Government declines to withdraw tramadol from the market

JAKARTA (JP): The Ministry of Health has played down demand from the Indonesia Health Consumer Empowerment Foundation to withdraw analgesic tramadol from the market and list the drug as a synthetic narcotic to ensure stricter control.

The ministry's Director General for Drug and Food Control Sampurno said on Monday that at the moment the ministry has no plans to change the tramadol classification from a strong drug to a synthetic narcotic.

He said even the U.S. Food and Drug Administration, known for its strict control over drugs, and the World Health Organization did not classify tramadol as a narcotic.

"There should be a strong reason (for such a demand)," Sampurno told The Jakarta Post by phone. "We should also take into account the international standard."

The ministry, he said, has imposed stricter controls over illegal sales of strong drugs outside pharmacies.

"So, don't be confused between a drug's category and its control. We do control drugs here," said Sampurno, adding that the ministry had just summoned 20 drug manufacturers, calling for their accountability over widespread sales of illegal strong drugs.

But he added that he was not willing to be trapped in prolonged controversy over tramadol.

"Let's allow only those from the medical profession, such as pharmacologists or the medical association, talk about it," Sampurno said.

Last week, the foundation raised its demand via the mass media -- the second one after an earlier failure to obtain a response from the ministry -- that the government withdraw tramadol and list it as a synthetic narcotic.

Citing medical literature, Tramadol Systemic, the foundation's chairman, Marius Widjajarta, said that: "It has been estimated that the analgesic potency of tramadol is one-tenth that of morphine."

"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."

If tramadol is categorized as a narcotic it would be prescribed by doctors under stricter control. Doctors and pharmacies selling the drug would be obligated to report its sales to the ministry every month.

At present, the ministry categorized tramadol as a strong drug which is available upon prescription without obligation to report its sales to the ministry. But in reality, tramadol can be obtained from sidewalk drug vendors.

Prescribed tramadol is used for the management of moderate to moderately severe pain, such as to treat pain following orthopedic and gynecological procedures, including caesareans.

Marius disclosed on Monday that following the foundation's request, a ministry expert had requested the organization submit literature being used to back up its claims. He declined to name the expert.

"They (the ministry) say that our literature is not reliable ... I can't understand why," Marius told the Post.

He revealed that the foundation used medical references, such as Internal Medicine and MIMS -- a list of drugs released by drug producers. It also consulted Law No. 22/1997 on narcotics.

He further disclosed that the drug's producers have classified tramadol as a narcotic with analgesic potency.

The foundation also released on Monday 17 of tramadol's brand names. They are Bellatram, Dolana, Dolsic, Forgesic, Katrasic, Orasic, Radol, Seminac (not Feminax as published in this page last Wednesday), Simatral, Tradonal, Tradosik, Tradyl, Tramal, Traumasik, Trunal DX, Tugesal and Zumatram.

When asked for the foundation's next move, if the ministry refused its demand again, Marius said it would request the ministry release statements refuting the medical literatures as "false".

"It's confusing how the ministry keeps insisting that our literature is not reliable, while at the same time doctors and even medical students use them," Marius said. "So, if the ministry said that the books are not dependable, they need to clarify it." (ste)