May 17, 2012

Cialis Approved to Treat Benign Prostatic Hyperplasia

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.

Source: FDA

FDA Warns Consumers Not to Eat Raw Oysters Harvested from Hood Canal Area 4 in Washington State

Oyster recall affects 23 states

Fast Facts
• 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

Source: FDA

Lymphoma Risk From TNF Blockers in Teens, Says FDA

The U.S. Food and Drug Administration (FDA) continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL), primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factor (TNF) blockers, as well as with azathioprine, and/or mercaptopurine.

Crohn’s disease and ulcerative colitis cause inflammation of the digestive system. Common symptoms are pain in the abdomen, cramps, and diarrhea. Bleeding from the rectum, weight loss, joint pain, skin problems and fever also may occur. Children with the disease may have growth problems, develop intestinal blockage, and experience malnutrition. [Read more...]

Dengue Fever Diagnostic Test Approved for Marketing

The U.S. Food and Drug Administration (FDA) today allowed marketing of the first test to help diagnose people with signs and symptoms of dengue fever or dengue hemorrhagic fever, a leading cause of illness and death in the tropics and subtropics.

The dengue virus is transmitted to humans by the bite of an infected Aedes mosquito. As many as 100 million people worldwide are infected by the virus each year, according to the U.S. Centers for Disease Control and Prevention (CDC).

Symptoms of dengue fever include high fever, severe headache, severe pain behind the eyes, joint pain, muscle and bone pain, rash and mild bleeding involving the nose or gums, and easy bruising. [Read more...]

Company Recalls Hazelnuts Linked to E. Coli

DeFranco & Sons of Los Angeles, Calif. is voluntarily recalling bulk and consumer-packaged in-shell hazelnuts and mixed-nut products containing in-shell hazelnuts. The recalled products are linked to seven cases of Escherichia coli O157:H7 in Michigan, Minnesota and Wisconsin and may cause serious illness.

Consumers who have purchased bulk in-shell hazelnuts or mixed-nut products containing in-shell hazelnuts should check with the retailer to determine if they are subject to the recall, or throw the nuts away. [Read more...]

Epilepsy Drug Topiramate May Increase Birth Defect Risk

New data suggest that the drug Topamax and its generic versions (topiramate) increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, the U.S. Food and Drug Administration (FDA) said today.

Before prescribing topiramate, approved to treat certain types of seizures in people who have epilepsy, health care professionals should warn patients of childbearing age about the potential hazard to the fetus if a woman becomes pregnant while using the drug.

Topiramate also is approved to prevent migraine headaches, but not to relieve the pain of migraines.

“Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Alternative medications that have a lower risk of birth defects should be considered.”

[Read more...]

Hypertension Drug Letairis Gets New Boxed Warning: No Monthly Liver Enyme Test Required

Monthly liver enzyme tests are no longer required for those taking Letairis tablets (ambrisentan), according to the U.S. Food and Drug Administration (FDA). The drug is used to treat high blood pressure in the vessels that carry blood to the lungs (pulmonary arterial hypertension, or PAH).

Citing data from clinical trials and post-market reports, the FDA said that the drug poses only a low risk of liver injury. Information related to potential serious liver injury and the need to monitor for such serious injury is being removed from the drug’s boxed warning. [Read more...]

New Drug (Daliresp) to Treat COPD Approved

The U.S. Food and Drug Administration approved roflumilast (Daliresp), a pill taken daily to decrease the frequency of flare-ups  or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD).

COPD is a serious lung disease that makes breathing difficult. Symptoms can include breathlessness, chronic cough and excessive phlegm. An exacerbation can last up to several weeks and result in lung function decline, increased risk of death, and may be associated with severe anxiety.

Cigarette smoking is the leading cause of COPD, according to the National Heart, Lung, and Blood Institute. COPD is the fourth leading cause of death in the United States. [Read more...]

New Drug, Edarbi, Approved to Treat High Blood Pressure (Hypertension)

The U.S. Food and Drug Administration today approved Edarbi tablets (azilsartan medoxomil) to treat high blood pressure (hypertension) in adults.

Data from clinical studies showed Edarbi to be more effective in lowering 24-hour blood pressure compared with two other FDA-approved hypertension drugs, Diovan (valsartan) and Benicar (olmesartan). [Read more...]

Test for Kidney Transplant Management Cleared by FDA

The U.S. Food and Drug Administration today announced that it has cleared a test to help manage potential organ rejection in kidney transplant patients. The test, called QMS Everolimus Immunoassay, monitors the blood level of everolimus, a drug that helps prevent rejection in kidney transplants

Everolimus, marketed under the trade name Zortress, was approved by FDA in April 2010 for use in adult kidney transplant patients who are at low-to-moderate immunologic risk.. [Read more...]