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While Dermatology Association Labels Accutane Registration System a Disaster, Advocates of Strict Control of the Drug Say Criticism is Exaggerated

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By Steven DiJoseph

For years, it has been well-publicized that Accutane, a drug used to treat severe acne, can pose a significant risk of birth defects if taken during pregnancy.

Both Accutane and its generic versions, which include the active ingredient known as Isotretonin, are known to cause birth defects when taken by pregnant women.

The FDA and the drug’s manufacturer, Hoffman-LaRoche, already provide information about this adverse health risk in the labeling and packet information for Accutane.

Unfortunately, research continues to indicate that despite all the warnings, some women continue to use Accutane while pregnant. This has been an ongoing problem for 23 years during which time the FDA has been unsuccessful in some 40 initiatives to prevent women from taking the drug while pregnant.

A report appearing online in Birth Defect Research in 2005 found that 34 women called a hotline run by the Organization of Teratology Information Services between April 2002 and September 2004 claiming they didn’t remember hearing the guidelines relating to Accutane usage and pregnancy. (A teratogen is a substance that causes birth defects.)

Surprisingly, eight of the 34 women said that they didn’t recall being counseled about birth control prior to taking Accutane, and 25 said that they had not taken a second pregnancy test before taking the drug.

In light of these continued problems connected to education about the drug, and partly in order to avoid personal injury litigation, the FDA introduced a new program with an entirely new set of rules for Accutane that will become mandatory on March 1.

Previously, women who wished to begin treatment with Accutane had to get birth control counseling and have two negative pregnancy tests prior to beginning treatment with the drug.

The new program, called “iPLEDGE,” requires that all women of childbearing age take the following steps:

· Sign an informed consent form in their doctor’s office;

· Personally register with iPLEDGE;

· Take two negative pregnancy tests in a doctor’s office within seven days of beginning treatment;

· Agree to use two forms of birth control while taking the drug;

· And get another negative pregnancy test in a doctor’s office within one week of requesting a refill.

Men are also asked to sign an informed consent form to indicate that they too are aware of the risks but they do not have to personally register with iPLEDGE.

Doctors, pharmacies, and wholesalers are required to register with iPLEDGE. Doctors must make sure that patients are aware of the drug’s risks before they sign a consent form and begin the procedures to ensure safety in relation to Accutane usage.

Pharmacies must make sure that they log onto iPLEDGE before filling a prescription for Accutane to make sure that the patient has taken the necessary safety steps. Finally, wholesalers must agree to only supply Accutane to pharmacies that have registered with iPLEDGE.

Information about the iPLEDGE program was also made available at (866) 495-0654, or online at www.ipledgeprogram.com.

Since its approval in 1982, thedrug has been linked to serious potential Accutane side effects including:

  • 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
  • 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
  • thyroid disorders
  • various allergic reactions
  • Some minor side effects include dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds.

In 1998, the Food and Drug Administration advised doctors who prescribe Accutane to watch their patients for signs of depression. Afterward, Hoffman-LaRoche notified doctors that the drug “may cause depression, psychosis, and, rarely, suicidal ideation, suicide attempts and suicide.”

This was one of the first indications that Accutane was headed for further problems. In January 2001, 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.

Birth defects are perhaps the most severe side effects to be linked to Accutane. 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 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) with a kit that 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.

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.

Since Accutane’s market approval, there have been 2,000 incidences of pregnancies among users, many of which ended in abortion. The FDA, however, has calculated that more than 160 babies were born with defects directly attributable to Accutane usage.

It is likely that there were actually more pregnancies that occurred in female Accutane users because there was no system for reporting Accutane-linked pregnancies at the time.

Apparently, however, these precautions and amendments relating to Accutane were not enough to prevent the continuation of some of the most severe side effects associated with the drug.

Reports of suicides and birth defects relating to Accutane continued to surface forcing the FDA and Roche to once again review Accutane’s warning label.

In May of 2005, a new study published in the American Journal of Psychiatry suggested that Accutane can actually change brain functioning. This is the first study to monitor brain functioning of Accutane patients and the first to show a direct biological link between the drug and depression.

The team of psychiatrists conducting the study found that the group of young adults taking Accutane showed decreased brain functioning of up to 21% in the front part of the brain – an area known to mediate symptoms of depression.

The authors of the study have now urged the FDA and Hoffman-La Roche to conduct further research on the drug. Accutane has now been linked to 266 cases of suicide in the United States including some high-profile cases such as the death of U.S. Congressman Bart Stupak’s son.

The March of Dimes, a national voluntary health agency whose mission is to improve the health of babies by preventing birth defects, premature birth and infant mortality, applauded the recent efforts of the FDA. Still, the organization had its doubts about the new registry.

For one thing, the registry does not regulate internet sales, therefore people can still acquire Accutane over the internet without understanding the severity of the health risks associated with it.

There was also concern that people might get confused with the many generic forms of isotretinoin and may still end up taking Accutane and putting themselves at risk without even knowing it.

In their alert regarding Accutane released in May of 2005, the FDA advised all Accutane patients to discontinue usage of the drug and inform their health care professional immediately if they experienced any of the following symptoms:

  • Feelings of sadness or crying spells
  • Loss of interest in activities once enjoyed
  • Sleeping too much or having trouble sleeping
  • Having increased irritability, anger, or aggressivity (i.e. temper outbursts, thoughts of violence)
  • Change in appetite or body weight
  • Trouble concentrating
  • Withdrawal from family or friends
  • Loss of energy
  • Feelings of worthlessness or inappropriate guilt
  • Thoughts of self-harm or suicide

In some situations, discontinuing the drug may not alleviate the problem and psychiatric evaluation or further medical investigation may be necessary.

Currently, litigation involving the following injuries is either in progress or being considered in a number of states:

  • Inflammatory Bowel Disease
  • Premature Closure of Growth Plates
  • Birth Defects
  • Ulcerative Colitis
  • Crohn’s Disease
  • Inflammatory Bowel Syndrome
  • 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
  • Thyroid Disorders

Many experts and consumer advocates believe the range of serious health risks (physical and psychological) associated with Accutane should have doomed the drug long ago. It is worth mentioning that recently a probe of the drug was launched by Health Canada as a result of an unusual number of strokes and heart attacks having been reported in people taking it. Everyone who associates his/her health problems with taking this drug shouldn’t hesitate initiating an Accutane lawsuit in Canada or elsewhere to get both moral and financial compensation. The fact that it is nothing more than a treatment for acne (regardless of how serious it may be) makes its survival all the more astounding to its critics.

Now, after only a few months of trial use of the registry system, the nation’s leading dermatology association, the American Academy of Dermatology, told an FDA advisory panel that the program was a “disaster.”

According to the Academy member Dr. Diane M. Thiboutot: “Pharmacies, prescribers and patients are confused and frustrated.” There have been hundreds of complaints from dermatologists prompting the association to request that the FDA delay the system’s mandatory starting date of March 1 by at least two months.

The agency has indicated it will rule on the request within a week. Proponents of the registry system maintain that the problems being encountered are being overblown.

The iPledge system was an effort to keep Accutane from being pulled from the market. The four manufacturers of the drug fully realized that, without reducing the number of miscarriages, abortions, and birth defects, Accutane’s days were numbered.

The strange thing about Accutane is that it was never intended to treat the huge number of patients for whom it is being prescribed. The severe, disfiguring type of acne the drug was designed for only affects some 6,000 patients in the U.S. Doctor’s, however, may prescribe the drug as they choose. Thus, over 2 million prescriptions for the drug are written each year.

As a result of what critics consider the over-prescribing of the drug, some 85,000 prescriptions each month are filled by women; many of these women become pregnant while taking the drug.

The problems with the system appear to be that it is inconvenient, cumbersome, and difficult to manage, while also suffering from slow telephone support when a doctor needs assistance. As a result, doctors are becoming discouraged and may simply stop prescribing the drug.

The FDA says it is aware of the problems and Covance, the company that operates the system, claims to be fixing them as quickly as possible. The process, however, often takes weeks to complete.

The strict regulations imposed by the iPledge system are seen as absolutely necessary by those who advocate tighter control of Accutane.

As reported in the New York Times, Dr. Peter A. Gross, the panel’s chairman and chairman of the department of internal medicine at Hackensack University Medical Center in New Jersey, dismissed the complaints. “You get no sympathy from me. If it takes a little more time, tough.”

In addition, Dr. Sidney Wolfe, director of health research at Public Citizen stated: “There is this never-ending whimpering coming from many dermatologists that someone is cramping their style and making it more difficult to prescribe something. The reason there are all these failed efforts to limit pregnancies is that dermatologists are prescribing Accutane to way too many people.”

According to the New York Times article: “Representative Bart Stupak, a Democrat from Michigan who has long advocated that Accutane be withdrawn from the market, said complaints about the new system were exaggerated. Mr. Stupak sent a letter to the committee insisting that there be no delays in putting the new control system in place.”

“‘But I expect that the F.D.A. will once again cop out and not do the right thing’ and agree to a delay, Mr. Stupak said in an interview.”

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