WASHINGTON  The Food and Drug Administration on Friday unveiled a report listing 20 drugs that the agency is investigating for potential side effects, as part of a new policy to warn patients and health-care professionals as early as possible.

The list includes a wide array of drugs, from Eli Lilly & Co. s antidepressant Cymbalta to Purdue Pharma LPs painkiller Oxycontin. It also addresses a range of adverse reactions, including cardiac arrest, cancer and Purple Glove Syndrome, which can result in patients having their arms amputated. (See the FDA s list of drugs that are under investigation.)

The FDA has already sent out warnings about a handful of the drugs on the list. The report lists TNF blockers  such as Johnson & Johnson s Remicade  as being potentially associated with cancer in children. In June, the FDA said it was investigating the possible link. TNF blockers target a compound known as tumor necrosis factor, which is overproduced in many patients with inflammatory diseases like arthritis and Crohn s.

But there appear to be new ones, too. The report lists Biogen Idec Inc. and Elan Corp. s multiple-sclerosis treatment Tysabri as potentially being associated with skin cancer. Medical journals have reported cases of melanoma in patients taking Tysabri, but the FDA hasn t previously said it was investigating the drug for this side effect.

The list, which the FDA will start issuing quarterly, is aimed at giving consumers and health-care professionals early indications of what the FDA is investigating, but it might end up creating more confusion. Indeed, the agency is concerned that people will stop taking a drug inappropriately  because it is on the list, said Paul Seligman, associate director of safety policy at the agency.

The FDA said it alerted companies whose drugs appeared on the list prior to it being made public  several companies said they received word late Thursday  and intends to give drug makers a heads-up in the future as well.

Drug makers said they support the FDA s additional efforts to be transparent about drug safety, but some expressed concern that the information was being communicated to patients without context and wondered about what patients might do with the information.

It is very, very important that patients and their physicians understand the benefits and the risks of the drug. To speak about one without the other could have an impact on patient perception of their medications,  said Tony Jewell, a spokesman for AstraZeneca PLC, whose psychiatric medication Seroquel made the list for the possible safety concern of overdose due to confusing sample-pack labeling.

Companies also cautioned that just because a drug is posted on the site doesn t mean a causal relationship has been identified, and it is also risky if patients go off their medications without consulting a physician.

The FDA s intention is for patients and doctors to use the list to be aware of potential adverse events and to encourage them to report any problems. The list doesn t represent a comprehensive list of drugs the FDA is investigating, the FDA s Mr. Seligman said.

The report is generated from the agency s adverse-event-reporting database. That compilation consists of voluntary reports from patients and health-care professionals, and is widely considered to capture only a fraction of the actual adverse events associated with any given drug.

Mr. Seligman said the FDA is hopeful the quarterly reports will encourage people to report adverse events.

Write to Jared A. Favole at jared.favole@dowjones.co

©2012 An Inconvenient Woman. All Rights Reserved.

©2012 An Inconvenient Woman. All Rights Reserved.

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Johnson and Johnson–Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall Of Infants’ Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) Non-Staining Due To Possible Metal Fragments

Media Contact:

Marc Boston

215-273-7649 (office)

215-429-7034 (mobile)

Bonnie Jacobs

215-273-8994  (office)

856-912-9965 (mobile)

FOR IMMEDIATE RELEASE — Fort Washington, PA (November 7, 2008) – Johnson & Johnson • Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants’ MYLICON® GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. The company is taking this action in consultation with the U.S. Food and Drug Administration (FDA). Although the potential for serious medical events is low, the company is implementing this recall to the consumer level as a precaution after determining that some bottles could include metal fragments that were generated during the manufacturing process. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately.

The two lots of Infants’ MYLICON® GAS RELIEF DYE FREE drops non-staining 1 oz. bottles included in the recall are:

Consumers can find the lot numbers on the bottom of the box containing the product and also on the lower left side of the sticker on the product bottle.

Consumers who purchased Infants’ MYLICON® GAS RELIEF DYE FREE drops non-staining included in this recall should immediately stop using the product and contact the company at 1-800-222-9435 (Monday – Friday, 8:00 a.m. – 8:00 p.m. EST) or via the internet at www.mylicon.com for instructions regarding how to dispose of the product and request a replacement or refund.

Infants’ MYLICON® drops are sold over-the counter, in retail stores and pharmacies, as an anti-gas medicine to relieve the discomfort of infant gas frequently caused by air swallowing or by certain formulas or foods.

The recall does not affect any Original Infants’ MYLICON® GAS RELIEF products (1/2 oz. or 1 oz. size) or Infants’ MYLICON® GAS RELIEF DYE FREE drops non-staining (1/2 oz. size).

The manufacturer has instructed retailers and wholesalers to return their inventories.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm

Regular Mail: Use postage-paid FDA form 3500 available at:

www.fda.gov/MedWatch/getforms.htm.

Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787

Fax: 1-800-FDA-0178

©2012 An Inconvenient Woman. All Rights Reserved.

Gardasil® Deaths, Gardasil® Side Effects, Gardasil® Paralysis -

Is the HPV Vaccine Given to Prevent Cervical Cancer Causing More Medical Problems?

A vaccine designed to prevent cervical cancer is coming under fresh scrutiny amid thousands of complaints linking it to a range of health problems.

Gardasil® has been the subject of 7,802 “adverse event” reports from the time the Food and Drug Administration approved its use two years ago, according to the Centers for Disease Control and Prevention.

Girls and women have blamed the vaccine for causing ailments from nausea to paralysis — even death. Fifteen deaths were reported to the FDA, and 10 were confirmed, but the CDC says none of the 10 were linked to the vaccine. The CDC says it continues to study the reports of illness.

Gardasil prevents the spread of human papillomavirus, known as HPV — a sexually transmitted virus that can cause cervical cancer in a relatively small number of girls and women.

The vaccine’s manufacturer, Merck & Co. Inc., says it has distributed more than 26 million Gardasil® vaccines worldwide, including nearly 16 million in the United States. It estimates that 8 million girls and women have received the vaccine in the United States since June 2006. V

Two girls allege in court that the vaccine made them sick.

One — Jesalee Parsons of Broken Bow, Oklahoma — got the shot at age 13.

Jesalee’s lawyer, Michael McLaren, said she got the shot on February 27, 2007 and soon developed a fever and felt pain. The next day, he said, Jesalee felt pain in her chest and abdomen.

Her mother, Laura Parsons, said Jesalee spent weeks in the hospital and underwent two surgeries after developing pancreatitis. She says the federal government should have studied the drug more before approving its use.

“I just feel let down by the government,” Parsons said.

Merck says it could be a coincidence that the girls got sick after receiving the vaccine.

The company said in a statement that an adverse event report “does not mean that a causal relationship between an event and vaccination has been established — just that the event occurred after vaccination.”

Merck said it would continue to evaluate reports of adverse reactions. It said it “updates product labels with new safety information as appropriate.”

Watch more on complications linked to Gardasil »

For Full Article and more video go to:

http://www.cnn.com/2008/HEALTH/conditions/07/07/cervical.cancer.vaccine/

A sincere thank you to major media outlets, CNN, the Washington Post and the New York Times, for following and reporting the Gardasil® adverse events and asking probing questions about the safety and effectiveness of this aggressively-marketed Merck product.

©2012 An Inconvenient Woman. All Rights Reserved.

©2012 An Inconvenient Woman. All Rights Reserved.