October 3, 2022

Sertraline is used medically mainly to treat the symptoms of depression and anxiety. It has also been prescribed for the treatment of obsessive-compulsive disorder, post-traumatic stress disorder, premenstrual dysphoric disorder, panic disorder, and bipolar disorder. It was first approved by the FDA in 1991. The patent for this brand-name drug expired in December 2005. It is anticipated that the generic drug will be available in the United States in June of 2006, manufactured by Andrx, Aurobindo, Genpharm, Ivax, Mylan, and Roxane. In Scandinavia a generic drug called Sertralin, manufactured by HEXAL is available. The price differences between Zoloft and Sertralin are as high as 1.50 dollars per pill.

Sertraline can have a number of adverse effects, including insomnia, asthenia, gastrointestinal complaints, tremors, confusion, dizziness, anorgasmia, and decreased libido; it can induce mania or hypomania in around 0.5% of patients. It has also been known to cause minorweight loss. It is contraindicated in individuals taking MAOIs or undergoing electroconvulsive therapy.

Until 2003 Zoloft was only approved for use in adults ages 18 and over; that year it was approved by the FDA for use in treating children ages 6 to 17 with extreme obsessive compulsive disorder. In June, 2004, Britain banned the use of Zoloft by minors and in February, 2005, Pfizer was forced to change the labeling of Zoloft to include information regarding increased incidences of suicidal behavior and depression in adolescent users of the drug.

According to mentalhealth.com, Zoloft is not currently recommended or advised for use in individuals under the age of 18. After these changes, multiple incidences and at least one medical study showed an increased risk of suicide in seniors who were taking Zoloft. In response to these findings, the FDA released a public health warning. This warning indicates that anyone currently using Zoloft for any reason has a greater chance of exhibiting suicidal thoughts or behaviors regardless of age. This warning is questionable, however, due to the types of illnesses Zoloft is used to treat, it is impossible to determine if these tendencies are a side effect of the drug or the illness the drug is meant to treat.

Zoloft and Pregnancy

Zoloft has long been seen as the best option for breastfeeding mothers who wish to continue breastfeeding and be able to take their antidepressants. Despite its apparent safety and effectiveness during the breastfeeding period, recent studies and consumer complaints have seen a need to alter Zoloft’s labeling regarding use during the third trimester of pregnancy.

Though there are no teratogenetic defects associated with Zoloft, there is reason to be concerned about its effects on infants who were exposed to sertraline during the third trimester in utero. It seems that Zoloft use in late pregnancy significantly increases the potential need for hospitalization and breathing assistance in the newborn period and has also been shown to cause an increased risk of neonatal death.

In light of this increased risk it is still being used due to the greater potential risk of a seriously depressed mother to herself and her unborn child. Like all other medications Zoloft’s use must be decided only after carefully weighing out all potential risks and benefits.

As part of the Food and Drug Administration’s (FDA) on-going efforts to increase the available generic drug alternatives for American consumers, the agency today approved the first generic version of Zoloft tablets, sertraline, as well as a liquid concentrate, sertraline hydrochloride, version of the product.

Sertaline is for Depression

Sertraline tablets are indicated for the treatment of major depressive disorder (MDD) in adults and the liquid concentrate is approved for the treatment of MDD and some anxiety related disorders. In 2005, Zoloft was the sixth highest-selling brand-name drug in the United States, with retail sales totaling $2,561,069,000.

“Generic drugs are safe and effective alternatives to brand name prescription products and can provide for significant cost savings for the American public,” said Gary J. Buehler, Director, Office of Generic Drugs. “Our office is committed to increasing the number of approved generic alternatives as quickly as possible.”

The FDA Generic Drug Process

The economic benefits of FDA’s generic drug approval program are significant because generics can cost a fraction of the price of the brand name drugs and generic drugs represent about two-thirds of total prescription doses sold in the United States in 2004, according to IMS data on U.S. retail sales. Competition from generic drugs that are safe and effective alternatives may quickly lead to reductions in spending. The savings would likely increase as more competitors enter the market (See http://www.fda.gov/cder/ogd/generic_competition.htm).

FDA’s Office of Generic Drugs (OGD) continues working expeditiously to review and take action on generic drug applications. For more information on other first generic versions, please see http://www.fda.gov/cder/ogd/approvals/1stgen0506.htm.

For additional information related to FDA’s Office of Generic Drugs, please go to: http://www.fda.gov/cder/consumerinfo/generic_equivalence.htm.

13 thoughts on “FDA approves generic Zoloft drug Sertaline

  1. I am with zolf for 9 months. I feel better sleep
    Afterv 2-3 month of its use I felt some discomfort, retardation in thinking, no interest of doing anything and something extra that i cannot clearly explain.

  2. Our 14 year old son has been taking this for 5 days and we have not had any side effects to speak of. He has depression and some suicidal thoughts. The difference in him has been amazing so far. I know they say that it takes a couple of weeks to get into the system so maybe it is just the thought of something giving him relief that has helped him. We will see. It is wonderful to not walk on egg shells around him waiting for the next negative comment or explosion.

  3. I am a 35 yr old mother of 4 wonderful children. My 13 yr old daughter has recently and i mean just today started taking a low dosage 50 mgs of the generic form of this. Please any help i could get with this. Just to know signs to watch for with her that maybe the meds are messing up. She has not had the sucicidal tendancies but after reading up on this it scares me to think this could come upon her with this medication.

  4. I have been on Zoloft for all but 10 years and it has done wonders for me. I sufer from panic disorder that had alot of phobias attached. Now I am forced to take the generic form and I am scared to death that it will not help the same as Zoloft. I have no choice but to take the generic at this time.

  5. I’ve personally been taking Sertraline for just over four months and I love it. I’ve had no side effects and left over money each month to buy additional groceries and even pay for my gym membership.

  6. Ciao sono Michele e ho 44 anni desidero scrivere la mia esperienza con lo Zoloft. Causa il concatenarsi di varie situazioni sono caduto in depressione grave nel ottobre del 2003. Mi sono rivolto ad uno psicoterapeuta e mi ha prescritto lo Zoloft cp 50mg. Ho iniziato a sentire gli effetti della terapia solo dopo sei mesi e più. Sono stato seguito con interesse e costanza dal terapeuta che mi aveva in cura e posso dire che ora, marzo 2009, mi sento in grado di lasciare la terapia farmacologica e tornare a condurre “una vita normale”. Non è stato facile! Perchè lasciare una terapia dopo quasi 6 anni induce, a mio avviso, una dipendenza perlomeno psicologica anche se non sul piano organico. Gli effeti collaterali sono stati nel mio caso: irritabilità, stachezza fisica e una sensazione di vertigini.
    Non posso dire con certezza che anche questi disturbi siano la conseguenza dell’abbandono della terapia con lo Zoloft, ma presumo che lo siano, visto le indicazioni del psicoterapeuta a cui mi ero rivolto. Di una cosa sono certo, che e non lo avessi assunto come cura oggi probabilmente non sarei qui a scrivere questo commento.

  7. My doctor ordered sertraline today but after reading this site i am afraid that I may be alergic to this med. I have very low tolerance to meds, but I most often run into a allerigic reaction to meds if there are any. What do you think that I should do? Call the doctor? get another medication? forget the whole thing????? Please advice. Thank you
    cherejohn@comcast.net Chere Ferguson.

  8. Been on sertaline for 3 years suffering from Chronic Depression and PTISD have taken the name brand and two generics I found that the colouring agent used in one of the generics gave me tummy upset and I now take 200mg of the other generic with no side effect.

  9. I started taking Sertraline a few months agoand I love it. I have no side effects as of yet and I am in such a better mood. It was a lifesaver.

  10. I am 15 and my mother passed away on may 21st and I became very depressed but sertaline doesnt work, It just gives me suicidal Thoughts. The side effects I am getting at severe blurry vision at sometimes and diaharea. Really, sertaline isnt for kids….any way.

  11. I took Zoloft since 1993 — now insurance requires sertaline. It doesn’t work. I’m becoming seriously depressed. No one believes me when I say the generic drug doesn’t work.

  12. Karen, Zoloft worked great for me also, and then I was FORCED to take Sertaline or pay $150.00 per month even with 2 medical coverages ( my husbands and my own). I am having many side effects that I didn’t have on Zoloft that I will not put up with. How can these pharm. co’s get away with this crap!!??

  13. I have been on Zolft in the past and it is a life saver. I have been perscibed it again and this time a generic was given to me Sertaline. I have been seeing my Gastronologist thinking I am having a colits flare up and it is my Medicine, Severe Diaharea, loss, and stomach cramps. I am going to go on the name brand it is over $100.00 more then my co-pay but I cant go with out it.
    -–

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