Parker Waichman LLP Injury Alerts
ACCUTANE: Another Example of the Risk versus Benefit Equation Gone AwryJan 1, 2004 In each of our Newsletters dealing with dangerous prescription drugs we have stressed the two factors which have repeatedly proved to be problematic with respect to the marketing of such drugs. The first is purely one of timing. All too many drugs are being released long before their safety has been fully evaluated or demonstrated. Public Citizen/Health Research Group (http://www.citizen.org/hrg), a highly regarded watchdog organization, now strongly suggests that people not use most prescription drugs for a period of seven years from the date they are first released.
Unfortunately, the goal of pharmaceutical companies is to bring new drugs to market as quickly as possible since their financial stake in each new drug is enormous, and the competition between manufacturers is fierce. As a result, direct to consumer advertising, which often uses well-known celebrities and athletes as spokespersons, has been utilized to bombard the public with attractive ads which make it appear as if all new drugs are extremely beneficial and relatively harmless. Potential side-effects and adverse reactions which may be quite serious, or even fatal, are usually relegated to small print on the bottom of the television screen or printed advertisement, or compressed into a brief verbal statement at the end of the commercial.
The second problem, which is quite troublesome to say the least, is the dramatic increase in the harm or risk that will be tolerated when weighing the potential benefits of a new prescription drug. Traditionally, even drugs which promised significant benefits would be subjected to greater testing over longer periods of time when significant side-effects or adverse reactions were possible. If the drug was developed to treat a relatively minor condition, the possibility of dangerous side effects usually spelled the end of the drug in terms of FDA approval for marketing. Today, however, drugs are routinely given FDA approval without sufficient long-term testing and without adequate warnings despite evidence of significant side-effects and adverse reactions. This has repeatedly resulted either in the need for upgraded warnings one or more times after a drug is already on the market or in dangerous drugs being pulled from the market only after causing numerous serious injuries or deaths.
Probably the most alarming situation today, however, is when a drug designed to treat a relatively minor condition is approved by the FDA and permitted to remain on the market despite clear evidence of significant side effects or adverse reactions. In such cases, the risk versus benefit equation has all but vanished from the pharmaceutical companies’ consideration and the FDA’s standards. Accutane is an example of such a drug.
What is Accutane and why are people willing
to ignore its potentially serious side effects:
Accutane is a prescription drug, manufactured by Hoffman-LaRoche Pharmaceuticals, with an active ingredient called Istotretonin. It is primarily used to treat nodular acne, a condition that is resistant to other treatments, including antibiotics, and is characterized by the appearance of many nodules or cysts. These nodules are inflammatory lesions filled with pus and get lodged deep within the skin. The lesions can cause pain, permanent scarring, and negative psychological effects. Since the use of Accutane may carry with it extremely serious side effects, it is imperative that those interested in beginning treatment discuss the severity of their condition with their physician to determine whether the possible benefits of Accutane are worth the risks associated with it. One must remember, however, that as serious as the acne may be, it is still acne and not a life-threatening or debilitating disease.
A brief list of the more serious potential side effects include birth defects when taken by pregnant women, psychological problems including possible suicide, neurological problems, stomach, bone and muscle problems, hearing and vision problems, problems with fats and cholesterol in the blood, and various allergic reactions. Some minor side effects include dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds.
One of the main problems with Accutane was that, when it was first approved by the FDA in 1982, it was “hyped” as the biggest breakthrough in acne treatment over the past 20 years. It is still the only drug that has been known to clear up severe acne after only one course of treatment which lasts approximately five months. Accutane was, therefore, immediately attractive to those with cases of severe acne and their parents.
About 550,000 prescriptions are written for Accutane each year and about 15 million have been issued since the drug first appeared on the market. Approximately 85% of the patients who take Accutane report a complete and prolonged remission of their acne. While Accutane offers real hope (both physical and psychological) to those afflicted with the type of serious acne sometimes indelicately referred to as “pizza face”, is that potential benefit worth the enormous risks?
Part of the hype stems from the fact that people who have severe acne are looking for a miracle cure, something that will allow them the chance to clear up their skin and have it stay that way permanently. These people have suffered more than just pain and the physical manifestations of severe acne. Invariably, they have also suffered intense emotional suffering brought about by varying degrees of embarrassment, self-consciousness, rejection, and humiliation. Understandably, Accutane often presents an attractive option to people who have become quite desperate to simply live and enjoy a “normal” life.
The original warnings prove inadequate:
As with many of the newer prescription drugs, the original warnings concerning Accutane were thought to be adequate. In January of 2001, however, Roche began mailing doctors, psychiatrists, and pharmacists, information about the recent discovery of links between Accutane and various psychological problems. By that time, the FDA had already received reports concerning 66 suicides and 1,373 cases of psychiatric problems. The drug’s information packet had already been updated in 1986 to include information about links between Accutane and depression.
The new update now includes a warning specifically related to the development of suicidal tendencies. In fact, those taking the drug must now sign an acknowledgment that they are aware of the psychiatric risks, including depression, feelings of sadness, irritability, unusual tiredness or appetite loss, and suicidal thoughts associated with Accutane usage. (This fact makes the purchase of Accutane on the internet quite dangerous). The drug now comes complete with a medication guide detailing both the pros and cons of using Accutane and what to look for in terms of symptoms of side-effects.
Another significant, and often ignored, risk
makes Accutane even more dangerous:
Birth defects are another severe side-effect that medical professionals are now quite concerned about. While birth defects are specifically listed as a possible side effect associated with Accutane, there are still women who are using the drug without being properly aware of the harm it can do to their unborn child. The list of possible birth defects include: hydrocephaly (enlargement of the fluid-filled spaces of the brain); microcephaly (small head); heart defects; facial deformities; and mental retardation. The number of patients taking the drug has increased and almost half are females in their childbearing years between the ages of 15 to 44.
From the time Accutane was first released up until 2001 there had been 2,181 reports of women becoming pregnant while using Accutane. Within that number there have been 1,310 elective abortions, 242 spontaneous abortions, 192 normal babies born, and 166 reports of babies with birth defects. The warnings originally released with Accutane in 1982 designated it as Category X, which means that it must be avoided under all circumstances by pregnant women and nursing mothers. Yet in 1983 reports of babies being born with certain defects began to surface. As a result, in 1988, Roche launched the Pregnancy Prevention Program (PPP) in order to educate women about the dangers of using Accutane while pregnant.
The PPP kit included a contraceptive booklet, checklists to help assess whether patients could comply with the drug’s requirements, and a consent form for patients to sign stating that they were fully aware of the risk of birth defects. Although most women have been more careful when using Accutane, pregnancies have still resulted in situations where hormonal contraception alone was used. It has now been emphasized that two forms of contraception are necessary for women who are sexually active while on an Accutane regimen.
In 2001, Roche and the FDA also developed what is known as the System to Manage Accutane-Related Teratogenicity (SMART), a plan which requires those female Accutane users in their childbearing years, who have not had hysterectomies, to take and submit a pregnancy test every month before receiving a 30-day refill of the medication. In addition, before receiving the initial prescription, women must have two negative pregnancy tests. Prior to these restrictions, there were still a fair amount of pregnancies being reported by female Accutane users. However, since the introduction of the PPP and SMART programs, women in general seem to be more aware of these particular risks associated with Accutane and, as a result, fewer “at risk” pregnancies have been reported.
Additional risks associated with Accutane:
While the risk of significant (and often life-threatening) psychological problems and serious birth defects are clearly two of the most serious potential Accutane-related risks, there are many more possible side effects which are also specifically listed in the warning that accompanies all Accutane prescriptions. These other risks, some of which were mentioned earlier, include ulcerative colitis, Crohn’s disease, inflammatory bowel disorder, rectal bleeding, abdominal pain, central nervous system injuries, bone and muscle loss, cardiovascular injuries, liver and kidney damage, pancreatitis, immune system disorder, lupus, hearing and vision damage, and thyroid disorders.
The enormous number of serious risks associated with Accutane has made it one of the most closely monitored prescription drugs in history. The following represent only some of the large number of Accutane-related cases and reports:
* In October of 2002, a 15-year-old high school student in Palo Alto, California, who was taking Accutane for acne, committed what was noted as an apparent suicide when he threw himself in front of a train. His parents claim that Accutane was the cause of this and have commenced a lawsuit against Roche.
* The family of a 22-year-old Virginia man who committed suicide while taking Accutane is now suing Roche for $2.5 million.
* In November of 2002, the FDA said that in addition to the known side-effects, Accutane may now also be related to aggression and violent behavior in users. This new information has been added to the warning labels.
* In April of 2002, the family of a 15-year-old boy, who crashed a stolen plane into a Tampa, Florida high-rise, sued Roche for $70 million citing Accutane as having prompted their son’s suicidal behavior.
* In May of 2002, Liam Grant, the father of a boy who committed suicide after taking Accutane, sought to have the drug banned by registering a complaint with the Medicines Control Agency (MCA), the body that licenses drugs in Britain.
* In 2001, a dermatologist named Dr. Frank W. Yoder, who was hired by Hoffman-LaRoche, began to speak out about his concerns regarding Accutane after his tests yielded troubling results. The company then filed a lawsuit in an attempt to conceal Yoder’s information in order to limit unfavorable publicity about the dangerous side effects of Accutane and also to discourage parents of children with birth defects from suing the company. Hoffman-La Roche claimed that the research information was highly confidential and Yoder’s responsibility to the company was to keep it that way.
* In 2000, United States Congressman Bart Stupak said his 17-year-old son’s suicide was probably linked to his Accutane medication.
Taking into consideration the enormous amount of literature on the subject, it is clear that for those contemplating a regimen of Accutane to treat their acne, the documented risks posed by the drug far outweigh the benefits to be gained through its use. Some people will argue that without Accutane their lives were difficult and they had already been living with depression and anguish as a result of having severe, untreatable acne. While this may be true, the problems pale in comparison to risks such as suicide, permanent birth defects, and many of the other side effects associated with the drug. Very few prescription drugs have ever carried such serious warnings or have required signed acknowledgments of those risks from the patients themselves.
Before beginning treatment, people interested in taking Accutane should be extremely familiar with both the pros and cons of the drug and should have several conversations with their physician or dermatologist to be sure that Accutane is right for them. Careful medical monitoring should accompany the drug’s use and the patient’s family and friends should be vigilant for any personality changes or other signs that the drug may be having a dangerous emotional or psychological impact on the person involved. Certainly, Accutane should not be taken by any person who is under stress and not being monitored properly on a daily basis (such as college students living away from home) or by pregnant women and nursing mothers.
If you or anyone you know have been taking Accutane and have experienced any of the side-effects mentioned in this article, or have had any unusual physical or psychological reactions, you should discontinue the drug and immediately consult your and physician. If you believe think you may have an Accutane-related case, you should contact Parker & Waichman for a free case evaluation and answers to any questions you might have.
In our October 2003 and August 2002 Newsletters we brought you up-to-date information about the herbal supplement Ephedra which has been linked to heart attacks, strokes, and sudden death. According to Bush administration officials, as of December 2003, Ephedra will now be banned in the United States. The ban marks the first time that the FDA has removed a dietary supplement from the market since 1994, and although it will not take effect for several months, the Secretary of Health and Human Services has urged consumers to stop taking Ephedra entirely. The ban will most likely generate a court challenge from Ephedra manufacturers who still contend that the supplement is safe when used as directed. The problem is that it is virtually impossible to monitor Ephedra use and people are putting themselves at risk when they do not use the drug properly. Critics call the ban long overdue. New York and Illinois have already banned Ephedra and Florida has a ban on its sale to minors. Canada is considering restrictions on the substance and a number of stores including GNC have self-imposed bans on its sale in any form.
We are again recommending that anyone now using Ephedra stop taking it immediately and consult their physician if they are experiencing any possible adverse effects. Those who have questions or believe they may have an Ephedra-related case should contact Parker & Waichman for further information or a free case evaluation.