Drug Side Effects

Drug safety officials Tuesday imposed the government's most urgent safety warning on Cipro and similar antibiotics, citing evidence that they might lead to serious tendon ruptures that could leave patients incapacitated and needing extensive surgery. The Food and Drug Administration ordered makers of fluoroquinolone drugs -- a potent class of antibacterials -- to add a prominent "black box" warning to their products and develop literature for patients emphasizing the risks.

The Food and Drug Administration wants to add its most serious warning label to epilepsy drugs, based on evidence that they increase the risk of suicide in patients. FDA scientists have proposed adding a "black box" warning about suicide risks to all drugs used to treat seizures. An FDA analysis of nearly 200 studies showed that patients taking anti-seizure drugs were more likely to have suicidal thoughts and behaviors than those taking placebos. Although the reported problems were extremely rare, the FDA found that drug-treated patients faced about twice the risk.

Aranesp, biotech giant Amgen Inc.'s once-highflying anemia drug, took another hit Wednesday when the Food and Drug Administration ordered new restrictions on the way physicians prescribe it to cancer patients. Amgen's most successful biotech franchise, Aranesp has been under review by U.S. health officials since it was tied to a greater risk of heart attack, stroke and death at high doses in cancer patients nearly two years ago. Anemia is a common side effect from chemotherapy.

Penis enlargers and constricting rings to maintain erections have inadequate directions for use and can have harmful effects, from rupturing blood vessels to causing gangrene of the penis, the Food and Drug Administration said in guidance to import inspectors. "Basically, the labeling of these devices falsely states or implies they will treat impotence, prolong erection, and increase the dimensions of the penis," the FDA said.

Federal regulators say a drug from Pfizer Inc. and Ligand Pharmaceuticals Inc. effectively treats osteoporosis, but they are concerned about deaths, blood clots and other problems seen in company studies. The Food and Drug Administration noted that women treated with Pfizer's Fablyn were more likely to die of cancer or stroke than those taking a placebo. The FDA posted its review of the drug online in advance of a meeting Monday with outside advisors.

Prescription drugs sometimes cause serious side effects. A ruling by the U.S. Supreme Court expected this fall could radically alter consumers' ability to seek recourse from drug makers should they suffer harm. The case, called Wyeth vs. Levine, may lead to a new interpretation of federal law, which would shield pharmaceutical companies from the most common kind of lawsuit.

Federal health regulators said Friday that they were reviewing an experimental use of blockbuster anemia drugs made by Amgen Inc. and Johnson & Johnson that have been associated with higher death rates in a study involving stroke patients. This month J&J reported results from a German trial in which more stroke patients treated with its drug Eprex died than those taking a placebo.

The safety of skin wrinkle fillers from companies led by Medicis Pharmaceutical Corp. and Allergan Inc. will be reviewed by a U.S. advisory panel next month. Food and Drug Administration advisors will meet Nov. 18 in Gaithersburg, Md., to hear safety concerns and recommend studies for existing and new wrinkle treatments, according to a notice posted on the agency's website. The next day, the advisory panel will discuss evaluation of cosmetic devices that use various energy sources to treat skin conditions.

Genentech Inc. said a second patient taking its psoriasis treatment, Raptiva, had developed a rare brain infection. A 73-year-old woman died from progressive multifocal leukoencephalopathy after taking Raptiva, South San Francisco-based Genentech said. Genentech reported Oct. 2 that a 70-year-old patient taking the drug for more than four years developed PML.

Genentech Inc.'s Avastin, widely prescribed for colon cancer and some lung tumors, was linked to significantly higher rates of vein clotting in an analysis of earlier studies. Patients who got the drug were 33% more likely to have blood clots develop in their veins than those who didn't receive it, said researchers led by Shenhong Wu, a cancer specialist at Stony Brook University in Stony Brook, N.Y. Avastin, Genentech's top-selling drug, with $2.3 billion in 2007 U.S. sales, bears a warning for high risk of clots in arteries.