Advisory re local receipts issued by local stores; advisory re Bacolod Chicken Inasal restaurant; local news; web sites with free info

Advisory re official receipts issued by some local stores. The paper used for receipts appears to have a coating, as a result of which the printing on said receipts appears to fade faster. This is detrimental for customers.

Local info:

Bacolod Chicken Inasal restaurant, at Robinsons Ermita, issued, on August 19, 2008, an official receipt wherein the VAT charge is separate from the charge for food. Based on information from the Department of Trade and Industry, said issuance of said type of receipt is a violation of the Price Tag Law.

"Caloocan offers apprenticeships to residents
Unemployed Caloocan City residents 15 years old and above can now apply for apprenticeship with any participating company in the city and be entitled to receive wages not less than 75 percent of the prevailing minimum salary rate, Mayor Enrico Echiverri said"

"Marikina offers free breast cancer screening
Women from Marikina City's 16 barangays can avail of breast cancer screening for free starting on Aug. 21.
The service will be initially offered at the barangay hall of Barangay Malanday. Pre-registration is ongoing at yje Breast Cancer Screening Section on the 3rd floor of the Marikina Healthy City Center."


Foreign news:

FDA Approves New Genetic Test for Patients with Breast Cancer
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01857.html
FDA News

FOR IMMEDIATE RELEASE
July 8, 2008


Media Inquiries:
Karen Riley, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab).

The SPOT-Light HER2 CISH kit is a test that measures the number of copies of the HER2 gene in tumor tissue. This gene regulates the growth of cancer cells.

A healthy breast cell has two copies of the HER2 gene, which sends a signal to cells, telling them when to grow, divide and make repairs. Patients with breast cancer may have more copies of this HER2 gene, prompting them to overproduce HER2 protein so that more signals are sent to breast cells. As a result, the cells grow and divide much too quickly.

“When used with other clinical information and laboratory tests, this test can provide health care professionals with additional insight on treatment decisions for patients with breast cancer,” said Daniel Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health.

The SPOT-Light test counts the number of HER2 genes in a small sample of removed tumor. The removed piece is stained with a chemical that causes any HER2 genes in the sample to change color. This color change can be visualized under a standard microscope, eliminating the need for the more expensive and complex fluorescent microscopes required to read assays already on the market. Unlike existing tests, the SPOT-Light allows labs to store the tissue for future reference.

Patients who over-produce HER2 protein are typically treated with the drug Herceptin, which targets HER2 protein production. This helps to stop the growth of HER2 cancer cells.

The FDA based its approval of the SPOT-Light test on a study using tumor samples from patients with breast cancer in the United States and Finland. These studies confirmed that the test was effective in determining how many HER2 genes were in these patients.

SPOT-Light is manufactured by Invitrogen Corp. of Carlsbad, Calif. Herceptin is manufactured by Genentech, of San Francisco, Calif.

FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures'
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01852.html

FDA News

FOR IMMEDIATE RELEASE
June 17, 2008


Media Inquiries:
Rita Chappelle, (301) 827-6242
Consumer Inquiries:
888-INFO-FDA

Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet.

Those companies and individuals warned, the complete list of fake cancer 'cure' products and their manufacturers along with a consumer article on health scams can be found here, http://www.fda.gov/cder/news/fakecancercures.htm.

"Although promotions of bogus cancer 'cures' have always been a problem, the Internet has provided a mechanism for them to flourish," said Margaret O'K. Glavin, the FDA's associate commissioner for regulatory affairs. "These warning letters are an important step to ensure that consumers do not become the victim of false 'cures' that may cause greater harm to their health."

The FDA urges consumers to consult their health care provider about discontinuing use of these products and to seek appropriate medical attention if they have experienced any adverse effects.

The products contain ingredients such as bloodroot, shark cartilage, coral calcium, cesium, ellagic acid, Cat's Claw, an herbal tea called Essiac, and mushroom varieties such as Agaricus Blazeii, Shitake, Maitake, and Reishi.

Because these products claim to cure, treat, mitigate or prevent disease, and these products have not been shown to be safe and effective for their labeled conditions of use, they are unapproved new drugs marketed in violation of the Federal Food, Drug, and Cosmetic Act.

Examples of fraudulent claims for these products include:

* "Treats all forms of cancer"
* "Causes cancer cells to commit suicide!"
* "80% more effective than the world's number one cancer drug"
* "Skin cancers disappear"
* "Target cancer cells while leaving healthy cells alone"
* "Shrinks malignant tumors"
* "Avoid painful surgery, radiotherapy, chemotherapy, or other conventional treatments"

The Warning Letters are part of the FDA's ongoing efforts, in collaboration with the Federal Trade Commission (FTC) and Canadian government agencies, to prevent deceptive products from reaching consumers. The initiative originated from consumer complaints and a web search for fraudulent cancer products conducted by the FDA, FTC and members of the Mexico–United States–Canada Health Fraud Working Group. Earlier this year, FTC sent Warning Letters to 112 Web sites falsely promoting cancer "treatments" and referred several others to foreign authorities.

Parties that fail to properly resolve violations cited in Warning Letters are subject to enforcement action up to and including seizure of illegal products, injunction, and possible criminal prosecution.

Consumers and health care professionals should notify the FDA of any complaints or problems associated with these products. These reports may be made to MedWatch, the FDA's voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm .

To read about efforts in Canada to educate consumers about health scams, go to http://www.competitionbureau.gc.ca/epic/site/cb-bc.nsf/en/02614e.html .



Fake Cancer Cures
http://www.fda.gov/cder/news/fakecancercures.htm

Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet.

* FDA Press Release
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01852.html

* Warning Letters
http://www.fda.gov/cder/news/fakecancercuresWL.htm

* 125 Fake Cancer "Cures" Consumers Should Avoid
http://www.fda.gov/bbs/topics/factsheets/fakecancercures.html


* Consumer Information: Beware of Online Cancer Fraud
http://www.fda.gov/consumer/updates/cancerfraud061708.html



U.S. FDA update re Exenatide (marketed as Byetta)

Information for Healthcare Professionals Exenatide (marketed as Byetta)
http://www.fda.gov/cder/drug/InfoSheets/HCP/exenatide2008HCP.htm
Update 8/18/2008: Since issuing Information for Healthcare Professionals in October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.

Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis. If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis.

FDA is working with the maker of Byetta, Amylin Pharmaceuticals, Inc., to add stronger and more prominent warnings in the product label about the risk of acute hemorrhagic or necrotizing pancreatitis.


The prior FDA ALERT on the topic of acute pancreatitis in patients taking Byetta is shown below.

FDA ALERT [10/2007]: FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta, a drug used to treat adults with type 2 diabetes. An association between Byetta and acute pancreatitis is suspected in some of these cases.

Healthcare professionals should instruct patients taking Byetta to seek prompt medical care if they experience unexplained persistent severe abdominal pain which may or may not be accompanied by vomiting. If pancreatitis is suspected, Byetta should be discontinued. If pancreatitis is confirmed, Byetta should not be restarted unless an alternative etiology is identified.

FDA has asked and the maker of Byetta, Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the PRECAUTIONS section of the product label.

This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA is not advising practitioners to discontinue prescribing the product. FDA intends to update this sheet when additional information or analyses become available.

To report any unexpected adverse or serious events associated with the use of this drug, please contact the FDA MedWatch program and complete a form on line at http://www.fda.gov/medwatch/report/hcp.htm or report by fax to 1-800-FDA-0178, by mail using the postage-paid address form provided on line, or by telephone to 1-800-FDA-1088.

The Byetta full prescribing information will include new information in the PRECAUTIONS section about the potential for acute pancreatitis in patients taking Byetta.

Recommendations and Considerations

* Healthcare providers should be alert to the signs and symptoms of acute pancreatitis. Symptoms include persistent severe abdominal pain that can radiate to the back and may be accompanied by nausea and vomiting. Acute pancreatitis is typically confirmed by the presence of elevated levels of serum amylase and/or lipase and characteristic findings by radiological imaging.

* Discontinue Byetta if pancreatitis is suspected. If pancreatitis is confirmed, do not restart Byetta unless an alternative etiology for the pancreatitis is identified.

Information for the patient: Physicians who prescribe Byetta should discuss with their patients:

Byetta is a medicine given by injection to help treat adults with type 2 diabetes. Commonly reported side effects of Byetta include nausea, vomiting, diarrhea, indigestion and upper abdominal discomfort. However, the presence of unexplained, severe abdominal pain, with or without nausea and vomiting, raises the suspicion of acute pancreatitis, a potentially serious condition that requires prompt medical attention. Therefore, patients taking Byetta should promptly seek medical care if they experience unexplained severe abdominal pain with or without nausea and vomiting.

Background Information and Data

FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients treated with Byetta. Twenty-seven of the 30 patients had at least one other risk factor for acute pancreatitis such as gallstones, severe hypertriglyceridemia, and alcohol use. In six patients the symptoms of pancreatitis began or worsened soon after the dose of Byetta was increased from 5 micrograms twice daily to 10 micrograms twice daily. Twenty-one patients were hospitalized. There were no reports of hemorrhagic or necrotizing pancreatitis. However, five patients developed serious complications including dehydration and renal failure; suspected ileus; phlegmon; and ascites. Twenty-two of the 30 reports indicated that the patients improved after discontinuing Byetta.

Details in three reports indicated that the symptoms of acute pancreatitis returned when Byetta was restarted. Nausea and vomiting returned in two patients when Byetta was restarted. In a third patient, abdominal pain returned when Byetta was restarted and abated after Byetta was permanently discontinued.

FDA has asked and the maker of Byetta, Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the Precautions section of the product label.