Defective antidepressant raises concerns about generic drugs

Posted on Friday, October 12, 2012

  • 12
  • October

With the economy still in recovery and many Texas residents finding ways to cut expenses, the popularity of cheaper, generic brand pharmaceuticals has soared. However, the government recently revealed that it mistakenly approved a generic antidepressant, but later revealed it as a defective drug. This mistake may revive longstanding concerns about the quality of generic drugs in general, in addition to harming those who used the medication.

The generic drug, Budeprion XL, was supposed to be equivalent to the popular antidepressant Wellbutrin XL. Wellbutrin has been prescribed to treat depression, anxiety and the effects of nicotine withdrawal.

In 2008, regulators described the two drugs as being essentially the same. This approval came despite complaints from hundreds of patients who had switched to the generic version of the drug. The patients who switched complained of side effects ranging from headaches to anxiety and insomnia. Later testing of the generic drug revealed that it did not release its key ingredient properly.

Last year, generic drugs comprised 80 percent of the 4 billion prescriptions written in the United States. However, the Food and Drug Administration approval process for generic drugs is much quicker and more streamlined, as generic drug producers are not required to repeat the same studies as the original drug manufacturers did.

While the lack of costly studies makes generic drugs cheaper and more accessible to the public, a concern exists that the streamlined approval process may sacrifice quality. When a patient has suffered illness or even death as the result of being prescribed a defective drug, that person or his or her family may be entitled to seek compensation from the drug's manufacturers.

Drug manufacturers may be held responsible on a number of products liability theories, including that the drug was defectively designed or that the manufacturer failed to adequately warn the patient of possible side effects. Patients injured by defective drugs may be able to recover money for the injuries they have suffered, and can receive compensation for future care that will result from the patient's use of the dangerous drug.

Generic drugs have provided millions of patients with access to treatment that they otherwise may not have been able to afford. However, the fact remains that generic drugs are sometimes approved prematurely and may be dangerous even when their non-generic counterparts are safe.

Source: The Washington Post, "Defective antidepressant may revive longstanding quality concerns surrounding generic drugs," Oct. 4, 2012

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