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Are generic drugs always safe?

Generic prescription medications can be less effective than their name-brand counterparts. It's rare, but it happens.

By Stacy Johnson Mar 20, 2013 2:25PM

This post comes from Angela Colley at partner site Money Talks News.

 

Money Talks News logoIf you're taking a new medication, you might worry about issues like cost and side effects. What you shouldn't have to be concerned about is whether a generic is as safe or effective as its name-brand counterpart.

 

But there have been situations where generics weren't as effective, and were even potentially dangerous.

Let's look at both sides of the generic drug issue.

 

Image: Pills (© MedicalRF.com/Corbis)Generics are cost-effective

Generics are appealing because they're cheap. Eight out of 10 people in the U.S. use generics, which the FDA says saved them about $158 billion on prescriptions in 2010.

 

Generics can save you up to 80% over brand names, Consumer Reports says. You can buy a one-month supply of many generic drugs for $4 at Wal-Mart and other pharmacies.

 

Are they safe?

The FDA requires generics to "have the same quality and performance of name-brand drugs." But that's not the same thing as saying they have to be identical.

 

As this article from ConsumerLab.com points out, generics may have the same active ingredient, but not always the same mechanism releasing it from the pill. That can differ from the original product and also vary from generic to generic.

 

While not common, there have been instances when generics don't work as well as the name brand. One example: a generic equivalent for antidepressant Wellbutrin XL 300mg, called Budeprion XL 300mg. 

 

The problem was a different rate of release into the blood, which generated patient complaints about reduced efficacy. One patient on Budeprion XL 300mg said he became horribly depressed and suicidal, ABC News reported in 2007.

 

The manufacturer took Budeprion XL 300mg off the market last year, and the U.S. Food and Drug Administration issued a statement that said, in part: 

The U.S. Food and Drug Administration (FDA) has reviewed new data that indicate Budeprion XL 300 mg (bupropion hydrochloride extended-release tablets), manufactured by Impax Laboratories Inc., and marketed by Teva Pharmaceuticals USA Inc., is not therapeutically equivalent to Wellbutrin XL 300 mg.

What you should do

Instances like this are rare. But if you're using a generic drug, stick with one specific generic brand unless directed otherwise by a doctor. While active ingredients may be identical, the chemicals used to deliver them may not be.  This can make time-release medications more susceptible to error.

 

Drugs that require precise blood-absorption rates include blood thinners, anti-seizure medications, and medications that treat irregular heartbeats. Consumer Reports found that generic drugs in these categories performed just as well as brand names. But as the example above demonstrates, there can be exceptions. 

 

How to avoid problems

Keep an eye on sources like the FDA's Web page listing recalls, market withdrawals and safety alerts. Other tips:

  • Don't switch to another drug company's brand (generic or name) without first consulting your doctor.
  • When switching from a name brand to a generic or vice versa, note any changes you feel and tell your doctor.
  • Find a pharmacy with a reliable supply of your specific medication. 
More on Money Talks News and MSN Money:

 
4Comments
Mar 20, 2013 5:58PM
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The example given in this article was a product that the FDA atypically failed to actually review.  When the FDA tests a generic drug, it must conform to certain standards of equivalence.  The FDA admitted their screw up in this instance: they approved the 300mg version based on the release-time characteristics of the 150mg version.  This particular issue will not happen again.
Mar 20, 2013 5:23PM
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A Ford Falcon is not quivalent to a Ford Shelby.  They both will get you from one point to another.  The Shelby will run faster and may get you more tickets.  The Falcon will get you there, but at a slower, safer speed.  The two are not equivalent, but they essentially do the same job.  The Falcon is a much less expensive vehicle. Should everyone go out and buy a Shelby because it is somewhat "superior" in the minds of some?  I see this article as trying to discredit less expensive drugs to have people spend more money with the legal drug lords.  I am "horribly depressed" at the "ask your doctor" ads.  Should I go out today and buy some Wellbutrin XL300 mg?  SCREW the entire medical establishment, congress and the legal drug lords!!!  They are all crooks!!!!
Mar 20, 2013 5:28PM
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NO drug is safe! They all have side effects!  The purpose of the legal drug lords, the medical establishment, the legal drug lord outlets nd Congress is to get all the money you have!!!  They are not here to make you well! They are a "for profit" business!! If they made us well, they would lose business.  Instead, they cook up junk that will seem to help one ailment but will creae other ailments in the process. Therefore, they can increase their business and the sucking power of their money suction machine.  Unless we open our eyes and begin to speak up, we will be a nation of addicts.  Nobody will be working.  No taxes paid.  Those going to a doctor or hosptilal will go for free. That should cure the problem!!!  I am not a friend of the FDA nor the legal drug dealers!!!!
Mar 21, 2013 2:02PM
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Wonder who put up the money for this BS study ?

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