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 If the formulation is flawed enough to be withdrawn from the market, then we think patients should be informed and allowed to substitute a better formulation at no additional cost to them.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.