1st suspected victim of Ortho Evra reported

Three Taipei city councilors held a press conference Monday, calling on drug administration authorities to investigate a case involving a 33-year-old woman who suffered a stroke and lapsed into a coma after using Evra contraceptive patches.

According to councilor Huang Shan-shan, the victim, identified by the surname Li, was a product designer in Taipei’s Neihu Technology Park who had no previous history of illness. She was rushed to the Armed Forces General Hospital Jan. 21 after suffering a stroke but has not yet regained consciousness.

From the contents and receipts in her handbag, Li’s family members found that she was using Evra Transdermal Patches bought from Shanghai Union Dispensary Co.in Taipei. Her national health insurance record shows that the contraceptive patches were purchased without a doctor’s prescription, in apparent violation of the law.

Huang asked Taipei City Government officials in charge of drug administration to take action against the pharmacy.

Another councilor, Pan Hwai-tzong, said sales of the contraceptive patch should be banned in Taiwan because cases of blood clots, strokes and other serious side effects caused by Ortho Evra patches have already been reported in the United States and Canada.

Chiang Yu-mei, director of the Food and Drug Division of Taipei City’s health department, said that according to the law, the pharmacy that sold Li the contraceptive patches without a prescription should be subjected to a fine of between NT$30,000 and NT$150,000.

She also said her division will recommend to the Cabinet-level Department of Health to re-evaluate the legality of the skin patch.

The Evra Transdermal contraceptive patch, introduced in Taiwan in 2004, is manufactured by Ortho McNeil Pharmaceuticals, a division of Johnson and Johnson.

The product was first introduced in the United States in 2002 under the trade name Ortho Evra as an alternative to birth control pills. Worn on the body once a week for less than two months, the patch delivers a steady flow of hormones through the skin into the bloodstream to inhibit ovulation and prevent pregnancy.

By November 2005, there were 23 deaths in the United States linked to the patches, of which 17 were directly related to blood clots.

Canadian health authorities have also reported that 17 people have suffered serious side effects linked to the patch since it was marketed there in early 2004, with two of the 17 dying. Experts believe the increased estrogen level on the patch — 60 percent more than an oral contraceptive — is related to the higher risk of developing serious blood clots.

In 2006 alone, Johnson and Johnson faced 500 claimants in lawsuits seeking compensation for deaths and injuries caused by the Ortho Evra patch. Many of the victims were teenagers and young women of childbearing age who suffered strokes, heart attacks, pulmonary embolisms and deep vein thrombosis. U.S. news media have reported that the manufacturer has adopted a strategy to settle as many lawsuits as quickly and quietly as possible and at the same time keep the mega-buck patch on the market for fear of losing billions of dollars in future sales.

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