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I’m sure at some point or another if you have ever had to take a prescription medication, you’ve taken a generic form.  In my home state of WV, it is a law that they have to give you a generic medication unless a brand name drug is specifically requested.

Generic medications have provided many Americans a way to save money using an alternative to brand named medications.  In fact, it has been estimated that by using generic drugs, consumers have saved $8-10 billion per year on their prescription needs.

In order for a generic drug to gain FDA approval it must meet the same standards at its brand-name counterpart.  A generic drug must: have identical active ingredients; be the same strength, dosage forms, and type of administration;  they must possess the same use indications; must have the same rate and extent of absorption as the brand name drug; meet the same expectations for identity, strength, purity, and quality; it must also be labeled the same as the brand name drug. So in essence, one can expect that a generic drug will have the same effects and safety profile as the brand named drug. However, this is not always the case.

When a generic form of Wellbutrin XL 300 mg came onto the market (Budeprion XL 300 mg) some of those who switched from the brand to the generic experienced a side-effect that did not occur when taking Wellbutrin.  The FDA received 85 post-marketing reports between January 1 and June 30, 2007 from patients who had switched to the generic form and experienced an unwanted side-effect.  In 78 cases, there was a loss of effect for the antidepressant after the switch was made.  In a number of cases it was reported that they experienced new onset or worsening of side effects.  Personal accounts of those who had taken the brand name drug, Wellbutrin for months or years left people feeling well and their symptoms of depression were controlled successfully.   However, after switching to the generic form, Budeprion, many patients reported experiencing headaches, irritability, nausea, and insomnia.  Some experienced episodes of becoming aggressive or upset easily, crying, weight gain, or a return of their original depression symptoms and worse, some experienced thoughts of suicide while on the generic form.  Fortunately, more than half of those who decided to switch back to the brand-named Wellbutrin XL 300 reported noted improvement of their depression symptoms and other side effects.

Upon receiving these reports ConsumerLab.com jumped at the chance to test and see if the extended-release (XL) and the sustained-release (SR) versions of Bupropion were actually equivalent to the original Wellbutrin and vice versa.  The analysis concluded that while each produce contained the amount of active ingredient it claimed (bupropion hydrochloride) the rate of release for the ingredient varied, which raised concerns over their equivalency.

In addition, ConsumerLab.com also noticed that the package inserts for the generic form contradicted information that was published by the FDA about it.  While the insert claimed that the generic form had been clinically tested, the FDA had no evidence that it had.  In additon, the insert also states that food didn’t affect the absorption rate, but the FDA acknowledged that there have not been studies done to support this.  The insert states that the absorbption rate was about 5 hours, while the FDA had reported it to be 2-3 hours.
This evidence was reported to the FDA, who issued a statement in April of 2008, that stated that they consider the generic form to be “bioequivalent and therapeutically equivalent with Wellbutrin XL 300mg.”  Eventhough they admitted to small differences in the pharmacokinetic profiles, they stated that they “are not outside estabilished boundaries for equivalence nor are they different from other bupropion products known to be effective.”

In addition, a spokeswoman from the FDA stated that they consider the generic product to be labeled correctly and that the differing statements were actually copied from the original package insert for Wellbutrin XL. She went on to explain the reason for this is that the label of a generic drug must match the drug it copies.

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