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The anti-clotting drug Plavix must now carry a “black box” warning on its label, alerting patients and doctors that some people don’t metabolize the medication properly, U.S. health officials said Friday.

Patients with a certain genetic variation can’t convert the blood thinner into its active form, which puts them at risk for heart attack and stroke, the U.S. Food and Drug Administration warned.

“If the patient makes less of the active form, there is less antiplatelet effect in the blood, and the patient may not receive the full benefit of Plavix treatment,” Mary Ross Southworth, FDA’s deputy director for safety in the division of cardiovascular and renal products at the Center for Drug Evaluation and Research, said during an afternoon press conference.

These patients are called poor metabolizers, she said.

Clopidogrel (Plavix) is generally prescribed after a heart attack, stroke or a procedure to open blocked coronary arteries. It usually makes platelets less likely to form blood clots, thus reducing the risk of heart attack, unstable angina, stroke and cardiovascular death in patients with cardiovascular disease.

For the drug to do its work, liver enzymes, especially one called CYP2C19, must convert the drug to its active form. In patients with low levels of the enzyme, the drug may be less effective in preventing heart attack, stroke and cardiovascular death, according to the FDA.

About 2 percent to 14 percent of people fall into this category, with the percentages varying by race. About 2 percent of whites have the variation, while 4 percent of blacks and 14 percent of Chinese people do, Southworth said.

But patients should not stop taking Plavix without consulting their doctor, the FDA said, noting a test to assess the CYP2C19 genotype can determine if a patient is a poor metabolizer.

In May 2009, the FDA required mention of the problem on the bottle label, but additional data from a recent study has caused the agency to call for the “black box” alert, its strongest warning.

That study, which the FDA asked Plavix’s makers to conduct, found less antiplatelet activity in people who were poor metabolizers than in patients who had no problem converting the drug.

However, when Plavix was given at higher-than-usual doses, the poor metabolizers showed more active drug in their blood than when they received lower doses, the researchers noted.

Patients who cannot convert Plavix well should use another anti-clotting drug or try an alternate strategy, such as a dosage increase, the FDA advised. Anti-clotting drugs that might be substituted for Plavix include ticlopidine (Ticlid) and prasugrel (Efient), the FDA said.

>”Efient doesn’t need this enzyme as much to form its active metabolite so it does not have the primary problem, and we know some people will consider using that,” Dr. Robert Temple, director of the FDA’s Office of Drug Evaluation, said during the press conference.

On the other hand, “ticlopidine was the first member of this class and has a fairly high frequency of some unpleasant hematologic problems, so it has lost popularity considerably,” he said.

Another recent study found that heart attack patients taking Plavix plus a proton pump inhibitor, such as Prilosec or Nexium, may be at increased risk of death or another heart attack, because this combination also prevents Plavix from being fully metabolized. The FDA is conducting a safety review about potential interactions of these commonly prescribed medications.

Plavix is made in partnership by two pharmaceutical giants, Bristol-Myers Squibb and Sanofi Pharmaceuticals. A Bristol-Myers spokesperson told the Associated Press that the new labeling would be added to Plavix during the next two months.

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Technorati Tags: Nexium, Plavix, Plavix treatment, Plaxix prescription, Prilosec

A senior Thai official voiced hope Monday for a WTO solution on the production of low-cost generic drugs, an issue that has stirred friction with Western companies.

A military-backed government in 2006 suspended patent protections for expensive cutting-edge treatments for AIDS, cancer and heart disease, giving Thais access to cheap copycat versions.

Activists against AIDS and poverty hailed Thailand as a global leader, but the kingdom has faced heavy pressure and threats of legal action from Western pharmaceutical firms.

Trade Representative Kiat Sittheeamorn told the American Chamber of Commerce in Thailand that the government was in talks with all sides and hoped for an eventual solution under the World Trade Organization.

“What we would like to see is US engagement with the WTO in order to come up with a multilateral regime that is good for all,” Kiat said in remarks videocast in Washington.

“It is a very sensitive issue, but we also recognize that we don’t want to violate any patent rights,” he said.

“I think the final goal for all is to be able to have affordable drugs for all the Thai people while recognizing the ownership rights” of patent holders, he said.

Campaigners voiced outrage last year when they said they obtained a letter showing Prime Minister Abhisit Vejjajiva’s government would not license more generic drugs as the issue was holding up free trade talks with the United States.

In its last annual report in March 2009, the US Trade Representative’s office said Thailand was within its WTO rights to approve generic drugs but called for “transparency and due process.”

Major pharmaceutical firms argue that generic drugs ultimately hurt patients by depriving the companies of funding for research and development.

Former US president Bill Clinton in 2007 struck a deal with two generic drug makers in India that now provides lower-cost AIDS treatment to more than two million people in developing countries, including Thailand.

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Technorati Tags: affordable drugs, generic drug makers, generic drugs, Thailand

Many people whose doctors start them on medications for conditions like diabetes and high blood pressure may never fill those prescriptions, a new study suggests.

Researchers found that among more than 75,000 Massachusetts patients given drug prescriptions over one year, 22 percent of the prescriptions were never filled. The rate was even higher — 28 percent — when the researchers looked only at first-time prescriptions.

Such “non-adherence,” the study found, was common even among patients prescribed drugs for chronic conditions that can have serious health consequences.

Between 28 percent and 31 percent of new prescriptions for diabetes, high blood pressure and high cholesterol, for example, went unfilled, according to findings published in the Journal of General Internal Medicine.

Exactly why many patients did not fill their prescriptions is unclear. One possibility is that, when health problems cause few or no symptoms — as with high blood pressure or high cholesterol — people may not see the need for a medication.

“If they do not fully understand the reason that they are being prescribed the medication, they may be less likely to take it,” lead researcher Dr. Michael A. Fischer, of Brigham and Women’s Hospital in Boston, told Reuters Health in an email.

Cost could also be an issue, Fischer added — particularly when people are unsure of why a drug is being prescribed.

All of the patients in the study had health insurance. But even with coverage, people may have high co-payments for medications or may be prescribed a drug not covered by their plan, Fischer and his colleagues note.

For their study, the researchers used a database of electronic drug prescriptions for patients in two Massachusetts health plans, along with pharmacy claims records to verify whether the prescriptions were filled.

The study found that of almost 196,000 “e-prescriptions” written between 2004 and 2005, about 78 percent were filled. Of the more than 82,000 prescriptions for new drugs, just under 72 percent were filled.

Patients were least likely to pick up prescriptions for pain drugs, with only 45 percent of new prescriptions being filled. Between one- quarter and one-third of new prescriptions for conditions like depression, asthma and gastrointestinal ills also went unfilled.

More studies, according to Fischer, are needed to weed out the reasons why many people never fill their prescriptions — whether cost, worry over side effects, a desire to avoid medications or other issues.

For now, he said, people with questions about their new prescriptions should not hesitate to bring them up with their doctors.

“If you are not sure why you are being prescribed a medication, ask your doctor directly,” he said. “One of our jobs as physicians is to educate and advise our patients, and being sure that they understand their medication regimen is a big part of that job.”

Fischer added that in cases where people have left their prescriptions unfilled, they should not be “afraid” to tell their doctors. “Then they can talk with you about why you are not taking the medication and work with you to find a medication that you can use.”

SOURCE: Journal of General Internal Medicine, online February 4, 2010.

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Technorati Tags: prescriptions, prescriptions for diabetes drugs, prescriptions for pain drugs

Generic-drug makers Teva and Actavis, backed by Swedish buyout firm EQT, have placed make-or-break bids for German peer Ratiopharm but drug major Pfizer is expected to also be a contender, sources said.

Ratiopharm could stay in takeover talks with two or even three bidders, as some bids, which had been due by the end of Friday, are seen within a close range of 3 billion euros ($4.11 billion), said the people, who are familiar with the procedure.

That would make the deal the biggest generics takeover since Teva’s $7.5 billion purchase of U.S. rival Barr, announced in July 2008.

The world’s largest drug company Pfizer, previously seen as an unlikely candidate, has re-emerged, defying a relatively unfavorable impression it left with regional law-makers in southwestern Germany, where Ratiopharm is headquartered, according to the people.

Industrial heir Ludwig Merckle is selling Ratiopharm as part of concessions made to creditor banks by his late father Adolf Merckle, who committed suicide in January 2009 after losing control over his business empire to lenders during the financial crisis.

Industry analysts said Teva, the world’s largest generics company, has deeper pockets and stands to gain more from potential cost cuts at family-owned Ratiopharm than does Actavis/EQT.

The Nordic consortium, however — which has enlisted former Ratiopharm Chief Executive Claudio Albrecht for advice — has improved its chances after pledging to protect jobs in the region.

“Teva seems to have a better financial position and the infrastructure to capture cost synergies. However, the smaller size of Actavis may appeal to the family-owned seller,” analysts at Jefferies said in a note. “Also, an Actavis acquisition may be somewhat more job friendly.”

Pfizer has already struck a string of collaborations and acquisitions to bolster its range of generics, particularly off-patent injectable drugs. An alliance with India’s Strides Arcolab Ltd last month marked the latest step.

For its part, Teva has said it plans to more than double total revenue and almost triple sales in Europe by 2015, a venture analysts say would require acquisitions worth $15 billion.

Ratiopharm could become Teva’s fast track to the No. 1 spot in Germany’s generics market, the world’s second-biggest, where Teva now trails Novartis, Ratiopharm, and Stada.

The acquisition would also make Teva the largest generics player in Europe, where its presence has been below Teva’s global average.

A spokesman for Ratiopharm declined to comment, as did spokespeople for Teva, Pfizer and EQT. Ratiopharm previously said a deal would be closed in the first quarter at the earliest.

Sources have said that debt-laden Actavis sought backing from EQT for the takeover bid in an aggressive move to boost the Icelandic firm’s market value after it failed to find a new owner last April.

(Reporting by Ludwig Burger, Frank Siebelt, Philipp Halstrick and Alexander Huebner in Frankfurt, Quentin Webb in London; Editing by Keiron Henderson)

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Technorati Tags: Actavis, generic drug maker, injectable drugs, Pfizer, Ratiopharm

They’re not Scrooges, but people with allergies and asthma can have bad reactions to certain holiday traditions and need to take special steps to prevent sneezing and wheezing, according to the American College of Allergy, Asthma and Immunology (ACAAI).

Those who are allergic to live evergreens may choose to decorate with artificial plants, but both live and artificial trees can trigger symptoms, experts say. They offer the following hints to help people avoid allergy and asthma symptoms over the holiday season:

• Some allergies are triggered by terpene, which is found in the oil or sap of live evergreen trees, wreaths and garlands. Other allergy sufferers may react to mold or pollen on trees and natural decorations. The ACAAI suggests washing pollen and mold off live trees, especially the trunk, with a garden hose and leaving the tree in a bucket of water in the garage or a covered porch while it dries. Wear gloves when handling the tree to protect against contact with sap.
• For those who are allergic to dust and mold, even artificial trees can be a problem if they haven’t been stored properly. Because dust and mold can accumulate on these items, it is a good idea to wash the tree outside before setting it up inside the house for decorating. The best way to store an artificial tree is to place it in an air-tight bag or container.
• Ornaments and other decorations can also gather dust and mold and are best stored in air-tight containers. Thoroughly clean each item before putting it on display.
• Artificial snow spray shouldn’t be used indoors because it can trigger asthma and allergy symptoms. Other potential triggers include scented candles, potpourri and other scents, and wood-burning fireplaces, the ACAAI warns.
• Food allergies are another potential problem during the holidays. Those with food allergies should ask party or dinner hosts about the ingredients used in each dish. It is also a good idea to prepare a dish you know is “safe” for you to eat and bring it along to share. When hosting a gathering, talk to guests in advance about food allergies.
• When traveling, remember to pack your asthma and allergy medications. If the trip requires air travel, keep those items in a carry-on bag. Bringing a pillow and mattress cover is recommended for those affected by dust mites.

Stress doesn’t cause allergies or asthma but can weaken your immune system. Make sure you take time in your busy holiday schedule to stay on top of your allergy and asthma symptoms so that illness doesn’t ruin your holiday plans. People with asthma should talk with their doctor about getting a flu shot, the ACAAI recommends.

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Technorati Tags: allergies, asthma, food allergies, prevent alergies, prevent asthma