The biopharmaceutical corporation Shire has announced a voluntary recall of six lots of Daytrana, a medication patch used to treat ADHD. According to a Dec. 3 article in the Philadelphia Business Journal, Shire says the recall is not a safety issue, but a functional one:

The company said patients and caregivers could have difficulty removing the liners. Some Daytrana patches do not meet or in the future may not meet their release liner removal specification, the company said.

The company stressed the action is not due to safety issues. "All Daytrana patches can continue to be used unless the release liner cannot be removed or the patches are damaged while being opened," Shire officials said.

In a Dec. 7 article on the website bnet.com, journalist and drug marketing expert Jim Edwards wrote that the latest recall should prompt Shire to end production of Daytrana:

This is the eighth recall of the Daytrana patch, a product on which Shires manufacturer, Noven, makes no profit because recall costs far exceed the revenues it gets from selling the thing, according to Novens most recent 10-Q. Daytranas marketing is already under investigation by the feds.

Its time to say it out loud: The Daytrana ADHD patch does not work, never has done, and should be quietly ditched by Shire and Noven before the FDA wakes up.

Labels: medications, patch, recall

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Shire, plc, has announced that it is withdrawing its European Marketing Authorization Application (MAA) for Daytrana®, an ADHD medication. Daytrana® is a patch, developed for children ages six to 12, that releases a steady, low dose of ADHD medication for up to 9 hours.

"Shire stated that its decision to withdraw the MAA was based on the fact that European regulatory authorities had requested an addiction clinical study for Daytrana® in a European patient population, and that Shire planned to enter the European ADHD market through the previously-announced acquisition of a... product that is already approved in Europe."

Shire will continue to market Daytrana® in the United States, where it has already been subjected to clinical tests and approved. Source: BusinessWire

Labels: medications, treatment, patch

Posted By: Aspen Education Group 0 Comments