safety concerns

The Food and Drug Administration has just announced a restructuring. The agency will be adding a new department, the Office of Pharmaceutical Quality, to rectify some serious manufacturing problems that have come to light over the past decade.

Last year, drug recalls affected 70 million drug units. As alarming as that sounds, it is actually an improvement over previous years when 225 million units were recalled annually.

The new Office of Pharmaceutical Quality will pay special attention to extended-release drugs. This is in large part because the agency discovered that some generic forms of Wellbutrin XL 300 were not bioequivalent. This discovery and certain others forced the FDA to reconsider its approach to extended-release generic medications.

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  1. Matt S.

    I was excited when they reviewed Concerta and that ended up being done right. I was hoping they’d continue with Adderall XR since one brand of that is horrible and the other two are made by Shire and are just like the brand with different writing and they are Adderall.

    My guess, the kids are on concerta nowadays more often and a lot of angry moms were calling about it.

  2. Dan

    And what about those generics that are produced in other countries ????

  3. PP

    Nomenda (Memantine) was supposed to go generic this year, but the manufacturer came up with an Extended Release tab. Now insurance won’t pay for the old 10 mg tab and the new XR formulation is on back order. Having seen the effect on myhusband I think the original formulation is better, at least for him.

    When are we going to get some controls on big Pharma ?!!!

  4. Mary

    It is about time.

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