FDA: Authorities seize unapproved Crescendo drug

The Food and Drug Administration said authorities seized an unapproved drug marketed by Crescendo Therapeutics LLC, following two inspections of the California company.

According to the FDA, Crescendo has been marketing its HybriSil topical corticosteroid treatment to treat scars and skin disorders for noninvestigational purposes despite previous FDA warnings. Though the company submitted an investigational new-drug application for HybriSil, it allowed limited distribution of the treatment for investigational use only, the FDA said.

During the first inspection in April 2011, the FDA found that Crescendo was marketing HybriSil as a prescription topical corticosteroid, intended to treat scars and skin disorders. FDA warned the company in November 2011 that HybriSil was an unapproved new drug product, which could not be marketed without approval by the FDA based on data showing that the product is safe and effective for its intended use. On January 3, 2012, Crescendo submitted an Investigational New Drug Application for HybriSil that permitted the limited distribution of the product for investigational use only. However, a subsequent FDA inspection conducted later that month confirmed that Crescendo continues to distribute HybriSil for non-investigational purposes.

The FDA also determined that HybriSil is misbranded because its labeling fails to carry adequate directions for use. In a follow-up January 2012 inspection, the FDA found that Crescendo was still distributing HybriSil, despite the warnings.

“This action was taken because Crescendo Therapeutics continued to sell unapproved new products,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “The FDA continues to be committed to protecting consumers against new drug products marketed without FDA approval.”

There are many other topical corticosteroids approved by the FDA for treating skin disorders that are available to consumers.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm305006.htm

FDA warned LifeSouth about Blood Labeling

From the Montgomery Advertiser

In January, the Food and Drug Administration issued a warning about improperly labeling contaminated blood to a business that was sued earlier this week for allegedly giving a Montgomery hospital contaminated blood that led to a man contracting HIV.

But Kim Kinsell, general counsel for LifeSouth Community Blood Centers, said that the FDA warning concerned an isolated incident at a Huntsville blood center and that there is little chance that facility had any connection to the blood sample in Montgomery.

http://www.montgomeryadvertiser.com/article/20120518/NEWS02/305180025/FDA-warned-LifeSouth-about-labeling-blood

Calcium Supplements May Be Bad for Your Heart

Calcium supplements can almost double the risk of a heart attack, according to new research, and should be "taken with caution" and only for medical reasons, such as to prevent bone thinning. The study contradicts the commonly held belief that consuming extra calcium can help prevent heart disease or a stroke.

The findings are based on a study of the calcium intake of 23,980 men and women in Heidelberg, Germany, who were aged 35-64 when they joined a local cohort of the European Prospective Investigation into Cancer and Nutrition (EPIC) study in 1994-98. Researchers checked participants' health for 11 years afterwards, during which time 354 of them had a heart attack and 260 a stroke and there were 267 associated deaths. They also tracked how much calcium they consumed from any source.

http://www.guardian.co.uk/society/2012/may/24/calcium-supplements-heart-risk

Osteoporosis Drugs Link to Leg Fractures

New research shows common drugs for osteoporosis may increase the risk for a certain type of fracture.

The study of 500 adults who suffered fractures found those taking bisphosphonates were more likely to have an atypical fracture of the femur.

These bone breaks are relatively rare, but of the patients who did experience this fracture 80% had been taking the drugs. The longer the patient took bisphosphonates, the higher the risk.

http://www.wowt.com/news/headlines/Osteoporosis_Drugs_May_Increase_Risk_of_Fracture_152571985.html

Hospira Recalls One Lot Of Opioid Analgesic Injection

Hospira has initiated a nationwide voluntary recall of one lot of Hydromorphone Hydrochloride Injection 1 mg/ml, with the knowledge of the FDA, after it was found that the opioid analgesic injection contained more than the intended fill volume.

The recalled product is a prefilled glass cartridge for use with Carpuject Syringe system. The affected lot number is 07547LL, which has an expiration date of July 1, 2013.

The FDA in a statement said that opioid pain medications such as Hydromorphone have life-threatening consequences if overdosed. Those consequences can include respiratory depression (slowed breathing or suspension of breathing), low blood pressure and reduced heart rate including circulatory collapse.

 http://www.rttnews.com/1885898/hospira-recalls-one-lot-of-opioid-analgesic-injection.aspx?type=fdr

FDA Drug Safety Communication: Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod)

The U.S. Food and Drug Administration (FDA) has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya (fingolimod).  The agency also has evaluated additional clinical trial and postmarket data for Gilenya, including reports of patients who died of cardiovascular events or unknown causes.  FDA could not definitively conclude that Gilenya was related to any of the deaths (see Data Summary, below). However, based on its reevaluation of the data, FDA remains concerned about the cardiovascular effects of Gilenya after the first dose. Data show that, although the maximum heart rate lowering effect of Gilenya usually occurs within 6 hours of the first dose, the maximum effect may occur as late as 20 hours after the first dose in some patients (See Data Summary).  
For this reason, Gilenya is now contraindicated (FDA advises against its use) in patients with certain pre-existing or recent (within last 6 months) heart conditions or stroke, or who are taking certain antiarrhythmic medications. See CONTRAINDICATION section of the drug label.
FDA continues to recommend that all patients starting Gilenya be monitored for signs of a slow heart rate (bradycardia) for at least 6 hours after the first dose.  FDA is now recommending hourly pulse and blood pressure measurement for all patients starting Gilenya.  Electrocardiogram (ECG or EKG) testing should be performed prior to dosing and at the end of the observation period.  Cardiovascular monitoring should continue until any symptoms resolve.
In addition, FDA is now also recommending that the time of cardiovascular monitoring be extended past 6 hours in patients who are at higher risk for or who may not tolerate bradycardia.   Extended monitoring should include continuous ECG monitoring that continues overnight. See DOSAGE AND ADMINISTRATION section of the drug label. These higher risk patients include those:

• Who develop severe bradycardia after administration of the first dose of Gilenya
• With certain pre-existing conditions in whom bradycardia may be poorly tolerated
• Receiving therapy with other drugs that slow the heart rate or atrioventricular conduction
• With QT interval prolongation (a type of heart rhythm abnormality) prior to starting Gilenya, or at any time during the cardiovascular monitoring period
• Receiving therapy with other drugs that prolong the QT interval and that can cause a serious and life-threatening abnormal heart rhythm called Torsades de pointes

 http://www.fda.gov/Drugs/DrugSafety/ucm303192.htm

DMAA News for May 8, 2012: GNC, Vitamin Shoppe Keep DMAA Products in Stores

From CNBC:

Ten days after the FDA sent warning letters to manufacturers of supplements with DMAA in it, the nation’s largest supplement retailers still have the product on the shelves

 Although companies have insisted that DMAA is a product that exists in nature (from the geranium plant), the FDA has challenged that assertion. Since DMAA wasn’t previously approved as a supplement, it would technically be considered a drug and therefore be subjected to more stringent oversight. Dietary supplements do not have to be approved before hitting the market. Those that are considered drugs cannot be sold before receiving FDA approval. While the FDA said in its warning letters that the safety record of DMAA is not clear, Vitamin Shoppe and GNC seem to be making the bet that DMAA is in fact safe. 

The two retailers could potentially get their money back from the manufacturers, but if DMAA is proven to be dangerous, the companies would still have legal exposure

 http://www.cnbc.com/id/47338971

May 2, 2012 DMAA Product List

We've been investigating products regarding DMAA for some time now, and with news this past week from the FDA about warnings over DMAA, have compiled this list of products:

Distributor/Manufacturer        Product

Total Body Nutrition                1,3 D Bomb 1,3 D Nox

CTD Labs                                  Adralin

Serious Nutrition Solutions     Adrena-G

United Health                           Avidex

These are in addition to those noted by the FDA

Exclusive Supplements	Biorhythm SSIN Juice
Fahrenheit Nutrition	Lean Efx
Gaspari Nutrition	Spirodex
iSatori Global Technologies, LLC	PWR
Muscle Warfare, Inc.	Napalm
MuscleMeds Performance Technologies	Code Red
Nutrex Research	Hemo Rage Black Lipo-6 Black Ultra Concentrate Lipo-6 Black Lipo-6 Black Hers Ultra Concentrate Lipo-6 Black Hers
SEI Pharmaceuticals	MethylHex 4,2
SNI LLC	Nitric Blast
USP Labs, LLC	Oxy Elite Pro Jack3D

May 1, 2012 DMAA News: FDA challenges marketing of DMAA products for lack of safety evidence

The U.S. Food and Drug Administration today issued warning letters to ten manufacturers and distributors of dietary supplements containing dimethylamylamine, more popularly known as DMAA, for marketing products for which evidence of the safety of the product had not been submitted to FDA.

Also referred to as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, the ingredient is in dietary supplements and is often touted as a "natural" stimulant.  

The companies receiving warning letters and their product names are:

Company	Product(s)
Exclusive Supplements	Biorhythm SSIN Juice
Fahrenheit Nutrition	Lean Efx
Gaspari Nutrition	Spirodex
iSatori Global Technologies, LLC	PWR
Muscle Warfare, Inc.	Napalm
MuscleMeds Performance Technologies	Code Red
Nutrex Research	Hemo Rage Black Lipo-6 Black Ultra Concentrate Lipo-6 Black Lipo-6 Black Hers Ultra Concentrate Lipo-6 Black Hers
SEI Pharmaceuticals	MethylHex 4,2
SNI LLC	Nitric Blast
USP Labs, LLC	Oxy Elite Pro Jack3D

"Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that and that makes the products adulterated," said Daniel Fabricant, Ph.D., Director of FDA’s Dietary Supplement Program.

Specifically, the warning letters cite the companies for marketing products for which a notification had not been submitted for the use of DMAA as a New Dietary Ingredient (NDI). Under current law, dietary supplement manufacturers or distributors who use certain dietary ingredients not marketed in a dietary supplement prior to October 15, 1994, are responsible for notifying the FDA of evidence to support their conclusion that their dietary supplements containing NDIs are safe. Manufacturers or distributors must submit notification at least 75 days before marketing their products. The companies warned today were marketing products for which this requirement had not been met.

The FDA warning letters also advised the companies that the agency is not aware of evidence or history of use to indicate that DMAA is safe. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers, marketers and distributors of dietary supplements are responsible for ensuring that they are marketing a safe product.

The FDA letters noted that DMAA is known to narrow the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath and tightening in the chest to heart attack. The agency has received 42 adverse event reports on products containing DMAA. While the complaints do not establish that DMAA was the cause of the incidents, some of the reports have included cardiac disorders, nervous system disorders, psychiatric disorders, and death.

The agency additionally warned the companies that synthetically-produced DMAA is not a “dietary ingredient” and, therefore, is not eligible to be used as an active ingredient in a dietary supplement. DSHEA defines a dietary ingredient as a vitamin, mineral, amino acid, herb or other botanical, a dietary substance for use by man to supplement the diet, or a concentrate, metabolite, constituent, extract, or combination of these substances.