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Heparin Syringes Might be Contaminated, Covidien Ltd. Warns

Another company, Covidien Ltd., has recalled a heparin product. Covidien announced a recall of its prefilled syringes containing heparin on Friday, after the company said it was informed by its supplier, Scientific Protein Laboratories, that two lots of Heparin Sodium USP active pharmaceutical ingredient it received might contaminated with the same chemical recently found in heparin recalled by Baxter Healthcare over the past few months. Scientific Protein Laboratories also supplied a contaminated ingredients to Baxter for its heparin, which has been linked to more than 700 serious reactions and possibly 19 deaths among patient in the US.

The Covidien heparin recall came just a week after another company, B. Braun Medical, initiated its own heparin recall as a precautionary measure, and American Health Packaging, a unit of AmerisourceBergen Corp, said it was voluntarily recalling 1,421 units of heparin injection vials as part of Baxter’ broader recall. Heparin sourced from China has also been recalled in German, France, Italy, Denmark and Japan, and the US Food & Drug Administration (FDA) is currently detaining all heparin imports to the US at their points of entry until they can be subjected to further testing. (more…)

Vytorin Criticized at Cardiology Conference

The makers of Vytorin were subject to scathing criticism this weekend a the annual meeting of  the American College of Cardiology for their handling of a study that showed the cholesterol-lowering medication did  not provide any more benefits than cheaper statins alone.  What’s worse, a panel of four prominent cardiologists convened to discuss the results of the much-delayed ENHANCE trial recomended that Vytorin only be used as a last resort.

“Our strongest recommendation is that people need to go back to statins,” said panel member Dr. Harlan Krumhotz. “We really think there’s just a small group of patients who cannot get to target (cholesterol) on statins.” He said doctors should maximize the doses of statins and then try adding other drugs such as niacin-based drugs or fibrates in an attempt to lower LDL cholesterol levels as current practice guidelines recommend. The doctors said that Vytorin shouldn’t be widely used until a larger study proves whether the pill reduces the risk of heart attacks and deaths, the doctors said.  The recommendations came after Merck and Schering-Plough released the full ENHANCE study at the meeting. (more…)

Videx and Ziagen HIV Drugs Linked to Heart Attacks

Videx, made by Bristol-Myers, and Ziagen, made by GlaxoSmithKline, PLC, are both under review by the the Food and Drug Administration (FDA), amid concerns that the HIV drugs may increase the risk of heart attacks. The FDA’s review was prompted by the release of a recent study—The Data Collection on Adverse Events of Anti-HIV Drugs or, D:A:D, Study— that found evidence of a higher heart attack risk among patients taking Videx and Ziagen. In that study, researchers reviewed heart attack risk among patients taking certain medicines from the NRTI class—nucleoside reverse transcriptase inhibitor—of AIDS drugs.

Glaxo and Bristol-Myers said their own evaluations did not reveal any risk of increased heart attack linked to the study; however, according to the FDA, patients taking either Ziagen or Videx “had a greater chance of developing a heart attack than patients taking other medications.” The study was conducted with 33,347 HIV-1 infected patients living in North America, Europe, and Australia who were monitored to evaluate the short- and long-term adverse effects of treatment with anti-HIV drugs.The FDA did say that the study indicated that the risk did not appear to increase over time and seemed reversible after drugs were stopped. “The effect was not seen six months after stopping the drugs,” confirmed the FDA. But, the FDA did say it believed analyses of the D:A:D study were not complete, adding that researchers had not evaluated heart-attack risk when patients were taking two other NRTIs: Gilead Sciences Inc.’s Viread and Emtriva. The study reviewed the relative risk of heart attack among cumulative use, recent use (currently or within the past six months), and past use (last use greater than six months ago). (more…)

FDA Warns on Regranex Cancer Death Risk

The Food & Drug Administration (FDA) is conducting an ongoing safety review of Regranex, a gel used by diabetics to treat leg and foot wounds. The FDA says it believes that there may be some evidence for an increased risk of death from cancer in patients who had repeated treatments with Regranex.

Regranex is a medicine that is a recombinant form of human platelet-derived growth factor which is applied directly to diabetic foot and leg ulcers that are not healing. The recombinant form of platelet growth factor has a biologic activity that is much like that produced naturally by the body. Growth factors cause cells to divide more rapidly. For that reason, the FDA said Johnson & Johnson, the maker of Regranex, continued to monitor studies begun before Regranex was approved for any evidence of adverse effects such as increased numbers of cancers. (more…)

Singulair Suicide Link Probed by FDA

The Food & Drug Administration (FDA) is looking into reports that Singulair, a popular drug used to control asthma, might be linked to suicidal thoughts and behavior. The FDA said it anticipates that it may take up to 9 months to complete the ongoing Singulair safety evaluations. As soon as this review is complete, the FDA will communicate the conclusions and recommendations to the public.

Singulair was approved to treat asthma and the symptoms of allergic seasonal allergies and to prevent exercise-induced asthma. Singulair, marketed by Merck & Co,. is one of a class of drugs called leukotriene receptor antagonists. Other leukotriene modifying medications include Accolate, which is also a leukotriene receptor antagonist and Zyflo and Zyflo CR, which are leukotriene synthesis inhibitors. (more…)

FDA Wants More Testing, Follow-up Studies for Drug Coated Stents

The Food & Drug Administration (FDA) has released proposed guidelines for drug coated stents. According to The Wall Street Journal, the proposed drug coated stent guidelines would mark the first concrete change since the FDA held a two-day meeting in December 2006 about whether such stents increase the risk of clots compared with bare-metal stents years after the procedure. The guidelines aren’t expected to affect drug coated stents already on the market, but cold delay stents in development.

In 2006, the safety of drug coated stents was called into question when the Cleveland Clinic published an analysis of fourteen stent studies covering more than 6,000 patients that found those with drug coated stents were four to five times more likely to suffer from blood clots than those implanted with bare metal stents. Since then, use of the drug coated stents has dropped dramatically. (more…)

World Trade Center Workers Can Sue New York City, Appeals Court Rules

 An appeals court ruled that thousands of lawsuits filed by World Trade Center rescue workers made ill from toxic dust at Ground Zero can go forward, refusing New York City‘s claims that it had immunity from such lawsuits.The city was appealing a 2006 decision by the United States District Court in Manhattan that ruled it might only have partial immunity in regards to World Trade Center rescue worker lawsuits.

The city has not yet said if it would appeal the ruling to the US Supreme Court, and according to The New York Times, Mayor Michael Bloomberg and advocates for the World Trade Center rescue workers have asked Congress to reopen the Sept. 11 Victims Compensation Fund to compensate injured workers in lieu of the litigation. (more…)

Auction Rate Securities Fraud Lawsuits Filed Against Morgan Stanley, Merrill Lynch

The failure of the  auction rate securities market has yielded several lawsuits.  According to Reuters, the auction rate securities lawsuits filed against Morgan Stanley and Merrill Lynch claim the brokers had artificially supported the auction rate securities market, causing their investments to become illiquid. They also claimed that the firms had recklessly misrepresented the risks of such investments.

Investor Gary Miller, who filed suit against Morgan Stanley, is seeking an injunction that would force the broker to rescind millions of dollars it executed in auction rate transactions from March 2003 through February 2008, and compensatory damages for himself and other investors in those securities. The other suit, filed against Merrill Lynch by Frederick Burton, alleges the company deceived the investing public and issued misleading information to clients in violation of the Exchange Act. He is also seeking compensatory damages. Both lawsuits, filed in federal court in Manhattan, are seeking class action status. (more…)

Heparin Recalled in France, Italy and Denmark

Heparin  recalls have now spread to Europe, with  France, Italy and Denmark  being the latest countries to recall the blood thinner because of contamination issues. Like the heparin made by Baxter International in the US, regulators in Europe believe the drug has been contaminated with chondroitin sulfate.  However, there have have been no reports of serious reactions or deaths to heparin in France, Italy or Denmark.  Heparin made by Baxter has been linked to more than 700 adverse reactions and 19 deaths in the US.

Heparin is a vital drug used in surgery, dialysis, and for the bedridden.  Other drugs thin blood, but their effects are not as quick or easily reversed. In the US, Baxter first recalled 9 lots of heparin in January, after the drug was linked to serious, and sometimes fatal reactions in some patients. Those reported reactions to Baxter heparin included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening. In February, Baxter expanded the heparin recall to include all of its heparin products, and suspended sales of its drug. Last week, B. Braun Medical initiated its own heparin recall as a precautionary measure, and American Health Packaging, a unit of AmerisourceBergen Corp, said it was voluntarily recalling 1,421 units of heparin injection vials as part of Baxter’ broader recall.  Baxter manufactures about half of all multiple-dose heparin vials sold in the US, while B. Braun Medical supplies 10%-15% of the U.S. supply of injectable heparin.  Despite the massive heparin recalls, US regulators have said that there is no shortage of heparin.   (more…)

Brake Problem Prompts Yamaha Rhino ATV Recall

 The Yamaha Rhino ATV, already considered dangerous because of its high number of rollover accidents, is being recalled because of a brake problem. Today’s Yamaha Rhino ATV recall covers 7800 Model Year 2008 Rhino YXR450 and YXR700 Side-by-Side Vehicles sold at Yamaha dealers nationwide from October 2007 through March 2008 for between $8,300 and $12,000. Consumers with a recalled Rhino ATV should stop using them immediately and contact any authorized Yamaha Rhino dealer to schedule a free repair.

 According to the Consumer Product Safety Commission (CPSC), the brake caliper on the left front wheel of the recalled Yamaha Rhino ATVs could have been made incorrectly, resulting in brake fluid leaking. This can cause a loss of braking and control of the vehicle, posing a serious safety risk to the driver and passenger. No injuries have been reported in relation to  the defective brake caliper, but this is not the first time the Yamaha Rhino has  raised safety issues. (more…)

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