Posted on 11/20/2001 2:04:30 PM PST by aculeus
Women taking a popular contraceptive pill face the risk of pregnancy because of a packaging mixup.
Douglas Pharmaceuticals, which makes Estelle-35 ED tablets in West Auckland, is recalling two batches - numbers 13379 and 13534 - totalling 39,000 blister packs of the pills.
Estelle-35 is also used to control acne.
Pharmacies nationwide are contacting the thousands of women who use the pills and advising them to check the batch number.
The company, which has been making the drug in New Zealand only since September 1, says there is little chance women using it could become pregnant.
But it urges women using Estelle-35 for contraception to have a pregnancy test, which the company will pay for.
The Family Planning Association advises women taking Estelle-35 to be careful for the next seven days and use contraceptive protection such as condoms, but not to stop taking the pills.
Each monthly blister pack contains 28 pills - 21 yellow ones containing a contraceptive drug and seven white inactive pills which are mainly sugar. The pills are meant to be taken in the prescribed sequence.
A Wellington pharmacist told the company last Thursday that in one blister pack an inactive pill had been placed on day nine, where an active pill should be.
The company, which alerted doctors and pharmacists on Monday, says it has moved as quickly as it could on the recall.
Women prescribed Estelle-35 are shocked by the mixup.
"I hadn't actually started them, but if I had I would be really, really worried and very angry that someone had made a mistake like that," said one Auckland woman, who did not wish to be named. Estelle-35 was her sole form of contraception.
Another said she would definitely take up the matter with her doctor.
Douglas Pharmaceuticals managing director Graeme Douglas said yesterday that the one blister pack known to be faulty was thought to be the only one and a case of human error.
The mistake happened up to six weeks ago.
He said a quality-control camera had picked up a problem and automatically shut the production line. In line with company policy, about 40 blister packs were discarded to get rid of any faulty ones.
"We assume that one that should have been discarded was not."
The batches recalled were the one containing the faulty pack found in Wellington and the subsequent one.
He did not know how many of the blister packs in those batches had reached pharmacy shelves.
"What remains in our warehouses has been checked and we haven't found one offending pack."
Family Planning's national medical adviser, Dr Christine Roke, said the situation was potentially serious as Estelle-35 was widely used.
"Diane-35, which preceded this pill, was very popular. This pill is probably the second- or third-most popular pill."
A side-effect of Estelle-35 was that it treated acne, but its primary use was as a contraceptive, she said. Many women used it for both purposes.
Picky!
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