Are Generic Drugs Safe?

Photo (cc) by epSos.de

If you’re going on a new medication, you might worry about things 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 cousin.

But there have been situations when generics weren’t as effective, and even potentially dangerous.

In the video below Money Talks News founder Stacy Johnson spoke with Dr. Tod Cooperman about the safety of generic drugs. Check it out, then read on to find out what you need to know before you fill that script.

Now, let’s look at both sides of the generic drug issue…

Generics are cost-effective

The most appealing thing about generics is they’re cheap, sometimes dirt-cheap. That explains their popularity: Eight out of 10 people in the United States use generics, which the FDA says saved about $158 billion on prescriptions in 2010.

Generics can save up to 80 percent over brand names, something hard to pass up. You can buy a one-month supply of many generic drugs for $4 at Walmart.

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 Dr. Cooperman pointed out in the video and this article on ConsumerLab.com, 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.

The FDA says, however, the difference of blood absorption – used to measure effectiveness – between generics and name brands averages only 3.5 percent.

An example…

While it’s not common, there have been instances when generics don’t work as well as the name brand. One example: a generic equivalent for anti-depressant Wellbutrin XL 300mg, called Budeprion XL 300mg. The problem was an ineffective blood-absorption rate, and the result was unhappy patients. One patient on Budeprion XL 300mg said he became horribly depressed and suicidal, according to this article from ABCNews.

The FDA took this generic off the market late last year, issuing a statement including the following language:

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.

When a problem with a medication occurs, don’t count on it being pulled from the shelf immediately.

Generic Budeprion XL 300mg hit the market in 2006. In 2007, Consumer Lab issued a report saying that the generic version released 34 percent of the active ingredient in the first two hours, while Wellbutrin released 8 percent. In short, “the generic did not act like a once-a-day formula but more like an immediate release formula.”

Despite Consumer Lab turning over their findings to the FDA, it wasn’t until 2009 that an FDA study revealed the XL 300mg version of Budeprion was only approved based on the effectiveness of the XL 150mg version. And it wasn’t until October 2012 that the FDA forced Teva to remove it from the market.

What you should do

Instances like this are rare. But if you’re using a generic drug, stick with one specific brand unless directed otherwise by a doctor. Because 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 need precise blood-absorption rates include blood-thinners, anti-seizure medications, and medications that treat irregular heartbeats. Consumer Reports found generic drugs in these categories performed just as well as brand names. But as the example above demonstrates, there are exceptions to every rule.

How to avoid problems

Keep an eye on sources like the FDA’s 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
  • Ask your doctor for a recommendation before taking a generic time-release medication.
  • Find a pharmacy with a reliable supply of your specific medication. If your pharmacy runs out but has the name brand, call around for a drug store that does have your generic in stock.

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