Ever since the FDA approved the HPV vaccine two years ago…

Posted by: admin  :  Category: Pharmacy news, medicine
vaccine
Dr. Shobha S. Krishnan, M.d. asked:

Ever since the FDA approved the HPV vaccine two years ago, its introduction into the health community has been embroiled in a medical, social, cultural and political controversy. At first glance, the debut of a vaccine to fight most cervical cancers looks like an exciting advance in the history of women’s health. However, many people are unable to separate the ethics from the basic scientific facts: the virus is transmitted through sexual contact and hence the vaccine is recommended for 11 or 12-year-old girls, before they first become sexually active. vaccine-two-years-ago#more-776″ class=”more-link”>Read more…

FDA Panel Backs Denosumab As Osteoporosis Treatment > AMGN

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   By Jennifer Corbett Dooren
   Of DOW JONES NEWSWIRES

WASHINGTON (Dow Jones)–A U.S. Food and Drug Administration panel on Thursday unanimously backed the use of denosumab, a proposed Amgen Inc. (AMGN) drug, to treat osteoporosis in postmenopausal women.


The panel is currently voting on a series of questions including whether denosumab should be approved to prevent osteoporosis and whether the drug should be used in patients undergoing hormone therapy to treat breast or prostate cancer. Hormone therapy increases the risk of bone loss. Read more…

FDA warns of e-cigarette risks

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The Food and Drug Administration is warning consumers about potential health risks associated with electronic cigarettes.

Also known as “e-cigarettes,” electronic cigarettes are battery-operated devices designed to look like and be used in the same manner as conventional cigarettes. Read more…

FDA Head Promises Stronger Enforcement Of Food/Drug Safety

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Food and drug companies that commit safety violations will face faster and more aggressive action, the new commissioner of the U.S. Food and Drug Administration said Thursday.

“The agency must show industry and consumers that we are on the job,” Margaret Hamburg told an audience of food and drug industry lawyers, the Associated Press reported. “Companies must have a realistic expectation that if they are crossing the line, they will be caught.” Read more…

UPDATE 2-US FDA chief vows to speed up inspections, warnings

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* FDA to streamline warning letter process

* Agency to act more aggressively in some cases

* Changes may trigger more warning letters -Hamburg (Adds FDA comments, details on new letter policy, background, byline)


By Susan Heavey Read more…

APhA Advises Consumers on Acetaminophen Use – FDA

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Patients Urged to Take Acetaminophen Products as Recommended on the Labeling

WASHINGTON, DC – The American Pharmacists Association (APhA) advises consumers to take acetaminophen products as recommended on the labeling and seek guidance from pharmacists or other healthcare providers on evaluating medication options. This recommendation comes as the Food and Drug Administration (FDA) convened a public advisory committee meeting on June 29 and June 30, 2009 regarding acetaminophen use in both over-the-counter (OTC) and prescription (Rx) products, the potential for liver injury, and potential interventions to reduce the incidence of liver injury. Read more…

CDC presents H1N1 update

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Novel influenza virus is still active in off-season; vaccine is in development.

Widespread or regional activity involving novel H1N1 influenza virus is evident in 20 American states, CDC told reporters in a news conference on Friday. As schools begin reopening next week, the rapid spread of the virus in summer camps in the United States could portend greater problems. “It’s very unusual for that kind of illness to be occurring at this time of the year,” explained Anne Schuchat, MD, Director of the National Center for Immunization and Respiratory Diseases. “The novel H1N1 viruses are making up 98% of all the subtyped viruses we have, subtype influenza A viruses, and we’re seeing them dominate here in the U.S.,” she said. In the Southern Hemisphere, where seasonal influenza is occurring, novel H1N1 has been found in many countries, Schuchat explained, adding, “This virus is capable of causing a range of illness: severe life-threatening disease that requires intensive care unit and mechanical ventilation and also milder illness that gets better on its own. And this is really important for people to know this virus is out there, it’s circulating, it causes a range of illness, and we in the United States have to get ready for the fall.”

Schuchat emphasized the importance of health care workers getting immunized, especially during this season with the presence of the novel H1N1 virus. She said, “We do expect seasonal influenza viruses to circulate as well, and we need to be prepared for both of them.”

FDA anticipates that the novel H1N1 vaccine, once it is developed, will be given in a two-step dosage. Pharmacists should be prepared to advise patients about getting the single dose of vaccine against seasonal influenza and a possible two doses of vaccine against H1N1. For the latest in H1N1 statistics, check CDC’s FluView Web page: www.cdc.gov/flu/weekly.

FDA is working now to update its guidance to schools on the handling of H1N1 viruses. Schuchat stated, “We’re in the process of reviewing all the information learned from the spring and what are the benefits and unintended consequences of school dismissals, and what are the best ways to keep kids healthy and learning and to minimize disruption, as well as to minimize the real impact that this new virus can have.” Schuchat discouraged the use of Tamiflu or other antivirals as a preventive measure. Instead, she recommended more traditional methods of good handwashing and hygiene.

In other influenza-related developments, CDC on Friday released recommendations for seasonal influenza vaccine and FDA approved an additional diagnostic test for the 2009 H1N1 influenza virus.

Carli Richard (crichard@aphanet.org)

Posted July 27, 2009

FORTEO – FDA approves new drug indication for Forteo

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On July 23, Eli Lilly and Company announced that the Food and Drug Administration (FDA) has approved a new use for its osteoporosis drug Forteo (teriparatide) to treat osteoporosis associated with sustained, systemic glucocorticoid therapy in men and women at high risk of fracture. Glucocorticoid therapy is the most common cause of secondary osteoporosis, leading to bone loss and an increased risk for fracture, according to a statement from Eli Lilly. Read more…

FDA approves vaccines for upcoming flu season

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The U.S. Food and Drug Administration has announced that it has approved a vaccine for 2009-2010 seasonal influenza in the United States. The seasonal influenza vaccine will not protect against the 2009 H1N1 influenza virus that resulted in the declaration of a pandemic by the World Health Organization (WHO) on June 11, 2009. Read more…

Generic Plan B approved by FDA

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Jul 14, 2009
By: Alaina Scott, Senior Editor
Drug Topics E-News

The Food and Drug Administration has approved the first generic version of the 0.75 mg Plan B emergency contraceptive tablets. For women ages 17 and under, levonorgestrel, the generic product, will be available by prescription only.Plan B, manufactured by Duramed Pharmaceuticals of Cincinnati, was first approved in 1999 for prescription use only by women of all ages. In 2006, Plan B was approved for nonprescription use by women ages 18 and older, remaining available by prescription only to women ages 17 and under.

The latest approval permits marketing of a prescription-only generic product for women ages 17 and under. No generic levonorgestrel product for emergency contraception can be approved for nonprescription use by women ages 18 and older until Aug. 24, 2009, when the marketing exclusivity for nonprescription use held by Duramed expires.

The generic levonorgestrel tablets 0.75 mg are made by Watson Laboratories in Corona, Calif.

Levonorgestrel can prevent pregnancy after unprotected intercourse and after known or suspected contraceptive failure. It is not effective in terminating an existing pregnancy and does not protect against sexually transmitted diseases, including HIV infection.