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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: Flagrante Delictu who wrote (15921)	2/26/1998 2:34:00 PM
From: celeryroot.com	Read Replies (1) \| Respond to of 32384

Happy BDay Bernie

To: Flagrante Delictu who wrote (15921)	2/26/1998 2:36:00 PM
From: Henry Niman	Read Replies (1) \| Respond to of 32384

Bernie, Happy Birthday. At least you shouldn't have to worry about your acne treatment making you depressed: Acne Drug Linked To Suicide Risk By Alicia Ault ROCKVILLE, MD (Reuters) -- The US Food and Drug Administration (FDA) issued a statement Wednesday advising physicians and consumers about reports of "depression, psychosis, and rarely suicidal thoughts and actions" related to use of the acne drug isotretinoin (Accutane). The FDA and Hoffmann-La Roche, the pharmaceutical company that markets the drug, also announced that labeling of the drug will be changed to strengthen the current warning about a risk of depression in patients using the drug. For more than a decade, such reports have been trickling into the FDA's MedWatch system, an information system used to track drugs in the marketplace. Information about depression was included in Accutane labeling in 1986, but "we have moved it from the adverse reactions section into the warning section so that it captures the attention of physicians more readily," said Eileen Leach, medical director of dermatology products for Hoffmann-La Roche. The FDA and Hoffmann-La Roche said that, so far, there seems to be no direct link between Accutane and these effects. "We cannot uncover a cause and effect in humans," said Leach, noting that the company has consulted outside experts and the literature for evidence. The company noted that many of the drug's users are teenagers who are "at particular risk" for depression, and that the severe, nodular acne treated by the drug may be further cause for depression. The FDA agreed, but was concerned after receiving some two dozen reports of patients whose psychological symptoms improved after stopping Accutane therapy, but worsened with re-start of the drug. "To us that's an important clue that something might be occurring," said Jonathan Wilkin, director of the FDA's division of dermatologic and dental drugs. Wilkin said an internal FDA task force is continuing to investigate these cases to determine if there is any causal link between Accutane and depression or suicide. He notes that "there is some suggestion in the literature that hypervitaminosis A might be associated with mood disorder," which the agency will continue to explore. Accutane is derived from vitamin A. In the meantime, with continuing reports, "we think it would be prudent for physicians to think about these things when caring for patients for whom they've prescribed Accutane," said Wilkin. The FDA is telling physicians that for patients who exhibit symptoms, "merely discontinuing the drug may be insufficient to remedy these adverse events, and that further evaluation may be needed." In a "Dear Doctor" letter mailed on February 23rd, Hoffmann-La Roche advised physicians that depression and other adverse psychological events with Accutane use "are uncommon but, because of their potential consequences, clinicians should be attentive to any new behavioral signs and symptoms."