The FDA has just banned the importation of pharmaceutical ingredients from the largest drug company in India, but it is not the first time. Four of Ranbaxy’s five manufacturing facilities once made drugs or active ingredients for the US market. (The fifth plant manufactures drugs for other markets.) When the FDA uncovered forgery, fraud and a failure of good manufacturing processes, it censured three of those plants. Now the remaining Ranbaxy facility with US-oriented manufacturing is no longer permitted to send products to the US until corrective steps are complete.
An FDA spokeswoman said, “We are taking swift action to prevent substandard quality products from reaching U.S. consumers.” An inspection had found that quality control data had been fudged. Tests were repeated until the desired results were obtained and nonconforming data was apparently discarded.
FDA inspectors noted the laboratory was in “significant disrepair.” Windows could not be closed and flies were “too numerous to count.” A refrigerator used to store samples was full of water from melting ice that was dripping on the floor.
Ranbaxy has been in trouble with the FDA since 2008. Last spring the manufacturer pleaded guilty to felony charges involving adulterated drugs and paid the largest generic drug safety settlement in history, $500 million in fines and civil claims.
What Does This Mean?
For more than a decade, readers of our newspaper column have been complaining about lapses in generic drug quality. At first we thought these were rare instances, but as more reports arrived we started investigating the FDA’s oversight of generics. What we discovered was that the agency seemed more focused on approving generic drugs than inspecting foreign plants.
Ranbaxy was on our radarscope long before the latest debacle. Here are just a few of the messages we received:
“The Ranbaxy generic for Diflucan [fluconazole] from India did not work for me.” T.T., June 21, 2007
“Generic brands have differences between them too! I was stable on fluoxetine from one company. Then out of the blue the pharmacy changed my fluoxetine to “RANBAXY” brand FLUOXETINE for about 6 months.
“I fell into a deep depression and felt suicidal and had no idea why. My psychiatrist discharged me from her care, saying that she couldn’t help me.
“For some unknown reason my pharmacy switched me back to my previous brand of fluoxetine. In a few days I felt better. Then it all clicked. I could have committed suicide, and it would have been due to the fact that PHARMACEUTICALS NEED TO BE BETTER REGULATED.” S.T., April 13, 2008
“I have been on Tenormin [atenolol] for 28 years. Within this time I have used generics, and they are not all the same. I reacted adversely to the Rugby brand with pounding temples and heartbeat.
“I recently was switched to Ranbaxy without being told. My heart was beating too hard, and my blood pressure was wacky, as though one pill worked and one did not. I called my pharmacist and got one day of true Tenormin until he could get the Sandoz atenolol I had been taking. Now that I am now back on it, I feel normal. I wrote Ranbaxy a note to let them know that I do not think they have the correct formulation.” Cheri, May 8, 2008
“CVS recently substituted a generic acyclovir by RANBAXY. It is useless.” D.L.E., May 9, 2008
“I have been on Minocin antibiotic therapy for rheumatoid arthritis for five years now, and am 90 percent better. At one time I was switched to the Ranbaxy generic. I got worse so we went back to the brand name.” Rose, August 4, 2008
“My atenolol blood pressure prescription was refilled and it didn’t work. I’ve been on it for 20 years with no problems.
“The new one is manufactured by Ranbaxy and my old bottle was Sandoz. I asked the pharmacy to switch it out but they wouldn’t. I went to another pharmacy today and got the Sandoz and within a few hours, my pressure was back to 121/82 (it wouldn’t go below 144/111 with the Ranbaxy brand and got as high as 160/114).
“When I told my doc, she said I’m the third patient that told her about this same problem with exactly the same drug. She advised me to stay away from the Ranbaxy version.” J.Q., January 23, 2009
Ranbaxy isn’t the only company that has come under scrutiny. Other pharmaceutical firms have also gotten into trouble. Two manufacturers of long-acting generic bupropion, used to substitute for the brand name Wellbutrin XL 300, were selling products that were not bioequivalent. The heart medicine digoxin produced by the generic manufacturer Actavis had to be recalled because of dangerous dosing problems. Sandoz had to recall its blood pressure pill, metoprol, because of “deficiencies in documentation and in-process controls.”
Although we have been reporting generic drug problems to the Food and Drug Administration for many years, they usually reassure us that there is nothing to worry about. Right around the time we were receiving the first complaints from consumers about Ranbaxy products in 2007, Ranbaxy employee Dinesh Thakur was filing a whistleblower complaint with the FDA. He was concerned that data were being adjusted to make the company’s drugs look better than they really were. Without being alerted by this whistleblower, the FDA would probably not have discovered the widespread problems at Ranbaxy.
Will The Ranbaxy Import Ban Cause You Trouble?
The FDA has blocked import of active pharmaceutical ingredients from Ranbaxy plants that go into making the following drugs:
- Atorvastatin tablets
- Lorazepam tablets
- Doxycycline monohydrate capsules
- Donepezil tablets
- Clorazepate tablets
- Midozolam liquid
We asked the FDA whether Ranbaxy products still on pharmacy shelves should be recalled and whether patients should return their generic drugs to pharmacies. A representative told us that they were unaware of any reports of problems from patients. So far the agency is not requiring the removal of any current Ranbaxy products and it specifically states:
“The FDA recommends that patients not disrupt their drug therapy because this could jeopardize their health. Patients who are concerned about their medications should talk with their health care professional before discontinuing treatment.”
The company told us, “Ranbaxy strongly believes that the product on the market does not pose any health risk to patients.”
An unspoken complication of the Ranbaxy ban could be serious shortages of some of the medications listed above. There are already so many other drug shortages that hospital pharmacies often have to scramble to make substitutions.
If the FDA is so concerned about quality control that it has banned these popular Ranbaxy products from the U.S. market, why isn’t it taking them off pharmacy shelves?
What do you think? Does this latest generic drug scandal make you wonder about the quality of the pills you are swallowing? Do you trust the FDA to monitor generic drug quality? Share your own story below in the comment section.