The active ingredient in the acne drug Accutane— known generically as isotretinoin—more than doubles the risk of depression, according to a recent study.  The study is the first controlled investigation to find a statistically significant link between Accutane and depression, Dr Anick Berard, from CHU Sainte-Justine Research Centre in Montreal, and colleagues, state in a report in the Journal of Clinical Psychiatry.  “Current guidelines should possibly be modified to include psychiatric assessments of patients prior to and during isotretinoin therapy,” the researchers wrote.

Berard’s team studied 30,496 people from Quebec, Canada, who received at least one Accutane or isotretinoin prescription from 1984 through 2003.  During the study period, 126 of these individuals received a depression-related diagnosis, hospitalization, or treatment.  Also, based on earlier research, the researchers focused on isotretinoin use in the five months prior to the depression diagnosis—the risk period—as compared with a five-month period a year before the diagnosis—the control period.  After accounting for potential factors that might influence the results, isotretinoin exposure was associated with a greater than 2.6-fold relative risk of depression, the team found.  “Because depression could have serious consequences, close monitoring of isotretinoin users is indicated,” Berard and colleagues concluded. (more…)

Suicide is common in the US, representing the fourth leading cause of death for those aged 18 to 65 and the third leading cause for those aged 15 to 24.  Add to those figures the complexity of medications.  In recent years, disturbing reports have suggested that  side effects of some popular drugs - such as Chantix, Accutane, Singular and Paxil - include suicidal thoughts and behavior.

Reports have been filed with drug makers and the Food and Drug Administration (FDA) on at least six drugs or drug classes that may be linked to suicide or suicidal thoughts.  Recently, the FDA released notices about several such medications including Singlulair; Epilepsy drugs including carbamazepine, gabapentin, felbamate, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, and valproate; and the smoking-cessation drug Chantix.  Reports have been filed on SSRI antidepressants including Paxil and Prozac, the influenza drug Tamiflu, and the acne medicine Accutane.   “The brain is a complex organ, and most of the drugs are complex as well,’’ says Dr. Thomas Laughren, head of the division of psychiatric products at the FDA.  “It’s not unreasonable to think that a drug that gets into the brain may have effects other than you hope they would.’’ (more…)

A woman who said she developed ulcerative colitis from taking Accutane was awarded $10.5 million by a New Jersey jury yesterday.  It was the third of 425 lawsuits alleging that Accutane caused inflammatory bowel disease in some users to go to trial.  All three cases have resulted in multi-million dollar judgments against Hoffman-LaRoche, Inc., the maker of Accutane.

Approved by the Food & Drug Administration (FDA) in 1982, Accutane has been the subject of controversy for years. In addition to inflammatory bowel disease, the drug has been associated with myriad other serious side effects. It first garnered attention in the late eighties for causing severe birth defects. It has also been known to cause psychiatric problems, and has been linked to 266 cases of suicide in the United States.  In addition to inflammatory bowel disease, Accutane has also been associated with problems of the liver, kidneys, central nervous system, and pancreas, as well as the cardiovascular, musculoskeletal and auto-immune systems. (more…)

Accutane prescriptions might now be a little easier for women to fill.  The government announced some changes Wednesday designed to ease access to the drug.  A program entitled iPledge-a risk management program designed to reduce the risk of fetal exposure to isotetinoin (Accutane) prescribed for the treatment of severe recalcitrant nodular acne-was amended to ensure that every user of Accutane (or its generic substitutes), every doctor who prescribes it, and every pharmacy that sells it follow strict rules ensure sure women do not become pregnant while on the drug.  Among those rules are month-by-month prescriptions based on monthly pregnancy tests.

But last summer, the Food and Drug Administration (FDA) heard evidence that iPledge has not ended the problem.  There were 122 pregnancies in the program’s first year and another 37 in the four months since.  Another 19 pregnancies occurred in women who managed to get the drug despite never enrolling in iPledge.  Despite this, in October, the FDA agreed to a few changes, announcing Wednesday that iPledge is now implementing these changes.  Women of childbearing age who do not fill a prescription within seven days of a pregnancy test will be allowed to get another test and then fill the prescription, with the exception of the initial prescription.  Until now, those who didn’t act within seven days were frozen out of the program for the next 23 days.  Those women will have to fill the prescription within seven days of a pregnancy test rather than within seven days of first seeing their doctor.

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