Baxter and FDA notified healthcare professionals of the potential for life threatening medication errors involving two Heparin products, Heparin Sodium Injection 10,000 units/mL, and HEP-LOCK U/P 10 units/mL.
Baxter is aware of fatal medication errors that have occurred when two Heparin products with shades of blue labeling were mistaken for each other. Three infant deaths resulted when the higher dosage Heparin Sodium Injection 10,000 units/mL was inadvertently administered instead of the lower dosage of HEP-LOCK U/P 10 units/mL. The currently marketed

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.

People are mixing supplements, herbs and over-the-counter medications and prescription drugs to cure themselves of ills, unaware that they could be making themselves sicker, says George Grossberg, M.D., director of the division of geriatric psychiatry at Saint Louis University.

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.

Director-General of Health, Stephen McKernan, is warning people about the potential health dangers associated with 5 Chinese medicine products which have been found to contain undeclared prescription medicines for weight loss and erectile dysfunction.

This statement about the 5 products is being issued by the Director-General under Section 98 of the Medicines Act 1981, following investigations by the Ministry of Health's medicines safety arm, Medsafe.