Are Generic Drugs as Effective as Name Brands?

• “No”

  

  “Product Information for Generics May be Incorrect and Misleading”

• No Objections Yet

Product Information for Generics May be Incorrect and Misleading

ConsumerLab

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After the FDA took the unusual step, as noted earlier, of issuing a report about  Budeprion XL (a generic version of Wellbutrin XL), ConsumerLab.com discovered that the Budeprion XL package insert (dated 6/2007) is INCORRECT AND MISLEADING.  For example, the Absorption section of the insert states that “Budeprion XL” is not affected by food.  However, the FDA report clearly states that Budeprion XL is affected by food, while Wellbutrin XL is not.  In fact, based on data in the FDA report, maximum blood levels of drug average 20% higher when Budeprion XL is taken with food than when it is not taken with food.  It is easy to see this as a problem for a person who sometimes takes the drug with food and somes does not and has no idea that this matters.  The Budeprion XL insert also claims that the maximum blood level of drug is reached at “about 5 hours” while the FDA notes it to be “2 to 3 hours.”

APPARENTLY, SOME INFORMATION IN THE BUDEPRION XL PACKAGE INSERT IS BASED ON DATA FOR WELLBUTRIN XL, NOT BUDEPRION XL. ConsumerLab.com has reported this error to the FDA and has asked that it be corrected.

It is difficult to know how common such errors are with generic drugs because the FDA typically does not release their bioequivalency data, making independent investigation of most generics impossible.

Evidence

Link

FDA Review of Equivalence of Bupropion XL and Wellbutrin XL

Next Argument

"No" ConsumerLab

• Consumers are Reporting Problems When Switched to Generic Drugs
  0
• Generics Are Not Tested for Safety and Efficacy
  0
• Generics Drugs are Given Much Leeway in How They Perform
  0
• Binders, Fillers, and Other Chemicals May Be Different
  0
• Delivery Mechanism and Rate of Release May Be Different
  0
• Product Information for Generics May be Incorrect and Misleading
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• There May Be Manufacturing Problems with Some Generics
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"No" Peter Kowey MD

• Therapeutic Margins Are Too Small
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• Low Drug Levels are As Bad As High Levels
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• We Have Enough Variance in Drug Therapeutics—We Don’t Need More
  0

"Yes" Generic Pharmaceuticals Association

• By Law, Generic Medicines Are the Same Medicines as Brands
  0
• Generic Medicines and Brand Medicines Deliver the Same Health Benefits
  0
• Generic Medicines Must Meet Same High Quality Standards as Brands
  0
• Post-Marketing Surveillance Requirements
  0
• Generics Provide Significant Savings to Consumers
  0

"Yes" Consumers Union

• Generics Must Have the Same Active Chemicals
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• The Basics
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• Switching Drugs
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"Yes" Amer Soc of Health System Pharmacists

• Generics are as Effective as Brand-Name Medications
  0
• Individuals May React Differently to Any Drug
  0
• Affordable Medications Bring Good Health to More People
  0

Most Objections

• Generics Must Have the Same Active Chemicals
  0
• Generics Drugs are Given Much Leeway in How They Perform
  0

Do Generic Drugs Work?

• Yes
• No

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