Drug Side Effects

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.

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. If you experience a serious reaction that you suspect may be linked to a medication you took, what can you do now, and how would a ruling in favor of the drug companies change that?

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.

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.

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.

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.

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.

As young survivors of the modern era of cancer treatment enter the third and fourth decades of their lives, they find themselves poster children for the hope of medical progress -- and also for the toll taken by cancer's toxic treatments. The cure rate for childhood cancer is one of 20th century medicine's greatest success stories. Before 1970, few children with cancer made it. Today, nearly 80% of children who have cancer are cured, according to the American Cancer Society's 2008 statistics.

As symptoms of depression go, there is none much clearer than having thoughts of suicide. But a spate of recent announcements from federal health officials suggests a surprising new interpretation of suicidal fantasies and the depression they are thought to signal: Sometimes, sadness, anxiety and self-destructive thoughts are not symptoms but side effects -- of medicine.

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.