DRUG ALERT-2 6th January 2010.

Recalls and Withdrawals
Tylenol Arthritis Tablets

The National Pharmacovigilance Centre would like to notify healthcare professionals and the general public about the recall of Tylenol Arthritis Pain Caplet 100 count bottles with distinctive red EZ-OPEN Cap (full list of the affected batches provided on the link below), by the Manufacturer, McNeil Consumer Healthcare and US Food and Drugs Administration.

This is as a result of mouldy, musty, or mildew-like odour that was associated with nausea, stomach pain, vomiting and diarrhoea. The odour is caused by the presence of a chemical 2, 4, 6-tribromoanisole, believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this chemical have not been well studied, and to date all observed events reported to McNeil were temporary and non-serious.

For details on the affected batches log on to: www.fda.gov/safety/Recalls/ucm195690.htm

Although the Food and Drugs Board has not registered Tylenol Arthritis Tablets for use in Ghana, the Centre wishes to advice healthcare professionals and the general public who may have purchased this product to report to the National Pharmacovigilance Centre through the following contact;

Office line:  +233 (0) 21 235 100, +233 (0) 21 233 200 

Mobile:       +233 (0) 24 4310 297

E-mail:        drugsafety@fdbghana.gov.gh

DRUG ALERT1 - PRECAUTIONARY VOLUNTARY RECALL OF CERVARIX VACCINE IN THE UNITED KINGDOM

The Food and Drugs Board has received information from GlaxoSmithKline (GSK) Biologicals, the marketing authorization holder for Cervarix Vaccine (Human papillomavirus (HPV) 16li and 18li) about the precautionary voluntary recall of Lot No. AHPVA043BB. The vaccine is to protect against cervical cancer. This recall is in the United Kingdom only where this lot was distributed as part of the national immunization programme.

This follows the tragic death of a 14 year old girl, who had received vaccination from the above lot of the vaccine in Coventry in the United Kingdom. GSK is now undertaking a voluntary recall of this lot, pending further investigation.

No other lots are affected by this recall and the risk: benefit assessment for the vaccine remains unchanged; there is currently no proven link between the vaccine and the suspected adverse event reported.

Cervarix has been approved for use in developing countries by The World Health Organisation (WHO) and the according to the UK authorities, the HPV immunization programme is now entering its second year with at least 1.4 million doses having been administered across the UK. The ten most common suspected adverse events reported up to the end of July include dizziness, headache, nausea, pain in extremity, syncope, vomiting, malaise, fatigue, pyrexia and rash.

Another HPV vaccine, Gardasil Vaccine is approved for use in the U.S.A for routine immunization of females aged 9-26 years and the Food and Drugs Agency (FDA) and Centre for Disease Control (CDC) continue to closely monitor the safety of this vaccine. As of December 31, 2008, 32 deaths had been reported to the Vaccine Adverse Events Reporting System (VAERS) of the USA. In the majority of cases with available autopsy reports, death certificates and medical records, the causes of death were explained by factors other than the vaccine. Based on the review of available information by the FDA and CDC, Gardasil continues to be safe and effective; its benefits outweigh its risks. Gardasil is registered in the UK but not for routine immunization.

In October 2008, the Food and Drugs Board (FDB) granted a conditional approval status to Cervarix Vaccine for a period of one (1) year for use in prevention of cervical cancer in females 10-45 years of age. During this period we have continuously closely monitored the safety of the vaccine through an active monitoring programme. Reports from this active study will inform the Board of subsequent regulatory decisions to take on its final approval.

Although the importation and use of this vaccine is currently restricted to one facility (Akai House Clinic Accra), all healthcare professionals are kindly requested to inform the FDB on the availability and use of the vaccine in their institutions.

This will enable the Board take further steps to ensure that the vaccine is closely monitored to ensure any new risks identified will be captured by the safety monitoring system and the balance of risks and benefits remains positive.

All enquiries and reports can be sent to the Chief Executive through the following contacts:

Telephone: 021 235100 / 021 233200
Mobile: 0244 310297 Fax: 021 229794
Email: fdb@fdbghana.gov.gh
drugsafety@fdbghana.gov.gh


Yours faithfully,
SIGNED

DR.STEPHEN K. OPUNI
CHIEF EXECUTIVE