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Bahrain has temporarily suspended registration of popular medications used to treat digestive problems following concerns they may contain a cancer-causing chemical.
Following steps taken by the UAE’s Health and Prevention Ministry, Bahrain yesterday announced suspending the registration, importing and distribution of all medicines containing ranitidine.
National Health Regulatory Authority (NHRA) chief executive Dr Maryam Al Jalahma told the GDN yesterday that the move was a precautionary measure.
She added that any potential withdrawal will only be done after global health regulators reveal the findings of an investigation into the drugs.
The GDN reported last week that ranitidine, a medication widely known by its brand name Zantac and generic alternatives Navidine and Histac, could contain small amounts of a cancer-causing chemical called N-nitrosodimethylamine (NDMA).
“No new registrations will be issued for the drug until we check the results of the laboratory analysis,” said Dr Al Jalahma.
“Regarding the drugs that are in the market, we are waiting for the analysis of those as well, which is being conducted in Saudi Arabia as well as in the UAE.
“Based on the results we will take the decision on which brand or batch is to be withdrawn and which are to be retained in the market.”
WARNING
On September 13, the NHRA issued a warning notice to pharmacies in Bahrain following a similar announcement from the US Food and Drug Administration (FDA).
The FDA followed by the European Medicines Agency (EMA) and Health Canada have launched an investigation to assess the health risk level of the chemical.
Several pharmacies in Bahrain have reported an increase in patients seeking clarification on whether they should stop taking or replace ranitidine due to possible contamination.
However, some of the experts attempted to allay public fears, saying the FDA has only mentioned the brand Zantac, which the GDN reported last week was not available in the Bahrain market.
However, Zantac’s substitutes, Navidine and Histac, which also contain ranitidine, are widely available and among the most popular medicines sold over-the-counter (OTC).
“People have been asking if they should change the medicines,” said one pharmacist on condition of anonymity.
“However, as of now we have no information from the NHRA to remove any of the drugs containing ranitidine from the shelf.
“I think there is nothing to worry about as the FDA has confirmed the concern is only on some brands from certain countries of origin.
“If there is a concern, which will be based on the lab test results and if that batch is in the market, then we will be alerted by the NHRA.
“Zantac is the only brand that the FDA has named.”
Zantac is manufactured by Paris-based pharmaceutical company Sanofi, which in a statement last week said it planned to work closely with the FDA in the investigation.
RATIO
The medication treats heartburns and ulcers and could contain NDMA which, according to the FDA, was already detected in certain blood pressure medications last year.
UAE health authorities also said on Monday that they will not withdraw these medicines until the acceptable ratio of NDMA is established by international health authorities.
OTC Ranitidine is approved to prevent and relieve heartburn associated with indigestion and sour stomach, while prescribed drug treats multiple indications including ulcers and gastroesophageal reflux diseases.
raji@gdn.com.bh
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