Govt urged to withdraw tramadol

JAKARTA (JP): The Indonesia Health Consumer Empowerment Foundation urged the government on Tuesday to withdraw analgesic tramadol from the market and categorize the drug as a synthetic narcotic available only with a prescription.

The Ministry of Health has categorized tramadol as a "strong drug". The generic drug comes in 17 brand names, including the extremely popular Feminax, Belatram and Tramal. They can be freely obtained without prescription.

Equipped with medical literature and Law No. 22/1997 on narcotics, the non-governmental organization's chairman Marius Widjajarta told the media that tramadol was a synthetic narcotic.

"It has been estimated that the analgesic potency of tramadol is one-tenth that of morphine," he said, quoting a booklet on the drug, Tramadol Systemic.

"Tramadol can cause opioid dependence and may potentially be abused. Tolerance development, drug seeking behavior and craving have been associated with the use of tramadol."

The foundation issued the same demand earlier this month after it failed to obtain a response from the Ministry of Health until taking its case to the mass media.

The ministry's director general for drugs and food supervision, Sampurno, has stood by the government's policy of classifying tramadol as a "strong drug", and insisted the analgesic potency of tramadol was one-six thousandth that of morphine -- not one-tenth as the foundation claimed.

He also said tramadol was not listed as a narcotic drug by the International Narcotics Control Board.

Marius said he saw no reason behind the ministry's defense of the drug's classification, saying 16 manufacturers of the drug had classified tramadol as a narcotic with analgesic potency.

"If the directorate general wants to protect consumers, it would be better if they immediately withdrew the drug and changed its classification from a strong drug to a synthetic narcotic," Marius said.

When asked what action the foundation would take if the ministry refused to withdraw tramadol, he said: "We would question the credibility of the directorate general of drug and food supervision here ... and what's behind all of this."

Sampurno could not be reached for further comment on Tuesday.

Marius said that presently, although considered a strong drug available only by prescription, tramadol could be found not only in pharmacies, but on offer by sidewalk vendors across the city.

He displayed the tramadol he bought from sidewalk vendors in Central Jakarta.

Tramadol capsules were purchased for between Rp 300 and Rp 600 each and tramadol suppositories sold for between Rp 1,000 and Rp 2,000. Ampules, or small sealed glass tubes containing one dose of a sterile medicine to be injected hypodermically, cost between Rp 6,000 and Rp 7,000 each.

"The prices are as low as parking fees ... very cheap and easy to get without a prescription," Marius said.

Prescribed tramadol is used for the management of moderate to moderately severe pain. It has been used to treat pain following orthopedic and gynecological procedures, including caesarean sections.

He said if tramadol was listed as a narcotic, it would be prescribed by doctors under stricter controls.

"If a drug is classified as a narcotic, doctors and pharmacies selling the drug should report its sales to the ministry every month," Marius said.

Unfortunately, there is no political will from the government, particularly the ministry, to change its policy and regulate the sale of tramadol, he said. (ste)