The U.S. Food and Drug Administration today issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in health care antiseptics marketed under the over-the-counter drug monograph. [Read more…]
The U.S. Food and Drug Administration today approved Raplixa (fibrin sealant [human]), the first spray-dried fibrin sealant approved by the agency. It is used to help control bleeding during surgery. [Read more…]
The U.S. Food and Drug Administration today approved Avelox (moxifloxacin) to treat patients with plague, a rare and potentially fatal bacterial infection. The agency approval for plague includes use of the drug for the treatment of pneumonic plague (infection of the lungs), and septicemic plague (infection of the blood). Avelox is also approved for prevention of plague in adult patients. [Read more…]
Today the U.S. Food and Drug Administration approved the Senza spinal cord stimulation (SCS) system (Senza System) as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, low back pain and leg pain. The Senza System can reduce pain without producing a tingling sensation called paresthesia by providing high frequency stimulation (at 10 KHz) and low stimulation amplitudes. [Read more…]
As part of its overall efforts to address compounded drugs, the U.S. Food and Drug Administration today released a draft “Guidance for Industry (GFI) #230, Compounding Animal Drugs from Bulk Drug Substances.” Current law does not permit compounding of animal drugs from bulk drug substances, but the FDA recognizes that there are limited circumstances when an animal drug compounded from bulk drug substances may be an appropriate treatment option. [Read more…]
The U.S. Food and Drug Administration proposed a rule today that would require animal drug sponsors of all antimicrobials sold or distributed for use in food-producing animals to obtain estimates of sales by major food-producing species (cattle, swine, chickens and turkeys). The additional data would improve understanding of how antimicrobials are sold or distributed for use in major food-producing animals and help the FDA further target its efforts to ensure judicious use of medically important antimicrobials.
The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.
Simponi works by blocking tumor necrosis factor (TNF), which plays an important role in causing abnormal inflammatory and immune responses. Previously approved to treat rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis (arthritis affecting the joints in the spine and the pelvis), Simponi is now approved to treat adults with moderate to severe ulcerative colitis that is resistant (refractory) to prior treatment or requires continuous steroid therapy. [Read more…]
The U.S. Food and Drug Administration has released a new tool to help bolster the food industry’s defense measures against an act of intentional food contamination. The Food Defense Plan Builder is a comprehensive, easy-to-use software program designed to help owners and operators of food facilities—ranging from primary production and manufacturing to retail and transportation—develop customized plans to minimize the risk of intentional contamination at their individual food facilities.
The FDA does not require food facilities to implement food defense plans, but many facilities have voluntarily put such plans into place to safeguard their products. [Read more…]
Cialis (tadalafil) was approved today by the FDA for treating the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged, and for the treatment of BPH and erectile dysfunction (ED), when the conditions occur simultaneously. Cialis was approved in 2003 for the treatment of ED.
Common symptoms of BPH include difficulty in starting urination and a weak urine stream; a sudden urge to urinate; and more frequent urination including at night.
The severity of symptoms of BPH can be measured using the International Prostate Symptom Score (IPSS). In two clinical trials, men with BPH who took 5 milligrams (mg) of Cialis once daily experienced a statistically significant improvement in their symptoms of BPH compared to men who were treated with placebo. The trials based their findings on a reduction in total IPSS scores.
In a third study, men who experienced both ED and BPH and who took 5 mg of Cialis once daily had improvement in both their symptoms of BPH and in their ED compared to men who were treated with placebo. The improvement in ED was measured using the Erectile Function domain score of the International Index of Erectile Function.
“BPH can have a big impact on a patient’s quality of life,” said Scott Monroe, director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research. “A large number of older men have symptoms of BPH. Cialis offers these men another treatment option, particularly those who also have ED, which is also common in older men.”
Cialis should not be used in patients taking nitrates, for example nitroglycerin, because the combination can cause an unsafe decrease in blood pressure. Also, the use of Cialis in combination with alpha blockers for the treatment of BPH is not recommended because the combination has not been adequately studied for the treatment of BPH, and there is a risk of lowering blood pressure.
The FDA has approved eight other drugs to treat symptoms of BPH: Proscar, (finasteride), Avodart (dutasteride), Jalyn (dutasteride plus tamsulosin), and the alpha blockers: Hytrin (terazosin), Cardura (doxazosin), Flomax (tamsulosin), Uroxatral (alfuzosin) and Rapaflo (silodosin).
Cialis is manufactured by Indianapolis-based Eli Lilly and Co.
Oyster recall affects 23 states
• The U.S. Food and Drug Administration is warning consumers not to eat raw oysters harvested from an area of Hood Canal in Washington State following an outbreak of illness in that state caused by Vibrio parahaemolyticus bacteria.
• Raw oysters harvested from “growing area 4” in Hood Canal from August 30 to September 19 have been linked to three confirmed and two possible cases of Vibrio parahaemolyticus illness.
• All ill persons reported consumption of raw oysters.
• There have been no reports of hospitalizations or deaths resulting from consuming the oysters.
• The Washington State Department of Health has closed the growing area associated with the illnesses. Commercial oyster harvesters and dealers who obtained oysters from this growing area have initiated a recall and notified their commercial customers in affected states of the recall.
• Shipping and other records provided by Washington State indicate that oysters harvested from this area were distributed to establishments in 23 states and four foreign countries. Washington State authorities have notified those states involved of the recall.
• Those who have recently purchased oysters should check with the place of purchase and ask if they were harvested from the affected growing area.
What is the problem?
Raw oysters harvested and shipped from Hood Canal Area 4 in Washington State between August 30 and September 19 have been linked to illnesses caused by Vibrio parahaemolyticus bacteria.
What are the symptoms of Vibrio illness?
Illness is typically characterized by nausea, vomiting, and diarrhea. The symptoms begin from a few hours up to five days after consumption of raw or undercooked seafood, particularly shellfish, or after ingestion of surface waters.
Who is at risk?
Persons at risk are those who traveled to Washington State and consumed oysters that were harvested from Hood Canal Area 4 or who purchased oysters in a state to which these oysters were distributed and ate them. Individuals with weakened immune systems, including people affected by AIDS, chronic alcohol abuse, liver, stomach, or blood disorders, cancer, diabetes, or kidney disease can be more susceptible to vibrio illness and should avoid eating raw oysters, regardless of where they are harvested.
What Do Consumers Need To Do?
Consumers in the affected states should inquire of the retailer, restaurant, or other facility about the source of the oysters offered for purchase. If the oysters were definitely or possibly harvested from Hood Canal Area 4 in Washington State, and have not yet been consumed, they should not be eaten. If the oysters were already consumed and no one became ill, no action is needed. If you develop a diarrheal illness within a week after consuming raw or undercooked shellfish, see your healthcare provider and inform the provider about this exposure.
Where Were the Oysters Distributed?
Records obtained by Washington State health officials indicate that raw oysters from this area of the Hood Canal in Washington State were distributed to 23 states: Alaska, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Illinois, Indiana, Maryland, Minnesota, Mississippi, Missouri, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Texas, Virginia, Utah, and Washington. Oysters from this area were also distributed internationally to the People’s Republic of China, Indonesia, Thailand and Taiwan.
What is Being Done about the Problem?
The Washington State Department of Health has closed Area 4 of Hood Canal to shellfish harvesting. All product harvested and shipped between August 30 and September 19 has been recalled. Washington State has notified all other states where product was shipped that they should hold and destroy product.
Who Should be Contacted?
The FDA encourages consumers with questions about seafood safety to call 1-888-SAFEFOOD