July 8, 2008 – 4:24 pm | One Comment

In a move sure to stir controversy, the American Academy of Pediatrics (AAP) recommended on Monday that a more aggressive approach to treating high cholesterol in children should be implemented, even if it means prescribing …

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Articles in FDA

Pills in Gorton’s Fish Fillets Found to be Herbal Supplements
March 10, 2008 – 8:20 pm | 5 Comments

Gorton’s Inc. has announced that the tablets found in Crispy Battered Fish Fillets turned out to be over-the-counter herbal supplements. The company pointed out that the incident in Pennsylvania is an isolated case.

Amgen’s NPLATE Effective, but Not Without Risks
March 10, 2008 – 6:31 pm | 7 Comments

The Food and Drug Administration (FDA) panel will vote Wednesday on whether Amgen’s drug, NPLATE, provides enough benefit to counteract the side effects associated with its use. NPLATE is intended to treat Idiopathic Thrombocytopenic Purpura …

Common Schizophrenia Drug on Trial
March 8, 2008 – 4:31 pm | 9 Comments

The pharmaceutical giant, Eli Lilly, is being sued by the state of Alaska over allegedly covering up the potential risks of Zyprexa (olanzapine). Attorneys for the state argue that the company knew that the drug, …

Estrogen Linked to Breast Cancer Recurrence
March 8, 2008 – 10:38 am | 5 Comments

A new study published in the March issue of Cancer Epidemiology, Biomarkers and Prevention demonstrates that women who have a recurrence of breast cancer have almost twice as much estrogen in their blood than those …

Vaccine – Autism Link, Afterall?
March 7, 2008 – 6:30 am | 30 Comments

Officials from the U.S. Department of Health and Human Services have agreed that vaccines administered to a 9-year old girl contributed to her condition. Hannah Poling of Athens, GA, and her family may be receiving …

Contaminated Heparin Found in Germany
March 6, 2008 – 8:22 pm | 3 Comments

German authorities have recalled a popular blood-thinner heparin, due to some 100 reports of adverse reactions. According to the reports, german heparin produced by Rotex Medica GmBH Arzneimittelwerk contains active ingredient that did not come …

ABILIFY Now Available for Younger Patients with Bipolar Disorder
March 3, 2008 – 9:35 pm | One Comment

Otsuka Pharmaceutical Co., Ltd and Bristol-Myers Squibb Company have announced that a new drug for treatment of bipolar disorder in children and adolescents is now available. ABILIFY (aripiprazole) has been approved by the FDA for …

Heparin Vials Recalled by Baxter
March 2, 2008 – 11:24 pm | One Comment

Baxter announced a voluntary recall of all remaining lots of various heparin related drugs and heparin flush products. The initial recall was announced January 17, 2008 as a precautionary measure as reports came in of …

Nexium for Children Approved
March 1, 2008 – 10:30 am | 6 Comments

The FDA approved esomeprazole (Nexium) to help short term gastroesophagel reflux disease (GERD) in children between the ages of 1 and 11. The drug was approved in 2 forms: the delayed release capsule and a …

China Says…
February 28, 2008 – 3:41 pm | No Comment

China’s State Food and Drug Administration said in a recent released statement that it is the receiving country’s responsibility to ensure the safety of pharmaceutical ingredients they import from other countries.