New Dry-Eye Drug Recalls And Shortages Cause Alarm Among Sufferers

Earlier this year, Here & Now reported on a nationwide shortage of drops and gels that relieve a condition called dry eye. Severe forms of the condition cause such intense pain — compared to being stabbed in the eye with glass — that it's been known to drive sufferers to suicide.

While some drops and ointments are now trickling back onto shelves, the community has been hit by recalls of more than 120 of the more affordable generic brands.

The recalls started with generic brands sold by Walmart, Walgreens and CVS, but now it has spread to some brand-name drugs, says Rebecca Petris (@DryEyeZone), founder of the not-for-profit Dry Eye Foundation. All of the recalls are coming from a single manufacturer: Altaire Pharmaceuticals.

“We're seeing them come out progressively, and we haven't seen the end of it yet,” Petris tells Here & Now’s Robin Young. “We really need the manufacturers whose products are not being recalled to step up and tell us because the confusion out there with this number of product recalls is such that nobody knows what is safe and what is not.”

The recall is due to the “potential for nonsterility,” according to the FDA, although Altaire has been careful to state that there have been no actual failed sterility tests, Petris says.

“However when you've got recalls of this magnitude, obviously there is a problem,” she says. “Even if there hasn't been a reported incident of someone having a problem, they would not be pulling hundreds of thousand products off of the shelves without serious concerns about sterility.”

On when the recalls started being issued 

“This started for me on the Fourth of July. I was actually in the office that morning and I started getting emails from readers who were sending me copies of notices that they were getting from Walmart about products that they had purchased that had been recalled. So I went online and found sure enough on the FDA site there was a notice of a recall of quite a lot of eyedrops and ointments. That was a huge concern to me because Walmart's Equate brand was actually the main replacement for the ointment that we've been missing so much all this time, that had been out of production for a long time.

“But there was a bigger concern to me and that was that I knew this particular manufacturer of the generic is a major supplier of generics to a lot of different stores under a lot of different brand names, and due to the nature of the recall, I imagine that there were gonna be a lot more shoes dropping. And yes that was absolutely the case. We went from 11 products then to, at the last count, we're up to, I believe, 120 that have been announced now.”

On how the shortage of Refresh P.M. created a domino effect 

“The one little bit of good news that I've got right now is that Refresh P.M. is back at least in some small quantities in some stores, and I know that they have more on the way to others. But the broader impact of the shortage of ointments that's been going on for a year and a half is nowhere near over because the absence of that one has had a domino effect on other brands. We've had shortages of ointments and gels for a long time now. So these recalls, which also include dozens of ointments, could not possibly be coming at a worse time.

“Actually, people have been receiving emails from Allergan about Refresh P.M. being back. They're going to stores, and they're saying they're already gone or that they bought every one that was there.”

On the high cost of these drugs

“The brand-name ones like Refresh P.M. can be up there around the $20 and above point. And that's an additional concern for me. With this sweeping series of recalls of the generic brands of all of these eye products, it's that we've got so many folks on say fixed incomes and the elderly in particular that they depend on these generic brands to be able to afford them. But we've got people that go through a tube of ointment in a few days or a week, or a box of drops in a couple of days, and they can't possibly pay brand-name prices for those equivalents. So we're just getting hit from all sides right now in our dry-eye world.”

On the pain that people with dry eye experience

“The Dry Eye Foundation has actually just recently launched a really exciting new project to document the experiences of our community. We started a survey [at] the beginning of July for Dry Eye Awareness Month, but it's going to extend far beyond Dry Eye Awareness Month. It's going to be an ongoing survey. We're taking an extensive inventory of what exactly do people experience from dry eyes so that we can start to package and present this information so others can understand better what dry eye really means. It sounds so trivial, so insignificant, and yet you get people just as you said who are in so much distress.

“There is dry eye — little D, little E — that's just a nuisance, put some drops in already. And then there's dry eye — all caps — and it's a completely different animal. In our survey results so far, we're finding that the people that are reporting the highest levels of distress have not just one feeling, like a feeling of dryness, they've got 15 different feelings. They're having difficulty keeping their lids open. They're experiencing pain — burning, stinging — light sensitivity. It's debilitating and can seriously interfere with people's careers and personal lives, which are other things that we're surveying in great detail.”

On the lack of medical consensus on how to diagnose and treat dry eye

“I think many people don't recognize it for what it is. And one of the reasons for the levels of distress people experience when they've had this for some time is that when they first start experiencing a problem and they do the natural thing — they go see their eye doctor — there's a long cycle before they get the kind of detailed diagnosis and detailed treatment path that they need. Many times it's just a cookie cutter, 'Oh, you have dry eye. Take these drops,' or, 'Here's a prescription drug or have some plugs,' but what they really need is someone to pick apart the puzzle and figure out what's really going on. Because dry eye is just a vague bucket term for a whole lot of things going on in the eye. It is a totally nonspecific diagnosis in my opinion.

“This is ... one of the greatest things that we struggle with. It's that experience of, 'My eyes are bothering me,' and I go into the eye doctor and they say, 'Gosh actually this looks pretty good,' or, 'Well, you look a little dry, so let's do this.' But there's this mismatch between what I'm experiencing and what they're seeing and finding ways to bridge that gap are really super important. It's known in the medical community that these things don't match up that you can experience a lot of pain from what might look not as significant in a medical exam. And yet that pain is real and needs to be addressed and needs to be treated.

“So one of the other things that the Dry Eye Foundation is trying to do right now is to popularize a symptom survey. It's a scientifically validated, little 12-question thing that people can go and in 30 seconds they can just answer a few questions. It will spit out a number and that number represents the severity of their dry eye. So you can just fill out the numbers, print it out, take it into the doctor's office, and when they say, 'Gosh this doesn't look like there's anything going on,' you can say, 'But my number on this [score] is 65. That means I have severe symptoms. Can we talk some more please?' We want to empower people with ways to communicate about what's going on that help them to get to solutions more quickly.”

Karyn Miller-Medzon produced and edited this story for broadcast with Todd Mundt. Samantha Raphelson adapted it for the web.