Accutane Birth Defects Attorneys
Accutane was approved for sale in the U.S. in 1982. Almost immediately, evidence of birth defects from Accutane quickly began to surface. Enough reports were submitted to the FDA that, in 1984, they held a special committee meeting to discuss the risks of Accutane in relation to pregnancy. As a result, the FDA required that a birth defects warning be added to Accutane information and that a letter be sent to doctors warning of Accutane birth defects risks. In 1988, an FDA report called Accutane an "imminent hazard" and recommended removing Accutane from the market. In response, the FDA required even stronger warnings about Accutane birth defects and required the institution of a program of physician and patient education and an informed consent form that had to be signed by the patient. They also called for additional research into this serious side effect, but did not pull the drug off the market. In response, Roche started its Pregnancy Prevention Program
Two years later, in 1990, the FDA issued this finding regarding Accutane-related birth defects: "The magnitude of injury and death has been great and permanent, with 11,000 to 13,000 Accutane-related abortions and 900 to 1,100 Accutane-related birth defects."
In May of 1991, an FDA report concluded that the Pregnancy Prevention Program was not working as many patients continued to get pregnant while on Accutane.
In response to calls to withdraw Accutane, Roche proposed more intensive patient education on the drug's risks of birth defects.
With Accutane still on the market and still being prescribed to females of child-bearing age, in 1996 the FDA required that an Accutane Medication Guide be provided to every patient for whom Accutane was prescribed. Also known as a MedGuide or PPI (patient package insert) the Accutane Medication guide, states in part: "Accutane can cause birth defects (deformed babies) if taken by a pregnant woman" and can cause miscarriage, premature birth and infant death.
Of particular concern is the fact that this dangerous drug is not even being reserved for severe and disfiguring acne. In 1996, a press account of FDA documents stated, "More than 90 percent of females treated with Accutane did not have severe cystic acne."
In August of 1997, the FDA accused Roche of failing to submit adverse reports, which drug companies are required by the FDA to report. In February of 1998 an FDA memo concluded that Roche "had not acted in good faith to truly and accurately answer questions relating to Accutane use in women and pregnancy exposure." The memo recommended "active consideration of removal of Accutane from the market.
In 1999, a Boston University study indicated that about 3 in 1000 women who took Accutane became pregnant.
In 2002, with pregnancies continuing and the drug still on the market, the FDA required Roche to take additional steps to prevent pregnancy in patients taking Accutane. Roche responded by requiring that a woman sign a patient information/consent form and have two negative pregnancy tests prior to beginning treatment with Accutane and must take a pregnancy test each month while on the drug. Only after the testing can the prescription be refilled. Two forms of birth control are also required while the woman is using Accutane and for at least a month after.
If you or a loved one has suffered from the birth defects, miscarriages and other pregnancy complications from taking Accutane, please call or e-mail our Accutane birth defects attorneys today and we will evaluate your Accutane claim for free.