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Safety Alerts


Signal Communication

1 Cautionary Statement on Benylin Paediatric 100mls Cough Syrup, Batch No 329304 and 329303
8. Methotrexate and Muscle spasm

Methotrexate (MTX) is a drug developed as a structural analogue to folic acid. As a folic acid antagonist, it blocks the synthesis of purines by inhibiting numerous regulatory enzymes. MTX produces an intense anti-inflammatory action and inhibits cell division. MTX is used in treatment of certain neoplastic conditions, rheumatoid arthritis and psoriasis. It is reported that muscle spasms could be associated with MTX, especially in those patients on chronic low doses.

Muscle spasms associated with MTX could impair the quality of life of patients, especially long-term users with chronic diseases. Prescribers need to be aware that muscle spasms could be present with the use of MTX and watch their patients for this possible adverse reaction. It is important to educate the patients about this adverse reaction and encourage them to report such experiences.

Methotrexate is a registered product in Botswana. Muscle spasms or muscle cramps are not currently mentioned in the product information leaflet (SmPC). Click the link below for further information.

9. Clotrimazole and Vaginal Haemorrhage

Vaginal clotrimazole is indicated for vulvovaginal infections with Candida species, and available as creams and as vaginal tablets.
The imidazole clotrimazole has a broad spectrum of fungistatic activity against skin infections with yeasts and moulds by inhibiting ergosterol synthesis. About 3 to 10% of vaginally applied dose is systemically absorbed.

Vaginal bleeding was reported with the use of clotrimazole vaginal preparations. The bleeding type and severity varied from bloody discharge-mild-menstrual like bleeding-worse than menstrual bleeding as mentioned by the reporter. The time taken for onset to bleeding with clotrimazole varied from immediately after administration to two days

Prescriber should inform women about the occurrence of vaginal haemorrhage with the use of clotrimazole in a similar way as with vaginal miconazole. Attention for this association is warranted, since vaginal bleeding may be indicative for additional vaginal or endometrial conditions. Patients should be encouraged to report such.

There are 5 Clotrimazole products registered in Botswana. For further information on the article click here.

10. Blindness and Retinal disorder associated with Clomifene Citrate: Cases series assessment

Clomifene Citrate (clomiphene) citrate has both estrogenic and anti-estrogenic properties and used for induction of ovulation since 1962. Clomifene Citrate is reported to have been associated with visual problems, especially with increased dosage or duration of therapy. Visual Symptoms like blurring is mentioned in SmPC of Clomifene Citrate https://www.medicines.org.uk/emc/product/961. However, it is stated that the visual symptoms are mild and reversible. The visual disturbances may become irreversible with increased dosage or duration of therapy. If the patient complains of visual disturbances, treatment should be discontinued, and ophthalmologic evaluation performed. Clomifene Citrate is registered in Botswana and based on its wide use prescribers are urged to be cautious when prescribing Clomiphene citrate to patients.

A detailed Ophthalmic examination before the start of Clomifene citrate and regular ophthalmic examinations after starting the drug should be considered in all patients taking Clomifene citrate. For further information explore the link below.

11. Azathioprine and Erythema nodosum (EN)

Azathioprine (Azathioprine®, Imuran®) is an immunosuppressive antimetabolite that is indicated for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, polymyositis, autoimmune chronic active hepatitis, pemphigus vulgaris, polyarteritis nodosa, autoimmune haemolytic anaemia and chronic refractory idiopathic thrombocytopenic purpura.

Erythema nodosum (EN) is a cutaneous disorder that is characterized by tender red nodules, commonly on the shins of the lower legs, and without the formation of pus. The nodules disappear spontaneously within three to six weeks and resolve without residual scarring. However, the nodules can return after a period of time. EN can be triggered by exposure to medicines and micro-organisms but can also occur in combination with systemic diseases. EN is estimated to occur in up to 15% of patients with Crohn’s disease and is linked to an increased disease activity of inflammatory bowel disease. EN is more common in women than in men, and mostly arises in early adulthood.

Cases of EN are reported with use of Azathioprine. A total of 4 cases were reported in Netherlands, a further 70 cases on Eudravigilance and 94 on the WHO Global database. In majority of the cases patients recovered 3 weeks after withdrawal of the Azathioprine. Prescribers, while prescribing Azathioprine are therefore urged to inform patients and be on the lookout for EN. For further information please click here.

12. Loperamide and Acute Pancreatitis in Patients with History of Cholecystectomy: Signal Strengthening

Loperamide is an over-the counter (OTC) antidiarrheal with opioid receptor affinity. WHO global individual case safety reports database has received 35 case reports of loperamide and loperamide: simethicone and pancreatitis or acute pancreatitis. The recent safety signal communication from WHOI International drug monitoring program strengthens association between loperamide use and pancreatitis. Pancreatitis is not labelled in the European SmPC available at the Electronic Medicines Compendium https://www.medicines.org.uk/emc/product/188/smpc nor on the US FDA’s label.

Loperamide is a registered medicine in Botswana and it is available as OTC medicine. Therefore prescribers, pharmacists who dispense loperamide as OTC medicine are urged to be cautious with the use of loperamide. It is important to educate the patients to report any symptoms immediately. Click the link below for more details on Loperamide use and acute pancreatitis.

COVID-19 Vaccine fact sheets for vaccines listed for emergency use in Botswana

Find the links below for the downloadable files

Name File
BoMRA AstraZeneca Covid-19 Factsheet for Public Download
BoMRA Comirnaty Covid-19 Factsheet for Healthcare Professionals Download
BoMRA CoronaVac Covid-19 Factsheet for Public Download
BoMRA Comirnaty Covid-19 Factsheet for Public Download
BoMRA Janssen Covid-19 Factsheet for Public Download
BoMRA Janssen Covid-19 Factsheet for Healthcare Professional Download
BoMRA Moderna Covid-19 Factsheet for Public Download

Dr. Seima Dijeng

Dr Seima Dijeng is the Acting CEO of BoMRA. Before assuming the acting appointment role, he served as the Director of Licensing and Enforcement, overseeing inspections and licensing of premises, laboratory services, import and export control, and enforcement.

A career regulatory professional with over 15 years of experience across both the food and pharmaceutical sectors. He has been part of the BoMRA executive management since 2018.

During his tenure as the Director, he coordinated the development of structures, processes, and guidelines to support regulatory activities and services for the licensing and enforcement department.

He holds a Master of Science in Food, Safety, and Risk Analysis from University College Dublin, the Republic of Ireland, Bachelor of Veterinary Science, from the University of Queensland in Australia.

Dr. Kefentse Motshegwa

Dr. Motshegwa is the Director of Veterinary Services at the Ministry of Agriculture. His illustrious career in veterinary services spans over 23 years in various positions within the veterinary space.

He previously served as Deputy Director – Compliance at the Department of Veterinary Services, Chairperson of the National Residue Committee, and Coordinator of Performance of Veterinary Services Evaluation for the World Organisation for Animal Health founded as OIE.

He brings to the Board a wealth of experience in compliance and regulation in animal health, food safety & veterinary medicines. He is a member of the Botswana Vaccine Institute Board of Directors.

He holds a Master of Science in Biology and Control Parasitic Diseases and Vectors from the University of Liverpool, School of Tropical Medicine, and a Bachelor of Veterinary Medicine from the University College Dublin, Ireland

Dr. Ditiro Duma Coyne

Dr. Coyne is a veterinarian with a career spanning over 15 years in mixed private practice in Gaborone. He has been actively involved in animal welfare and has been the veterinary advisor to the Botswana Society for the Prevention of Cruelty to Animals for several years.

He was the President of the Botswana Veterinary Association for 8 years and has made great strides in advancing Continuous Professional Development for Veterinarians in the country. He brings to the Board vast experience in veterinary education and advocacy as well as Animal Health and Production.

He is currently the World Small Animal Veterinary Association Country Representative for Botswana.

He holds a Bachelor of Veterinary Medicine and Surgery, and a Bachelor of Sciences Veterinary Biology both from Murdoch University, Australia.

Ms. Elizabeth Kelentse

Ms. Kelentse is the Pharmaceutical Care Improvement Specialist at the Botswana-University of Maryland School of Medicine Health Initiative.

She is an enthusiastic and hardworking Pharmacist who brings vast experience to the Board. Her career spans over 12 years from clinical pharmacy to community pharmacy, medicines regulatory experience in the evaluation of clinical trials protocols, and pharmacovigilance: health care management and public health programming.

She has served on the executive committees of the Pharmaceutical Society of Botswana, Botswana Health Professions Council, Young African Leaders Initiative Alumni as well as the National Adverse Events Following Immunisation.

She holds a Bachelor of Science (Pharmacy) University of West Indies St Augustine, Trinidad & Tobago.

Ms. Matshediso Matome

Ms. Matshediso Matome is a Faculty of Health Sciences lecturer at the University of Botswana. She is a seasoned academic who brings to the Board vast experience in the areas of research, health risk management, and delivery of innovative, quality, and cost- effective healthcare solutions for the public and private sectors.

Ms. Matome has previously served in various leadership and senior management positions, including Claims Manager and Head of Managed Care at the Associated Fund Administrators.

She holds a Master’s degree in Pharmacology and Toxicology from, the State University of New York Buffalo, NY, USA, and a Bachelor of Pharmacy, from Albany College of Pharmacy, Albany, USA

Dr Kobedi Segale

Dr. Segale is the Registrar of the Veterinary Surgeons Council. He is a passionate veterinary surgeon with intimate experience in the regulation of the veterinary profession. He has previously served as Deputy Director – Disease Control Division, in the Department of Veterinary Services, responsible for national animal health strategies, programs, and legislation. Dr. Segale brings to the Board a wealth of experience in monitoring and evaluating animal health programs veterinary public health, import and export controls, and animal traceability.

He holds a Master of Science in Tropical Animal Health, from the Institute of Tropical Medicine, Antwerpen, Belgium, and a Bachelor’s degree in Veterinary Medicine from the University College of Dublin, Ireland.

Ms. Mmama Mhlanga – Fichani

Ms. Mhlanga – Fichani is the Vice President, Human Resources and Communications, at Khoemacau Copper Mining. She is a human resources professional with an illustrious career, spanning over15 years in senior management positions. She has held senior leadership positions in diverse industries including, Director of Human Resources at Air Botswana and the Country Head of Human Resources at Standard Chartered Bank Botswana, Head of Human Resources at Be Mobile, Human Resources Manager at African Comprehensive HIV/AIDS Partnership and Human Resource Manager at Non-Bank Financial Institutions Regulatory Authority, respectively.

She brings to the Board vast experience in human resources and communication, organisational effectiveness, employee relations, and change management.

Ms. Mhlanga – Fichani holds a Master’s Degree in Business and Workforce Development from the University of Pennsylvania, USA, a Bachelor of Science in Business Management Human Resources Management, and Marketing Management, from Fairmont College, West Virginia USA, and a Degree of Associate of Science in Business Science- Human Resources Management, September, Calhoun State Community College, Decatur, Alabama, USA.

Mr. Modisa Kebonyemodisa

Mr. Kebonyemodisa is a Partner at Kebonyemodisa Law Office, he is admitted attorney of the High Court of Botswana. Before venturing into private practice, he worked as a Senior Prosecution Counsel at the Directorate of Public Prosecutions.

Mr. Kebonyemodisa is an accomplished legal advisor with over 15 years of experience providing legal counsel to businesses of all sizes. He brings to the Board vast experience in legal practice, corporate law, and extensive knowledge in the legal profession.

He holds a Bachelor of Law degree from, the University of Botswana and Trial Advocacy, Justice Advocacy Training (NITA) (Botswana)

Ms. Tiny Ralefala

Ms. Ralefala is a finance professional with a proven record of leadership, corporate governance, and risk management.

Her impressive professional track record spans over 26 years in finance, audit and accounting in reputable institutions as well as in civil service.

She previously worked as the Chief Finance Officer for Citizen Entrepreneurial Development Agency. Prior to her joining Citizen Entrepreneurial Development Agency she worked as the Finance Manager at the Motor Vehicle Accident Fund.

As a Chartered Financial Accountant, Ms. Ralefala brings to the Board a wealth of experience accustomed to managing projects in finance, audit and risk. She holds a Bachelor of Commerce degree from the University of Botswana. Ms. Ralefala is a fellow member of the Association of Chartered Accountants and the Botswana Institute of Chartered Accountants. She is the current Botswana Institute of Chartered Accountants Practice Review Committee Chairperson.

Dr. Lorato Mangadi-Mokama

 Dr. Lorato Mangadi- Mokama is the  Head of Operations at the Botswana Public Officers Medical Aid Scheme.
She has previously held other  leadership roles within the private healthcare industry, including Chief Operations Officer at the Botswana Medical Aid Society and Managing Director at MRI Botswana Limited. Prior to that, she practiced as a medical doctor in the public health sectors of Australia and Botswana.

Healthcare administrator and funding expert, with her extensive background in the private healthcare industry, she brings to BoMRA a wealth of experience and knowledge in business management and leadership.

She holds a Bachelor of Medicine from the University of Newcastle (Australia) and a Master of Business Administration from the University of Botswana.

She also has various leadership and professional certifications including Executive Leadership Program from Wits Business School and Healthcare Economics from Harvard Business School

Dr. Kegomoditswe Biki Maphane

Dr Kegomoditswe Biki Maphane is the Senior Manager – Safety and Sustainability Development at Debswana Diamond Company, Jwaneng Mine. He is a specialist in Occupational Medicine, Safety & Sustainable Development.

He has held various positions within the Debswana mines, including the Jwaneng Mine Hospital superintendent, and rose to executive leadership.

Dr Maphane provides leadership to the BoMRA Board and oversees the governance and strategic direction of the Authority. He holds a Bachelor of Medical Sciences, and Bachelor of Medicine / Bachelor of Surgery from the University of Melbourne, Australia