Guardian

NIGERIA on Tuesday joined the league of nations that have imposed stiffer controls on the use of Rophypnol, a drug which Police said was administered on a young lady Cynthia Osokogu before she was abused and murdered by her Facebook friends last year.

Minister of Health, Prof. Onyebuchi Chukwu, had hinted after a Federal Executive Council (FEC) meeting late last year that government was considering banning the use of the drug out- rightly to check its abuse.

But Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), Dr. Paul Orhii, who briefed the media on government’s final decision on the drug in Abuja, stressed that a risk-benefit analysis of the drug revealed that the benefits far outweighs its dangers and had such, taken the decision to step down initial considerations to ban the drug, which is clinically known as Flunitrazepam.

According to NAFDAC, following an action plan approved by the minister of Health and safety review of submissions by NAFDAC and the National Drug Safety Advisory Committee (NDSAC), tougher measures have been introduced in addition to the status of the drug as a Prescription Only Medicine (POM).

Some of the measures for the additional control measures for the drug, whose street name is ‘ Date Rape’ drug, includes that its distribution would be limited and restricted to determined outlets and dispensed only on the prescription of doctors.

“Marketing Authorisation Holders (MAH), are to also submit mandatory quarterly reports on distribution and use of the medicine to NAFDAC. Government will henceforth ensure full implementation of the risk management plan by the Marketing Authorisation Holders,” Orhii declared.

He added, “Post Market Safety Surveillance (PMS) of the product is to be further strengthened and stringent enforcement by relevant government agencies will be ensured. We also embark on an intensive enlightenment campaign on the dangers of abuse of the drug.”

He appealed to members of the public, especially young ladies to be wary of association with those he described as criminally mined individuals, who might use the drug to take undue advantage of them.

He added, “we are familiar with the sad story of Cynthia Osukogu, who died as a result of an alleged abuse of Rohypnol. This press conference is convened to brief you on some of the far-reaching measures taken by NAFDAC to control the use of Flunitrazepam in the country of which Rohypnol is one of the registered brands.

“Flunitrazepam is registered in Nigeria by Roche Nigeria as a 1mg tablet with the brand name, Rohypnol. The other brand registered is Swinol by Swiss Pharma Nigeria Limited.”

“Flunitrazepam is a benzodiazepine which is one of the most frequently prescribed classes of medications in the world. It is indicated in the short-term treatment of sleep disorder (insomnia).

“In the anesthesiology, the ampoules are indicated for sleep induction, although injectable forms are not registered in Nigeria. Listed adverse reactions include paradoxical reactions, anterograde amnesia, a condition in which events, which occurred while under the influence of the drug are forgotten. Flunitrazepam is documented globally to be associated with high risk of abuse and misuse including its implication in date rape (drug facilitated sexual assault), the NAFDAC boss explained.

Orhii concluded, “due to its high potential for abuse, it is controlled to varying degrees in different countries while the drug is still registered and freely used in many countries.

“ In the United States of America, Flunitrazepam is strictly controlled. In Nigeria, until the recent incidence which claimed the life of Miss Osukogu, there had not been any report in the national database.”