Article Search

 Life of pain after using lice shampoo
    Wendy Knowler
    October 27 2008 at 08:47AM 		Get IOL on your
mobile at m.iol.co.za

The directions for use which appear in large print on the side of the box of Gambex lice shampoo are not hard to follow. They read: "Wet hair thoroughly with warm water. Apply about 30ml (2 tablespoonfuls) to the affected area and work into a luxuriant lather. Rub vigorously for a few minutes, making sure that all hair areas have been covered by the shampoo and wash off completely. If necessary, repeat treatment in 24 hours."

The active ingredient appears in massive letters: Gamma Benzene Hexachloride".

It's widely known as lindane.

Lice infestation is most common in children aged between four and 11, and arguably the most common place for a parent to put a child, in order use a shampoo to work up a "luxuriant lather" on its head, would be in the bath.
Continues Below ↓





'Why are there no warnings about using it in the bath?'
And so it was that Sharon van Rensburg, a South African now living in Australia, put her 10-year-old son Lachlan in the bath in order to rid him of the lice which had taken up residence in his hair.

She was living in South Africa at the time and on discovering the infestation, visited a chemist, found the shelf with the lice treatment products, and chose Gambex, made by Aspen Pharmacare.

"We used the product once, the lice remained, so we reapplied the shampoo as directed," Van Rensburg says.

"Some weeks or months later there was another outbreak of lice at the school and a note sent home to treat children.

"We went to the local pharmacy and Gambex was recommended, so we used it again."

'Most parents are not aware that Gambex is actually a pesticide'
In all, Lachlan had three lice infestations and each time was treated with Gambex two to three times, at intervals of five to seven days.

He remained in the bath with the shampoo on his head for about 10 minutes before rinsing it off in the bath, and he remained sitting in the bath for some time, as children tend to do.

How Gambex shampoo was used on Lachlan, and how often, is a crucial issue, because the young boy developed a rare adverse effect of lindane use - aplastic anaemia, which essentially means his bone marrow shut down and failed to produce platelets.

Lachlan suddenly started coming out in bruises all over his body.

Blood tests revealed that all his blood counts were low - platelets, haemoglobin and white cells - Lachlan's bone marrow was in the process of shutting down, and a transplant was his only hope.

Luckily his younger brother was a perfect match, and the transplant took place at Sydney Children's Hospital on August 26.

Lachlan went on a course of chemotherapy and immunosuppressive therapy a week before the operation, and is currently visiting the hospital three times a week for immunosuppressive transfusions to prevent a rejection of the transplant, something he'll have to keep doing until early December.

His mother's been told that long-term effects of Lachlan's ordeal include the fact that he will "almost certainly" not be able to have children, as the treatment causes sterility.

"He will always be hypersensitive to the sun and will require extreme vigilance with sun protection for the rest of his life," Van Rensburg says.

Naturally, the first thing Van Rensburg did was have a good hard look at the packaging, and package insert on the Gambex shampoo she'd bought.

Under "side effects and special precautions" in the insert, the following appears: "Aplastic anaemia may occur after prolonged topical exposure (daily application for three weeks)."

"We certainly didn't use the product continuously for three weeks," Van Rensburg says.

She has since discovered that applying the chemical to wet skin increases absorption, as does sitting in water with the chemical in it.

The Gambex package insert does contain the following warning: "Total body application can be dangerous. Gamma Benzene Hexachloride should be used with caution, especially with children," but it's arguably a very vague warning and there's not a single warning on the bottle itself or on the box.

"This shampoo is sold over the counter in South Africa but is banned in 52 countries around the world and severely restricted in 21 others," Van Rensburg says.

"In Australia, US, UK, Singapore, Hong Kong and EU countries you cannot use this product without a prescription and it marked with a warning that the product should only be used once.

"The products in South Africa contain no warnings on the packaging, and in fact recommend repeated treatment if the head lice are not completely cleared.

"The insert notes that one of the possible side effects of using the product daily for three weeks could be aplastic anaemia," Van Rensburg says.

"But the World Health Organisation advises that anyone under 50kg is at risk of hypoplastic or aplastic anaemia and/or other things, from just one 30ml exposure to the shampoo."

Lachlan weighed about 33kg when Gambex was applied to his head and clearly, this is a product bought mainly for use on children, who rarely weigh more than 50kg.

Van Rensburg is naturally appalled that South African consumers don't have the benefit of the restrictions and compulsory warnings on lindane shampoos as those in other countries do.

"Why does the South African health department allow it to be sold over the counter, without any clear warnings on the bottle or box to indicate the seriousness of this toxic chemical?

"Why is it not made available by prescription only? Why is it not sold in single dose form as it is in some parts of the world?

"Why are there no warnings about using it in the bath?"

I tried very hard to get a response from the health department, delaying the appearance of this column for a number of weeks in the hope that one would be forthcoming, but sadly not.

I had better luck with Aspen Pharmacare.

Medical affairs manager Michelle Singleton began by saying that the company "empathises with the child's experience".

She said the company had informed the Medicines Control Council (MCC) about Lachlan's case, as it was legally required to do, having heard about it from "a family representative" and obtained an opinion from his physician.

"We are taking this reported case very seriously to the extent that we have submitted to the MCC a proposal updating the currently approved package insert. We would also like to include a patient information leaflet that will accompany the current packaging to better communicate any medical terms in simple understandable language to our valued customers."

Aspen also plans make more changes, in line with the US's Food and Drug Administration's (FDA) Public Health Advisory Regarding Labelling Changes for Lindane Products, including:

  • More detailed instructions on the proper use of Gambex, especially the amount to apply, how long to leave shampoo on, and the need to avoid retreatment;

  • Information regarding adverse events reported following Gambex use with repeat or prolonged application;

  • Advising that repeat usage is not recommended; and

  • The volume of shampoo necessary for use for treatment.

    But the new warnings could only be included once the company got the go-ahead from the MCC, and when that happened, the outer packaging - also known as the box - would also be changed, she said.

    As for why Gambex is sold over-the-counter in this country, and not on prescription, she said the availability of Gambex and all other pharmaceutical medicines was determined by the MCC, which considers Gambex to be a Schedule 1 (only sold by pharmacies but no prescription necessary) product. "These compounds are extensively used all over the world with few complaints. It is therefore implied that severe complications with topical treatment with lindane is extremely unusual and appears to occur mainly (possibly only) in cases of very incorrect use," Singleton said.

    "Regarding Lachlan, there may be a causal link between the anaemia and the possible use of Gambex."

    "While care is taken to ensure sufficient information for use by the consumer, such information requires continuous updates and improvement which is precisely what we are currently doing for the Gambex Shampoo product."

    I then forwarded this response to Sharon van Rensburg in Australia.

    "I find it strange to read that they empathise with Lachlan," she said, "yet they have made no attempts to contact us at all, as far as I am aware. I do not even know which physician they are referring to."

    She welcomed the news of the proposed changes to the packaging and inserts, but remains adamant that the product should only be available on prescription from a doctor, that it not be used on wet skin, and that the quantity in the bottle be limited to a single dose. And she questioned why it's taken Aspen so long to consider applying the FDA recommendations on the packaging of its lindane product in SA.

    "A search on 'Lindane' on the US FDA site shows how many years back these warnings were issued to pharmaceutical companies in the US," she said. She rejects Aspen's claims that she misused the product. The FDA's current labelling advisory states that while some serious adverse events reported in association with lindane products have been due to misuse, there have been rare case reports of serious reactions with apparently normal use.

    And finally, Van Rensburg makes an important point about the number of reported cases of adverse effects of the use of lindane products.

    "We believe that the incidence of Gambex-acquired aplastic anaemia is underreported because so far in both in South Africa and Australia, one of the first questions every doctor has asked us has been: 'Has Lachlan been exposed to any pesticides?'"

    "This is standard medical practice when a doctor is treating a patient presenting with aplastic anaemia. Our answers were always, 'No' as we do not use any pesticides.

    "If the medical profession also included a question of 'Have you used any head lice treatments?' then we would possibly see a more accurate reporting of the adverse affects of the shampoo Gambex.

    "Most parents are not aware that Gambex is actually a pesticide."

    Singleton says Aspen has received only two other adverse events reported - a hypersensitivity reaction and contact dermatitis - associated with the use of Gambex. "The limited reporting did not warrant a change in scheduling status or specific action relating to labelling," she said.

    Lice shampoos containing the chemical gamma benzene hexachloride on sale in South Africa are Gambex® and Quellada®; in most other countries it goes by the brand Lindane® or Kwell®.

      • This article was originally published on page 6 of The Star on October 27, 2008
    • Email StoryPrint Story
    BOOKMARK THIS STORY
    Social bookmarking allows users to save and categorise a personal collection of bookmarks and share them with others. This is different to using your own browser bookmarks which are available using the menus within your web browser.

    Use the links below to share this article on the social bookmarking site of your choice.

    Read more about social bookmarking at Wikipedia - Social Bookmarking

    muti