December 5, 2007 – New Zealand’s Centre for Adverse Reactions Monitoring (CARM), the counterpart to the Saudi Food and Drug Authority’s Pharmacovigilance Center, issued a safety update about the pain medication tramadol and association with increased risk of a serious adverse drug reaction know as serotonin syndrome. In addition, the safety update notes an increased risk of seizure with the use of tramadol.

Sign and symptoms of the serotonin syndrome are listed below:

mental status changes (confusion, mild degree of mania)

myoclonus (spasm or twitching)

hyperreflexia (reflexes are exaggerated)

sweating

shivering

tremor

diarrhoea

fever

The CARM report included three patients who developed the serotonin syndrome while taking other drugs that have an effect to serotonin. Serotonin is a naturally occurring chemical transmitter in humans. The other drugs taken by these patients in addition to tramadol were paroxetine (Paxil), thioridazine (Mellaril), fluoxetine (Prozac, Sarafem) and citalopram (Celexa). Paroxetine, fluoxetine, and citalopram belong to the family of antidepressants known as selective serotonin re-uptake inhibitors (SSRIs).

The CARM had also received 10 reports of seizures being associated with the use of tramadol. The CARM reports suggest that the risk of seizures with tramadol may be increased by high doses, with the use of other drugs, and a history of epilepsy.

Tramadol was originally approved for marketing in Saudi Arabia in 1994. It is heavily promoted to doctors as being equivalent to acetaminophen and codeine (TYLENOL NO. 3) and having a low potential to cause addiction. In fact, tramadol appears to be no more and sometimes less effective than combinations of codeine with aspirin or acetaminophen.

Tramadol products available in Saudi Arabia are sold under several brand names including Tramadone and Tramal. Tramadol is also sold in combination with paracetamol under the brand name Zaldiar Tablets.

ACTIONS THAT HEALTHCARE PROFESSIONALS AND PUBLIC SHOULD FOLLOW:

Tramadol use can increase the risk of a serious adverse drug reaction known as serotonin syndrome.

Take care when you use Tramadol with antidepressants.

Use Tramadol with a recommended dose to avoid its serious reactions.

Tramadol shares chemical similarities to pain medications such as morphine and codeine and may cause dependence.

REPORT ADVERSE DRUG REACTIONS TO THE SAUDI FDA

The public and health professionals are encouraged to report adverse drug reactions the National Pharmacovigilance Center on the Internet at .