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Weekly News Round Up - February 22, 2012

Unreliable Dosing System Prompts Nationwide Recall of Infants’ Tylenol

Infants’ Tylenol SimpleMeasure dosing system results in “flow restrictor” pushed into bottle; McNeil initiates voluntary recall Read More...

Over 500,000 bottles of Infants’ Tylenol (acetaminophen) Oral Suspension, 1 oz. Grape Flavor have been recalled due to consumer complaints about the dosing system. The McNeil SimpleMeasure dosing system consists of a syringe that is inserted into a “flow restrictor” at the top of the bottle that allows accurate dosing. Some consumers reported that the flow restrictor was pushed into the bottle when the syringe was inserted. If the flow restrictor is pushed into the bottle, the Tylenol should not be used. See the press release for lot number and UPC codes of the affected product. Consumers who are in possession of the recalled Infants’ Tylenol may continue to use it as long as the flow restrictor remains in place.

Korlym Approved For Treatment of Endogenous Cushing’s Syndrome

Korlym (mifepristone) approved to control high blood sugar in endogenous Cushing’s Syndrome; contraindicated in pregnancy Read More...

Endogenous Cushing’s Syndrome is a rare disorder that results in overproduction of the adrenal hormone cortisol, leading to high blood sugar (hyperglycemia). The FDA has approved the orphan drug Korlym (mifepristone) as a 300 mg oral tablet to control hyperglycemia in patients who have type 2 diabetes or glucose intolerance and are not candidates for surgery, or have not responded to prior surgery. In Korlym clinical trials, significant improvement in blood sugar control, including a reduction in insulin use by some patients was seen. Common side effects include nausea, fatigue, headache and arthralgia. Although pregnancy is rare in Cushing’s Syndrome due to the suppressive effect of cortisol on reproduction, the labeling will include a boxed warning against use in pregnancy; the use of Korlym will terminate a pregnancy.

Study: Implanted Microchip Delivers Osteoporosis Drug

Researchers at Harvard and MIT develop remote controlled microchip to deliver Forteo, possibly other drugs Read More...

A daily, painful injection can play havoc with patient adherence to drug therapy. But in a small study, seven women were implanted with a microchip that delivered a daily dose of the osteoporosis drug, Forteo (teriparatide). Researchers claim the microchip delivered the drug as well as daily injections, and blood tests indicated similar rates of bone formation. Compliance rates with the microchip rose, but questions remain about the stability of the drug at body temperature, which must normally be refrigerated. Experts predict the possibility that the microchip could be a vehicle for other injectable therapies in the future, as well.

FDA Takes Action To Reduce Prescription Drug Shortages

Shipments of life-saving cancer drugs are underway; FDA moves on President's order to “take action” to reduce drug shortages Read More...

The U.S. Food and Drug Administration (FDA) has undertaken a series of steps to address the drug shortages that have been plaguing the U.S. health care system. This week the FDA announced that the acute lymphocytic leukemia drug methotrexate would be sourced from several manufacturers. A newly approved, preservative-free version of methotrexate for intrathecal use would be available from APP Pharmaceuticals. Doxil (doxorubicin), used for ovarian, bone marrow and AIDS-related skin cancers has also been in short supply. However, in a rare move the FDA will allow temporary importation of Lipodox, a replacement drug for Doxil made by Sun Pharma Global FZE of India. And in an effort to address one of the roots of drug shortages, FDA has sent draft guidance to manufacturers detailing new requirements for notification of drug supply deficits.

Bio-T-Gel Approved: Testosterone Replacement Therapy For Men

Testosterone gel is FDA-approved for men to treat low testosterone levels Read More...

Bio-T-Gel (testosterone gel) has been approved for treatment of low testosterone levels, a condition that afflicts between 4 and 5 million men nationwide. The causative factors in low testosterone levels may be an inadequate production or a signaling disconnect between the brain and the testes. Hypogonadism typically occurs in men when testosterone levels fall below 300 nanograms/deciliter. Low testosterone not only results in reduced sexual desire, but also fatigue, decreased energy, and depressed mood. BioSante has licensed Bio-T-Gel to Teva Pharmaceuticals for all U.S. regulatory and marketing activities. BioSante is also developing LibiGel, a testerone gel product for low testosterone in women, but Phase III trial efficacy measures have not met statistical significance.