Caraco, a division of the huge Indian drug company Sun Pharmaceutical Industries, Ltd, has had to recall 41,127 bottles of the antidepressant venlafaxine (Effexor XR). According to our calculations, that equals 2,109,630 pills that must be pulled off pharmacy shelves in the U.S.

The question is, will any patients be advised to return their pill bottles to their local pharmacy for a refund and/or substitution? For reasons that we do not understand, that rarely happens. The rules for drug recalls seem different from those for cars or other consumer products. Pharmacists are told to examine their inventory and strip their shelves of Caraco’s venlafaxine (Lot #s JKM2305A, JKL5054A, JKL5054B, JKM2305B) because “the product did not meet the drug release dissolution specifications.” Pharmacists will not be permitted to dispense these pills, but patients will not be told whether they have already received pills from the affected lots and will not be encouraged to return them. 

Do you feel as if you have passed through the looking glass into the world of Alice in Wonderland? The FDA has classified this recall as a “Class II” event. This is considered an intermediate threat that could cause “temporary or medically reversible adverse health consequences.” Although there is a serious risk requiring recall of the product in question, there is presumably no immediate danger of death or other serious injury. Does that reassure you? It does not reassure us. If the formulation is flawed enough to be withdrawn from the market, then we think patients should be informed and allowed to substitute a better formulation at no additional cost to them.

The problem is that most pharmacies do not put lot numbers on generic drug bottles. You will have a hard time determining whether your venlafaxine is part of the recall without contacting your pharmacist. Even then you may not get a clear answer because not all pharmacies keep track of the lot numbers they dispense to patients.

This is not the first time that Caraco has issued an “urgent drug recall.” On April 8, 2014, this division of Sun Pharma of India recalled a number of extended release venlafaxine pills because they too “did not meet the drug release specifications.” Over 250,000 bottles of venlafaxine and 128,000 bottles of the antihistamine cetirizine (Zyrtec) were pulled because of dissolution issues.

Sun Pharmaceutical Industries is the largest drug manufacturer in India. The company is acquiring Ranbaxy, another huge Indian generic drug company that has had its own manufacturing problems. Ranbaxy had to recall millions of generic atorvastatin (Lipitor) pills a couple of years ago. The FDA went so far as to ban all Ranbaxy products produced in four of its major manufacturing plants in India because of serious regulatory violations. Some of the products affected included lorazepam, doxycycline, donepezil, clorazepate and midazolam to name just a few. For a more comprehensive list of Ranbaxy products that were manufactured at its Indian plants that were banned from exporting to the U.S., here is a link.

Two other large Indian drug companies have also had manufacturing problems of late. Dr. Reddy’s Laboratories had to recall 13,000 bottles of the beta blocker heart drug metoprolol (Toprol XL) and Wockhardt removed more than 100,000 bottles of its generic metoprolol. Both formulations had dissolution problems.

The FDA continues to insist that all is fine in generic drug land. Insurance companies often require that patients purchase low cost products, largely because of FDA assurances. When people complain that there are problems with their generic pills, they are often dismissed.

The approval of generic drugs by the FDA is an opaque process at best. The agency rarely if ever releases bioequivalence data. The mantra goes something like this: trust us, we’re the FDA and we know what we are doing. You do not have to see the data upon which we base our generic drug approvals. Physicians, pharmacists, drug chain buyers and patients have accepted this without question. Many health professionals also assume that the FDA actually tests imported drugs for quality. Wrong! The agency has relied primarily on the honor system, trusting foreign manufacturers to do the right thing. That has proven to be a bad decision, based on the number of recalls we have seen in recent years.

What is the impact on patients? Here are just a few stories we have received:

“Yes- the generics from one pharmacy can absolutely differ!

“The pharmacies I have dealt with have one or two different generics for a particular drug that are dictated by the parent company and stocked by that chain’s warehouse. Another pharmacy may or may not have the same generic. That is the problem I ran into when my neighborhood chain pharmacy was bought by another chain. The warehouse that supplied them also changed, and I received a prescription for venlafaxine (Effexor) that plunged me back into depression. The new generic was manufactured by an Indian company that has had some of its generics banned by the FDA due to underdosing.

“I inquired as to what generic I had received previously (and that had worked fine), and found it at another pharmacy, to which I transferred my prescription. I had to fight the insurance company for three months, however, since I had a 90-day supply of the inferior drug on hand that I could not use. You need to find out the manufacturer of generics that work for you (usually the name of the company or an abbreviation will be on the bottle) and make sure you receive it next time. Good luck!” M.N.D.


“I started taking the branded antidepressant Effexor-XR 75mg about 10 years ago.  I was switched to the generic venlafaxine when it came out a few years ago. Last month the pharmacy changed manufacturers of the generic formulation and the pharmacist and my doctor said their was no difference. However after two weeks all the symptoms and problems such as worry and panic attacks that I had years ago came back and I decided to get a second opinion from a locally owned pharmacy.  They said that all generics are not the same. The pharmacist told me they only distribute venlafaxine that is manufactured by Greenstone which are red capsules and not yellow.

“Now after taking these for two weeks I am finally getting my life back and would not wish my experience on any one. I had to miss a few days of work because I literally couldn’t get out of bed I was so down and out. If anyone has had a similar experience I sure would like to know.” Larry


“Walgreens recently changed my Teva-generic Effexor XR 150mg (venlafaxine) to Aurobindo. I have been taking it for 5 days and am experiencing withdrawal symptoms. I am going to call Walgreens on Monday to notify them and will also submit the FDA reporting form. The FDA needs to do a thorough investigation of this company’s products!” S.T.


“I have been on venlafaxine for a couple years now for depression.  It has been a great med for me.  That is until my local pharmacy changed manufacturers of the 150mg XR, of which I take 2 a day.  I worked in said pharmacy when the warehouse switched mfgs.  I was VERY leery of changing mfgs, because of something that happened in the past with a different drug; same situation.

“My co-worker poo poohed me, saying it’s the same drug.  So, I got a 30 day supply, with a higher co-pay than the 90 day supply.  I wanted to see if it would be any different.  I was changed from the Teva generic of venlafaxine to a formulation made by Aurobindo.  The first month was ok.  I had a few ‘swimmy’ feelings, but over all, was ok.  I thought that feeling might be my blood pressure getting too high.  Then I had a 90 day prescription filled.

“After about 45 more days on the same dosage I’d been on for about 2 years, I began to have way more ‘swimmy’ feelings and dizziness.  I took my meds at the same time every day, like clockwork.  I went through this hell every day. It caused me problems at work and in my personal life.  I was not the same person.  As I said to a coworker, ‘I just don’t feel like me.’  I asked if we could order the Teva brand, and was told no, it wasn’t the manufacturer; there must be something else wrong.

“Well, last Tuesday I went to the doctor.  She asked me about symptoms, took my BP, checked my blood sugar, etc.  She said it sounded like withdrawal symptoms.  I tried taking one in the am and one at noon, but that just made the symptoms worse.  I feel that this is a manufacturing problem, where the medicine doesn’t release like it should.

“I am no longer working in that pharmacy, but still have to get my drugs from there.  Dammit anyway!  So, now that I’m not an employee, I’m going to put my foot down that they order the Teva generic.  I’m tired of feeling this way!  I tried so many different things before I got to this one, and this one works for me.  I’m feeling terrible, like I did before I started taking the venlafaxine.

“Maybe the manufacturer of generic drugs DOES make a difference….even though they say it doesn’t.” Stacey


What fascinates us regarding different generic formulations is that one person may find that a particular manufacturer’s product works well, while another person finds it causes problems. This suggests at least two possibilities. People vary in their response or generic manufacturers produce products that vary substantially one from another. Here are a few more examples of just such reports:

“In 2013, while traveling, I ran out of Effexor XR 75 mg. I received a generic refill by Teva at a Walgreens. Within 2 days I went into what I think was Effexor withdrawal — many side effects, including fuzzy vision. I switched back to Effexor XR in another city, which worked, but it took weeks before I was back to normal.

“When a generic releases most of the active ingredient at once instead of slowly over the 24- hour period, it is dangerous. FDA should decide these generics are NOT equivalent to extended release brand name meds. Thank goodness I was not driving when my body got messed up.” B.D.


“Some years ago I was prescribed Effexor XL 75 mg. daily for anxiety and mild depression, and took the brand name drug with good results. Two years ago, I again was prescribed Effexor and had good results, even though this prescription was for the generic drug. In March, I refilled my prescription and within two or three weeks, felt very depressed, anxious, and teary. I checked with the drugstore that had filled my prescription (as well as all my past prescriptions). I found out that their supplier had changed since the drugstore chain was bought by another well-known drugstore chain. Many of their generics were now made by different manufacturers. This had caused them to switch me from the generic Effexor made by Aurobindo to one made by Zydus.

“I also found out that some drugs made by Zydus have been banned in the U.S. due to possible underdosing. I got a new prescription, fought with the insurance company for refilling my prescription too early, and switched pharmacies to one that could give me Aurobindo’s generic. Now I am back on an even keel. My husband and I have since switched all our generic prescriptions from the original pharmacy, after finding more instances of their new supplier having generics from companies, some in India, with complaints about their quality.” M.D.


I have been on Effexor XR for 12 years and have been as good as I can get. I am a veteran and have always been able to get Wyeth Effexor…until a move and a new pharmacist. She insists that the generic is the same. I have tried her generic and within 3 days I was so dizzy I couldn’t stand up.

“Luckily I had tried her generic before being totally out of the brand name Effexor XR. I had my wife give me the brand name and I was fine by morning. I have only a few days left of the non generic. Don’t know what I am going to do. Anybody have any suggestions?

“I contacted Pfizer, the parent company of Wyeth. I asked them about the release system. Because the generic time release does not seem to be timed release it just dumps the drug all at once. Wyeth said the only generic they could guarantee that has the same time release as the original is their authorized generic; sold by Greenstone. If somebody has had experience with Greenstone I would like to hear about it.” L.A.


 

What has been your reaction to the generic antidepressant venlafaxine? What about other generic drugs? We would like to hear both positive as well as negative stories. Perhaps others can benefit from your experience.

 

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  1. LES
    Reply

    My husband gets very sick on Teva generic effexor. Vomits, migraines, can’t function. This product is made in India. The Zy-generics, or Zydus, works well. It is made in Pennsylvania, I believe. He feels best on the brand-name, non-generics, however.

  2. pp
    Reply

    It’s not the FDA we need to petition, it’s Congress. The House Commerce committee is the one to try to get to. WE need to petition them to have hearings on this, and why the FDA is the patsy of Big Pharma. It’s gong to cost money, but this needs to gotten right, and in the end will save money, not to mention lives!

  3. fkb
    Reply

    I have been on Effexor XR for over 10 years and it worked beautifully for chronic and sometimes severe depression. When the generic came out my insurance company switched me to this drug and at first I experienced no difference in how I felt, which was OK.
    I recently refilled my prescription and have noticed that I am crying more easily, over nothing specific, I am depressed and have no desire to interact with people… all the symptoms I had before I was on medication.
    I saw your Alert yesterday and now realize it’s not me, but my medication causing this regression. Printed out the article and will be having a discussion with my pharmacist tomorrow.
    Thank you for this most important information.

  4. Marie
    Reply

    I have never taken antidepressants, but I am interested because so many people are on them and all over the world. I live in Scandinavia.
    I think doctors, nurses etc. neither know enough about the medications nor about withdrawing from them safely.
    I would like to recommend “Psychiatric Drug Withdrawal – A guide for Prescribers, Therapists, Patients and Their Families” by Peter R. Breggin (2013). There are also some videos on his site.
    I have also enjoyed Robert Whitakers books “Mad in America” and “The Anatomy of an Epidemic”. You will always find something interesting on his site, madinamerica.com.
    I just saw a trailer for a documentary called “Numb”. There were other clips as well and some about withdrawal.
    I just love the Internet!

  5. sbp/
    Reply

    My daughter has informed me of a sight called to CARE2. Anyone can start a petition to have concerns that effect the general public brought to the attention of the Government agency in charge. People on facebook and other sites sign the petition and it is sent to the agency and your Senator and your Congressperson.
    How many lives must be put in danger or loss because all involved only care about profits and the bottom line. I was suicidal when I was given Verapamil instead of my other blood pressure meds. I was not warned that one of the side effects was that this medicine could bring on severe panic attacks which I used to suffer from I hadn’t had an attack in years but two weeks after starting the Verapamil I was a basket case suffering two or three attacks in one day. We don’t know how many people may have died because of these practices.

  6. JFR
    Reply

    Is there any way The People’s Pharmacy readers could sign a petition to the FDA to let them know we are fed up with this? Does the FDA not have enough funds to do a good job? Are there connections between the FDA and Pharmaceutical Companies. I just paid $100 + for 15 pills in order to get the Brand Name, and my insurance does not cover this.

  7. PR
    Reply

    I have taken Effexor XR 37.5 for 13 years. I was put on it when we had a tragedy in our family and the shock brought on depression. I cannot get off of it but am thinking of trying. The generic made me dizzy and “off.”
    BCBS is not happy that I am on the name brand after complaining to my doctor. My doctor was on the drug council in Dallas and has always said that generics do not dissolve in the body the way that the name brand does.

  8. J.L. J.
    Reply

    The generic Venlafaxine my pharmacist uses comes from Apotex, a Canadian pharmaceutical, but with ties to Indian manufacturers. I recently asked my doctor to increase my dose as the old one didn’t seem to be working. It still comes from Apotex. Now I worry it is because of faulty manufacturing practices, not that I needed an increased dose. How can I protect myself?

  9. Margaret
    Reply

    I had a similar experience last year with Atenolol. I had been taking it for ten years and it kept my blood pressure under control. Suddenly it wasn’t working any more, in fact my blood pressure went up after taking it. I told my doctor that I thought they were “fake pills”. She laughed and said “Let’s try something else.” I tried three different medications and none of them helped. Then I read your report on Ranbaxy and Atenolol! I still had the leaflet that came with the Atenolol so I looked at it and sure enough it was made by Ranbaxy. I showed your report to my doctor and she apologised for doubting me. She gave me a new prescription for Atenolol and I took it to CVS.
    Since your report said that the FDA had banned the importation of drugs from Ranbaxy, I assumed that the Atenolol would be from a different company. When I got home, I looked to see who was the manufacturer and saw “Ranbaxy”! I couldn’t believe it. I immediately went back to the store with a copy of your report and told the pharmacist that they were not allowed to dispense drugs from Ranbaxy. She gave me a dirty look and said “They’re fine! We have been dealing with them for years. There’s nothing wrong with them.” So I handed her the copy of your report and she threw it down on the counter and said “I know all about that.” She was very annoyed with me.
    She said she would “try” to get some but it might take several days. I told her to please do that. When I got the new prescription it was just like before – worked like a charm. Now I always check the manufacturer when I get a prescription. But isn’t it sad that we have to do this? Why can’t drugs be made in this country?
    Thank you so much for all the work you do on our behalf.

  10. BFS
    Reply

    Should someone taking this medication decide to stop taking the drug due to this notification, the withdrawal itself is a huge concern. Any number of reactions can occur and those results may be in a range of mild to severe. So not only could someone be stressed from the concern of problematic medication batch, switching to a generic or changing to a new rx, the results of how the mind and body respond to stopping the medication can be life threatening. Withdrawal is a concern of high magnitude that those who prescribe rarely have the knowledge or skills to assist with.
    PEOPLE’S PHARMACY RESPONSE:
    BFS, you make a crucial point. You will find many articles on our website about the terrible withdrawal symptoms associated with drugs like Effexor (venlafaxine). Such antidepressant medications MUST NEVER be stopped suddenly. Gradual withdrawal over many weeks or months is essential to avoid the side effects of stopping suddenly.
    Here are some links to click on for more information:
    http://www.peoplespharmacy.com/2009/09/07/getting-off-antidepressant-can-be-difficult/
    http://www.peoplespharmacy.com/2013/08/14/the-dangerous-downsides-of-antidepressants/
    http://www.peoplespharmacy.com/2013/04/22/antidepressant-withdrawal-feels-like-circles-of-hell/

  11. jk
    Reply

    A couple of years ago my doctor put me on digoxin for Afib. I took it for 3 days and started feeling funny. Couldn’t put my finger on how I felt but I thought the digoxin just had to have a chance to work.
    By the fifth day I got up in the morning and I had a rash and swelling on my left leg. I stopped taking the digoxin right away. About 10:00 am my pharmacist called to say the digoxin had been recalled and to stop taking it. He also called my doctor to tell him. Then the doctors office called to tell me there had been a recall. Of course it was the pharmacist that had called the doctor.
    I went to the doctor that same day and he gave me something….sorry I dont remember what…but by that same evening I had a rash with big welts all over me and my face was swollen. It took almost a month for me to feel better.
    Here is one instance where the pharmacist was on the ball. The recall was that there was a larger dose misslabeled. Needless to say I will never take that again. My Afib is now controlled with another medication.

  12. S.W.
    Reply

    My son and I have had problems with the generic lorazepam made by Ranbaxy. My son would go into withdrawal while taking it!
    I bought mine at a different pharmacy from a different manufacturer and had to share mine with him so he would not go into withdrawal. Then, we read in the news alert on People’s Pharmacy about Ranbaxy’s problems. My pharmacy recently bought their generic lorazepam from the manufacturer Sandoz, and it is the best generic so far. In fact, it is so strong that I have been able to reduce the dose! I informed the pharmacist that this is the best generic lorazepam of all manufacturers I have tried over the years I’ve taken it.

  13. P.Grossmann
    Reply

    Have have similar problems with Prevacid prescription. Have been on it for years with no problems. After I got a generic (don’t know what or what company) I found that it didn’t do the same job and had to take an additional tablet at each dose. Told my doctor about it. Have gone back to purchasing the Prevacid over the counter as I don’t have any faith in the generic.

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