FDA requiring suicide monitoring in drug trials
WASHINGTON The Food and Drug Administration is now requiring drug companies to closely study whether patients become suicidal during clinical trials, according to The New York Times. Makers of drugs to treat obesity, urinary incontinence, epilepsy, smoking cessation, depression and many other conditions are being asked for the first time by the drug agency to put a complete suicide assessment into their clinical trials.
About four years ago, discoveries were made that showed antidepressants may cause some children and teenagers to become suicidal. Top FDA officials at first discounted the findings but commissioned researchers from Columbia University’s department of psychiatry, led by Kelly Posner, to reanalyze the drugs’ clinical trials.
The agency then received an application for an obesity drug by Sanofi-Aventis called rimonabant. As agency reviewers looked over the drug’s clinical trial data, they discovered results that were believed to be able to cause psychiatric problems.
Unsettled by their experience with antidepressants, agency reviewers again mandated the use of Posner’s system. The testing found that the drug doubled the risks of suicidal symptoms. In June, an FDA. advisory committee voted unanimously that the agency reject rimonabant because of its psychiatric effects, and Sanofi-Aventis withdrew the application.
Medicines to treat acne, hypertension, high cholesterol, swelling, heartburn, pain, bacterial infections and insomnia can all cause psychiatric problems, effects that were discovered, in most cases, after the drugs were approved and used by millions of patients. The FDA, however, has so far determined that the drugs’ benefits outweigh their psychiatric risks.
The last time one medicine’s side effect led the FDA to re-examine its drug approval process was in 1992, when it discovered that Seldane, a popular antihistamine, could cause dangerous heart arrhythmias. Tests revealed other drugs that could affect heart rhythms, and the agency soon mandated that almost all experimental medicines be tested for heart rhythm effects. Unlike the Seldane example, however, not every experimental drug program must use the new suicidal symptoms scale.
Posner said in an interview with The Times that, so many companies and academic research programs were adopting the suicide questionnaire that she was having trouble keeping up with the demand for its use. The questionnaire has been translated into 80 languages, and Posner has trained scores of teams of investigators from around the world on how to use it.
FDA halts clinical trial of ALS drug
LOS ANGELES The Food and Drug Administration has told CytRx to stop its clinical trial of the drug arimoclomol, which is being developed to treat amyotrophic lateral sclerosis, or Lou Gehrig’s disease, because of the need for additional analysis of previous animal studies involving the drug, according to published reports.
CytRx said in a release that it has asked for further clarification from the FDA, and said that “arimoclomol has been shown to be safe and well-tolerated after being administered to about 185 study volunteers.”
ALS is a progressive condition that affects nerve cells in the brain and spinal cord.
Study indicates that drive-through can distract pharmacists
COLUMBUS, Ohio A new study in the International Journal for Quality in Health Care has indicated that pharmacists who work at stores with drive through windows are more likely to be distracted and those distractions can lead to processing delays, reduced efficiency and even dispensing errors.
The pharmacists who were surveyed reported that the design and layout of their workplaces has an impact on dispensing accuracy, especially the presence of drive-through window pick-up services. Results also indicate that automated dispensing systems in pharmacies are likely to reduce the potential for errors and enhance efficiency.
Even with stringent internal quality controls, pharmacists nationally make an estimated 5.7 errors per 10,000 prescriptions processed, according to the study, which translates to more than 2.2 million dispensing errors each year.
According to the survey, pharmacists perceive that the drive-through window has the biggest impact on causing pharmacists and their staff to take extra steps (average agreement response of 3.7 on a 5-point scale); reducing efficiency (average response of 3.8); and causing delays in prescription processing (average response of 3.7). The respondents also attributed dispensing errors (average response of 3.2) and communication errors (average response of 3.3) to the presence of a drive-through window.
“A pharmacist or staff member could be responsible for four or five tasks, and serving people at the drive-through window is just one of them,” said Sheryl Szeinbach, the study’s lead author. “Some people seeking the convenience of the drive-through window don’t care about getting information. They just want the medication, and they want it as fast as possible. They should probably think about that and at least look at the medication and make sure it’s OK. And if they have questions, it may behoove them to come into the pharmacy.”