Potentially dangerous medicines withdrawn from sale

Mitya Underwood

• Last Updated: November 16. 2009 12:30AM UAE / November 15. 2009 8:30PM GMT

ABU DHABI // Health officials have removed several potentially dangerous remedies from pharmacy shelves across the capital after a survey found that many over-the-counter cough and cold medicines sold in the country do not comply with international safety standards.

A team of experts from Health Authority-Abu Dhabi (HAAD) have removed stocks of some remedies from pharmacies due to the initial findings.

HAAD declined to reveal the exact names of the products affected and was unable to confirm the amount of stock withdrawn.

In total, 105 medicines, all of which were legally registered by the Ministry of Health, are being tested by the Poison Drug and Information Centre (PDIC) at HAAD. The authority said further products were likely to be removed.

Children were particularly at risk, said Dr Yasser Sharif, the section head of the medication and medical product safety department at HAAD.

“A lot of parents administer the medicines themselves, but they are not fully aware about the product and accidental poisoning occurs,” he said.

“A lot of people think [cough and cold medicine] is not a serious subject but it is one of the most common poisoning dangers for children.”

One cough syrup tested in the survey, which contained the antihistamine promethazine, carried instructions saying it was recommended for children as young as 12 months.

Dr Sharif said, it was “well documented” that promethazine could cause respiratory failure in children under two. The product was one of those removed by HAAD.

Another remedy checked, and subsequently removed, contained a level of pseudoephedrine, a decongestant linked to infant deaths in the US, which was “the highest among all of the Ministry of Health registered products”, according to Dr Sharif.

The packaging also carried a graphic of a small child, despite it not being recommended for children under six.

Parents have welcomed the survey, although some felt it was already the responsibility of the authority to monitor the safety of medications that did not fully comply with international standards.

Silvia Fadel, 32, who works at the American University in Dubai, and is a mother of two, said she had simply assumed over-the-counter medicines were safe.

“I feel that if it’s something that’s legal, then it’s something we should trust. “If there’s hidden or unavailable information, then definitely we should rethink what’s out there,” she said. “But, ultimately, it’s the Health Authority’s responsibility.”

Dr Sharif said the fact that many remedies were imported, combined with the lack of a standardised national labelling system in the emirates, exacerbated the potential health risks.

HAAD said poor labelling was a major cause for concern. “Usually, the pharmacists rely on the information which is listed on the label of the product with regard to indications, doses, and the age of the patient who can use the medication. This common practice raises a lot of safety concerns, especially with the availability of many cough and cold products.”

It added that its long-term plan was to introduce a standard method of labelling, possibly along the lines of that used by the US Food and Drug Administration (FDA).

“When we look at the products in the UAE we have to adopt our own guidelines, taking into account those used in Europe and the US,” Dr Sharif said. “But we need to see where we stand locally and benchmark this against international standards. We work well with the Ministry of Health and adopting our own national labelling policy is important for everyone.”

The medicines survey looked at the concentration of active ingredients and whether remedies came with childproof caps and adequate measuring devices, along with appropriate labelling and instructions. It also measured alcohol content. According to the Fatwa Hotline, Muslims are advised to use remedies that contain no more than five per cent alcohol, but should avoid those containing alcohol completely if possible.

Dr Sharif said in the UAE, as in most countries, there was a commonly held misconception that medication was always necessary to combat a cough or cold, particularly in children.

“Children get colds six to eight times a year on average, and it will only take them seven to 10 days to recover by themselves,” he said.

In addition to being potentially hazardous, recent studies have revealed few, if any, over-the-counter cough and cold remedies actually work. Earlier this year, the Medicines and Healthcare Products Regulatory Agency’s Commission on Human Medicines in the UK reported that “there is no evidence that [cough and cold medicines] work, and they can cause side effects, such as allergic reactions, effects on sleep or hallucinations”.

Following the report, the British government recommended children under six should not be given any such medicines. The FDA said last year they should not be given to children under four.

The Ministry of Health decided this year that children in the UAE under six should only be given cough and cold medicines if prescribed by a doctor.

Of the 56 medicines tested by HAAD so far, just three complied fully with FDA regulations for over-the-counter products. These include clarity of instructions and accurate dosages for specific age groups.

Out of the 56, a total of 32, or almost two thirds, carried details stating they were recommended for children under two. One had instructions, which if followed, would “definitely lead to overdose in children”, the survey found.

Anyone concerned about a medicine can call a helpline on 800-424.

munderwood@thenational.ae

* With additional reporting by Zahra Hankir