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Generic antidepressant pulled from
U.S. shelves after FDA finding

Los Angeles Times, by Melissa Healy

Original Article

Posted By:LittleHoodedMonk, 10/6/2012 12:26:05 PM

The Food and Drug Administration took a highly unusual step this week: It acknowledged that a widely used generic drug -- a copycat of the antidepressant Wellbutrin XL -- was not the equivalent of the original drug produced by GlaxoSmithKline since 2003. (Snip) In recent years, a number of pharmacologists have raised concerns about the FDA's standards for approving a range of generic medications -- concerns that the agency has turned away with the unbending assertion that all generics on the market are "the same as those brand-name drugs in dosage form, safety, strength, route of administration, quality,

Comments:
The article point seems to be that our FDA is not doing ''due diligence'' when allowing some drug company to come in and claim that their drug is exactly what the major pharmaceutical company invented, ran clinical trials, and then massed marked for ''obscene profits.'' We all know that even our own doctors & health care plans turn US consumers to use generics in the case of keeping prices down. Even our pharmacies are geared to sell this cheaper [knock-off] version in an attempt to keep our business, in the larger store it is usually housed [like Wal-Mart].

  

Post Reply  

Reply 1 - Posted by: youngtexan, 10/6/2012 12:47:45 PM     (No. 8914303)

Lets see. The pull the generic ones off the shelves. Forcing us to pay more for name brand, but then the name brand companies gets sued for millions if anything happens to the patients. Then they have to pull theirs off too. Pretty soon, we won't have any meds left to take. We've got way too many laws that we need to get rid of.


Reply 2 - Posted by: earlybird, 10/6/2012 12:52:05 PM     (No. 8914313)

This is an important article. Whether you post a Reply or not you should read it.

A family member is now on generic Lexapro and seems to be doing fine. But any change from the present manufacturer of that generic will be closely watched. All generics of the same drug are not created equal.

Our family has had excellent results with generics from Teva. My husband's generic simvastatin was switched to a company called Lupin, located in Goa. He had side effects which were noticeable. I got the pharmacy and our health insurance to get him on Teva's generic and he is back to doing well.

Generics do not have to exactly match the original formulation as to its active ingredient(s). I remember seeing a percentage of variation that was FDA-acceptable. The inactive ingredients - those ingredients that deliver the active ingredient(s) - are often a problem to some users.

My doctors will not permit anything but the original brand when hormones of any kind are involved because even a tiny variation can be too much in something like thyroid supplementation, for example.

We must be proactive, paying attention to our reactions to various generic meds which are indeed a bargain if they do not cause their own problems.


   

 

  


 
Reply 3 - Posted by: earlybird, 10/6/2012 1:01:00 PM     (No. 8914328)

Although we tend to be cynical about Wikipedia, it often has the most complete and detailed information and the information is footnoted and supported. This is an example of very good information:

http://en.wikipedia.org/wiki/Generic_drug


Reply 4 - Posted by: Susannah, 10/6/2012 1:09:16 PM     (No. 8914352)

Thanks so much for posting this article, OP. I have an elderly relative taking the pulled drug. I shall consult the doctor and the pharmacist.

Many thanks also to the other posters for providing additional info.


Reply 5 - Posted by: Heraclitus, 10/6/2012 1:18:47 PM     (No. 8914379)

Very interesting. Long ago discovered that only brand-name thyroid replacement was effective.

Now, on a number of blood pressure meds, will try to observe efficacy of generics.

Family member with GERD must only use brand-name meds.


Reply 6 - Posted by: philly_patriot, 10/6/2012 1:21:03 PM     (No. 8914385)

This is the reason I, and others pay the extra money for brand vs generic for some medications.


Reply 7 - Posted by: woofwoofwoof, 10/6/2012 1:47:03 PM     (No. 8914424)

The article says but I think should emphasize far more that it did not seem to be a matter of the active ingredient not being right, but that it was not doing the *extended* time-release thing properly.

While that's important, too, it's also fixable, and may be a little more of a quality-control issue than chemical. Anyway I'm always suspicious of time-release pills, something like eating an ice-cream cone might throw off the absorption rate of some drugs.


   

 

  


 
Reply 8 - Posted by: Avogadra, 10/6/2012 1:50:33 PM     (No. 8914430)

The FDA is ruthless when it comes to monitoring brand name drug formulations. The generics are a whole other ballgame.

Generics can have a range of drug per pill/capsule different from that listed on the package. (Usually it will be less than the brand name.) Generics can change the dye color of a pill if they wish. No need for them to test whether the dye might interact with the drug and make it less/more potent than the brand name. (Usually it will be less potent.) Generics can have different types of carrier than the brand name version of the drug. That means they may be absorbed faster or slower than the brand name.

And the variables multiply when more than one generic formulation is available from different places. Pharmacies will buy from the company that gives them the best deal, and this may change from month to month. Buyer beware.


Reply 9 - Posted by: Bucolic Buffalo, 10/6/2012 2:08:49 PM     (No. 8914458)

Why post this stuf from the LA times. it forces me to pay to read the articles from this paper. I refuse to pay to read the la times article posted here. If i wanted a subscription To the LA times would sign up for it witoput going through lucianne.com

Should a reader have comments about the editorial conduct of this site please address the staff through emails given and not in replies. In this case, it is akin to attacking LCom editorial Staff. LCom Staff.


Reply 10 - Posted by: noddy, 10/6/2012 2:18:52 PM     (No. 8914464)

''All generics of the same drug are not created equal.'' You got that right #2. The generic for Synthroid (hypo thyroid) is certainly not the same. The real thing only costs a little more than the generic.


Reply 11 - Posted by: SoCalGal, 10/6/2012 2:33:44 PM     (No. 8914482)

Re #9, I read and post articles from the Los Angeles Times online all the time without signing up for anything. Not sure what you are using to access, but something is wrong on your end, IMHO.


Reply 12 - Posted by: earlybird, 10/6/2012 2:37:04 PM     (No. 8914489)

Re #2, "All generics of the same drug are not created equal", my meaning was that the generics of a specific drug, produced by various manufacturers, are not equal, not the same as each other.

It is pretty well understand that any generic is not an exact copy of the brand drug.

Read the Wikipedia citation linked for clarification. It's worth the time.


   

 



 
Reply 13 - Posted by: Trigger2, 10/7/2012 6:37:50 AM     (No. 8915352)

This sounds more like the FDA is already invoking the Death Bill provision for taking the blue pill or the red pill.



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