while the abuse of OxyContin has decreased, which is good, the problem is that there is now a surge in the use of heroin.  This may lead to an increase in heroin related overdoses and other public health and safety issues associated with the street drug.

The Washington University scientists published their findings in the New England Journal of Medicine:

Cicero TJ, Ellis MS, Surrat HL. Effect of abuse-deterrent formulation of OxyContin.  The New England Journal of Medicine, July 12, 2012.

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?

Clinical trial considerations on male contraception and collection of pregnancy information from female partners

Please find a recently published article by me and several of my colleagues related to the need for male contraception in clinical trials.  These considerations are also applicable to other settings outside of clinical trials.

There is little guidance regarding the risk of exposure of pregnant women/ women of childbearing potential to genotoxic or teratogenic compounds via vaginal dose delivered through seminal fluid during sexual intercourse.

These recommendations, based on a precaution principle, provide a consistent approach for minimizing the risk of embryo-fetal exposure to potentially harmful drugs during pregnancy of female partners of males in clinical trials. Proactive targeted collection of pregnancy information from female partners should help determine the teratogenic potential of a drug and minimize background noise and ethical/logistical issues.