Are generic drugs really the same as name brands?


HOUSTON – Generic drugs are cheaper, but a Local 2 investigation is revealing why some doctors and researchers say certain generics do not always work the same as name brand medicines.

They say that's why particular generic drugs are making some patients sick.

"It's frustrating," said Jillian Holden, a patient suffering from epilepsy in Houston. "Since all this generic stuff happened, it's just not the same."

Doctor visits were a thing of the past for Holden, but that was before what she angrily calls the "switch."

"I thought generic drugs were the same, that's how they're conveyed," Holden said.

For years, Holden's epileptic seizures were under control. However, when her insurance company stopped paying for name brand anti-seizure drugs, she was forced to take a generic version of the medicine instead. Soon after she switched, Holden said she began twitching, developed a rash, and had new seizures requiring several trips to the emergency room.

"They were potentially life-threatening side effects," said Dr. Reeta Achari, a Houston neurologist and Holden's doctor. "What had gone wrong was that she switched to generics. This young lady who felt great is no longer feeling well because of a change in her medications. Generics are not the same as brand names."

The Food and Drug Administration's website is clear, name brand and generic drugs have the same quality and performance. However, Achari said for certain drugs, she's found that's not always true.

"In areas where you have to be exact in getting the right dosage, generics are nowhere near that," Achari said. "As a physician, I have no idea what my patients are getting."

While generics must have the same active ingredient as name brand drugs, they can vary on how much of the active ingredient is in each pill. FDA rules say generics can have as little as 80 percent of the active ingredient or as much as 125 percent.

The amount of active ingredient can change every time you get a generic refill because each refill could be made by a different generic drug manufacturer. Patients usually have no idea there is a difference.

"I think it is a big deal. I think it's a bigger deal than people realize," Achari said. "We don't know how to track problems."
"It's a can of worms, they (FDA) don't want to open up," said Dr. Tod Cooperman, president of ConsumerLab.com

After Cooperman heard similar complaints about a generic anti-depressant medicine, ConsumerLab researchers tested the drug and found huge differences in how it works.

"The generic was acting like an immediate release drug, while the brand name was more of a once-a-day medication," Cooperman said in an interview with Local 2 Investigates. "They were really completely different."

The drug was eventually pulled from the market. Cooperman and Achari want more FDA testing on generics. While the FDA said it is aware of patients who may be experiencing problems with generic drugs, the agency says it doesn't have the resources to perform "independent clinical studies" on generic drugs and lacks authorization to force drug makers to do it themselves.

"FDA is aware that there are reports noting that some people may experience an undesired effect when switching from brand name drug to a generic formulation or from one generic drug to another generic drug," said a statement on FDA.gov.

"FDA wants to understand what may cause problems with certain formulations if, in fact, they are linked to specific generic products. FDA is encouraging the generic industry to investigate whether, and under what circumstances, such problems occur. FDA will continue to investigate these reports to ensure that it has all the facts about these treatment failures and will make recommendations to healthcare professionals and the public if the need arises."

Cooperman and Achari said patients who have experienced problems typically take generic versions of thyroid medicines, anti-seizure drugs, anti-depressants or blood thinners.

Holden said she immediately felt better after she started taking the name brand anti-seizure drug again. While she tries to convince her insurance company to pay for the name brand, Achari is giving her samples of the name brand medicine.

Experts said if you take generics, you should ask to know the specific manufacturer of the generic drug you're given at the pharmacy.

If it works well, ask to have that same manufacturer every time. Otherwise, any refill could be a different generic made by a different manufacturer and you wouldn't know.

You can also ask for an "authorized generic" medicine. That means it's the exact same medicine as the brand name, just sold under a generic name.

For more information:

  • http://1.usa.gov/1l3J7k5
  • http://bit.ly/1ly4Dfk
  • www.consumerlab.com