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Accutane (isotretinoin) Information
Accutane Side Effects | Legal Information
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 Birth Defects
Pursuant to FDA Rules and Regulation, the reporting of Adverse Side Effects is on a voluntary basis. In other words, the doctor, hospital, or other medical person or facility are not required by law to report an adverse side effect from a drug. The FDA reported that perhaps only one in one hundred side effects ever get reported. One could only imagine about how many serious Adverse Side Effects there are from taking Accutane, that have never been reported to anyone!
Under Federal Law, the manufacturer of a drug is required to revise its label to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug.
The FDA has required Hoffmann-La Roche to revise their Accutane label numerous times. Because of birth defects and other serious side effects, Accutane has been before the FDA in excess of twenty times. Despite the increased warnings, and measures taken under the direction of the FDA, birth defects remain one of the most troubling side effects of Accutane. Roche's most recent label states, CONTRAINDICATIONS AND WARNINGS: Accutane must not be used by females who are pregnant. Although not every fetus exposed to Accutane has resulted in a deformed child, there is an extremely high risk that a deformed infant can result if pregnancy occurs while taking Accutane in any amount even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. Presently, there are no accurate means of determining, after Accutane exposure, which fetus has been affected and which fetus has not been affected.
Major human fetal abnormalities related to Accutane administration in females have been documented. There is an increased risk of spontaneous abortion. In addition, premature births have been reported.
Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted.
Cases of IQ scores less than 85 with or without obvious CNS abnormalities have also been reported.
Perhaps the birth defects caused by Accutane are the saddest of all the adverse side effects of the drug. Tiny little babies are either killed by the drug, or suffer from horrible defects caused by the drug for as long as they live. They have no choice in the matter and are completely innocent. There have been thousands of elected abortions because the mother became pregnant while taking Accutane. There have also been thousands of spontaneous abortions as a result of the mother taking Accutane while she was pregnant. Either way, it means the death of a baby.
Congressional Investigation
Because of birth defects and psychiatric side effects, Accutane and its manufacturer, Hoffmann-La Roche, Inc. are currently the subject of a Congressional investigation. The Subcommittee on Oversight and Investigations of the House of Representatives Energy and Commerce Committee reconvened its investigation into Hoffmann-La Roche and Accutane in early December 2002. One of the members of that Committee, Congressman Bart Stupak stated the following during the Congressional Hearing.
The drug manufacturer, Hoffmann-La Roche, ... has continued to put profits before people. They have done everything possible to prevent the American people from learning of the psychiatric injuries and deaths associated with Accutane. Even, today I'm sure Roche will deny any causal effect of Accutane with the abortions, deaths, and suicides caused by their product.
The drug was licensed by the Food and Drug Administration (FDA) in 1982 as an oral prescription drug for the treatment of severe acne. However, he raised serious concerns that many individuals have been prescribed this drug for less severe forms of acne.
During the Congressional Hearing, the President and Chief Executive Officer of Hoffmann-La Roche, Inc. (USA), George B. Abercrombie, testified before the Committee. After giving various statements and making representations under oath regarding studies, marketing, clinical trials, and Roche's relationship with entities in Mexico, two members of the Committee told Mr. Abercrombie they did not believe his testimony, and that he had given the testimony in front of the Committee with a "straight face." Significantly, not a single member of the Committee spoke in support of Hoffmann-La Roche. The investigation is continuing.
About Birth Defects, Accutane & Hoffmann-La Roche
Because of severe birth defects caused by Accutane, it has been compared to Thalidomide, and said to be on the same scale as Thalidomide. A representative of the March of Dimes told a Congressional Committee investigating Accutane and Hoffmann-La Roche that despite current voluntary safety measures taken by the manufacturer, many pregnant women and their developing fetuses are continuing to be unnecessarily exposed to this drug and major birth defects have developed in their babies. ...The March of Dimes strongly recommends FDA-mandated implementation of a single program that is designed to put in place a more stringent system that would reduce exposure to developing fetuses from Accutane/isotretinoin.
SOME HISTORY OF ACCUTANE & BIRTH DEFECTS -
Accutane is produced by Hoffmann-La Roche. It was approved by the FDA in September 1982, for use in cases of severe recalcitrant cystic acne unresponsive to other therapies including systemic antibiotics.
At the time of approval, it received an FDA pregnancy Category X rating, because it had been shown to cause birth defects in animals. Category X designation means that because of the dangers posed by this drug in pregnancy, Accutane should not be used by women who are pregnant or are at risk of becoming pregnant. Patient benefit never outweighs fetal risk.
Soon after market introduction in September of 1982, reports of children born with birth defects due to in utero Accutane exposure began to appear in the literature and to be received by the FDA.
In 1984, the FDA convened its Dermatologic Drugs Advisory Committee to discuss the problem of Accutane and pregnancy exposure. The Committee recommended that product labeling be "strengthened" to warn physicians and patients of the risks to the fetus posed by first trimester exposure to Accutane.
In 1985, an article appeared in the New England Journal of Medicine describing "isotretinoin embryopathy," the constellation of birth defects attributable to Accutane. From this report, it was estimated that in about 33% of the cases, the danger arose because women were being started on Accutane after they had become pregnant. Up to 25% of pregnancies with first trimester exposure which came to delivery had a birth defect, with severity ranging from mild to severe. Birth defects could involve the head, face, brain, or heart.
In 1988, an FDA report found evidence that Accutane was being used on women of childbearing age, far in excess of the labeled indication. It was being used on women with milder or no acne. Although the incidence of severe cystic acne was roughly two and a half times higher in men than in women, Accutane usage was nearly equal. Dermatologists prescribed 80-90% of the drug. The report also estimated that up to 5% of women of childbearing potential treated with Accutane between 1982 and 1986 had experienced first trimester pregnancy exposure to it. Of these, at least 60% had undergone induced abortion (a two-fold increase above the baseline national rate). This report recommended that the FDA consider removing Accutane from the market as an "imminent hazard."
The FDA's Dermatologic Drugs Advisory Committee, which didn't want to accept the implication that dermatologists were prescribing Accutane outside its labeled indication, and didn't want to accept the evidence that large numbers of pregnancy exposures, birth defects and abortions had occurred. This Committee recommended that the product label for Accutane be strengthened, that a program be started to educate physicians and patients on the use of this drug and its risks, and that women be required to sign an informed consent prior to treatment with it.
The FDA and Hoffmann-La Roche rewrote the product label for Accutane. The new label implied that the risk of severe birth defect was virtually 100% and that this risk applied to all trimesters of pregnancy. The professional labeling (that intended for physicians) also included a line drawing of the head of a child with a composite of numerous defects. Further down on the label was a statement instructing women who become pregnant while using Accutane to discuss with their physicians the "desirability of continuing the pregnancy." At a May 1989 Advisory Committee meeting, Dr. Sidney Wolfe of the Health Research Group told the FDA and the Committee that this labeling would "coerce women" into abortion.
Hoffmann-La Roche implemented its "Pregnancy Prevention Program," which included physician educational mailings, educational advertising, and visits to physician offices by company representatives to deliver a "Pregnancy Prevention Kit." This kit included various forms for the physician to use in determining if female patients met the labeled indication for the drug and to assist in educating them about the teratogenic risk and the need to practice contraception while on Accutane.
In a letter to Hoffmann-La Roche, the FDA stated that the purpose of the "Pregnancy Prevention Program" was not simply a reduction of birth defects but the elimination of pregnancy exposure. At three open public Advisory Committee meetings on the subject of Accutane held in 1989 and 1990, officials of the FDA publicly stated that the goal of the Program was to limit the use of Accutane to those women with the labeled indication and to eliminate pregnancy exposure.
In 1989, the FDA presented the Accutane issue to two separate groups, the Dermatologic Drugs Advisory Committee and the Fertility and Maternal Drugs Advisory Committee. The composition of the Dermatologic Committee is almost exclusively dermatologists and that of the Fertility and Maternal Drugs Committee almost exclusively gynecologists. These meetings were intended as progress reports to update the committees as to what had happened in the year since the 1988 meeting. An FDA report was prepared which concluded that there was little evidence of substantive change in the problem. It also described for the first time the problem of contraceptive failure and its implications for the Pregnancy Prevention Program.
In May 1990, and FDA report was prepared assessing the impact of the Pregnancy Prevention Program during 1989. This was presented before a combined meeting of the Dermatologic Drugs and the Fertility and Maternal Drugs Advisory Committees. Since the start of marketing in 1982, Accutane had been prescribed to over 600,000 women of childbearing, representing more than 1% of women in this age range. Based on national data relating to the use of contraception and contraceptive failure, it was estimated that 2-3% of women treated with Accutane had had a first trimester pregnancy exposure to the drug. Furthermore, based on data from a survey paid for by Hoffmann-La Roche, it was suggested that many physicians were not performing serum pregnancy tests prior to starting their female patients on Accutane; indeed, the great majority of women treated with Accutane during the first year of the Pregnancy Prevention Program had had at least one absolute contraindication to the use of the drug. Nevertheless, the combined Committee decided that it was too soon to make a decision on whether the Program had succeeded or failed.
In May 1991, an FDA report was written in preparation for an advisory meeting scheduled for the end of the month. This report concluded that the Pregnancy Prevention Program had failed to achieve either of its primary goals, and that in fact the two goals were inconsistent because Accutane could not be given to women without pregnancy exposure to it occurring, because of contraceptive failure if for no other reason. The level of Accutane use in women of childbearing age had not changed much from the previous year, with an estimated 57,000 new women and more than 100,000 women (new and retreatment) receiving Accutane during 1990. Of this group, an estimated 2-5% had first trimester pregnancy exposure to the drug, with over 75% of these ending with either spontaneous (drug-induced) or medically induced abortion. About 30% of pregnancy exposures were due to Accutane being prescribed and started in women after they had conceived; that is, substantial numbers of exposures were the result of Accutane being given to pregnant women by their physicians. Updated data from the survey sponsored by Hoffmann-La Roche was used to show that fewer than half of the women treated with Accutane and enrolled in the survey had a serum pregnancy test performed prior to starting the drug, and that more than 95% of women enrolled in the survey had one or more absolute contra-indications to the use of Accutane as defined in the drug's label. The report concluded that Accutane could not be given to women without pregnancy exposure occurring in 2-5% of cases, with subsequent fetal injury or death (due either to Accutane itself or to induced abortion) in the majority of these. This report was over-ridden by FDA officials who disagreed with the report's conclusions and recommendations.
At the advisory meeting of the combined committees held on May 21, 1991, the goals of the Pregnancy Prevention Program were not stated, abortion due to Accutane was not mentioned, and the magnitude of pregnancy exposure to the drug was hardly discussed. The committee decided that the language describing the indication for Accutane should be broadened, that product labeling should state that the estimated risk of birth is about 25%, and that the Pregnancy Prevention Program was successful, with no major changes in marketing or use of Accutane required.
POINTS TO PONDER -
1. In 1989, it was learned publicity that during the controlled clinical trials of Accutane prior to its marketing (1982), 5% of the women enrolled in these studies became pregnant while on Accutane, despite signed informed consent, contraceptive counseling and use, and education about the potential risk of birth defects. These pregnancies ended with abortion, and the enrollment of women in the studies was reduced.
2. Product labeling has never described this fact, nor has its implication for fetal safety (or lack thereof) been publicly discussed.
3. Within the FDA, abortion has been viewed as an acceptable solution to the problem of Accutane usage and pregnancy exposure. Hoffmann-La Roche has viewed abortion as the solution since early in marketing. The reasoning offered by the manufacturer and by officials within the FDA is that the real goal of the Pregnancy Prevention Program is the elimination of birth defects, which can be accomplished in two ways: (1) prevent pregnancy exposure from occurring or (2) prevent those exposed pregnancies from coming to delivery by abortion. The thrust of product labeling and the full awareness of contraceptive failure from even before the time of marketing show which approach has been adopted. FDA officials have been careful to avoid or prevent public discussion of this for fear that pro-life groups would learn that what is occurring is "abortion for cosmetic reasons."
4. The use of advisory committees by the FDA for this issue shows how the underlying bias among committee members can be used to guarantee that certain FDA policies or decisions will be recommended or affirmed by the Committee. Data for 1990 show that over 90% of all Accutane was prescribed by dermatologists, that most women receiving the drug didn't have the disease for which the drug was approved, and that most women didn't even have an initial serum pregnancy test performed by their physician before starting Accutane. How likely is it that dermatologists sitting on this committee, representing the constituency responsible for the magnitude of the existing problem, would ever find fault with the status quo, would ever recommend major changes in marketing? How likely is it that a committee of gynecologists would be sensitive to the abortion issue, which lies beneath the surface of Accutane use in women? Although one would think that pregnancy category X designation was intended to protect fetal health as a priority over that of the patient directly receiving the drug, the FDA has consistently chosen to champion the interests of those advocating unblemished complexions, at a cost of thousands of fetal deaths which have been silently swept under the rug by the FDA bureaucracy and the producer of Accutane.
5. In 1989, Dr. Edward Lammer presented data showing that up to 40% of pregnancies exposed to Accutane during the first trimester ended with spontaneous abortion (miscarriage) which is three times higher than occurs among pregnancies where no Accutane has been used. (This should be combined with the data showing that about 60% of remaining pregnancies end with induced abortion; the end result being that fewer than 25% of first trimester pregnancies exposed to Accutane reach delivery. Of those coming to delivery, as already noted, up to 25% may have a birth defect of some degree of severity.)
6. As of December 11, 2002, no adequate program to eliminate birth defects from Accutane has been put into place. Officials of the FDA and other groups interested in preventing birth defects as a result of Accutane exposure, are at a loss as to how to prevent birth defects from the drug, absent withdrawal from the market.
FDA - Accutane Information Page
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If you believe you have been injured or have suffered a severe side effect from the use of Accutane, it may be that you are entitled to compensation.
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