Any teenager will tell you that acne can drive you crazy, but is it enough to make you kill yourself? Since its debut in the market in 1982, enraged parents and lawyers have been involved in Accutane hospitalization and the death of suicides of more than 200 teenagers in the United States.
Acccatane (isotretinoin) is one of the most popular and controversial Hoffman-Laroche pharmaceuticals. Doctors prescribe Accutane for patients with severe nodal acne, who do not respond to systemic procedures with antibiotics.
Michigan Democrat Bart Stupak lost his son, BJ, to suicide in May 2000, while the teenager used Accutane. Since then, Rep. Stupak has conducted a crusade for further research to establish Accutane risks for birth defects and mental disorders such as depression and suicide.
While the safety of isotretinoin is hotly contested, there are previous users of Accutane, such as 21-year-old Krista Savino, who viewed the drug as Godsend. The controversy of Congressman Stupak, Savino vows to do everything possible to keep Accutane on the market. Savino sometimes suffers from severe acne, which she considers her condition to be “the social equivalent of suicide.” Acckaina gives her clear skin and confidence to leave her home without feeling too shy.
Hoffman-LaRoche, following FDA guidelines, lists depression as a possible side effect of Akkaten. Despite this, the link between isotretinoin and the development of depression and / or suicide residues is overshadowed.
Like Senator Stupak, an accountant in Dublin, Liam Grant, accuses Roakkuen of suicide death of his 20-year-old son, also known as Liam. Grant claims that his son showed signs of severe depression after taking Roakkanan several months before his death.
According to the British newspaper The Sunday Times, Grant spent almost £ 500,000 on independent research to try to prove that roacutane is causing depression. Grant hired Douglas Bremner, a medical doctor at Emory University, to conduct an investigation. Grant hopes to use this research to force Roche Pharmaceuticals to accept responsibility for Liam’s death.
The results of Dr. Bremner, published in the American Journal of Psychiatry, have made progress in determining the effect of Akkaten on the brain. Dr. Bremner explains that to treat depression, isotretinoin should affect the brain.
The Roaccutane study of Dr. Bremner involved 28 healthy men and women between the ages of 18 and 50. During the study, the brain function of the subjects was measured using positron emission tomography (PET) before and after four months of isotretinoin treatment. However, there was no difference in the severity of depressive symptoms between the isotretinoin groups and antibiotics before or after treatment. Research has shown that isotretinoin treatment is associated with changes in brain function.
The results of Dr. Bremner require further study of the drug isotretinoin. However, insufficient funding may prevent such research. The American Academy of Dermatology wants clinical trials to prove that isotretinoin causes depression or "psychological events" before it stimulates stronger warnings and more stringent rules for treating acne. However, the FDA does not have funding to cover testing.
While understanding the effects of Acccatane, Dr. Bremner agreed with David J. Graham, MD, MPH - Deputy Director for Science and Medicine at the FDA's Drug Safety Administration. Graham warns that Accutane should be removed from the market.
Dr. David Graham paints a complex image of how the FDA safely defines a drug. He says that using the Standard for Evaluating Drugs and Research (CDER) for the safety of drugs on a pistol that holds 100 cameras. The gun symbolizes the medicine, while the bullets pose a serious safety problem with the drug. “Using the CDER standard only when you have 95 or more bullets in a pistol will you agree that the pistol is loaded and there is a security problem,” explains Dr. Graham. He adds that if there were only 90 bullets in the cell, CDER would have concluded that the pistol was not loaded and that the medicine was safe.
The FDA strengthens the risk mitigation action plan (RiskMAP) for Accutane and the generic version of isotretinoin in the hope of reducing the likelihood of birth defects related to fetal acne. Women now have to submit negative pregnancy tests before filling out their isotretinoin prescription every month. Some dermatologists practiced this pregnancy monitoring without pushing the FDA. This new measure does not mention depression or suicide, which may result from the use of isotretinoin.
Dr. Bremner adds that patients taking isotretinoin should ask about depression, they are not just open about it. Debatable symptoms of depression are an additional indication that physicians prescribing isotretinoin can affect the well-being of their patients.
It’s great to live in a country that inspires entrepreneurship, freedom and independence. It all comes with a price. The buyer decides how much they are willing to pay. The FDA exists to protect the consumer. If you think that the efforts of the FDA are insufficient or powerful, you have medical options.
Jeffrey Redmond MD, author of The Good News on Women & # 39; s Hormones, suggests using hormone therapy and / or using Retin-A if Accutane looks too risky for you.
