Effexor to go Generic
Earlier this month, Intellipharmaceutics International inc. announced that the FDA had accepted its application to produce a generic version of antidepressant Effexor. Specifically, this filing targets the extended release (XR) version of the medicine.
At issue is the ANDA (abbreviated new drug application). Since this filing has been accepted, the application now will move to the FDA's more complete review process. There is, of course, no guarantee that the drug will pass this review, but having the ANDA approved is an important first step. Intellipharmaceutics officials stated they will begin efforts to prepare for commercializing the product, and are seeking a distribution partner for the United States.
This comes as sobering news for patients and attorneys involved in lawsuits related to side effects caused by this medication.
Effexor, in its original form, has been linked to birth defects when taken by pregnant women. Studies by Danish doctors found that medications similar to Efffexor could result in a 40 percent greater risk of physical deformities in babies. Risk of heart defects rose by as much as 60 percent in the same study, particularly among women taking the medicine during their first trimester.
Apart from very minor differences, generic medications are chemically identical to their parent drug. This means that any risks posed by the original medicine are highly likely to be carried forward in the generic formulation as well. Since the availability of generic alternatives increases the presence of the drug in the market, the risk of defects rises.
A recent case for a different drug, but a similar generic vs. proprietary situation, ruled that the original manufacturer cannot be held liable for damages caused by generic medicines. This means that manufacturers have no responsibility for a great many of the injuries their formula results in.
