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Weekly Drug News Round Up - May 1, 2013

Plan B One Step: Approved OTC for Women 15 and Older

Proof of age will be required; can be bought during normal store operating hours whether the pharmacy is open or not Read More...

The U.S. Food and Drug Administration (FDA) has approved Plan B One-Step (levonorgestrel) emergency contraception (“morning-after pill”) for women 15 years of age and older without a prescription. Teva submitted an amended application after the FDA turned down a request in December 2011 to make the product available to all females. The FDA’s ruling this week is independent of a pending April 2013 court order to make emergency contraception available to all women without age limits. The status of Plan B, a two-pill regimen now available generically for women 17 and older without a prescription, and Ella (ulipristal), a prescription-only contraceptive pill, has not changed.

Kcentra Approved for the Urgent Reversal of Anticoagulation

Kcentra does not require blood group typing or thawing and can be administered more quickly than plasma Read More...

Warfarin (Coumadin), and other vitamin K antagonist (VKA) anticoagulants are used to prevent blood clots in patients who have conditions such as abnormal heart rhythms (atrial fibrillation) or artificial heart valves. These drugs may lead to acute bleeding as a serious side effect in some patients who receive excessive doses. The U.S. Food and Drug Administration (FDA) has approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of VKA anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States.

Epilepsy Drug Potiga Linked to Eye and Skin Discoloration

Patients should not stop taking Potiga without talking to their health care professional Read More...

The U.S. Food and Drug Administration (FDA) is warning the public that the epilepsy medication Potiga (ezogabine) can cause blue skin discoloration and eye abnormalities characterized by pigment changes in the retina. FDA does not currently know if these changes are reversible. Reports have involved blue pigmentation around the lips, nail beds, face, legs or eyes. The skin discoloration generally occurred after four years of treatment with Potiga, but has appeared sooner in some patients. All patients taking Potiga should have baseline and periodic eye exams. Patients who are taking Potiga and develop any changes in vision or any skin discoloration should contact their healthcare provider.

FDA Limits Duration and Use of Samsca Due to Liver Injury

Samsca treatment should be stopped if the patient develops signs of liver disease Read More...

The U.S. Food and Drug Administration (FDA) has determined that Samsca should not be used for longer than 30 days or in patients with underlying liver disease because it can cause liver injury, potentially leading to liver transplant or death. Samsca (tolvaptan) is used to treat hyponatremia (low levels of sodium in the blood) in those with heart failure and certain hormonal imbalances. Samsca treatment should be stopped if the patient develops signs of liver disease. Treatment duration should be limited to 30 days or less, and use should be avoided in patients with underlying liver disease, including cirrhosis.

FDA Approves Procysbi for Nephropathic Cystinosis

Procysbi is a delayed-release capsule taken every 12 hours Read More...

The U.S. Food and Drug Administration (FDA) has approved Procysbi (cysteamine bitartrate) in patients 6 years of age and older for the management of nephropathic cystinosis. Cystinosis is a fatal, rare genetic condition that affects roughly 500 patients in the U.S. and about 3,000 worldwide. The buildup of cystine causes kidney damage, and results in slow body growth, weak bones and kidney failure. Cystagon (cysteamine), an immediate-release oral tablet taken every six hours, is also approved for cystinosis. Clinical trials show that Procysbi is as effective as Cystagon in controlling cystine levels.