Monday, 15 July 2013 09:30

Public Alert notice on contaminated Isotab 20mg (Isosorbide Mononitrate)

The attention of the National Agency for Food and Drug Administration and Control (NAFDAC) has been drawn to the World Health Organization (WHO) Information Exchange System, Alert No. 125 on “Contaminated Isotab® (Isosorbide mononitrate) incident in Lahore Pakistan”.

The contaminated Isotab® (Isosorbide mononitrate) purportedly manufactured by Efroze, Karachi, Pakistan was implicated in the deaths of 107 patients and serious adverse reactions in more than 450 patients in Lahore (Punjab, Pakistan). Tests carried out on Isotab® revealed that the drug was contaminated with pyrimethamine in quantities large enough to cause substantial overdose. From the information available to date, the contamination has only been found in the production batchJ093, as samples of the same medicine tested from other batches have not shown any contamination with Pyrimethamine.

Although Isotab® (Isosorbide mononitrate) is not registered by NAFDAC for distribution in Nigeria, other brands of the anti-anginal medicine (Isosorbide mononitrate) are duly registered by NAFDAC and available in the Nigerian market.

Consequent on the above, NAFDAC hereby alerts healthcare providers and patients on this medication to be vigilant and ensure they do not purchase or use this contaminated batch. While affirming that Isotab® and other unregistered medicines are not approved for free sale in Nigeria, we urge healthcare professionals and patients who obtain their drugs from outside sources to exercise necessary caution in making their purchases.

NAFDAC is committed to ensuring that all medicines offered for sale in Nigeria are safe and of appropriate quality. We urge you to forward to the National pharmacovigilance Centre, NAFDAC, all reported adverse reactions to medicines used in your facilities or by your patients.

For further clarification on this alert and other medicine related issues, please contact the NPC by email: This email address is being protected from spambots. You need JavaScript enabled to view it. or call 07098211221


The National Agency for Food and Drug Administration and Control (NAFDAC) wishes to draw the attention of the general public to the regulatory action taken by the Agency on the following drugs, some of which have been banned /restricted internationally.

  1. CODEINECONTAINING COUGH SYRUPS. Codeine is an opiate used for its analgesic (pain reliever) and more commonly antitussive effect(cough suppressant) in cough syrups. Codeine containing cough syrups are effective in the management of certain cough. However, it has a high potential for abuse and may present some serious adverse reactions to the user. For these reasons, access to codeine containing cough syrups has been restricted in several countries. Some of the known adverse effects of codeine include: respiratory depression; hallucination and physical dependence as a result of continued use.

NAFDAC is working with the Pharmacist Council of Nigeria (PCN), National Drug Law Enforcement Agency(NDLEA) and National Institute for Pharmaceutical Research and Development(NIPRD) to arrest the increasing abuse of these cough syrups in Nigeria. NAFDAC is embarking on massive public enlightenment campaign on the dangers of abuse of codeine containing medicines in Nigeria. The Agency has put in place strategy to limit the supply and distribution of codeine containing cough syrups in Nigeria. Prescribers and dispensers are encouraged to prescribe and dispense these cough syrups rationally. Consumers are advised to take codeine containing cough syrups only on prescription by health care professionals.

ROSIGLITAZONE (AVANDIA, AVANDAMET)belongs to a class of antidiabetic drugs used to treat Type II diabetes. Worrying concerns on this drug were raised when it’s use in exposed patients was associated with increased cardiovascular adverse effects. The European Medicines Agency (EMA) had recommended the withdrawal of the drug from the European market after it concluded that the benefit/risk of rosiglitazone was unfavourable due to its cardiovascular risk. The US FDA, the French Drug Regulatory Authority and many other drug regulatory authorities also had similar conclusion to the EMA. While the drug has been banned in Europe, Avandia is still available in the US, though with severe restrictions on its use. Consequently, In October 2010, NAFDAC directed Glaxo SmithKline Nigeria, the Marketing Authorization Holder(MAH) of Avandia in Nigeria to develop and forward to NAFDAC a comprehensive risk management plan for the drug as a means of ensuring restricted access by patients. GSK Nigeria has also been advised to ensure that all patients who are currently on Avandia are evaluated by their physicians and any adverse drug reaction observed reported to NAFDAC. NAFDAC also advise that as much as possible patients should be placed on safer alternatives unless the benefit of the use of Avandia far outweighs the risk as determined by the managing physician. The Agency’s position on the continued use of Rosiglitazone has been communicated to healthcare practitioners through a “Dear HealthCare Provider” letter which is available on NAFDAC website; The Agency will carryout a review of the effects of these directives to the MAH in April 2011 to determine the safety profile in Nigeria population and the consequent appropriate action.

  1. AVASTINis a drug that was approved for the treatment of breast cancer. Investigations by the US FDA have shown that patients on Avastin experienced high blood pressure and fatigue. A follow up investigation by the manufacturer, Roche also revealed that the drug does not significantly prolong the lives of patients when compared to chemotherapy. The US FDA has proposed a ban of the drug due to the observed serious side effects and its failure to slow tumor growth or help breast cancer patients. In view of the current findings on Avastin, NAFDAC is closely monitoring the safety/efficacy of this drug with a view to determining appropriate regulatory action. NAFDAC also wishes to advise all healthcare practitioners to closely monitor the use of Avastin and report any observed adverse effects to the National Pharmacovigilance Centre, NAFDAC Abuja.
  2. CHLORZOXAZONEis a centrally acting muscle relaxant which has been linked with hepatotoxicity, a rare but serious adverse drug reaction. Other adverse reactions that may be associated with the use of Chlorzoxazone include; gastrointestinal bleeding, drowsiness, dizziness, light headedness and malaise. Studies have also shown that there is no evidence of the superiority of the effectiveness of one muscle relaxant from another; however its combination with analgesics tends to produce superior pain killing effects than the single formulated muscle relaxant.

Currently, two brands of Chlorzoxazone are licensed for distribution in Nigeria by NAFDAC. One of the registered brands is a combination product, while the other brand is a mono-component product of Chlorzoxazone.

In view of the safety concerns on the use of Chlorzoxazone, healthcare providers are advised to prescribe and dispense this drug rationally. NAFDAC also wishes to advise healthcare providers to actively monitor the use of Chlorzoxazone in their patients with regards to its potential to precipitate hepatotoxicity.

VALPROATE SODIUM:This is an anti-epileptic drug which is normally prescribed as a prophylactic medication. It has been found to cause neural tube defects in children born to women who took this drug during pregnancy. The affected children suffer from what is known as "foetal anticonvulsant syndrome", or FACS, which causes a range of neural, behavioral and physical disorders. These disorders include; cleft palate and spinal bifida, learning difficulties, behavioral problems and abnormalities in movement, speech, vision and hearing. In Nigeria,EpilimandEpivan, brands of sodium valproate are registered for use as anti-epileptic drugs. NAFDAC strongly advise that women within the reproductive (child bearing) ageSHOULD NOTuse this drug. However, antiepileptic drugs, including valproate, could be administered to women of childbearing potential only if they are clearly shown to be essential in the management of their medical condition.

Rho (D) IMMUNE GLOBULIN INTRAVENOUS (HUMAN) (WinRho SDF, RhoGAM, Vinobulin) -an immune globulin used to treat immune thrombocytopenic purpura (ITP) in patients with Rh-positive blood. ITP is a type of blood disorder where the person has a very low number of platelets. The US FDA and Baxter (Manufacturer of WinRho SDF) warns that administration of this drug can lead to intravascular heamolysis, anaemia and multisystem organ failure, acute respiratory distress, renal failure and disseminated intravascular coagulation. NAFDAC hereby notifies healthcare professionals that cases of intravascular heamolysis and it’s complications including fatalities have been reported in patients treated for immune thrombocytopenic purpura (ITP) with WinRho. Healthcare professionals are advised to be cautious with the drug as it could lead to clinically compromising anemia and multisystem organ failure including respiratory distress syndrome. The Boxed Warning Information in the product insert (WinRho SDF) should guide healthcare professionals on steps to minimize/manage these adverse effects.

  1. GENTAMYCIN280mg/2ml: Gentamycin is an aminoglycoside antibiotic used in the treatment of bacterial infections. The use of high dose (280mg/2ml single unit) Gentamycin injection has been associated with high risk of ototoxicity, nephrotoxicity and increase incidence of endotoxin reactions. Consequently, NAFDAC has deregistered and withdrawn it from circulation. The decision to withdraw Gentamycin 280mg injection is in agreement with international best practice which disapproves the use of high dose Gentamycin injection. Please note that the lower strengths of Gentamycin injection are not affected by this withdrawal. Duly registered Gentamycin 10mg, 40mg, 80mg and other approved lower strengths of the injection are available for clinical use in Nigeria. NAFDAC is in consultation with the market authorization holders of Gentamycin 280mg injection in Nigeria to ensure their mop up from circulation.

Cough Syrups Containing Mucolytic Agents: Mucolytic agents such as acetylcysteine , ambroxol, bromhexine, carbocisteine e.t.c are incorporated into cough syrups because of their ability to break down mucus and relieve respiratory difficulties sometimes associated with cough. The use of cough syrups containing mucolytic agents has been restricted in infants and children under two years of age in the US, Australia, Canada and UK due to their inefficacy and serious potential health risk. Current pharmacovigilance data from the French Health Agency showed that mucolytic containing cough syrups have the potential to aggravate respiratory symptoms when used in children. Consequently, the French Health authority took the decision to contraindicate the use of cough syrups containing mucolytics in children below 2years of age.

NAFDAC has initiated steps with the Marketing Authorization Holders and manufacturers of these cough syrups in Nigeria to ensure the products are appropriately labeled and contraindicated in children below 2 years. NAFDAC registered brands of cough syrups containing mucolytics include:Rhinathiol 2% Syrup, Kofarest Pd Syrup, Flemex Junior Syrup and Broncholyte Junior Elixir.

SIBUTRAMINE (Meridia, Exus Slima Exp).These are anti-obesity drugs which contain Sibutramine as active ingredient. Sibutramine acts by reducing food intake and increasing the metabolic rate. The common side effects are dry mouth, stomach upset, gastritis, headache, heat flushes.Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Sibutramine also interacts with drugs categorized as monoamine oxidase (MAO) inhibitors resulting in life threatening side effects. Because of these safety issues, the US and the European Union stopped the use of sibutramine containing medicines.

NAFDAC has issued a directive to the local manufacturer of Exus Slima Exp capsule to provide post marketing safety data of the drug in Nigerian population. A decisive regulatory action on the product will be taken by NAFDAC upon receipt of the safety data. In view of these safety concerns, NAFDAC hereby advise patients taking sibutramine containing products to report any observed adverse effects of the drug to their prescribers and ensure that an Adverse Drug Reaction Form(Yellow Form) is filled by their prescriber.

VIGOR 25:This is marketed as a dietary product to enhance male sexual drive. Vigor 25 has been found to contain a prescription drug, sildenafil which is used in the management of erectile dysfunction in men. Because of the potential of Sildenafil to cause serious adverse reactions, it is to be used strictly on prescription by a physician. Sildenafil is known to interact with hypertensive medication, particularly Nitrates causing dangerously low blood pressures leading to death.Vigor 25 is a counterfeit product. Consumers of this dietary product are advised to immediately stop its use to avoid its harmful effects. Vigor 25 is not registered by NAFDAC for use in Nigeria. The quality and safety of all unregistered product cannot be guaranteed by NAFDAC.

PROPOXYPHENE:Is a narcotic pain reliever and cough suppressant which acts by increasing the tolerance to pain. In addition to pain reduction, the drug causes sedation and respiratory depression. This drug as well as other formulations which contain the drug has been found to cause serious /fatal heart abnormalities. The USFDA proposed to withdraw the drug due to this recent discovery. This drug and drug products containing this component have not been registered for use in Nigeria by NAFDAC.

BYETTA (EXENATIDE):It is an injectable drug which is used in the treatment of Type II diabetes. It acts by mimicking the action of the hormone which leads to the release of insulin from the pancreas. This drug has been found to affect the function of the kidney leading to acute renal failure. The USFDA notified healthcare professionals of revisions to prescribing information for Byetta (Exenatide) to include information on post-marketing reports of altered kidney function, acute renal failure and insufficiency. The drug has not been registered for use in Nigeria. However, physicians are advised to exercise caution and to adequately monitor their patients who are on this drug for the identified adverse effects.

GnRH AGONIST(Gonadotropin-Releasing Hormone (GnRH) Agonists), is a synthetic peptide hormone which acts naturally in the body. It is used in the treatment of prostate cancer. The side effects of this drug are hypoestrogenism, including hot flashes, headaches, and osteoporosis. There are evidences of increased cardiovascular risk (such as myocardial infarction, stroke, and sudden death) in patients taking the medication. GnRH Agonist has also been found to increase fat mass and body weight, decrease lean mass and decrease insulin sensitivity thereby leading to diabetes mellitus. The U.S. Food and Drug Administration (FDA) has notified the manufacturers of the Gonadotropin-Releasing Hormone (GnRH) agonists of the need to add new safety information to the Warnings and Precautions sections of the drug label.

QUE SHEis a Chinese herbal sliming drug which is marketed as“an all natural blend of Chinese herb”. It has been found to contain four other prescription medication, fenfluramine, sibutramine, propranolol, and ephedrine. Fenfluramine and sibutramine are antiobesity drugs which have been found to cause heart attacks. Propranolol is an antihypertensive medication which reduces the blood pressure of the person taking the medication. The sale of this adulterated herbal drug has been stopped in America and the European Union. QUE SHE is not a NAFDAC approved product. The public is hereby warned not to consume this unwholesome herbal product.

Read 13862 times Last modified on Tuesday, 28 January 2014 12:51



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