Product Information for Generics May be Incorrect and Misleading

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.