Echothiophate iodide shortage leaves
US specialists struggling to find alternative for acute cases
in Fort Lauderdale, Florida
A TEMPORARY shortage in the US of echothiophate iodide which is
used to treat advanced glaucoma has left ophthalmologists scrambling
to find alternative solutions patients who need the drug.
“It’s a great drug, though a limited use drug. But for
months we haven’t been able to get it for our patients,”
said Wayne Bizer DO, an ophthalmologist based in Fort Lauderdale,
Wyeth Pharmaceuticals stopped manufacturing echothiophate iodide
(phospholine iodide) in the US and is now gearing up a plant in
the UK to produce it. Pharmacists like Jerry Feldman of Jerry’s
Drugs in Sunrise, Florida began stockpiling the drug six months
ago when the shortage began.
“I purchased as much as Wyeth would sell me — about
a dozen bottles — but I’ve run out since then,”
Mr Feldman said.
Echothiophate iodide, which can cause cataracts, is a drug used
in advanced glaucoma as a last resort — often in patients
who have already had cataracts removed. It’s also used for
esotropia in children when surgery will not correct the problem.
A few months ago, when treating a woman with advanced glaucoma,
Dr Bizer was forced to perform surgery because the drug was not
available for use.
“The surgery was successful. But I would have liked to have
avoided it when using an eye drop would take care of the situation,”
he said. Wyeth made the “strategic” decision to pull
the plug on echothiophate iodide after the company examined its
“overall pharmaceutical portfolio”.
But after contacting the American Academy of Ophthalmology (AAO),
the makers of the glaucoma drug rescinded their decision and, according
to AAO public relations representative Michelle Stephens, the AAO
and Wyeth were in talks for about a year about manufacturing it.
But by then, it was already too late. The plant where echothiophate
iodide had been manufactured in upstate New York had already shifted
to manufacturing another product. “So we had to find another
facility where we had the capacity to make the drug,” Wyeth
spokesperson Douglas Petkus said.
They eventually located a facility in Gosport, England. But while
that facility awaits FDA approval, the drug is unavailable except
through an IND process.
To get the drug, an ophthalmologist must complete appropriate forms
including a Statement of Investigator form. The drug is only being
sold directly to ophthalmologists; it is not available through pharmacies.
Mr Petkus said the company has informed ophthalmologists about the
availability of the drug through the IND process. The AAO received
a statement from the company in early January and it is now posted
on the AAO website www.aao.org.
“I didn’t see the statement until recently, while the
shortage has been going on for about a year,” Dr Bizer said.
Mr Petkus estimates that the facility in Gosport will have FDA approval
within the next 30 to 60 days from the time of writing. Then, the
company will begin marketing the drug in the US again.
“It will be available to ophthalmologists without going through
the IND process,” he said.
There is no shortage of the drug in Europe. To obtain an information
pack with directions on how to get echothiophate iodide through
an IND process, US ophthalmologists can call 1 800 666 7248 between
8 a.m. and 8 p.m. EST.
Florida Medical Centre, Fort Lauderdale, Florida, US