Accutane May Cause Depression
On December 4, 2000 a congressional hearing was held in Washington, D.C. on adverse side effects associated with the popular acne drug Accutane. The hearing, titled "Is Teen Acne Drug Linked to Depression and Suicide?" was called by lawmakers who have become concerned over growing reports that Accutane may cause depression and increase the risk of suicide. The hearing examined whether tighter controls should be imposed on Accutane, including beefed up warnings about its propensity to cause emotional problems. Some critics have even called for a ban on Accutane.
Accutane, also known as isotretinoin, is the only drug that effectively treats severe cystic acne. Cystic acne is the most serious form of acne. Accutane is manufactured by Roche Pharmaceuticals and was first approved in 1982. While Accutane's tendency to cause severe birth defects in children whose mothers take the medication is well known, emotional side effects are only recently coming to light.
The new scrutiny of Accutane is largely due to the tragic suicide of Michigan congressman Bart Stupak's son. After the suicide, Stupak learned that the FDA had received over 44 reports of similar suicides associated with Accutane since 1983. Stupak is now calling on the agency to conduct further studies into the drug's impact on the brain.
Roche claims that the suicides reported to the FDA were not associated with Accutane but rather were due to depression caused by the stigma of acne itself. According to Roche, "the multiple risk factors in the adolescents and young adults afflicted with the disfiguring disease [caused the suicides]." However, some members of congress believe that Roche and the FDA are not doing enough to investigate the connection between Accutane and depression. For instance, Congressman Stupak has determined that approximately 2 suicides per month can be attributed to Accutane.
As far as the birth defects associated with Accutane use are concerned, federal regulators are alarmed at the number of women who become pregnant while taking the drug. The FDA is looking into requiring Roche to better educate doctors and patients about the risks of Accutane associated birth defects. The FDA may require improved labels that better indicate the risk. Additionally, doctors are urged to ensure female patients are not pregnant when they prescribe Accutane. "As dermatologists, we strongly believe that limiting access to [Accutane] is a disservice to patients and erodes the patient-physician relationship," said Richard Scher, MD, president of the American Academy of Dermatology. "Education, not regulation, is the key to safe use of this drug to protect women of childbearing age" he added.
-- Article Courtesy of InjuryBoard.com
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