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Weekly Drug News Round Up - December 4, 2013

Onfi: Possibly Fatal Skin Reactions May Occur

Patients taking Onfi should seek immediate medical treatment if they develop a rash, skin blistering, mouth sores, or hives Read More...

The U.S. Food and Drug Administration (FDA) has issued a Drug Safety Communication that the anti-seizure drug Onfi (clobazam) can cause rare but serious skin reactions that can result in permanent harm and death. These skin reactions, called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur at any time during Onfi treatment, but are more likely during the first 8 weeks of treatment or when Onfi is stopped and then re-started. All cases of SJS and TEN in the FDA case series have resulted in hospitalization, and one case resulted in death. Patients should not stop taking Onfi without talking to their doctor.

Velphoro Approved for Hyperphosphatemia

When taken with meals, Velphoro adsorbs dietary phosphate in the gastrointestinal tract and prevents its uptake into the blood Read More...

Velphoro (sucroferric oxyhydroxide) has received US Food and Drug Administration (FDA) approval for the control of serum phosphorus levels in patients with Chronic Kidney Disease (CKD) on dialysis. Hyperphosphatemia, an abnormal elevation of phosphorus levels in the blood, is a common and serious condition in CKD patients on dialysis. Velphoro is an iron-based, calcium-free, chewable phosphate binder that requires less pills per day than other phosphate binders such as sevelamer (Renagel, Renvela). The recommended starting dose of Velphoro is 3 tablets per day (1 tablet per meal). Velphoro will be launched in the US by Fresenius Medical Care North America in 2014.

Signed Into Law: FDA Begins Regulation of Compounding Pharmacies

The new law doesn't provide the FDA with all the additional authority it sought Read More...

The U.S. Food and Drug Administration (FDA) has started regulating compounding pharmacies, defined as those which create new drug combinations or alter drugs for individual patients. The law was prompted by the 2012 deaths of 64 people who received fungus-contaminated, preservative-free methylprednisolone acetate given for joint pain. Compounding pharmacies, once registered with the FDA, are classified as outsourcing pharmacies, enabling them to sell bulk drugs to health-care facilities. However, since pharmacy registration is voluntary, unregistered pharmacies that ship tainted products will only be caught if contamination is reported.

BTG’s Varithena Approved for Varicose Vein Treatment

Varithena injection is used to treat small varicose veins of the lower legs Read More…

More than 30 million adults in the US have varicose veins, with women twice as likely as men to develop these swollen, gnarled veins. Varicose veins often require treatment for painful symptoms including cramps, throbbing, tingling and swelling. Varithena (polidocanol injectable foam), a sclerosing agent, has been approved for the treatment of incompetent veins and visible varicosities of the great saphenous vein (GSV) system, which runs the length of leg. Varithena is intended for intravenous injection using ultrasound guidance. Treatment is considered minimally invasive and no sedation is required. Other treatments for varicose veins include thermal ablation and surgery.

High Salt Content of Effervescent Drugs May Pose Heart Risks

It's the salt in these medications reacting with water that adds the fizz to the drugs Read More...

Researchers have recently found that some effervescent, or “fizzy” medications used for upset stomach, colds or flu symptoms may overdo it on salt content. One Alka-Seltzer tablet (aspirin, sodium bicarbonate, citric acid) contains 445 milligrams (mg) of salt. Taking the maximum dose -- two tablets four times a day -- equals over 3.5 grams of salt, more than double the American Heart Association's daily recommendation. Researchers found that patients taking at least two effervescent medicines during their study were at a 16 percent higher risk of heart attack, stroke or death compared with patients taking the salt-free versions of those same medications.