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Voices of/for Patients


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Reactions to the 13-Nov.-14 FDA Action on Generic Methylphenidate ER tablets; a sample from two popular blogs.

Published in: Health & Medicine
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Voices of/for Patients

  1. 1. Voices of/for Patients <br>Reactions to FDA Action<br>
  2. 2. 13-Nov-14, FDA takes action <br>Methylphenidate HCL ER Generic Tablets<br>
  3. 3. Reactions on two blogs: Church4EveryChild<br>ADHD Roller Coaster<br>
  4. 4. Church4EveryChild;<br>
  5. 5. &quot;It appears that the FDA allowed the generic manufacturers to “cut and paste” the data from Concerta’s pharmacokinetic studies and clinical trials and present this information as if it represented trials each company conducted with their own unique product.&quot;<br>
  6. 6. &quot;It’s EXTREMELY UNLIKELY that different drug delivery systems would produce EXACTLY the same results in terms of drug metabolism (pharmacokinetics) and drug effects (pharmacodynamics) as the brand name drug.&quot;<br>
  7. 7. &quot;In my mind, this is an utter and complete outrage when we’re talking about the most commonly prescribed drug for teenagers in the United States. I’d argue that this is a social justice issue.&quot;<br>
  8. 8. ADHD Roller Coaster <br><br>
  9. 9. Victory! Concerta Generics Downgraded!<br>
  10. 10. &quot;It’s tragic that so many people have already been adversely affected, and without warning.&quot;<br>
  11. 11. &quot;Not to mention having their concerns dismissed by some pharmacists. “It’s the same as the brand,” some pharmacists said. “No, it’s not!” we said. And the FDA heard us.&quot;<br>
  12. 12. &quot;You can bet ADHD Roller Coaster readers had much to do with that! Many of you followed through by filing a complaint with the FDA’s MedWatch program.&quot;<br>
  13. 13. To be continued.<br>