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FDA Advises Consumers to Stop Using Zicam; Active Ingredient Can Cause Loss of Smell

Posted On Jun 25, 2009 @ 12:24 PM by SEO Admin

In a press release dated June 16, 2009, the U.S. Food and Drug Administration (FDA) advised consumers to stop use of three over-the-counter Zicam Cold Remedy products: nasal gel, nasal swabs and the discontinued "kids size" swabs. The FDA’s advisory stated that the products are associated with the loss of sense of smell, called anosmia. Anosmia may be long-lasting or permanent. In addition to a loss of the sense of smell, patients have also complained of a loss of the sense of taste. The FDA has received more than 130 reports of loss of sense of smell associated with the use of these three Zicam products.   Many people experienced a loss of smell said the condition with the first dose; others reported a loss of the sense of smell after multiple uses. The active ingredient in Zicam is Zincum Gluconicum (Zinc Gluconate) which can cause nasal nerve damage.   If you notice a burning sensation in the nasal cavity or a loss of smell or taste while using Zicam, stop usingÂ

It Doesnt Take Much of a Gift to Influence Doctors Prescription Choices

Posted On Jun 2, 2009 @ 08:51 AM by SEO Admin

A principal underlying assumption regarding limits on and ethics guidelines addressing pharmaceutical promotion is that smaller gifts are unlikely to exert influence on prescribing decisions. Nonetheless, a substantial body of marketing and psychology literature suggests that even trivial items can exert influence irrespective of economic value. Adding a small gift such as personalized mailing labels, a pen or a coffee mug to a solicitation for donations has been shown to significantly increase donations. These types of gifts can also influence prescribing behavior, according to a study that appears in The Archives of Internal Medicine. (Arch Intern Med. 2009;169(9):887-893). The experiment found that exposure to these items results in more favorable attitudes toward marketed products and that medical school policies that restrict pharmaceutical marketing mitigate this effect. The study was designed to measure the influence of exposure to branded promotional items on rel

Black Box Warning Label Suggested For Flomax Due to Complications From Cataract Surgery

Posted On May 22, 2009 @ 01:32 PM by SEO Admin

Cataract surgery is the most commonly performed operation in the United States today, with nearly 2 million cataract operations performed in the United States each year. Benign prostatic hyperplasia (BPH), an enlarged prostate, is common in older men, affecting nearly 3 out of 4 men by the age of 70 years. BPH is often treated with tamsulosin hydrochloride (Flomax), an alpha-blocking drug that accounted for more than $1 billion in sales in 2007. This BPH/cataract combination is dangerous: A study to assess the risk of adverse events following cataract surgery in older men prescribed Flomax found that exposure to tamsulosin within 14 days of cataract surgery was significantly associated with serious postoperative ophthalmic adverse events. The researchers discovered that those who took Flomax two weeks before the procedure were 2.3 time

1789 Law and Nuremburg Code Intersect to Permit Claims To Proceed Against Pfizer For Conducting Medical Experimentation Without Consent

Posted On Feb 23, 2009 @ 10:04 AM by SEO Admin

The Alien Tort Statute, 28 U.S.C. 1350, a 1789 law, gives foreigners the right to raise tort claims in federal court to vindicate violations of 'the laws of nations.' The 10-principle Nuremberg Code was formulated as part of a war crimes trial conducted after World War II in which 15 doctors were convicted of crimes against humanity for conducting unconsented experiments. Seven of the doctors were sentenced to death. The 1789 law and the 20th Century Nuremberg Code intertwined recently as the U.S. Court of Appeals for the Second Circuit revived Nigerian families' damage claims for billions of dollars against Pfizer for allegedly secretly testing a new drug in a Nigerian hospital during a 1996 meningitis outbreak. The two cases under the consolidated caption of Abdullahi v. Pfizer, 05-4863 and 05-6768 involved claims that Pfizer allegedly secretly testing a new drug in a Nigerian hospital during a 1996 meningitis ou

Ovarian Cancer Test OvaSure Being Marketed Without Necessary FDA Approval

Posted On Oct 10, 2008 @ 09:56 AM by SEO Admin

The U.S. Food and Drug Administration warned clinical test giant Laboratory Corp. of America Holdings that it was marketing OvaSure, an ovarian cancer test, in violation of the law in that it did not have marketing clearance or approval from the FDA. OvaSure measures six proteins in blood samples and calculates the chances that the woman has ovarian cancer. LabCorp made the $220 test available in June, under a provision that exempts tests developed and offered by a single lab from the usual FDA review. Thus OvaSure did not go through an FDA review. But in a letter dated September 29 and released October 7, 2008, the FDA determined that because the test was developed at Yale School of Medicine but that parts of it were manufactured elsewhere, it must meet the agency's usual premarketing approval requirements, which could take up to a year. OvaSure does not diagnose cancer - it attempts to predict the likelihood of someone having the disease - which caused many experts to

They're Marketing Prescription Medications to Our Children in Our Schools

Posted On Aug 27, 2008 @ 08:49 PM by SEO Admin

Advocates for children are upset that Alloy Media and Marketing has run ads for prescription drugs from its Channel One website. Channel One provides free news and original programming to about 10,000 middle and high schools. Channel One is, in the opinion of many, a controversial in-school news program that makes viewing ads a compulsory part of the school day for grades six through twelve. One of Channel Ones drug ads links to Acneheroes.com, a kid-targeted website created by the pharmaceutical company sanofi-aventis to promote BenzaClin, a prescription drug for acne. The website features actor Cody Linley, who introduces himself as one of the stars of Hannah Montana, which airs on the Disney channel and is among the most popular television programs for children. As part of its user agreement with schools, Channel One has pledged not to market prescription drugs to its young audience. Yet ads for the prescription acne medications Differin and BenzaClin ran on the Cha

Medtronic Recalls Selected Heparin-Coated Products

Posted On Jun 12, 2008 @ 01:35 PM by SEO Admin

Medtronic, Inc., in what is termed a precautionary measure, has voluntary recalled selected products featuring its Carmeda BioActive surface, a coating applied to some devices used in heart bypass surgery and dialysis, because the coating includes contaminated heparin, a blood thinner that has been linked to 81 deaths. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. This action was taken subsequent to the U.S. Food and Drug Administration's April 8, 2008 recommendation to device manufacturers that heparin supplies be checked with newly-developed tests, and that affected products be evaluated for possible field corrective action. Limited lots of Carmeda-coated products were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). The patient risk associated with the pr

Direct to Consumer Advertising of Cypher Stent Draws Heavy Criticism and Points to Need for Legislation

Posted On May 28, 2008 @ 07:40 AM by SEO Admin

For several years the U.S. Food and Drug Administration has been reviewing a set of guidelines proposed in 2004 for advertising medical devices. Now, a television advertisement for a heart stent, metal mesh devices that are used to prop open arteries after they have been cleared of blockages, has been scrutinized and attacked in an op-ed article for failing to adequately warn consumers about the potential dangers of receiving a stent, including a ruptured coronary artery. The ad does warn of heart attack and stroke. The ad for the Cypher stent, made by the Cordis subsidiary of Johnson & Johnson, was the first to market a stent directly to consumers on television and uses the tag line life wide open. Similar ad campaigns have promoted hip and knee implants, including one featuring the golfer Jack Nicklaus, who underwent a hip replacement in 1999 using a device made by Stryker. According to the article by cardiologists Dr. William E. Boden and Dr. George A. Di

Governor Paterson Busy Protecting Citizens from Harmful Doctors, Drugs, Toys and Sexual Predators - Part 2

Posted On May 22, 2008 @ 11:43 AM by SEO Admin

Part 2 of this topic discusses new legislation regarding dangerous drugs, defective toys and sexual predators using the internet to prowl and prey. The information herein is set forth in press releases issued by the governor's office. Proposed legislation designed to protect patients from medical malpractice was discussed in Part 1 of this blog. Governor David A. Paterson has proposed legislation to limit the influence of pharmaceutical manufacturers over prescription decisions by banning gifts and payments from drug companies to physicians and other prescribers in excess of $50 per year. The bill would also require practitioners who m

Governor Paterson Busy Protecting Citizens from Harmful Doctors, Drugs, Toys and Sexual Predators - Part 1

Posted On May 20, 2008 @ 09:03 PM by SEO Admin

Last week was a busy week for New York's Governor David A. Paterson on issues often written about in this blog - medical malpractice, dangerous drugs, defective toys and sexual predators using the internet. Some bills were signed, others introduced. The most ambitious of these was on the medical malpractice front, Governor Paterson proposed legislation that offers more transparency for patients and tougher discipline for physicians; enhanced infection control requirements will facilitate the prevention of and response to infectious disease transmissions. Part 1 will discuss this legislation, Part 2 the others. The information herein is set forth in press releases issued by the governo

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