Deciding whether or not to alert patients to any potential treatment warnings before performing a procedure or prescribing a medication is not always a cut-and-dried issue. As a guideline, I figure that if a side effect has a 1 in 100 chance of happening, I think it is worth mentioning to a patient.
Using this communication guideline, I warn all patients for whom I prescribe intralesional kenalog (ILK) 3 mg/cc for inflamed acne cysts that they may experience atrophy, but that if they do, it is usually temporary. Specifically, I explain that a divet can result from both ILK or resolved inflammatory acne papules, pustules or cysts.
However, on the other hand, I do not routinely note that azithromycin has been correlated with development of transient, and even permanent, deafness (six cases reports) because this side effect is so rare when you take into consideration the millions of prescriptions written for this drug.
What We Need to Know Regarding Isotretinoin and Inflammatory Bowel Disease
That brings us to isotretinoin, a medication that in recent years seems to have engendered more discussion and controversy than the disease that it treats. Since its approval in 1992, up until 2000, 20 million prescriptions for isotretinoin were written. The Accutane patent expired on Feb. 7, 2002, but with the risk management program iPLEDGE, the isotretinoin molecule has not left the news.
Because of all of this attention, it is probably worth mentioning to patients all of the potential side effects to make them fully aware.
Rare Side Effect Worth Mentioning
A rather obscure side effect of isotretinoin is the induction of inflammatory bowel disease. Lawsuits have been filed regarding this side effect in several states including Nebraska and Illinois.
The first such trial ended last month when a jury ordered Hoffmann-La Roche to pay $2.6 million in damages. The corporation is appealing.
A lawsuit was reported in February of 2007 in Godfrey, Madison County, Illinois, involving 23-year-old Jason Christopher Peipert who sued both Roche Laboratories and his physician Daniel Goran, M.D., on Dec. 16, 2003. The claim was that Accutane caused him to sustain severe and permanent injuries.
The Madison County trial, which is set for October, will likely be watched around the country and could serve as a bellwether for hundreds of other lawsuits.
This section is based on a report in the Madison Record.1
Mr. Peipert claimed that Dr. Goran prescribed Accutane to him in 1999 for general care and treatment of acne. He claimed that Dr. Goran was negligent because he failed to recognize that Accutane is a difficult drug to manage in patients and failed to run diagnostic tests to ascertain whether he was developing the severe side effects of Accutane. Mr. Peipert also claimed that Dr. Goran prescribed Accutane to him more frequently and for periods longer than has been approved by the FDA and failed to advise him of the risks and side effects associated with Accutane.
According to court records, Mr. Peipert claimed that Accutane caused him to develop Crohn’s disease, the ulcerative and inflammatory disease of the bowel. He also claimed that once he began to experience certain side effects, Dr. Goran continued to prescribe the medication after failing to recognize that Accutane was causing the problems.
Mr. Peipert also cited the company, claiming that Roche either knew or should have known that Accutane was causally related to and associated with severe and life-threatening complications and side effects. He alleged that the medication was defective and contained unreasonably dangerous design defects and was not reasonably safe, therefore subjecting users to risks that outweighed the benefits of the drug.
Mr. Peipert also claimed that Accutane was insufficiently tested and that it caused harmful side effects that outweighed any potential utility. He further claimed that Roche failed to adequately instruct on the length of time an individual should be allowed to continue using Accutane.
On Feb. 20, 2007, Dr. Goran filed a motion for summary judgment claiming that none of Mr. Peipert’s witnesses disclosed opinions critical of his standard of care. Judge Hylla had not yet ruled on the motion. Dr. Goran, represented by Jeffrey Reel of Belleville, also claimed that Mr. Peipert did not develop symptoms associated with Crohn’s until 2 years after he stopped taking Accutane. Mr. Reel argued that there was no evidentiary basis from which the jury could conclude that he failed to properly advise Mr. Peipert of the risks and side effects of Accutane.
It should be noted that not all of these cases go forward. The family of a boy who killed himself by slamming a stolen single-engine plane into a skyscraper in Florida 4 months after the 9/11 attacks has dropped its $70 million lawsuit against the manufacturer of isotretinoin.
Other Evidence of a Potential Link
While all dermatologists are aware of the healing effects of isotretinoin, some data exist that link it to inflammatory bowel disease. In an article in the American Journal of Gastroenterology, Reddy et al examined all of the adverse reports filed with the FDA between 1997 and 2002 regarding isotretinoin to see if ulcerative colitis and Crohn’s diseases were linked to the use of isotretinoin.2
Specifically, Reddy was part of a group of investigators that queried the FDA for MedWatch reports containing the keywords isotretinoin, Accutane, colitis and IBD. In an article in Dermatology Times, Corey A. Siegel, one of the study’s authors, stated that “while the Physician’s Desk Reference lists IBD as a possible adverse event associated with use of isotretinoin, our goal was primarily to determine if this association was legitimate, and if so, what it means to physicians and patients.”3
The Results Of This Review
Reddy et al found 85 cases of ulcerative colitis and Crohn’s diseases associated with isotretinoin use. According to the Naranjo ADR probability scale, which evaluates the likelihood of a drug-related side effect:
• four cases (5%) scored “highly probable” for isotretinoin as the cause of ulcerative colitis and Crohn’s diseases
• 58 cases (68%) were “probable”
• 23 cases (27%) were “possible”
• no cases were “doubtful”.
Reddy et al concluded that in a subgroup of patients, isotretinoin might serve as a trigger for ulcerative colitis and Crohn’s diseases. Other reports from Europe have similarly noted that ulcerative colitis and Crohn’s diseases occur rarely following use of isotretinoin.4-7
I do not want to comment on the pending lawsuits — besides, the facts of every case are particular to that case. It would seem to me that ulcerative colitis and Crohn’s disease are only rarely linked to the use of isotretinoin; and in fact, the pyoderma faciale related to ulcerative colitis and Crohn’s disease is well treated with isotretinoin.8,9 On the other hand, the link of ulcerative colitis and Crohn’s disease to the use of isotretinoin was noted, however rare, in the 1980s and 1990s.10-12
What Should We Tell Our Patients?
It might seem prudent in the current litigation environment to query potential isotretinoin patients about depression, ulcerative colitis, Crohn’s disease, and other very rare side effects and warn them of the supposed association — however far-fetched — between acne and depression (which seems to have been disproved in a major study), ulcerative colitis and Crohn’s disease with isotretinoin use.
Perhaps iPLEDGE can be used as a platform to provide patients with data about obscure side effects of isotretinoin and require patients and doctors to document that isotretinoin might have rare side effects and that doctor and patient have considered these and decided that the benefits outweigh the risks of isotretinoin and that the patient has accepted the implications of risk.
It is widely accepted that malpractice cases and litigation flow from bad feelings that patients experience in regard to a doctor/patient interaction, even more so than bad outcomes. Educating patients and keeping lines of communication open are the first steps to avoiding litigation.
Deciding whether or not to alert patients to any potential treatment warnings before performing a procedure or prescribing a medication is not always a cut-and-dried issue. As a guideline, I figure that if a side effect has a 1 in 100 chance of happening, I think it is worth mentioning to a patient.
Using this communication guideline, I warn all patients for whom I prescribe intralesional kenalog (ILK) 3 mg/cc for inflamed acne cysts that they may experience atrophy, but that if they do, it is usually temporary. Specifically, I explain that a divet can result from both ILK or resolved inflammatory acne papules, pustules or cysts.
However, on the other hand, I do not routinely note that azithromycin has been correlated with development of transient, and even permanent, deafness (six cases reports) because this side effect is so rare when you take into consideration the millions of prescriptions written for this drug.
What We Need to Know Regarding Isotretinoin and Inflammatory Bowel Disease
That brings us to isotretinoin, a medication that in recent years seems to have engendered more discussion and controversy than the disease that it treats. Since its approval in 1992, up until 2000, 20 million prescriptions for isotretinoin were written. The Accutane patent expired on Feb. 7, 2002, but with the risk management program iPLEDGE, the isotretinoin molecule has not left the news.
Because of all of this attention, it is probably worth mentioning to patients all of the potential side effects to make them fully aware.
Rare Side Effect Worth Mentioning
A rather obscure side effect of isotretinoin is the induction of inflammatory bowel disease. Lawsuits have been filed regarding this side effect in several states including Nebraska and Illinois.
The first such trial ended last month when a jury ordered Hoffmann-La Roche to pay $2.6 million in damages. The corporation is appealing.
A lawsuit was reported in February of 2007 in Godfrey, Madison County, Illinois, involving 23-year-old Jason Christopher Peipert who sued both Roche Laboratories and his physician Daniel Goran, M.D., on Dec. 16, 2003. The claim was that Accutane caused him to sustain severe and permanent injuries.
The Madison County trial, which is set for October, will likely be watched around the country and could serve as a bellwether for hundreds of other lawsuits.
This section is based on a report in the Madison Record.1
Mr. Peipert claimed that Dr. Goran prescribed Accutane to him in 1999 for general care and treatment of acne. He claimed that Dr. Goran was negligent because he failed to recognize that Accutane is a difficult drug to manage in patients and failed to run diagnostic tests to ascertain whether he was developing the severe side effects of Accutane. Mr. Peipert also claimed that Dr. Goran prescribed Accutane to him more frequently and for periods longer than has been approved by the FDA and failed to advise him of the risks and side effects associated with Accutane.
According to court records, Mr. Peipert claimed that Accutane caused him to develop Crohn’s disease, the ulcerative and inflammatory disease of the bowel. He also claimed that once he began to experience certain side effects, Dr. Goran continued to prescribe the medication after failing to recognize that Accutane was causing the problems.
Mr. Peipert also cited the company, claiming that Roche either knew or should have known that Accutane was causally related to and associated with severe and life-threatening complications and side effects. He alleged that the medication was defective and contained unreasonably dangerous design defects and was not reasonably safe, therefore subjecting users to risks that outweighed the benefits of the drug.
Mr. Peipert also claimed that Accutane was insufficiently tested and that it caused harmful side effects that outweighed any potential utility. He further claimed that Roche failed to adequately instruct on the length of time an individual should be allowed to continue using Accutane.
On Feb. 20, 2007, Dr. Goran filed a motion for summary judgment claiming that none of Mr. Peipert’s witnesses disclosed opinions critical of his standard of care. Judge Hylla had not yet ruled on the motion. Dr. Goran, represented by Jeffrey Reel of Belleville, also claimed that Mr. Peipert did not develop symptoms associated with Crohn’s until 2 years after he stopped taking Accutane. Mr. Reel argued that there was no evidentiary basis from which the jury could conclude that he failed to properly advise Mr. Peipert of the risks and side effects of Accutane.
It should be noted that not all of these cases go forward. The family of a boy who killed himself by slamming a stolen single-engine plane into a skyscraper in Florida 4 months after the 9/11 attacks has dropped its $70 million lawsuit against the manufacturer of isotretinoin.
Other Evidence of a Potential Link
While all dermatologists are aware of the healing effects of isotretinoin, some data exist that link it to inflammatory bowel disease. In an article in the American Journal of Gastroenterology, Reddy et al examined all of the adverse reports filed with the FDA between 1997 and 2002 regarding isotretinoin to see if ulcerative colitis and Crohn’s diseases were linked to the use of isotretinoin.2
Specifically, Reddy was part of a group of investigators that queried the FDA for MedWatch reports containing the keywords isotretinoin, Accutane, colitis and IBD. In an article in Dermatology Times, Corey A. Siegel, one of the study’s authors, stated that “while the Physician’s Desk Reference lists IBD as a possible adverse event associated with use of isotretinoin, our goal was primarily to determine if this association was legitimate, and if so, what it means to physicians and patients.”3
The Results Of This Review
Reddy et al found 85 cases of ulcerative colitis and Crohn’s diseases associated with isotretinoin use. According to the Naranjo ADR probability scale, which evaluates the likelihood of a drug-related side effect:
• four cases (5%) scored “highly probable” for isotretinoin as the cause of ulcerative colitis and Crohn’s diseases
• 58 cases (68%) were “probable”
• 23 cases (27%) were “possible”
• no cases were “doubtful”.
Reddy et al concluded that in a subgroup of patients, isotretinoin might serve as a trigger for ulcerative colitis and Crohn’s diseases. Other reports from Europe have similarly noted that ulcerative colitis and Crohn’s diseases occur rarely following use of isotretinoin.4-7
I do not want to comment on the pending lawsuits — besides, the facts of every case are particular to that case. It would seem to me that ulcerative colitis and Crohn’s disease are only rarely linked to the use of isotretinoin; and in fact, the pyoderma faciale related to ulcerative colitis and Crohn’s disease is well treated with isotretinoin.8,9 On the other hand, the link of ulcerative colitis and Crohn’s disease to the use of isotretinoin was noted, however rare, in the 1980s and 1990s.10-12
What Should We Tell Our Patients?
It might seem prudent in the current litigation environment to query potential isotretinoin patients about depression, ulcerative colitis, Crohn’s disease, and other very rare side effects and warn them of the supposed association — however far-fetched — between acne and depression (which seems to have been disproved in a major study), ulcerative colitis and Crohn’s disease with isotretinoin use.
Perhaps iPLEDGE can be used as a platform to provide patients with data about obscure side effects of isotretinoin and require patients and doctors to document that isotretinoin might have rare side effects and that doctor and patient have considered these and decided that the benefits outweigh the risks of isotretinoin and that the patient has accepted the implications of risk.
It is widely accepted that malpractice cases and litigation flow from bad feelings that patients experience in regard to a doctor/patient interaction, even more so than bad outcomes. Educating patients and keeping lines of communication open are the first steps to avoiding litigation.
Deciding whether or not to alert patients to any potential treatment warnings before performing a procedure or prescribing a medication is not always a cut-and-dried issue. As a guideline, I figure that if a side effect has a 1 in 100 chance of happening, I think it is worth mentioning to a patient.
Using this communication guideline, I warn all patients for whom I prescribe intralesional kenalog (ILK) 3 mg/cc for inflamed acne cysts that they may experience atrophy, but that if they do, it is usually temporary. Specifically, I explain that a divet can result from both ILK or resolved inflammatory acne papules, pustules or cysts.
However, on the other hand, I do not routinely note that azithromycin has been correlated with development of transient, and even permanent, deafness (six cases reports) because this side effect is so rare when you take into consideration the millions of prescriptions written for this drug.
What We Need to Know Regarding Isotretinoin and Inflammatory Bowel Disease
That brings us to isotretinoin, a medication that in recent years seems to have engendered more discussion and controversy than the disease that it treats. Since its approval in 1992, up until 2000, 20 million prescriptions for isotretinoin were written. The Accutane patent expired on Feb. 7, 2002, but with the risk management program iPLEDGE, the isotretinoin molecule has not left the news.
Because of all of this attention, it is probably worth mentioning to patients all of the potential side effects to make them fully aware.
Rare Side Effect Worth Mentioning
A rather obscure side effect of isotretinoin is the induction of inflammatory bowel disease. Lawsuits have been filed regarding this side effect in several states including Nebraska and Illinois.
The first such trial ended last month when a jury ordered Hoffmann-La Roche to pay $2.6 million in damages. The corporation is appealing.
A lawsuit was reported in February of 2007 in Godfrey, Madison County, Illinois, involving 23-year-old Jason Christopher Peipert who sued both Roche Laboratories and his physician Daniel Goran, M.D., on Dec. 16, 2003. The claim was that Accutane caused him to sustain severe and permanent injuries.
The Madison County trial, which is set for October, will likely be watched around the country and could serve as a bellwether for hundreds of other lawsuits.
This section is based on a report in the Madison Record.1
Mr. Peipert claimed that Dr. Goran prescribed Accutane to him in 1999 for general care and treatment of acne. He claimed that Dr. Goran was negligent because he failed to recognize that Accutane is a difficult drug to manage in patients and failed to run diagnostic tests to ascertain whether he was developing the severe side effects of Accutane. Mr. Peipert also claimed that Dr. Goran prescribed Accutane to him more frequently and for periods longer than has been approved by the FDA and failed to advise him of the risks and side effects associated with Accutane.
According to court records, Mr. Peipert claimed that Accutane caused him to develop Crohn’s disease, the ulcerative and inflammatory disease of the bowel. He also claimed that once he began to experience certain side effects, Dr. Goran continued to prescribe the medication after failing to recognize that Accutane was causing the problems.
Mr. Peipert also cited the company, claiming that Roche either knew or should have known that Accutane was causally related to and associated with severe and life-threatening complications and side effects. He alleged that the medication was defective and contained unreasonably dangerous design defects and was not reasonably safe, therefore subjecting users to risks that outweighed the benefits of the drug.
Mr. Peipert also claimed that Accutane was insufficiently tested and that it caused harmful side effects that outweighed any potential utility. He further claimed that Roche failed to adequately instruct on the length of time an individual should be allowed to continue using Accutane.
On Feb. 20, 2007, Dr. Goran filed a motion for summary judgment claiming that none of Mr. Peipert’s witnesses disclosed opinions critical of his standard of care. Judge Hylla had not yet ruled on the motion. Dr. Goran, represented by Jeffrey Reel of Belleville, also claimed that Mr. Peipert did not develop symptoms associated with Crohn’s until 2 years after he stopped taking Accutane. Mr. Reel argued that there was no evidentiary basis from which the jury could conclude that he failed to properly advise Mr. Peipert of the risks and side effects of Accutane.
It should be noted that not all of these cases go forward. The family of a boy who killed himself by slamming a stolen single-engine plane into a skyscraper in Florida 4 months after the 9/11 attacks has dropped its $70 million lawsuit against the manufacturer of isotretinoin.
Other Evidence of a Potential Link
While all dermatologists are aware of the healing effects of isotretinoin, some data exist that link it to inflammatory bowel disease. In an article in the American Journal of Gastroenterology, Reddy et al examined all of the adverse reports filed with the FDA between 1997 and 2002 regarding isotretinoin to see if ulcerative colitis and Crohn’s diseases were linked to the use of isotretinoin.2
Specifically, Reddy was part of a group of investigators that queried the FDA for MedWatch reports containing the keywords isotretinoin, Accutane, colitis and IBD. In an article in Dermatology Times, Corey A. Siegel, one of the study’s authors, stated that “while the Physician’s Desk Reference lists IBD as a possible adverse event associated with use of isotretinoin, our goal was primarily to determine if this association was legitimate, and if so, what it means to physicians and patients.”3
The Results Of This Review
Reddy et al found 85 cases of ulcerative colitis and Crohn’s diseases associated with isotretinoin use. According to the Naranjo ADR probability scale, which evaluates the likelihood of a drug-related side effect:
• four cases (5%) scored “highly probable” for isotretinoin as the cause of ulcerative colitis and Crohn’s diseases
• 58 cases (68%) were “probable”
• 23 cases (27%) were “possible”
• no cases were “doubtful”.
Reddy et al concluded that in a subgroup of patients, isotretinoin might serve as a trigger for ulcerative colitis and Crohn’s diseases. Other reports from Europe have similarly noted that ulcerative colitis and Crohn’s diseases occur rarely following use of isotretinoin.4-7
I do not want to comment on the pending lawsuits — besides, the facts of every case are particular to that case. It would seem to me that ulcerative colitis and Crohn’s disease are only rarely linked to the use of isotretinoin; and in fact, the pyoderma faciale related to ulcerative colitis and Crohn’s disease is well treated with isotretinoin.8,9 On the other hand, the link of ulcerative colitis and Crohn’s disease to the use of isotretinoin was noted, however rare, in the 1980s and 1990s.10-12
What Should We Tell Our Patients?
It might seem prudent in the current litigation environment to query potential isotretinoin patients about depression, ulcerative colitis, Crohn’s disease, and other very rare side effects and warn them of the supposed association — however far-fetched — between acne and depression (which seems to have been disproved in a major study), ulcerative colitis and Crohn’s disease with isotretinoin use.
Perhaps iPLEDGE can be used as a platform to provide patients with data about obscure side effects of isotretinoin and require patients and doctors to document that isotretinoin might have rare side effects and that doctor and patient have considered these and decided that the benefits outweigh the risks of isotretinoin and that the patient has accepted the implications of risk.
It is widely accepted that malpractice cases and litigation flow from bad feelings that patients experience in regard to a doctor/patient interaction, even more so than bad outcomes. Educating patients and keeping lines of communication open are the first steps to avoiding litigation.
