Researchers Find Some Women Still Unaware of Serious Birth Defects Linked to Accutane Use during Pregnancy

For some time now, 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, now provide information about this adverse health risk in the labeling and packet information for Accutane.

New information, however, indicates, that despite all the warnings, some women continue to use Accutane while pregnant.

A recent report appearing online in Birth Defect Research 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 hadn’t been counseled about birth control prior to taking Accutane, and 25 said that they had not taken a second pregnancy test before taking the drug. Obviously, these women may contact <"">personal injury lawyers in order to start Accutane lawsuits against the drug’s manufacturer or negligent doctors.

In light of these continued problems connected to education about the drug, the FDA introduced a new program with an entirely new set of rules for Accutane.

Up until recently, 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.

For more information about iPLEDGE visit or call (866) 495-0654.

Since its approval in 1982, the drug 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, the maker of Accutane, 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, applauds the recent efforts of the FDA. Still, the organization has its doubts about the new registry.

For one thing, the registry will 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 is 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. 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.

This entry was posted in Legal News. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.