Generic Drugs: Are They Safe and Effective? Part Two

– Posted in: Medications

Lips with capsule, dark lipstickMore and more of the early psychiatric medications are reaching the end of their 20-year exclusive patents.

That means still-effective drugs like Wellbutrin®, Lamictal® and Paxil® now have generic equivalents. These generics are cheaper, and of course the insurance companies insist that they be prescribed instead of the brand names.

Part One of this two-part series provided information on how generic drugs are certified by the U.S. Food and Drug Administration and how to identify their pill bottles.

This article, Part Two, addresses a number of issues surrounding generics such as effectiveness, side effects, labeling and doctors’ attitudes toward them. The topics covered are:

  • Issues: Are generic and brand name drugs identical?
  • Issues: What about generics’ effectiveness?
  • Issues: What about generics’ side effects?
  • Issues: Generic drug labels don’t have to be updated
  • Issues: Doctors’ attitudes toward generic drugs

Be sure to read Part One of this series!
Part One provides basic information about generics, including how to read the pill bottle:
    • What is a generic drug?
    • How is a generic drug certified by the FDA?
    • How can I tell if my medication is generic?

Issues: Are generic and brand name drugs identical?

Mostly. To be therapeutically equivalent, a generic drug must match the brand name drug’s: {{1}}

  • Chemical properties
  • Rate of spread in the body
  • Extent of absorption
  • Targeting of the same body area

The FDA allows some variance between generics and brand names

The FDA allows some variability between the brand name and generic drugs in the test results – as much as a cumulative 45%, though the effective percentage is smaller. Therefore, certified generic drugs may not be exactly the same as a brand name. This variability has been questioned by some, but the FDA remains confident in their tests.{{2}}

Issues: What about generics’ effectiveness?

Psychiatric generics must be as close as possible to the brand names

Similar effectiveness is important when switching from a brand name drug to a generic and vice versa.

This is critical with psychiatric medications since a person’s drug “cocktail” is often delicately balanced over a long period of time. Some psychiatric drugs can act slowly, so it might be weeks before knowing if the new drug is effective.

There are three effectiveness problems that pop up when using generic drugs:

  • The FDA tests only the generic’s active chemical and its behavior in the body.
  • The FDA tests allow a relatively wide range of variability when measuring a generic’s performance, so no generic will be a perfect match.
  • A generic drug can come from any of a number of manufacturers, each with its own variations from the brand name. The pill you get in this bottle may be from a different manufacturer as the one from your next bottle.

As for changed effectiveness, scientists and doctors cannot tell you why many (or most) psychiatric drugs work, only that they do work with some people.

Even though a generic drug has tested as being therapeutically equivalent to a brand name drug, that doesn’t mean that a particular individual may not find the drug ineffective or requiring a different dosage.

Always note a generic drug’s manufacturer on the bottle (see Part One). If you are having an effectiveness problem, a changed drug manufacturer could be the source.

Issues: What about generics’ side effects?

The FDA does not test the color dyes or filler material of generics

Many people find that they experience new or heightened side effects when a generic drug is substituted for the brand name. These are often related to the way a generic drug is manufactured and packaged.

The FDA tests only a drug’s active chemical, and not any other part of the generic medication’s coloring dyes and filler that make up a pill. They assume that a generic drug will have the same side effects and safety profile as a brand name drug if it passes all its chemical tests.{{3}}

Some people report allergic reactions to dyes used for coloring the generic drug or to filler materials in the pill. If you are having problems with side effects, talk with your doctor. It could be that switching to a different generic manufacturer will reduce side effects. Some insurance companies allow a doctor to prescribe a brand name medication if the patient has problems with a generic drug.

Issues: Generic drug labels don’t have to be updated

Generics must have the same label information as the original brand name

The FDA mandates that a generic drug have the same label information as the brand name’s label at the time it was first approved. If a brand name manufacturer subsequently updates its label to reflect new findings (for example, side effects or drug interactions), the generic manufacturer is under no obligation to use the new label according to FDA regulations.

The U.S. Supreme Court decided the Pliva, Inc. v. Mensing case in 2011. A generic form of a brand name drug was administered to a person, resulting in bad side effects not listed on the label. The brand name drug’s label had been updated to show the side effect, but not the generic drug.

The Supreme Court ruled that a generic manufacturer can’t necessarily be held liable for a safety change in the brand name drug’s label. Rather, the generic manufacturer is bound to maintain the label of the brand name drug according to the FDA guidelines.{{4}}

A discussion of what to do about the labeling of generic drugs is beyond the scope of this article. Suffice it to say, you should know the manufacturer of every generic drug you are administered and look up the warning labels of both the generic and the brand name drugs to make sure they are the same. See Part One for how to read the label on a pill bottle.{{5}}

Issues: Doctors’ attitudes toward generic drugs

Over 25% of doctors won’t use generics for themselves or their families

Almost 50% of doctors surveyed in a recent study expressed concerns about the quality of generic drugs. Over 23% believed they were not as effective as brand name drugs, and more than 25% would not use generic drugs for themselves or for their families.{{6}}

Physicians are on the front lines, and hear first-hand patients’ complaints about generic drugs. But who do they report these problems to?

Generic drug manufacturers do not accept anecdotal complaints and do not do any testing other than that required by the FDA, since they cannot change the drug’s labeling anyway.

Complaints must go to the original brand name’s manufacturer, and for many older drugs the original manufacturer may no longer be making it. And remember, generic drug manufacturers are only required to have the same label information as the brand name at the time of initial testing and certification.

Again, this is a subject that is beyond the intent of this article. The best course of action is to:

  • Use a well-informed doctor
  • Research the drugs you are taking thoroughly
  • Don’t be shy about expressing your concerns to your doctor

What do you think?

I’ve had a number of problems with generic drugs, both with effectiveness and side effects.

For example, my doctor and I did battle for a year with my insurance company. I needed a brand name medication because I had tried several other generic drugs with zero to awful results (like rashes, swelling and increased depressive episodes). The company dodged with “you’re too old,” “try one of the others again,” and then saying the drug couldn’t be prescribed by a psychiatrist at all. We finally won, but it was a long, frustrating fight.

I’ve come to regard a new generic as I would an entirely new drug rather than a brand name’s functional equivalent. It may do everything the same, but it’s just as likely that it will require dosage adjustments or have side effects severe enough to stop taking it.

I’ve only scratched the surface on the subject of generic drugs. Let me know if you would like more articles about them.

Be sure to read Part One of this series!
Part One provides basic information about generics, including how to read the pill bottle:
    • What is a generic drug?
    • How is a generic drug certified by the FDA?
    • How can I tell if my medication is generic?

As always, your comments are welcome! If you have enjoyed this post, please consider subscribing to this blog, either via RSS or email at the top of your screen. It’s free! You can also follow me on Twitter from the same place. I would also appreciate your sharing this post using your favorite social media, such as StumbleUpon or Digg. Just click the little green “ShareThis” button at the bottom of this post.

PLEASE NOTE: The contents of this article are provided for informational purposes only. The author is not a trained or licensed medical professional and has based the article on authoritative information from outside sources as given in the footnotes. This article is not intended as a substitute for advice from a trained and licensed medical professional.

[[1]]Author unknown. Nomenclature (as excerpted from the Orange Book): Therapeutic Equivalence-Related Terms. FDA website: http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4137B1_07_Nomenclature.htm. Accessed 4/28/12. Accessed 4/28/12. [[1]]
[[2]]]Lowers, Jane; Howland, Robert H. Generic vs Branded Psychiatric Medications: Is There a Difference? Medscape website: http://www.medscape.com/viewarticle/762343. Section 3. [[2]]
[[3]]Pharmacother, Ann et al. Physician perceptions about generic drugs. 2011. Medline Medscape abstract. http://www.medscape.com/medline/abstract/21205953. [[3]]
[[4]]Lowers, Jane; Howland, Robert H. op cit. Section 4. [[4]]
[[5]] Medline Plus, an agency of the National Institutes of Health, has a searchable database of drug information, both for brand names and generics. It is very reliable and updated regularly. http://www.nlm.nih.gov/medlineplus/druginformation.html. Accessed 4/28/12.[[5]]
[[6]]Lowers, Jane; Howland, Robert H. op cit. Section 3. [[6]]

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4 Comments… add one
paul August 24, 2012, 8:43 am

According to my opinion, generic drugs are better option. It is true that these are less effective and results take time but these are beneficial for body if anyone can wait for results. [Ed: link removed]

Jennifer Johnson
Twitter:
December 16, 2012, 4:22 pm

My sister and her husband were overseas and told by doctors that generic drugs were useless in most cases.

I was amazed actually, as I always believed them to be the same just different packaging. I guess I should have realized they weren’t.

Thankfully I prefer natural solutions wherever possible although I know medications are certainly required by many.

redroadrecovery July 19, 2017, 1:58 am

Hi

According to me drugs are not bad for our life but yes if you consume overdose then it can be bad.

Like generic drugs are good for health. In many health cases doctors suggest their patients to take these drugs.

redroadrecovery
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