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Weekly Drug News Round Up - August 28, 2013

Antipsychotics May Triple a Child’s Risk of Getting Diabetes

Experts question "off-label" use of antipsychotic drugs for conditions other than schizophrenia and psychosis Read More...

Today, most prescriptions for antipsychotics, originally approved for psychosis disorders like schizophrenia, are written for treatment of bipolar disorder, ADHD and severe depression. In a new study published in JAMA Psychiatry, researchers reviewed records of 29,000 children ages 6 to 24 taking antipsychotic treatment for uses other than psychoses. Researchers compared these children to 14,000 matched controls that had started taking other medications, such as lithium for bipolar disorder, Ritalin for ADHD, or benzodiazepines for anxiety. Within the first year, users of antipsychotics such as Seroquel, Abilify and Risperdal had triple the risk for type 2 diabetes compared to users of other psychiatric medications.

Breastfeeding Moms Can Safely Take Most Medications

For many women, the risk of not taking a drug is greater than any toxic risk posed to their infant via breast milk Read More...

In a new report published online in the journal Pediatrics, experts state that most medications are compatible with breastfeeding. The American Academy of Pediatrics, in conjunction with the U.S. Food and Drug Administration (FDA), proposes new labels for medications that would outline in-depth information about the risks associated with drugs during nursing. There are some clear cases where medications can harm nursing infants, such as with radioactive contrast media for imaging studies, narcotic painkillers such oxycodone (Oxycontin), and with off-label use of drugs -- such as with metoclopramide (Reglan) -- used to boost milk production. However, many medications are deemed safe during breastfeeding and women should discuss this topic with their providers.

Valchlor Now Approved for Early Stage Cutaneous T-Cell Lymphoma

Topical mechlorethamine is currently recommended for early stage CTCL by the National Comprehensive Cancer Network Read More...

Ceptaris Therapeutics has received approval of Valchlor (mechlorethamine) Gel for the topical treatment of stage IA/IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have received prior skin-directed therapy. Valchlor is the first FDA-approved topical formulation of mechlorethamine, commonly known as nitrogen mustard. Mechlorethamine is also approved for intravenous treatment of mycosis fungoides, the most common type of CTCL. Valchlor gel is applied topically once a day. In clinical trials, no systemic absorption of mechlorethamine was detected with Valchlor treatment.

Galderma Receives Approval of Mirvaso Gel for Rosacea

Rosacea occurs in an estimated 16 million Americans and typically affects fair-skinned adults between 30 and 50 years of age Read More...

The U.S. Food and Drug Administration has approved Mirvaso (brimonidine) topical gel 0.33%, an alpha-2 adrenergic agonist for the treatment of facial redness associated with rosacea. Rosacea is a chronic skin disorder that leads to redness, visible blood vessels, and blemishes of the face. It usually starts on the cheeks and nose, but can also affect the forehead and chin. Mirvaso is applied once daily. The gel is currently indicated for adults and should be used cautiously in patients with depression or certain heart or autoimmune disorders. Oracea (doxycycline) and Metrogel (metronidazole) are treatments approved for the inflammatory lesions of rosacea.

Combination of Ribavirin and Sofosbuvir Cures Hepatitis C Virus

New HCV drugs under development are expected to cut treatment time from roughly 48 weeks to 12 weeks or less Read More...

In 60 patients, the combined use of ribavirin, a standard in the treatment of hepatitis C virus (HCV), with the investigational drug sofosbuvir resulted in a 48 to 68 percent clearance of HCV from patients with a difficult-to-treat form of the disease, as reported in the Journal of the American Medical Association. Treatment for HCV can be harsh due to drug side effects of treatments like ribavirin and interferon. Newer HCV agents will help free patients from interferon-based treatment. Gilead completed sofosbuvir FDA filing and was granted a priority review in June; the FDA is slated to make a final decision by early December.

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