Times Of Swaziland: UNWANTED PREGNANCY CONCERNS AS BIRTH CONTROL PILLS RECALLED

UNWANTED PREGNANCY CONCERNS AS BIRTH CONTROL PILLS RECALLED
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Mfanukhona Nkambule and Joseph Zulu on 24/11/2024 07:11:00


MBABANE - Women who are taking the recalled birth control pills want to know
about pregnancy risks.
In a statement on Friday, the Minister for Health, Mduduzi Matsebula, said those
who might have already used the pills should consult with healthcare
professionals. The recalled pills are YAZ Plus, Batch No. WEW96J. The minister
said the incorrect arrangement of tablets within some packs affects the efficacy
of the affected batch, meaning that the contraceptives will not yield the
desired effect of preventing a pregnancy.
He, however, clarified that the product is not available in the government
public health facilities.  He said: “The ministry is currently communicating
with private facilities and pharmacies to ascertain the level of distribution of
these units, facilitate appropriate communication for discontinuing the
prescribing and use of the affected batch of the product and the necessary
recall of this batch that may be on the market in Eswatini.” He said the
ministry is advising the public to inspect the batch number of YAZ Plus
contraceptives purchased or received at any private pharmacy or health facility.
Batch
“If the batch numbers and the appearance of the pills correspond, the person
should immediately stop using the contraceptives and return the product to the
respective pharmacy or health facility to exchange with the correct product or
get a refund,” advised the minister. It is understood that the contraceptives
were recalled via the South African Health Products Regulatory Authority
(SAHPHRA).  YAZ Plus is a birth control pill (oral contraceptive) that contains
two female sex hormones, the progestin drospirenone (3.0mg) and a low dose of
the estrogen ethinyl estradiol (0.020mg). The two female sex hormones are
synthetic and similar to those that occur naturally in your body.
The minister of health said the batch was distributed on November 9 and 24, 2023
and were recalled because of quality reasons. He said the product is
manufactured by Bayer, a German pharmaceutical company. BBC reports that
regulators in South Africa recalled the batch of the popular Yaz Plus
contraceptive pill after a packaging mix-up, which meant that the contraception
could potentially be ineffective. Manufacturer, Bayer Ltd, said women using
pills from the affected batch should stop immediately and seek medical advice.
A packaging mix-up led to a number of blister packs carrying 24 inactive pills,
instead of 24 hormone-containing active pills. The issue affected only a limited
number of packets in a specific batch labelled WEW96J, expiring in March 2026.
The erroneous batch has been recalled by Bayer, in consultation with the South
African Health Products Regulatory Agency. The company stressed that the “root
cause” of the mix-up had been identified and dealt with accordingly. A regular
pack of Yaz Plus contraceptives contains 24 active pills containing hormones,
which are pink in colour, followed by four hormone-free, inactive pills, which
are light orange in colour, according to the BBC. In the recalled batch, a
number of packs instead carried 24 hormone-free inactive pills and only four
active hormone pills. The concern is that a woman could be at risk of becoming
pregnant having taken inactive pills believing she was taking effective hormonal
contraception.
Recall
Bayer Ltd’s recall notice says: “While only a limited number of packs from
the respective batch is affected, as a precautionary measure, no tablets from
these packs shall be used until you have consulted your healthcare practitioner,
as they may potentially not provide the contraceptive protection you
expect.”Anyone who has acquired a packet of pills belonging to the stipulated
batch is advised to return the tablets to pharmacies for a replacement or
refund. Healthcare professionals, hospitals, pharmacies, doctors, nurses and
wholesalers that have packets of the affected batch should also return them.
In a statement, Bayer Ltd said: The root cause for the mix-up of tablets in the
packaging has been identified and corrective measures have been implemented.
‘‘The incident is limited to only one batch and no other batches are
affected, the company said. The South African Citizen reports that the issue
involves an incorrect arrangement of tablets within some packs, which may affect
the efficacy of this batch. Quoted by the Citizen, Sahpra CEO Dr Boitumelo
Semete-Makokotlela stated that the recall is necessary to protect the public
from the affected batch’s potential ineffectiveness.
Unaffected
“We urge members of the public who have Yaz Plus batch number WEW96J to
discontinue use and to return the packaging to their pharmacists for a
replacement with a pack from an unaffected batch or a refund,” she urged
consumers. Women using this contraceptive are advised to check the batch number
of their current tablet packs, discontinue use, return affected packs to their
pharmacist, and consult their healthcare professional. Dr Velephi Okello, the
Director of Health Services, said she was free to talk about the pregnancy
risks, but would like to do so via Nsindizo Tsabedze, the Communication Officer
in the Ministry of Health who did not answer his phone at the time of processing
this report.