The FDA announced the removal of two indications from the labeling for the antibiotic Ketek (telithromycin), as well as the addition of a black-box warning.

Following the recommendations issued by an advisory panel in December, the FDA removed indications for acute bacterial sinusitis and acute bacterial exacerbation of chronic bronchitis from Ketek's label. The drug's sole remaining indication is for the treatment of mild to moderate community-acquired pneumonia.

Topical high-potency steroid treatment of vitiligo in children is often successful, but may be associated with systemic effects, Canadian and US researchers report in the February issue of the Journal of the American College of Dermatology.

The treatment repertoire for vitiligo is "somewhat limited," Dr. Elena Pope told Reuters Health, but "high-potency steroids are efficacious in repigmentation of the lesions."

FDA notified healthcare professionals of updated labeling for Cialis, Levitra and Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve. FDA advises patients to stop taking these medicines, and call a doctor or healthcare provider right away if they experience sudden or decreased vision loss in one or both eyes.

FDA notified healthcare professionals and patients that companies that manufacture and distribute pergolide have agreed to withdraw the drug from the market. Pergolide is a dopamine agonist (DA) used with levodopa and carbidopa to manage the signs and symptoms of Parkinson's disease. Results of two new studies showed that some patients with Parkinson's disease treated with pergolide had serious damage to their heart valves when compared to patients who did not receive the drug.

Inhaled corticosteroids used to treat asthma can cause a number of oropharyngeal adverse events, including candidiasis and dysphonia, US researchers report in the Annals of Allergy, Asthma, and Immunology for March.

The oropharyngeal side effects that arise with inhaled steroid use can affect adherence to these medications. However, these adverse events have received much less attention than the drugs' systemic side effects, note Dr. Gary S. Rachelefsky from UCLA School of Medicine, and colleagues

In agreement with European Regulatory Authorities, GlaxoSmithKline (GSK) is informing you of recent safety data concerning rosiglitazone-containing products, i.e., Avandia® (rosiglitazone maleate) Tablets, Avandamet® (rosiglitazone maleate and metformin hydrochloride) Tablets, and Avaglim® (rosiglitazone maleate and glimepiride) Tablets. The information could be summarized as follows:

Amgen notified the oncology medical community of the results of a large, multicenter, randomized, placebo-controlled study showing that Aranesp ® (Darbepoetin alfa) was ineffective in reducing red blood cell transfusions or fatigue in patients with cancer who have anemia that is not due to concurrent chemotherapy.

Takeda and FDA notified healthcare professionals of recent safety data concerning pioglitazone-containing products. The results of an analysis of the manufacturer's clinical trial database of pioglitazone showed more reports of fractures in female patients taking pioglitazone than those taking a comparator (either placebo or active). The majority of fractures observed in female patients were in the distal upper limb (forearm, hand and wrist) or distal lower limb (foot, ankle, fibula and tibia).