Drug that could damage kidneys being sold over the counter here
- Jamaica Observer
07/08/2009 - A drug - Phospho-soda - that could cause severe kidney injury, especially in seniors, is still being sold over the counter in Jamaica, six months after its US manufacturer yanked it off American shelves.
The United States Food and Drug Administration (FDA) has frowned on Phospho-soda, an over-the-counter (OTC), bowel-cleansing drug, saying it could have "serious, adverse" effects on users and should be sold by prescription only.
In a December 2008 letter posted on its website, C B Fleet said it was doing a voluntary recall of its products Fleet Phospho-soda and Fleet Phospho-soda EZ Prep in accordance with an FDA recommendation that oral sodium phosphate preparations (OSPs) be prescribed.
"Since Fleet's Phospho-soda products are currently labelled and sold as over-the-counter products, Fleet decided voluntarily to remove them from the market as expeditiously as possible to address the FDA's decision," the drug company said on its website.
In its alert, the FDA said that when used for bowel cleansing, OSPs can lead to acute phosphate nephropathy - a rare but serious form of acute kidney injury associated with deposits of calcium phosphate crystals in the renal tubes, a condition which may cause permanent damage to the kidneys.
As such, it said OSPs used as bowel preparations, usually before medical procedures like colonoscopy, should be administered by prescription only. Those sold as OTC should only be used as laxatives and should carry a boxed warning to inform patients of the risks involved, the agency said.
Sunday Observer checks at several local pharmacies, however, revealed that neither had the Fleet brand been recalled, nor was there any boxed warning on the packaging.
The department of standards and regulation in the Ministry of Health did not respond to our queries up to Sunday Observer press time, but players in the industry said the decision not to recall the drug here was most likely based on the fact that Fleet Phospho-soda is not regulated in Jamaica as an OTC but as a "pharmacy only" drug. In theory, this means it should only be sold under the supervision of a registered pharmacist.
However, when the Sunday Observer checked with several Corporate Area pharmacies last week, this was not the procedure in place. We visited establishments between downtown Kingston and Washington Boulevard and at those where the product was in stock, it was placed on shelves outside the dispensary, along with drugs classified in Jamaica as OTC or "free sale", such as cough syrups, medicated soaps and multivitamins.
Local distributors of Phospho-soda, Facey Commodity Ltd stressed that C B Fleet's recall of the Phospho-soda product, which was directed at wholesalers and retailers, was "not a worldwide recall".
"The reason for that recall was that it was readily available and easily accessible to all and sundry in the States. It was being sold over-the-counter. The difference is that here, according to the registration, it is only sold by pharmacists. It's not registered in the island to be sold outside of the dispensary," a source from within Facey's pharmaceutical department said.
"The correct dispensing that should be taking place is that a person should ask at the dispensary for the product and then the pharmacist will conduct the relevant interview to decide whether the patient needs that drug and will offer advice with respect to the risks involved," said the source, adding that once the Fleet comes out with the new packaging with the boxed warning it will be made available here.
The Pharmacy Council of Jamaica reiterated that "those products are not for free sale. They are to be sold under the supervision of a registered pharmacist".
The council said that under Jamaican law, there were four classifications of drug laws here:
List 1 - free sale, OTC or exempt drugs (available in supermarkets and shops)
List 2 - pharmacy only (can only be sold under the supervision and with the knowledge of a registered pharmacist)
List 3 - all poisons, including narcotics
List 4 - prescription only
Fleet's OSP falls under List 2, pharmacy only.
FDA said it was aware of reports of acute phosphate nephropathy associated with the use of OSPs for bowel cleansing and said person 55 and over were among those most at risk.
"In some cases when used for bowel cleansing, these serious adverse events have occurred in patients without identifiable factors that would put them at risk for developing acute kidney injury," the agency said.
The Sunday Observer was unable to ascertain up to Thursday whether there have been reports of kidney problems arising from the use of OSPs locally but a 75-year-old woman - who asked that her name be withheld because of the sensitivity of the matter - told us that on the advice of her pharmacist, she used the OTC preparation prior to a colonoscopy and had "adverse" effects.
"I took 10 drops in a half glass of water, just like it says on the label, before I went to bed. I woke up about 2:00 am and I was soaking wet. My nightie, the sheet and the mattress were all soaking wet with both sweat and urine," the senior citizen disclosed.
"I was dizzy and staggering when I got up for my son to help me change the bed linen and my clothes," she added. Sweating "a little" at night, she said, was normal but "I've never really experienced anything like that before".
C B Fleet, meanwhile, has asked that consumers not purchase its products for bowel cleansing but to consult with their physician for alternatives.
If you or a loved one have been injured or suffered as a result of using Fleet Phospho-Soda you may be entitled to compensation. Conatact the Fleet Phospho-Soda Lawyers of Ennis & Ennis, P.A. today for a free nationwide case evaluation by filling out the form on this page or calling toll-free: 1-800-856-6405. Our experienced attorneys can answer any questions you may have about Fleet Phospho-Soda Recall, or a pending Fleet Phospho-Soda Lawsuit.
