From articles appended:
- Added to the lawsuits related to depression and suicide brought on by Accutane, ones on bowel disease.
These are just a few of the 7,000-plus lawsuits that have been filed against Roche over the debilitating side effects of Accutane.
- Accutane is now a generic drug sold under various names.
- annual Accutane sales at their peak, in 2000, were up to $759.4 million (Appended article, What is Accutane …?)
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The recent CBC article on harm to fetus omits:
- the high level of suicides associated with Accutane/Isotretinoin. Scroll down to last article, Congressional Committee finds . . .
- Accutane causes birth defects because it interferes with the body’s endocrine system. Well, MALES happen to have endocrine systems, not only females. The difference is that deformed babies can be directly and easily linked to the taking of the capsules. Uh oh – – lawsuits.
The nailing of responsibility (cause & effect) is otherwise difficult and expensive to prove.
That said, Accutane is known to artificially shut down the epiphyseal growth plates in bones.
The largest market for acne “cures” (Accutane) is adolescent males and females. Coincidentally this is also the time when bone growth is remarkably robust.
Statural growth can occur as long as the epiphyseal growth plates persist. The gonadal steroids (estrogen, testosterone) cause closure of the epiphyseal growth plates in late adolescence. The cartilage becomes entirely replaced with bone, and statural growth ceases. (ref https://courses.washington.edu/conj/bess/growth/growth.html)
More than a decade ago when I questioned the Health Canada scientist responsible for the registration of Accutane, I was told that the premature shut-down of the epiphyseal caused by Accutane only happens in a small number of cases.
How would she know:
- adverse drug effects are not well reported
- Doctors (e.g. a sports medicine doctor) who see a patient because of skeletal pains know nothing about the side effects of a drug taken for acne. And the patient is unlikely to associate the two.
Is anyone investigating to see what happens to the developing skeleton when a drug brings about an abrupt halt to bone growth, before it is complete? Do we have any idea of what the longterm consequences are?
Accutane and its generic offspring are very poorly researched and regulated. The harm done to teenagers is a sea upon which floats the harm to fetuses.
ACTION: I sent the Accutane information to Doctors Henry and Humphrey, named in this CBC article. And will tweet Robyn Sheremeta.
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http://www.cbc.ca/news/health/acne-accutane-pregnancy-1.3551549
Doctors stress that a powerful drug prescribed to fight acne needs to be taken under strict guidelines to prevent serious harm to a fetus, as a new study commissioned by Health Canada points to many failures in preventing pregnancy.
Isotretinoin was commonly sold as Accutane when it entered the market in Canada in 1983 to treat severe acne, which can cause scarring such as pockmarks. The medication is now available as Accutane Roche and in several generic forms. It’s also prescribed for more moderate cases.
- Boost training for doctors prescribing acne drug: researcher
- Severe acne treatment needs suicide risk checks: study
Since the drug can cause damage to the head, face, heart, central nervous system and limbs of a fetus, the prescribing information in Canada requires written consent from the patient, two negative pregnancy tests before treatment and the use of two reliable methods of birth control. These conditions apply to prescriptions dispensed to women of child-bearing age.
The study, published in Monday’s issue of the Canadian Medical Association Journal, suggests the pregnancy prevention program is not effective, with between 30 per cent to 50 per cent of women taking the drug not complying.
“The program is probably half as effective as it should be,” said the study’s lead author, Dr. David Henry, a senior scientist at the Institute for Clinical Evaluative Sciences and a professor at the University of Toronto.
Henry and his team used hospital and vital statistical data to study 59,271 female patients aged 12 to 48 in British Columbia, Saskatchewan, Manitoba and Ontario for about 15 years. Over that time, nearly 1,473 pregnancies, about 100 a year, occurred during the vulnerable period during and after treatment with isotretinoin. The risky period includes any time during the 42 weeks of a pregnancy.
Pregnancy losses
Of these pregnancies, 1,331 or 90 per cent weren’t completed. The majority, 70 per cent, were medically terminated because the patient and health-care provider were worried about the risk to the fetus or had ultrasounds showing abnormalities. Another 20 per cent of the pregnancies were lost spontaneously.
Of the remaining 10 per cent of live births, a total of 11 babies or nine per cent were born with abnormalities, which amounts to one or two children each year. Researchers don’t know the severity of the abnormalities or if use of the acne drug directly caused the congenital abnormalities.
Henry said he believes greater familiarity with the effective drug, which is generally well tolerated, has led to its use in less severe cases of acne.
Robyn Sheremeta says there was ‘zero monitoring’ after she was prescribed isotretinoin for her acne. (CBC)
“It should be reserved for more severe cases [of acne] because that just cuts down the number of women of childbearing age who are going to be exposed to the drug,” Henry recommended.
It’s estimated the average age of isotretinoin users in Canada is 24.
“Conjecture is that physicians who are coming through these days didn’t get the same scary messages that we did,” Henry said.
Dr. Shannon Humphrey is a dermatologist in Vancouver and a professor in the dermatology department at the University of British Columbia. She is a spokeswoman for the Acne and Rosacea Society of Canada and wasn’t involved in the study.
Humphrey said for many of her patients, the benefits of isotretinoin outweigh the risks.
“As physicians, we should not become complacent,” Humphrey said. “There are absolutely patients who have moderate acne, who’ve tried other alternatives and who are suffering, who have anxiety or depression or are not engaging in their daily life because of the stigma of acne. And for that patient, as long as they can understand the side-effect profile, as long as they can engage with the pregnancy prevention recommendations very stringently, that may very well be an ideal candidate for this medication.”
Outside of birth defects, the majority of side-effects from the drug include dry skin and sensitivity, she said. Doctors also monitor blood work to check cholesterol levels and liver function after prescribing the drug, which is generally taken for three to four months.
Dermatologist Dr. Shannon Humphrey says that for many of her patients, the benefits of the acne-fighting drug isotretinoin outweigh the risks. (CBC)
Now that isotretinoin is generic, there’s less emphasis on education about it for specialists, said Humphrey, who welcomes greater awareness.
Henry stressed that physicians need to be reminded of their obligations to comply with the prescribing guidance for the drug.
Robyn Sheremeta is a university student in Toronto who describes her acne as moderate and persistent. More than a year ago when she was 22, Sheremeta booked an appointment with a dermatologist at her family’s hometown in Edmonton. She thought she’d be prescribed antibiotics or another oral drug to “dull the acne.”
Sheremeta was already taking birth control pills. The dermatologist prescribed her a year’s supply of a different kind of birth control pill and mentioned using a second method when having sex, she said.
“There was zero monitoring,” Sheremeta recalled. “I didn’t do a single pregnancy test, no blood work. I was given a four-month set of [isotretinoin] pills.”
Sheremeta completed the treatment, the acne disappeared and she now feels it is back to mild to moderate.
Both Henry and Humphrey also said pharmacists can act as a second line of defence when dispensing the drug.
One of the limitations of the study was it only captured prescriptions, including for birth control, from provincial drug benefit insurance programs.
About one-quarter to one-third of women in the study filled birth control prescriptions, which was about the same as before they started the acne treatment.
Studies in Europe also suggest that changing contraceptive behaviour among isotretinoin users is difficult, the researchers said.
A spokesman for Health Canada said pregnancy rates for women taking the drug in other international jurisdictions are similar to those reported in Canada. The department is reviewing the results of the study.
Physicians are expected to follow a manufacturer’s risk management program if one is in place, as recommended by Health Canada, said a spokeswoman for the College of Physicians and Surgeons of Ontario.
Doctors are expected to practise competently and to maintain the applicable standard of practice when prescribing drugs, including when prescribing isotretinoin products, the college said.
The study was conducted by the Canadian Network for Observational Drug Effect Studies, or CNODES, which is funded by the Canadian Institutes of Health Research (CIHR).
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https://www.drugwatch.com/accutane/
http://www.accutaneaction.com/ (I don’t know if these people are still active)
We have over 2000 members who have suffered severe physical and psychiatric side effects. We are also working with similar groups in the US, Australia, Canada, United Kingdom, France, Norway, Sweden, Italy and South Africa.
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http://www.cbsnews.com/news/roches-accutane-suit-over-death-of-congressmans-son-nixed/
By Jim Edwards MoneyWatch June 11, 2009, 4:21 PM
Roche’s Accutane: Suit Over Death of Congressman’s Son Nixed
Last Updated Jun 11, 2009 4:21 PM EDT
Roche has won a ruling insulating it from allegations that its Accutane acne drug caused the suicide of U.S. Rep. Bart Stupak‘s son. B.J. Stupak started taking Accutane in 1999. In May 2000, at age 17, he shot himself in the head. The ruling states:
Laurie Stupak [B.J.’s mother] claimed that Roche was liable under negligence and strict liability for failing to warn that its prescription acne medication Accutane could cause suicide without premonitory [warning] symptoms.
The package of Accutane that B.J. Stupak was taking warned only of “changes in mood,” although the Physician’s Desk Reference said:
… may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts and suicide.
The court ruled that because Roche did not know at the time that patients on Accutane could experience a desire to kill themselves without any warning signs, that the Stupaks could not sue the company:
Because Stupak has failed to identify any evidence in the record that Roche knew or should have known that Accutane could cause suicide without premonitory symptoms, we affirm the district court’s grant of summary judgment.
Stupak, D-Mich., has been a critic of Accutane for years — both his sons took it. He told his story to a Congressional hearing in 2002. The Drug and Device Law blog notes that the ruling, from the 11th Circuit Court of Appeals is unpublished but may nonetheless influence the trial judge to turn down other cases.
© 2009 CBS Interactive Inc.. All Rights Reserved.
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https://www.drugwatch.com/accutane/
Last modified: October 5, 2015
What Is Accutane? Its Uses and Interactions
Accutane (isotretinoin) is a popular drug for severe acne created by Hoffmann-LaRoche Inc. The drug is linked to severe bowel disease and other side effects.
Accutane, approved by the U.S. Food and Drug Administration (FDA) in 1982, proved to be a miracle for some, offering blemish-free skin to those who had given up after trying many other treatments.
The drug works for severe (cystic) acne, providing long-lasting and sometimes complete reduction of acne for 80 percent of patients. However, clear skin may be accompanied by serious side effects like Crohn’s disease.
Following numerous reports of adverse events – and after doctors noted potential dangers with the drug and the FDA issued a black-box warning, Roche stopped manufacturing Accutane in 2009. Generic brands of the medication — Amnesteen, Claravis and Sotret — are still available.
Uses of Accutane
Accutane is part of a class of medications called retinoids and originally was marketed as a chemotherapy drug. It is known for its ability to treat acne that has not responded to antibiotics. The medication is a derivative of vitamin A and works by controlling the oil in the sebaceous glands. The acne it treats consists of nodules with a diameter or 5 mm or greater. Having this type of acne can be socially debilitating, so the potential of a cure can be life-changing.
Undergoing Accutane treatment is a commitment of time and energy. It can take months to be effective, and patients often must deal with side effects like dry eyes and headaches. In addition, acne may worsen during the beginning stages of treatment before it starts to clear up.
Doses of Accutane range from 0.5 to 1.0 mg/kg body weight per day, with a cumulative dose of greater than 100 to 120 mg/kg. Accutane comes in capsules of 10, 20 and 40 mg, and should be taken with food. Most patients take the medication for 15 to 20 weeks, and may repeat the treatment course if acne returns. Due to the risk of serious birth defects, women of child-bearing age must commit to programs aimed at preventing pregnancies during treatment.
Doctor Warnings
The first prescriptions of Accutane were written in 1982, and a year later came the first report of a baby born with malformations after Accutane was taken during pregnancy. In 1983, there were two “Dear Doctor letters” — special communications the FDA requires drug manufacturers to send out if the drug label is not complete in covering the extent and severity of side effects — sent out, alerting physicians of the possibility of birth defects. From 1984 to 1988, seven more of the letters went out.
The FDA was not alone in noting the dangers of Accutane. Dr. Frank Yoder, one of the scientists involved in the discovery of Accutane, wrote a letter to the Journal of American Medicine in 1983, informing the public of the possibility that Roche was not clear in alerting users of the toxicity associated with Accutane.
That same year, a nonprofit health advocacy group, Public Citizen, petitioned the FDA to add warnings of birth defects to Accutane labels. The FDA took action in 1985, when a black-box warning, indicating that Accutane can cause fetal deformities and possibly fetal death, was added to the medication.
By 1988, a pregnancy prevention program had been put into place, with the goal of decreasing the number of woman getting pregnant while taking the drug. The program was eventually effective in decreasing the percentage of woman getting pregnant while taking the drug, from 4 women per every 1,000 a year to less than 2 for every 1,000. However the number of prescriptions given out also increased, keeping the number of affected pregnant women taking Accutane high.
Other countries had even stricter rules about Accutane use by women of childbearing age. For example, in Britain, prior to receiving the medication, women were required to agree to have an abortion if they became pregnant during treatment.
The Centers for Disease Control (CDC) played a role in affirming the danger of Accutane by publishing information on the fetal toxicity of the drug, conducting a study of Accutane-exposed pregnancies to raise awareness, and sending a letter to the FDA in 1998 recommending that the drug not be sold due to these dangers. Also, the CDC division of Birth Defects and Developmental Disabilities received reports of infant death following maternal exposure to Accutane.
In June 2009, as the number of adverse events reported to the FDA and lawsuits from patients continued to grow, Roche stopped manufacturing Accutane. The company said it was an economic decision based on generic brands of the medication taking over the market. Accutane was recalled in 11 other countries.
Milder Side Effects of Accutane
Most people experience some measure of common side effects with Accutane use and should not be concerned unless these conditions worsen or become extremely painful. With more serious side effects, however, a doctor should be consulted immediately.
| Common side effects include: | |
| Diminished night vision | Increased bone injuries due to thickened or weakened bones |
| Increased reaction to UV exposure | Red, cracked or sore lips |
| Nosebleeds | Changes in nails |
| Peeling skin | Unusual hair growth or loss |
| Bleeding or swollen gums | Fatigue |
| Voice changes | Headache |
| Slow healing of cuts or sores | Cold symptoms |
| Dry skin and eyes | Muscle aches |
Birth Defects Related to Accutane
The FDA gave Accutane a pregnancy rating of X, which means it should not be taken during pregnancy because there is evidence of fetal abnormalities when it is used during pregnancy. The FDA reported that infants whose mothers took Accutane were born with both internal and external abnormalities such as cleft palate, missing ears, facial dysmorphism and central nervous system malformations.
In fact, among Accutane-exposed pregnancies, 42 percent of infants suffer from birth defects.
Because of the high risk of miscarriage and deformities, the FDA worked with Roche to create programs to ensure that Accutane users were not and would not become pregnant. The first program was put into place in 2002 and was called SMART (System to Manage Accutane Related Teratogenicity). SMART required qualification stickers on prescriptions, signed consent forms, patient education videos and information guides. In addition, doctors and pharmacists were required to read literature on the risks.
In 2006, a stricter system was put in place, called the i-PLEDGE program. The computer-based system required registration by pharmacies, doctors and patients. Within the system, negative pregnancy tests from approved labs were periodically required before medication was dispensed, prescriptions only covered 30 days at a time, and users were required to utilize two types of birth control.
According to a 2007 study funded by the Canadian Institutes of Health Research and published in the British Journal of Clinical Pharmacology, the rate of elective abortions for patients who got pregnant during Accutane use was 84 percent. This rate was based on 90 women, out of 8,609, who became pregnant while taking Accutane. Of the remaining pregnant women, three had spontaneous abortions, two had delivery trauma that resulted in neonatal death, and nine infants survived. One of the nine was born with face and neck abnormalities.
Gastrointestinal Disorders
Women of child-bearing age are not the only ones who have suffered after taking Accutane. Adults of all ages, as well as teenagers, have had their lives interrupted with other serious side effects, which may include inflammatory bowel disease and suicidal behavior.
Roche maintains that it was not aware of side effects relating to inflammatory bowel disease, however, early animal trials of Accutane by Roche showed evidence of gastrointestinal bleeding in dogs. Another early study by Roche of 523 patients found that 21 percent experienced gastrointestinal disorders.
Since Accutane’s release, many patients have sued after developing gastrointestinal conditions, mainly consisting of inflammatory bowel diseases that come in two forms. One is ulcerative colitis, associated with inflammation of the digestive tract and ulcers in the large intestine and rectum. The other is Crohn’s disease, which may develop anywhere in the intestinal tract and can cause fistulas and bowel obstructions. Both conditions can be devastating, causing patients to suffer for years from symptoms like vomiting, rectal bleeding and diarrhea. In addition, patients may require surgery to remove parts of the bowel.
Suicide
Psychiatric problems have also been linked to Accutane use. From 1982 to May 2000, the FDA received hundreds of reports linking isotretinoin use to depression, including 37 suicides, 110 hospitalizations for depression or suicidal behavior, and 284 cases of non-hospitalized depression. Roche responded to the reports of depression and suicide in 1998 by adding a warning to the medication’s label stating that Accutane could cause psychiatric disorders.
According to a study in the book Drug Injury: Liability, Analysis and Prevention, Drs. Donald Marks and Tzarina Middlekoop found that the number of formal adverse reaction reports, from national and international health agencies, of suicide and suicidal behavior associated with Accutane use reached 500, making it the fourth highest number of adverse reactions in the United States prior to 2005. The mechanism of action that makes Accutane cause psychiatric events is not fully understood, nor has a link between depression and Accutane been proven. However, the high number of reports of depression in people without a psychiatric history suggests there is a link.
Accutane Lawsuits
Kamie Kendall, a New Jersey Accutane user who was diagnosed with ulcerative colitis, won a verdict of $10.5 million in 2008. That verdict was later vacated.
In 2010, another bowel disease case involving Accutane was decided in Atlantic City, N.J., when Andrew McCarrell – who required five surgeries and the removal of his colon— was awarded $25.16 million. Roche is appealing.
In 2012, also in Atlantic City, two more claimants who developed bowel disease, Kathleen Rossitto and Riley Wilkinson, were awarded $9 million each for damages. Roche is also appealing these verdicts.
These are just a few of the 7,000-plus lawsuits that have been filed against Roche over the debilitating side effects of Accutane.
While some claimants receive millions — for damages and medical expenses — the numbers do not compare to the company’s revenue from selling the dangerous drug. For example, annual Accutane sales at their peak, in 2000, were up to $759.4 million.
Lawsuits against Roche are not limited to bowel disease. They also come from patients and families of patients who have experienced side effects such as birth defects, depression and suicide attempts. Because warnings were added slowly between the time Accutane was released in 1982 and the time it was discontinued in 2009, some cases hinge on the dates that the medication was prescribed, when health concerns were diagnosed, and when warnings were publicized.
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http://www.rense.com/general32/scu.htm
(copied, a UPI article)
Congressional Committee Finds Accutane Causes Suicide
By Steve Mitchell
UPI Medical Correspondent
12-12-2 (2002)
WASHINGTON (UPI) — A congressional oversight committee’s two-year investigation released Wednesday has found the acne drug Accutane frequently has been associated with suicide.
The investigation also made public an internal FDA memo from 1998 recommending the drug be taken off the market due to its potential to cause birth defects.
Staffers on the House Energy and Commerce subcommittee on oversight and investigations spent hundreds of hours culling internal memos, reports and e-mails obtained from the Food and Drug Administration and the Centers for Disease Control and Prevention, as well as from Accutane’s manufacturer, Roche U.S. Pharmaceuticals, part of Hoffmann-La Roche Inc., of Nutley, N.J.
More than 200 people have taken their lives while taking Accutane — and perhaps many more — but neither the FDA nor Roche has ever publicly admitted the suicides were due to the drug.
“This investigation leads to one conclusion: In some cases … Accutane results in severe cases of depression, suicide ideation, suicide attempts and suicide,” said Bart Stupak, R-Mich. Stupak’s son, B.J., died in 2000 from a self-inflicted gunshot wound while taking Accutane.
“If the FDA cannot or will not regulate Accutane, … then it is imperative for the U.S. Congress to act to protect the American public,” Stupak said.
Committee members grilled representatives from FDA and Roche on the findings of their investigation, charging both have failed to protect the public from the known risks of Accutane. Both denied the suicide link and said a new plan instituted earlier this year will lower the incidence of birth defects.
Accutane, first approved in 1982, is intended to be used as a last resort to treat severe forms of acne that cause scarring and cysts. It often works miracles, as patients have attested, because it can clear up their skin in a matter of months. However, the drug carries serious side effects. It is known to cause birth defects and an unknown percentage of people using the drug have developed depression and committed suicide.
The FDA and Roche maintained there is no scientific proof the drug caused the depression or suicide cases — although the labeling on the drug specifically warns of both possibilities. The FDA has confirmed 167 cases of suicide in people taking Accutane. Stupak said his office sent 37 more cases to the agency last week. He said, however, internal FDA documents suggested this was less than 1 percent of the total number of suicides by people on Accutane, indicating the real number could range from 2,000 to as high as 20,000.
Stupak also cited a 1994 FDA memo discussing a teleconference call with Roche. It said Roche concurred with the agency that there does appear to be a problem with Accutane and depression and suicide.
Roche’s president and CEO George Abercrombie said he was not familiar with the memo or the teleconference call.
Accutane also is known to cause birth defects, such as ear deformities — including a lack of an inner and outer ear — fatal heart defects and mental retardation. The committee obtained internal memos from the CDC and FDA that said risk of birth defects is so dangerous the drug should not be allowed to be sold. A CDC official wrote in a 1998 letter to the FDA that Accutane is just as serious a cause of birth defects as the cancer and leprosy drug thalidomide, and “we simply need to remove the drug from the market.”
Another FDA internal memo, written in 1998, said, “Accutane poses a significant public health threat and as such should be withdrawn from the market.”
The memos notwithstanding, the FDA has attempted to put provisions in place to inform women of this risk and warn them not to become pregnant while taking the drug. Despite these efforts, and warnings to physicians to prescribe the drug only for the most serious form of acne, the investigation found 90 percent of women who received the drug suffered only mild acne and nearly half of all prescriptions went to teens with mild cases of acne.
Pressed by committee members on this, FDA’s Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, said, “A proportion of people treated with this drug in the last decade had mild acne and should’ve been treated with other drugs.”
Roche’s Abercrombie disagreed, saying, “we believe the vast majority of use is” appropriate and in people who have severe acne.
The FDA has no control over how a drug is prescribed and physicians are essentially left to their own discretion to decide whether to limit a drug to the use for which it is approved.
Stupak noted although thalidomide is not used by women likely to have children, it is tightly controlled and regulated with a system that requires the physician, the pharmacist and the patient to be registered. “Yet, Accutane is not tightly controlled like thalidomide, and Accutane is marketed to women of child-bearing years despite its horrendous record of causing birth defects,” he said.
The FDA estimated about 2,000 pregnancies per year occur in women taking Accutane. Roche disputed that number, saying only about 2,300 pregnancies have occurred, in total, since the drug first became available 20 years ago.
“Roche isn’t telling the truth on that,” Stupak told United Press Interational. During the hearing, he cited a 1999 report from Roche that mentioned 93 pregnancies affected and 42 abortions in women taking the drug during only one-quarter of that year.
The FDA has worked with Roche to develop a new plan called the System to Manage Accutane Related Teratogenicity, or SMART, that began in April. This requires women to get a pregnancy test each month, receive repeat counseling about birth defects, and agree to use two forms of contraception while on Accutane. This new program will help curtail pregnancies in women on the drug and, therefore, birth defects, Woodcock said.
However, Lynn Martinez of the birth defects program at the Organization of Teratology Information Services, a national group that tracks prenatal exposures, said her organization is still getting calls from women who have become pregnant while taking Accutane even after the SMART program has gone into effect.
Many experts testifying before the subcommittee called for a mandatory registration similar to the thalidomide system. They urged that doctors, pharmacists and individuals taking the drug be required to register. This has been employed in Europe for Accutane and there are nearly no birth defects associated with the drug in that region, Stupak said.
FDA’s Woodcock said such requirements would violate patient confidentiality and, by making the drug harder to get, would only create a black market. Pressed on this by the subcommittee, she admitted there was no evidence tighter restrictions would lead to a black market.
The investigation also found Accutane is being purchased in Mexico and brought illegally into the United States, and it is available on approximately 40 Internet Web sites, where individuals can order it without a prescription or being informed of the risks, Stupak said.
Roche could help crack down on these illegally sold products simply by purchasing some of them and using the tracking codes on packaging to determine where they originated, Stupak told UPI. He noted Pfizer did something similar with its drug Viagra to curtail illicit sales.
Roche relies on regulatory and law enforcement agencies to control the illegal sales of Accutane, Abercrombie said. “As soon as we are made aware of illegal distribution, … we immediately turn that information over to the appropriate authorities,” he said.
The committee also faulted Roche for its ads targeting consumers, given the serious consequences that can result from the drug and the assumption by the medical community that patients should be strictly warned of the side effects.
Although the ads do not mention Accutane specifically, the purpose of the ads was to make consumers aware there were treatments for severe acne, Abercrombie said.
“What you just said is not a truthful statement,” said Peter Deutsch, D-Fla. He held up a Roche ad depicting a teenage male who did not appear to have acne. “You’re beyond the straight-face test, I’m sorry,” he added.
If FDA fails to regulate Accutane adequately, Congress could pass legislation regulating Internet sales of pharmaceuticals, requiring the FDA to more closely monitor people taking this drug and requiring the FDA to do a better job of controlling illegal importation of drugs, Stupak told UPI.
In response to the committee’s investigation, the FDA announced this week that it was placing importation restrictions on Accutane and warned consumers not to buy it over the Internet.
To add to the list of problems associated with Accutane, the FDA recently made the decision to include the risk of violent and aggressive behavior on the list of warnings on labeling.
Copyright © 2002 United Press International. All rights reserved.