Drug Side Effects

Government regulators said the connection between Pfizer's anti-smoking drug Chantix and serious psychiatric problems is "increasingly likely." The Food and Drug Administration said it has received reports of 37 suicides and more than 400 of suicidal behavior in connection with the drug. In November, the agency began investigating reports of depression, agitation and suicidal behavior among patients taking the popular twice-daily pill.

You'd probably be interested in a drug that'll keep you peppy even when you're running on fumes. How about a drug that can cause depression, anxiety, hallucinations, psychosis, mania and suicidal thoughts? How about chest pain, sores or serious rashes? You had to sift through the fine print of full-page newspaper ads that ran coast to coast last week to learn that these drugs are one and the same. The ads were for Provigil, which its maker, Cephalon Inc.

A young man reportedly taking the antidepressant Prozac has a history of significant psychiatric troubles, including self-cutting, obsessive thoughts and anxiety. But among the 27-year-old's current teachers and acquaintances, he has a reputation as a caring, dependable friend and a highly motivated student. Surely, say mental health professionals, this recovery was brought about by Prozac.

Combined hormone therapy to ease menopause symptoms such as hot flashes raises the risk of getting incorrect mammograms and biopsy tests to detect breast cancer, the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center has found. Women taking a combination of estrogen and progesterone for five years were 11% more likely to have an irregular mammogram than those not taking the pills, according to the report in Monday's Archives of Internal Medicine.

Years of high-profile court battles over drugs such as Vioxx and Celebrex, along with billion-dollar settlements and jury verdicts, could soon be a thing of the past. The U.S. Supreme Court, in an 8-1 decision, ruled last month that patients injured by most medical devices can't sue their manufacturers. And this fall, a similar case could extend the same legal protection to the much larger pharmaceutical industry -- a frequent target of lawsuits.

Roche Holding and GlaxoSmithKline said Tuesday that they had added new labels to their prescription flu medicines that contain reports of abnormal psychiatric behavior in some patients. A warning about cases of delirium and unusual behavior had been listed previously on Roche's drug, Tamiflu. That language was strengthened to say some cases were fatal.

Standing in front of a packed room of investors at a San Francisco conference early this year, Kevin Sharer took a repentant tone. He first flipped to a slide labeled: "One Year Ago, We Were in a Good Spot." The chief executive documented how Amgen's revenue increased nearly 30% from 2001 to 2006. Then he deadpanned: "What a difference a year can make." For Amgen Inc., Sharer's assessment couldn't be more true. The Thousand Oaks biotech pioneer that could do no wrong for most of its 25-year history is increasingly at risk of losing its place atop the spectacularly lucrative but equally treacherous biotech industry.

Johnson & Johnson and the Food and Drug Administration warned of reported liver damage and death in patients taking the company's HIV drug Prezista, according to a letter released Wednesday. The letter, which J&J sent to doctors this month, cited cases of drug-induced hepatitis, liver injury and death, though the problems have not been linked directly to Prezista, a protease inhibitor given in combination with Abbott Laboratories' ritonavir. A J&J unit said it would put a new warning on the label.

Consumers Union is pressing U.S. regulators to require that television commercials for medicines include a toll-free telephone number to report harmful side effects. The group, the publisher of Consumer Reports magazine, said it has collected about 56,000 signatures on a petition calling for the Food and Drug Administration to require the inclusion of the agency's phone number in TV ads. Consumers Union also released results from a telephone poll it had conducted showing that only 35% of respondents knew they could report side effects to the FDA. Legislation signed in September by President Bush requires the FDA's phone number to be listed in print ads for drugs.

The scope of concerns about the possible ill effects of a contaminated blood thinner from China grew significantly Tuesday as federal regulators urged makers of many kinds of medical devices that contain the drug to test their supplies. The products to be tested cover a spectrum of equipment and uses.