Who is responsible for Accutane depression claims?
Ultimately, Hoffmann-LaRoche is responsible for the damage caused by the product that they developed and promoted.
What did the Hoffman-LaRoche know about Accutane depression side effects and when did they know it?
The answers vary. Some of the risks of Accutane depression were known before the drug was released. Others became apparent only after the medication had been in use. Unfortunately, as one Congressional investigation discovered, Hoffmann-LaRoche attempted to suppress information about the serious psychiatric risks associated with their medication. The company focused on less serious side effects, like chapped lips and dry skin. More serious adverse reactions were treated as special cases or as not typical reactions. Unfortunately, these atypical Accutane depression reactions became more typical as the number of people taking Accutane grew.
Accutane made by Hoffmann-LaRoche is also sold on the Internet. Doctors fear that the Accutane depression problem will increase as patients turn to online pharmacies to buy their medications. Internet pharmacies may or may not comply with the procedures recommended by the FDA for prescribing Accutane. Female patients may buy the drug online and not receive the necessary warnings about the risk of birth defects. Counseling about the risk of depression is also missing, as is a doctor's evaluation of whether Accutane is an appropriate medication for various online patients.
What did Hoffmann-LaRoche know about birth defects?
Even before it went to market, Hoffmann-LaRoche and the FDA knew that Accutane would cause birth defects. Retinoid medications have long been associated with birth defects, miscarriage, and death of a fetus. These risks were noted when the FDA approved Accutane as a Category X medication.
In October 2001 – almost 20 years after Accutane had been approved for use – the FDA announced that it would require Hoffmann-LaRoche to change the way the company explained these risks to doctors and their female patients. Noting that, "In recent years, as more women have been receiving prescriptions for Accutane, the risk that pregnant women may be inappropriately using the drug has increased”, the FDA developed and implemented changes to the risk management program to prevent birth defects caused by Accutane.
What did Hoffmann-LaRoche know about Accutane depression and suicide?
Again, it is hard to say, although it is clear that Hoffmann-LaRoche realized that something was horribly wrong with their medication.
Depression and suicide are complex issues. However, a disturbing Accutane depression trend appears to be developing among Accutane users. Otherwise healthy teenagers who took the drug showed Accutane depression. Many of these teens and young adults would eventually attempt to take their own life or would exhibit signs of violence towards others. Hoffmann-LaRoche attempted to brush off any relationship between Accutane, depression, and side effects of psychosis, denying that there was any scientific proof that Accutane depression and suicide are linked. The company shifted the blame to the patients and their families, claiming that these teens must have had a previously existing mental illness, although most had no prior record of any psychiatric problems. Hoffmann-LaRoche also claimed that the unstable home life of these young people must have been a contributing factor in the decision to commit suicide.
The record indicates that Hoffmann-LaRoche knew otherwise: A 1997 FDA memo detailing a teleconference call with representatives from the company agreed with the FDA that there did appear to be a problem with Accutane & depression and suicide.
A recent Congressional investigation of Accutane provides a timeline of trouble. "In 1985, Accutane's package insert for physicians first mentioned receiving reports of depression in patients being treated with Accutane. In 1986, physicians were again notified that Accutane users who became depressed saw their depression go away when they discontinued Accutane. The depression came back when Accutane users were placed back on the medication. Physicians were also informed that simply removing the patient from Accutane therapy may not be sufficient to treat the depression and that a follow up for their depression may be necessary."
The investigation was led by Congressman Bart Stupak. Congressman Stupak became concerned about Accutane depression following the suicide of his teenage son, who was taking Accutane at the time of his death. The hearing focused on Accutane's link to birth defects, depression, and 173 suicides associated with Accutane use.