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Is taking generic drugs riskier than taking brand-name equivalents?

People who take prescription drugs in Jefferson County, Texas, generally expect that they can obtain complete and accurate information either from their doctors or from the warning label on the prescription. However, recent events indicate that generic pharmaceutical drug manufacturers may put people at risk with inaccurate labeling practices, and that victims of flawed generic drugs may have more difficulty seeking compensation.

Study questions generic label accuracy

Research has suggested that labels on generic drugs are often different than those found on their brand-name counterparts. A Regenstrief Institute study, led by an assistant professor at the Indiana University School of Medicine, compared more than 9,000 product labels for generic or name-brand drugs. The study reviewed 1,040 drugs that appeared with different manufacturer labels.

As described in an Indiana University article over the study, a significant 68 percent of the drugs showed different safety information on the label, although these differences often were minor. Alarmingly, though, 9 percent of the prescription drugs with labeling differences had at least 10 side effects that didn't match up. Some of these generic drug labels had information that was:

  • Incomplete or omitted
  • Outdated
  • Incorrect
  • Pertaining to the wrong drug

Even omitting information on prescription drug labels can be dangerous since, as the article points out, physicians often use this information when prescribing a drug or deciding what other drugs a patient can safely take. Incomplete safety information can lead to overlooked contraindications and have devastating or even fatal consequences.

Safety labels also may not reflect that a generic drug taken on its own has side effects or risks. This issue was recently highlighted by a Supreme Court decision in a case where a victim suffered terrible injuries after taking a generic drug. According to the New York Times, the Supreme Court reversed a state decision to award compensation and held that generic manufacturers cannot be held liable for failing to create a safer product.

Court ruling removes liability

This decision builds off of a 2011 ruling regarding the liability of generic drug makers. Then, the Supreme Court ruled that generic drug manufacturers cannot be held liable for failing to warn consumers about safety risks associated with a drug if the generic label contains the same information as the brand-name one. This is because federal law requires generic drugs to match the label of brand-name drugs.

By similar logic, the recent ruling holds that, since generic manufacturers can only produce a drug that is chemically the same as the brand-name drug, they cannot be accountable for damages that the drug causes. This limits recourse for consumers harmed by generic prescriptions.

Brand-name prescription drug manufacturers are still responsible for conducting safety tests and providing appropriate labeling, however, so victims of flawed brand-name drugs still have recourse. If you or a loved one has been harmed using a defective prescription drug, you should speak with an attorney about seeking compensation.