BI study: No drug interaction between Aggrenox, omeprazole
RIDGEFIELD, Conn. — An antiplatelet medication created by Boehringer Ingelheim is not affected when co-administered with a proton-pump inhibitor, according to results of a drug interaction study.
The drug maker — which presented the multiple-dose, open-label, randomized crossover study (that included 60 healthy subjects) at the International Stroke Conference in New Orleans — examined the interaction between Aggrenox (aspirin/extended-release dipyridamole) capsules in the 25-mg/200-mg strength and omeprazole. The drug maker said that it wanted to show that while omeprazole is shown to interact with some medications, it did not interact with Aggrenox.
“Omeprazole has been shown to interact with some medications that are metabolized through the CYP2C19 system. Aggrenox is not metabolized through the CYP2C19 system, however we wanted to understand if it would be affected when given together with omeprazole,” said John Smith, SVP clinical development and medical affairs at Boehringer Ingelheim. “We are pleased that these data have shown that omperazole does not interact with Aggrenox.”
Judge grants Cardinal Health temporary restraining order against DEA
DUBLIN, Ohio — Cardinal Health was granted a temporary restraining order Friday against the Drug Enforcement Administration’s suspension order of its Lakeland, Fla., distribution center.
A preliminary injunction hearing is currently scheduled for Feb. 13.
The move came after the DEA suspended registration of the Lakeland facility to distribute controlled medicines to pharmacy customers in Florida, Georgia and South Carolina. According to Cardinal Health, DEA took this action after alleging that some of the prescriptions filled at four of the 2,500 pharmacies served out of that facility were not written for legitimate medical reasons.
"I will point out here that, at the time we filled these orders, the pharmacies held valid state board of pharmacy and DEA licenses," Cardinal Health chairman and CEO George Barrett said. "We are outraged that the DEA took this action."
"Friday’s operation at the Lakeland facility is not DEA’s first visit," the DEA stated in a release issued Monday. "In December 2007, DEA issued an Immediate Suspension Order at the location due to its distribution of hydrocodone to ‘rogue’ internet pharmacies." That action, and similar actions at other Cardinal Health facilities across the United States, resulted in a $34 million fine, the DEA added.
The DEA also suspended the registration of two CVS/pharmacy locations in Sanford, Fla. in the same action. The DEA alleged the two CVS/pharmacy locations, located 5.5 miles apart, were filling oxycodone prescriptions far in excess of what a typical pharmacy dispenses.
Cardinal Health and the two CVS/pharmacy locations will be given an opportunity for an administrative hearing to determine whether the DEA Certificate of Registration at each of the three locations should be revoked. The final decision will be published in the Federal Register, the DEA stated.
The order from the U.S. District Court for the District of Columbia is available here.
FDA approves Vyvanse for adults with ADHD
PHILADELPHIA — The Food and Drug Administration has approved a drug made by Shire for attention deficit hyperactivity disorder, the company said Tuesday.
Shire announced the FDA approval of Vyvanse (lisdexamfetamine dimesylate) capsules as a maintenance treatment for adults with ADHD. The drug already was approved for use in children and was approved for treating ADHD in adults in 2008.
The company said the approval was based on a clinical trial that showed more ADHD patients controlling their symptoms with Vyvanse than with placebo.