Company apologizes for birth defects caused by drug given to pregnant women
German drug maker Gruenenthal Group is apologizing to women who took its morning sickness medication Thalidomide in the 1950s and 1960s, and to their children who suffered congenital birth defects as a result. The apology comes 50 years after the drug was pulled off the market for causing babies to be born with shortened arms and legs or with no limbs at all.
“We ask that you regard our long silence as a sign of the shock that your fate caused in us,” said Harald Stock, Gruenenthal Group’s chief executive, during an unveiling of a statute in the drug company’s city of Stolberg, symbolizing a child born without limbs because of thalidomide. The statue is called “the sick child,” which in German also implies cure. The statue’s name was criticized by a German victims group because the victims are now adults.
Thalidomide is a sedative that was sold in Germany under the brand name Contergan. It was given to pregnant women throughout Europe, Australia, Canada and Japan to help ease the symptoms of morning sickness. It was banned in 1961 after it was associated with defects in the eyes, ears, heart, genitals, and internal organs of developing fetuses. The drug was never approved in the United States.
The late apology is a tough pill to swallow for the victims, who are adults now. Numerous victims have filed lawsuits against Gruenenthal and its distributors over the decades but the drug company faces more than 100 lawsuits from survivors as part of a class action lawsuit. The company contends that when it developed Contergan, it acted on the basis of the available scientific knowledge at the time and met all industry standards for testing of new drugs that were known in the 1950s and 1960s. Victims say the apology does little to help with everyday struggles of living with serious birth defects, and that the punishment should match the crime.
Drug companies are being held more accountable now for their negligence in ensuring the safety of medications that can be prescribed to pregnant women, especially when those drugs can harm developing fetuses. Several lawsuits have been filed against the makers of selective serotonin reuptake inhibitors (SSRIs), the most prescribed antidepressant in the United States, claiming the drugs when taken during pregnancy resulted in birth defects including cleft lip and cleft palate, heart defects, persistent pulmonary hypertension, spina bifida.
Thalidomide is still on the market but is used as a treatment for multiple myeloma and leprosy. It is also being studied as a treatment for AIDS, arthritis and other cancers.
Source: PharmPro
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