Tainted Drops

Although it is rare the eye can be a portal for systemic infections to invade. It is a long hard road through the tear ducts and nasal cavity, but it is possible. This is why all eye drops must be sterile. Occasionally a mistake gets made where a patient places ear drops in their eyes which can lead to issues because ear drops are not sterile. Eye drops can be placed in the ear, but ear drops should not be put in the eye. Sometimes this allows for cost saving alternatives when some antibiotic ear drops can be expensive brand names while their ophthalmic equivalent may be an affordable generic. There is no issue using a sterile product in an unsterile environment but flip that situation around and you can get burned.

Recent failures in quality control for Globe Pharma, a large Indian pharmaceutical manufacturer have done just that, and it has resulted in patient harm across the country. Ophthalmic products from the company are distributed by a New Jersey based company Ezricare. Unfortunately, their artificial tears eye drops, a common over the counter product showed contamination with a strain of multi drug resistant Pseudomonas Aeruginosa. This bacterium has been a deadly enemy for some time killing about 2500 in the United States annually. It can be a difficult infection to treat and many of the drugs that once worked against it like Zosyn (Piperacillin & Tazobactam) are now ineffective. This troublesome strain from India has resulted in at least one death and five patients with permanent vision loss.

Some credit is due to the work of the CDC and FDA for tracking down and identifying the culprit quickly as infections in long term care facilities across thirteen states were genetically analyzed to confirm they were the exact same strain of Pseudomonas despite varying clinical presentations of the disease. Then they grabbed some of the suspected Ezricare drops off the shelf and sure enough the same strain was found in the drops. This was enough for the CDC to issue a full recall of the product. Indian investigators have halted Globe’s production of ophthalmic products pending an investigation. There may have already been some suspicion towards the quality because a month prior to the recall the FDA would ban the import of Global Pharma products due to an inadequate response by the company and concerns about their manufacturing process.

The hero riding to the rescue for those patients who contracted this infection is called Fetroja (cefiderocol). Retail cash price for a course of treatment is over two thousand dollars just for the drug. It must be administered IV so there will certainly be some administration costs involved. The high price is justified here though because Fetroja is one of a kind at the moment. Its novel mechanism of action puts it in a class all by itself as a siderophore cephalosporin.

Siderophore may be a new term to many people, essentially, they are small chemicals that bacteria and fungi use to obtain iron. They need iron to survive just like we do, and they obtain it by sending out siderophores which then bind iron creating a complex that travels back into the cell through small porin tunnels. Think of gram-negative bacteria such as pseudomonas like the death star, we need to penetrate the surface to do damage. This is the small thermal exhaust point we are shooting for and Fetroja is designed to sneak in by binding iron and catching a ride inside the cell. Binding the antibiotic to a siderophore compound also provided other benefits like increased stability against beta lactamases making future siderophore antibiotics vital weapons in our fight against drug resistant infections.

Jacob Hyatt Pharm D.
Father of three, Husband, Pharmacist, Realtor, Landlord, Independent Health and Medicine Reporter
www.pharmacoconuts.com

@Hyattjn

Bitcoin GtjoZgxE7WpTkWRE6JiEiXfUpqbWKxH4g

Litecoin ML1N31UVz6sRfo2m2oLaorXgPexUtv3Q3t

Pathways to Weight Loss

Placebo & NOcebo