Clinical trial very telling about Accutane risks

One way to check the veracity of a medication’s increased risk of complications might be to follow the (research) money. For instance, if clinicians don’t want clinical-trial participants to be pregnant or to become pregnant during the analysis, then the researchers probably know something about the fundamental incompatibility of fertility and the drug — information about which the manufacturer of the drug has a duty to know and to issue warnings.

This appears to be the case with Accutane. From its U.S. Food and Drug Administration approval in 1982 to its strictly market-based withdrawal in 2009 by Hoffmann-La Roche Inc., an estimated 13 million patients had taken Accutane, which contained isotretinoin.

Expected to have been completed in December 2012, the results of an interesting Brazilian clinical trial, testing the effectiveness and safety of low-dose isotretinoin, have not been posted yet by the National Institutes of Health. Although the outcome has not been published, this we know: Researchers did everything in their power to preclude fetal exposure to the acne-treatment drug.

What a pity that women who were pregnant or who were likely to become pregnant lacked the options that researchers nowadays have exercised — minimizing, if not precluding, the increased risk of birth defects and other fetal dangers.

Isotretinoin medications are marketed in the U.S. today through the FDA’s restrictive risk-management program, one of the safety objectives of which is to reduce fetal risks. The program’s procedures include patient counseling, spousal counseling, a patient pledge to use two FDA-endorsed methods of contraception, patient answers to health-related questions prior to refill, and mandatory formal pharmacy requests for FDA authorization to sell the drug.

Sotret is an isotretinoin drug marketed under this special oversight; this passage is nothing more than an example of how the FDA treats isotretinoin. Its warnings include the following: “Sotret must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin capsules in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.

“Birth defects which have been documented following isotretinoin exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported.”

A woman who took Accutane and whose child has suffered from birth defects got a raw deal, and she ought to be entitled to compensation. There is no turning back from victimization.

Think about what mothers go through — and not solely when these kids become teenagers. They conscientiously carried a child in their bodies, felt a prenatal connection to that child that a man cannot possibly begin to process, exercised the utmost prenatal care, lay in the protracted pains of labor, and bestowed life.

But, throughout their pregnancies, too many of these Accutane mothers unwittingly and irreversibly compromised the quality of that life because they took a prescription drug that they did not know — and should have known — was not worth the increased risk.

For those who believe these truths are solely about the filing of an Accutane lawsuit, look at an Accutane victim one day, in person or in a photograph. There may not be an opportunity, but, if so, talk to his or her mother about what it would mean to her to have the days near conception and the ensuing nine months back — with an opportunity to give her baby the life that the parents intended, the life that the offspring deserved and should have had. Can you look that mother dead in the eyes and tell her that a simple mea culpa is all to which she is entitled?

For too many people, for a lot of families, Accutane’s increased risk inflicted an inexorably devastating toll. The drug’s birth defects risk was unreasonable. And victims deserve compensation. That is where the Accutane attorneys at Reich & Binstock proudly and resolutely stand.

With nearly 30 years of experience handling the most complex pharmaceutical injury litigation, the personal injury attorneys at Reich & Binstock will study the situation of anyone who believes there is a case for an Accutane lawsuit and accordingly will advise her or him as to the viability of all legal options. This consultation is free-of-charge.

Reich & Binstock may be reached either through the electronic form on its Web site, www.reichandbinstock.com, or toll-free at 1-866-LAW-2400.