Researchers at a non-profit institute consider Pfizer Inc´s smoking-cessation drug Chantix/Champix should carry a stronger warning about the potential risks of accidental injury and death, after analyzing post-marketing data submitted to U.S. health regulators.

Genentech Inc´s psoriasis drug Raptiva must carry a highlighted warning about the risk of life-threatening infections, the U.S. Food and Drug Administration announced, such as progressive multifocal leukoencephalopathy (PML), of which there has been one confirmed case.

The U.S. health regulators have approved revisions to labels of erectile dysfunction drugs warning users of the possibility of sudden, temporary memory loss called ‘transient global amnesia. Drugs affected are Pfizer´s Viagra and Eli Lilly & Co’s Cialis. In May, the changes had already been approved for Bayer AG´s Levitra, jointly marketed in the U.S. by GlaxoSMithKline PLC and Schering-Plough.

Celgene Corp announced that Vidaza received expanded FDA approval to reflect new overall survival achieved in the AZA-001 survival study of patients with higher-risk myelodysplastic syndromes.

Patients should have their genotype tested before taking Glaxo’s AIDS drug Ziagen the FDA said. Administering the drug to people with a particular human leukocyte antigen may cause a life-threatening allergic reaction. The good news for Glaxo is that only about 5 percent of the population carry the genetic variant

Pfizer Inc has taken a stand that its epilepsy drug Lyrica should not be included with other drugs which the FDA considers should be carrying black box warnings of risks of suicidal thoughts. The Food and Drug Administration (FDA) still has the Pfizer drug on the list.

U.S. Food and Drug Administration (FDA) officials believe a black box label warning about the risk of suicidal thoughts and behavior with epilepsy drugs should be in place, and are pushing this decision on their advisory panel just a couple of days ahead of a public meeting on the issue.

The class of drugs called Erythopoiesis Stimulating Agents – ESAs or epoetins (EPOs) -should carry a new warning for their use in cancer patients stating that blood transfusion should be the preferred method of correcting anemia, the European health regulators agency (EMEA) announced. In this class of drugs are Amgen´s Aranesp and Epogen, and Johnson & Johnson´s Procrit/Eprex.

The FDA approved an update to the prescribing information for Merck & Co’s RotaTeq oral rotavirus vaccine –to help prevent rotavirus gastroenteritis in infants and children- to include the report of a fatal case of intestinal obstruction

Drugmakers Amgen and Wyeth have bolstered warnings about risks of infections, including tuberculosis on the label of their anti-inflammatory drug Enbrel. Previous Prescribing Information included a bolded warning, but the label carries now a black box warning and includes additional language regarding monitoring patients for tuberculosis

Schering-Plough Corporation reported that the Food and Drug Administration has approved label revisions for Pegintron and Rebetol combination therapy for chronic hepatitis C, recommending weight-based dosing of Rebetol based on patient body weight.

Baxter International Inc.´s inhaled anesthetic Suprane and Salix Pharmaceuticals Ltd.´s anti-inflammatory drug Colazal need new warning labels for potential risks in children, federal regulators said. The label for Suprane, known generically as desflurane, already carries warnings about other cardiac problems including heart attacks, irregular heart beats and unstable blood pressure.

The European Medicines Agency (EMEA) has concluded that warnings about liver injury should be added to the product information for Tysabri (natalizumab). The CHMP has requested that Elan Corp (ELN), the marketing authorisation holder for Tysabri, submits a variation to the marketing authorisation to implement these changes.