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Changes To Generic Drug Labels Proposed


An easy step by the FDA could make taking generic drugs safer. Now, you might not know all the generic's side effects.

Allison Zieve, director of litigation with watchdog group Public Citizen, said that is because of old Food and Drug Administration (FDA) rules and a 2011 Supreme Court ruling.

"If the labeling on a generic drug has failed to advise you of a safety risk, the Supreme Court has held you cannot sue the manufacturer - unlike a brand-name company," Zieve said.

The FDA is proposing a change that would allow generic drug makers to add some newly discovered risks or side effects, without going through a government approval process, she explained.

"The FDA rule is really very important and is overdue recognition that generic manufacturers need to be able to take responsibility for labeling,” said Zieve.

The original rules were written years ago, when generics were less popular, she said, adding that now more than eight out of 10 prescriptions are generic. Zieve advised if you have concerns about the safety or side-effects of a drug, you should talk to your doctor.

Often, generic drugs are much less expensive than name-brand drugs, which accounts for their popularity. And in many cases, people do not even know their prescription is generic - the decision is made between a doctor and a pharmacist.

Zieve said people should not feel that generic drugs are less safe than brand-name drugs, but it is wise to get the latest information about risks and side effects.

"The number of drugs that this has affected over the years is probably not huge. The number of patients who have suffered because of the lack of adequate warning is much bigger,” added Zieve.

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