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Eye Injections of Avastin Linked to Infections

Posted Sep 05 2011 11:58am
email Eye Injections of Avastin Linked to Infections Commentary: The recent waves of eye infections, endophthalmitis, after eye injections of Avastin to treat the blinding condition of wet macular degeneration , have caused safety concerns of Avastin. Repackaging or compounding the drug seems to be the source of infection.


avasitin1 Eye Injections of Avastin Linked to Infections

The cancer drug Avastin has been used by some doctors to treat macular degeneration, an off-label application.

Avastin comes in a 4 ml vial, which is meant for a cancer patient. It must be divided into numerous tiny doses of 0.05ml and each dose placed in a syringe for injection into the eye. The repackaging of the drug is handled by the compounding pharmacies under sterile conditions. This extra handling increases the risk of bacterial contamination and other problems. The cost of one dose of Avastin for eye injection is for a dose of FDA approved Lucentis.

Avastin has been used as off-label for the eye injections since 2005 and more than 2 millions of injections of Avastin have been performed in the USA alone. The safety profile of Avastin use has been comparable to Lucentis. Furthermore, a clinical trial sponsored by the National Eye Institute found that Avastin and Lucentis were equivalent in preserving or improving vision after one year.

The dilemma for the patients and the doctors is to choose which drug to use. The medical consensus is that Avastin and Lucentis are both equally efficacious and safe. However, the extra step of compounding Avastin for ocular use increases extra risk of infection if compounding is not done appropriately. It should be emphasized that patients with wet macular degeneration need frequent injections, from monthly to quarterly, in order to preserve their vision. Financial burden can be huge on fixed income medicare patients if they have to pay 20% of copay of $2000 every month. In another note, both Lucentis and Avastin are manufactured by the same company, Genetech. The patients are usually given the above information as the risks and benefits of the treatment during their informed consent process. The patients have the final say in which drug they choose.

Some have suggested that the debate of Avastin vs. Lucentis use should be revisited. It is important to note that off-label application of a drug is the norm in medicine. Avastin has been used successfully in other blinding conditions such as Diabetic Macular Edema, Vitreous Hemorrhage, Retinal Vein Occlusions, Neovascular Glaucoma, other Macular diseases (Myopic Degeneration, Ocular Histoplasmosis Syndrome,) more importantly Avastin is being used in premature babies with ROP (Retinopathy of Prematurity.)

The safety concern of Avastin for ocular use lies in the safety of packaging of the drug for ocular use. Compounding pharmacies are currently in the front line for packaging. Should or drug manufacturer take the initiatives of packaging or formulating the drug in a smaller vial of 0.1ml to decrease the risk of contamination.

A cluster of serious eye infections in Miami prompted the FDA to issue an alert to health care professionals around the country. Repackaged injections that go into the eye are the source of the infections.

Miami resident Esperanza Santiestaban has received several injections in her right eye to treat macular degeneration, and says she knew there was something wrong with the last one.

“It was a few hours after the injection. I started seeing little dots, a lot of dots and I lost the vision,” Santiestaban said. Her eye became very red, swollen and painful.

“We are representing six people who suffered similar catastrophic injuries as a result of this senseless and needless contamination,” said her attorney, Gary Alan Friedman.

According to the FDA, the drug Avastin was taken from sterile vials and repackaged into multiple single-use syringes distributed to several eye clinics, a process called compounding.

Investigators traced tainted Avastin injections to one pharmacy in Hollywood, the FDA said.

In at least one lawsuit related to the infections, InfuPharma compounding pharmacy in Hollywood was named. The owner would not comment because of pending litigation.

The cause of the infection is streptococcus, a strain of bacteria found in throats and noses. That strain was found in the eyes of twelve patients and seven unused syringes. All had the same bacteria and the same DNA, according to Dr. Harry Flynn of Bascom Palmer Eye Institute.

“We suspect somehow the moisture droplets from a person contaminated the medication during the compounding process,” he said.

All the infected patients were referred to Bascom Palmer Eye Institute for treatment. Doctors there have had years of experience with Avastin injections and say they have never seen anything like this.

“Given the fact that it occurred in four separate offices to three different ophthalmologists and the medications all arrived you would say it’s probably “ said Dr. Flynn.

Out of twelve patients seen with infections, ten have had serious vision loss and two have each lost an eye. Only two of the patients have had vision restored to what it was before the infection.

Santiestaban says she’s been told there is no chance she will regain her vision. She says she can’t even see a bright light in front of her eye, “And the doctor says if the pain continues, they have to remove the eye.”

Via KSEE24 News: Eye Injections Linked to Infections


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