2010 April Archive

GlaxoSmithKline, the drug maker, has announced it plans to remove zinc from its denture cream products that include Poligrip and Super Poligrip. The reason? Some studies have been a link between denture adhesives that contain zinc and neurological problems. The link has led to a class-action lawsuit filed in the Southern District of Florida representing 75 cases. The symptoms of zinc poisoning can include weakness and numbness, poor balance and pain in the extremities. Another popular brand made by Proctor & Gamble, Fixodent, which also contains zinc, is also the subject of a lawsuit. GSK will make a zinc-free version of its denture cream. If you feel you have experienced these symptoms, you need to seek medical care as soon as possible to have your condition identified. A Florida products liability attorney can give you a free case evaluation and help you protect your rights. #

Two drug safety reviewers believe that the diabetes drug, Avandia, should be removed from the market because of the drug’s link to thousands of heart attacks. Documents were released Saturday, February 20, the same day a report released by the Senate Finance Committee, suggest that drug maker, GlaxoSmithKline PLC, knew or should have known of the drugs’ dangers. The report also criticized the less than watchful eye of the Food and Drug Administration that is supposed to oversee drug safety.

Senators Max Baucus and Charles Grassley and their report suggests GSK understood there were heart risks associated with Avandia for several years, even before a study from the Cleveland Clinic suggested a link. The report suggests that Glaxo even went so far as to intimidate independent physicians and downplayed findings that a competing drug might be superior in reducing heart risks.

The report was compiled from some 250,000 documents, some supplied by Glaxo, the FDA and whistleblowers. Glaxo rejected the report’s conclusion.

Avandia had sales of 43 billion in 2006, but sales dropped off to less than half of that amount in 2009.

An advisory panel will be assembled by the Food and Drug Administration to assess the risks of Avandia, GSK’s second biggest seller. FDA Commissioner Margaret Hamburg says she is looking forward to that report.

FDA Reviews Are Not Favorable

Within the FDA, two reviewers in 2008 issued a memo that concluded Avandia’s risks exceed those of rival drug Actos, made by Takeda Pharmaceuticals. David Graham and Cate Gelperin wrote that as many as 500 heart attacks and 300 cases of heart failure were associated with Avandia use every month. Dr. Graham had argued to the FDA, as far back as 2007, that sales of Avandia should be halted.

If you or a loved one takes Avandia, you should know that in 2007, the FDA decided it should carry an addition warning about an increased risk of heart attack associated with its use when compared to a placebo. And even though the Cleveland Clinic researchers published a report warning of the heart attack risks, an FDA panel in 2007 voted 22-1 to keep it on the market.

When there is any doubt, the benefit of the doubt goes to the drug company and not the patient it seems. If you or a loved one have been taking Avandia and want to know more, consult with a Florida product liability attorney with experience in defective drugs. #

Source Article: http://edition.cnn.com/2010/HEALTH/02/20/avandia.study/index.html?eref=ib_topstories

As if Toyota doesn’t have enough problems with its unintended acceleration and insufficient braking. NHTSA, the National Highway Traffic Safety Administration reports that it has received 168 consumer complaints about steering difficulties with the 2009 and 2010 models of the Toyota Corolla and Matrix. 363,000 cars are potentially affected. The complaints say the steering becomes loose or “unresponsive.” One consumer complaint describes it as the car tends to “wander within a lane” while it’s still traveling straight. It makes it difficult for the driver to keep the car going in a straight line. Eight people say they had accidents when that happened and 11 individuals report they were injured. Toyota says in a statement that it is cooperating with the investigation. The troubled automaker may consider recalling the popular Corolla because of the potential steering problems. Last December, NHTSA began looking into the Corolla and Matrix for stalling problems. Unintended stalling has also been noted in the 2003 Sequoia. The steering problem represents the fifth NHTSA investigation of a Toyota vehicle. The Corolla trails the Camry as the second best-selling model for Toyota with 1.3 million sold last year, according to Autodata Corp.

What is the best car to buy? Given the recalls involving the very popular Toyotas, which were perceived as highly reliable, many in the market for a new car may be looking for guidance. The always reliable Consumer Reports has the new car best values of 2010 and surprisingly it shows the Honda Fit and Toyota Prius at the top of the list. Each earned a value score of 2.08, making them the best overall value. A score of 2.00 is equal to twice the value of an average car. How much do they cost? The Prius IV coming in a $26,750 costs more than the Fit at $16,020 and has a slightly higher cost per mile at 47 versus 42 cents per mile. In all, Consumer Reports considered reliability and value to be what it would cost to own the car for the first five years, including its performance and reliability. If a car performs well on road tests and is reliable, but costs less to own than comparable cars, it gets a higher rating.

Looking at the list of top eight cars, it includes: the Honda Fit, the Toyota Prius IV, the Hyundai Elantra Touring minivan, the Subaru Forester 2.5x, the Hyundai Santa Fe Limited, the Acura TSX (4 cyl.), the Infiniti M35 (RWD), and the Mini Cooper.

On the other side of the coin the worst values include the: Chevrolet Aveo5 1LT, the Dodge Avenger R/T, Dodge Caravan SXT, Dodge Nitro SLT, Wrangler Unlimited Sahara, Dodge Charger R/T, the Mercedes Benz 5550, and the Chrysler Sebring Convertible Limited. Visit Consumer Reports to also see the ratings of the car makers. #

It was a tragic early end to actress Brittany Murphy. A coroner has ruled that the drugs that killed the 32-year-old were common cold medications mixed to create “multiple drug intoxication.” Murphy had a cold and respiratory infection and self-medicated before she was found dead in her Hollywood Hills home December 20. The coroner says she had multiple medication-hydrocodone, acetaminophen and chlorpheniramine. She also had L-methamphetamine in her body.

How does one get these medications? Likely from your own medicine chest. Acetaminophen and hydrocodone make up Vicodin. Chlorpheniramine is an active ingredient in some over-the-counter medications. And L-methamphetamine is found in some inhalers. These are legal drugs. Murphy reportedly suffered heavy menstrual periods and had a chronic iron deficiency. That leaves someone vulnerable to infection. The drug Vicoprofen relieves pain from menstrual cramps and includes hydrocodone and ibuprofen. At the time of her death she was suffering from pneumonia. The coroner has concluded that this death was accidental and entirely preventable.

Over-the-counter drugs are generally taken without a doctor’s supervision and are considered safe when used as directed. There are exceptions. Remember the 14 pediatric cold and cough formulations pulled from drug store shelves in late summer 2007? In children the drugs had reportedly caused hallucinations, heart problems and even death. The Centers for Disease Control and Prevention reports unintentional poisoning deaths increased from 12,186 in 1999 to 20,950 in 2004. OTC drugs also do not generally come with a warning about combining them with other drugs. Then a third reaction is possible and not predictable. For example, Tylenol (and its active ingredient acetaminophen) is in a lot of other drugs such as Vicodin and Percocet. So if you take Tylenol that day as well as Vicodin, you may be overloading your liver, and damaging it. Murphy joins the ranks of other celebrities who didn’t think there could be anything wrong with over-the-counter drugs, after all they are legal. That includes Heath Ledger, Chris Farley and Michael Jackson, and those are only the famous folks. Everyday people take OTC drugs and assume they are safe. What’s interesting is that reports indicate that she was not a drug user, referring to illegal drugs, but when OTC drugs can have the same lethal consequences, the only difference is the law. #

Source Article: http://edition.cnn.com/2010/SHOWBIZ/Movies/02/25/brittany.murphy.autopsy/

Expect school lunches to look a lot different from the standard mac and cheese and hot dogs after this summer. The U.S. Department of Agriculture is launching its most sweeping reforms for the National School Lunch Program. In particular, ground beef will have to be ‘safe, wholesome and high quality” as well poultry, eggs and produce that feeds 31 million students every school day. One has to wonder, what were the standards prior to this? Did we not always vow to provide school children with the highest quality food possible?

When USAToday tried to answer that question in an investigation, the newspaper found that beef bought by the USDA intended for school lunch programs often does not get the same rigorous testing that fast-food chains undergo. And suppliers with a spotty record are not prevented from continuing to supply food for school lunches. So beginning this summer, expect testing for salmonella, E.coli 0157:H7 and other contaminants to be increased. The bacterial counts allowed will be lower. And the testing standards must meet those commercial buyers expect. Why should food for school children be any less than what a corporate fast-food establishment has come to expect?

Source Article: http://www.usatoday.com/news/education/2010-02-15-schoollunch15_ST_N.htm

Studies within the Food and Drug Administration reveal that Avandia, the diabetes medication, should be pulled from the market because of the link to heart attacks. The drug is made by GlaxoSmithKline (GSK) and the confidential studies were released as part of a report by the staff of the Senate Finance Committee.

The studies, released as part of a report on Avandia by staff of Senate Finance Committee members Chuck Grassley (R- Iowa) and Max Baucus (D- Mont.) said that GSK was aware as far back as 2007, that Avandia had a 43% higher risk of cardiovascular events, when Dr. Steve Nissen of the Cleveland Clinic published a study. The Senators also believe that a clinical trial that compares Avandia and rival, Actos, made by Takeda Pharmaceuticals, would be “unethical and exploitative.”

Avandia’s generic name is rosiglitazone, or rosiglitazone maleate. A black box warning was added to the drug, but the Senate committee concludes that GSK intimidated doctors who raised concerns, among them the FDA’s David Graham and Kate Gelperin. They concluded Avandia should come off the market because of the heart attack risk. An FDA panel voted in 2007 to leave the drug on the market.

Doctors believe if Actos was substituted for the blockbuster drug, Avandia, there would be 500 fewer heart attacks and 300 fewer cases of heart failure every month.

The Food and Drug Administration is warning the public to know what they are buying and taking when they purchase the antacid, Maalox. There have been at least five serious health events reported to the FDA from people who took Maalox Total Relief. That is not the antacid. The drugmaker, Novartis plans to change the label, but in the meantime know what you are taking. Both are liquid medications available over-the-counter. But Total Relief contains an aspirin-like drug. For people who suffer from intestinal and stomach bleeding or ulcers, this is not the drug to take. It is the drug to take if you do not suffer from those problems and have diarrhea, gas, and discomfort from overeating, nausea and heartburn. It should also never be taken by children recovering from a virus, or teens, and it should not be taken by people on blood thinners or on Plavix.

The Maalox everyone is familiar with, Advanced Regular Strength and Advanced Maximum Strength, is the formulation with the antacid and anti-gas ingredients. Check the FDA Web site for further instructions, but it is recommended for a sour and upset stomach, gas and heartburn. In September, Novartis will drop the name “Maalox” from the Total Relief formula. Always be sure to check with your pharmacist if you have questions about which form of Maalox is right for you. And if you are injured by a defective drug, you will need the assistance of a Florida injury lawyer to help you determine your next step.

The Consumer Product Safety Commission (CPSC) is recalling some drop-side cribs due to the potential for strangulation and suffocation of infants. February 9, Tuesday, the CPSC announced it was recalling Generation 2 Worldwide and “ChildESIGNS.” The drop-side cribs are made by Generation 2, which reportedly went out of business in 2005. The CPSC has received three reports of infants who have suffocated in the malfunctioning cribs. There have been 20 reports of malfunctioning drop-side cribs that can cause bruises and broken bones. There have also been eight reports of mattresses slipping when their support becomes detached.

The problem is with the plastic hardware that can break and cause the side of the crib to detach. When that happens, it creates a gap large enough for an infant or toddler to slip through and become wedged. The basic design of the cribs is defective. Unfortunately, many of them circulate in second-hand stores and garage sales.

The crib recall affects about 500,000 units of these cribs were sold at the popular retail outlets such as Kmart, Wal-Mart, and Buy Buy Baby. The cribs are priced up to $160. The model numbers recalled are on the Web site. Whether you buy one new, or at a garage sale, make sure the baby product you purchase is not on a dangerous products list with the CPSC. You should be able to return the defective item to the store for a full refund. The CPSC warns consumers should not attempt to fix these defective cribs themselves.

Source Articles: http://www.justicenewsflash.com/2010/02/10/cpsc-alert-reported-infant-fatalitiesinjuries-prompt-recall-drop-side-cribs_201002103301.html

The FDA reports that it is launching a new initiative to minimize damage from the ionizing radiation that comes from defective CT scans. Part of the campaign includes promoting personal medical imaging history cards. They will record the number of images one receives in a certain time period to minimize the cumulative number of radiation exposures. The initiative follows a series of reports from the Los Angeles Times that 260 patients were accidentally exposed to more than eight times the normal dose over a period of 18 months.

The FDA will hold public meetings March 30 and 31 to consider suggestions about further training requirements for CT scan operators. Also the groundwork must be laid for a national database to pre-determine the optimal dosage for any given procedure. The more radiation, the clearer the picture, but the manual override by operators is what has caused the overexposure problem. The use of CT scans has tripled since 1995 and many critics believe the review doesn’t go far enough. Up to one-third of the 70 million scans in the U.S. annually may be unnecessary. A 2007 study published in the New England Journal of Medicine, finds that up to 0.4% of cancers in the U.S. may be due to unnecessary scans. As it stands now, without a patient history card, it is up to the patient to remind medical technicians and their doctor of the number of scans they have received to avoid multiple, cumulative exposures.

Source Articles: http://abcnews.go.com/Health/CancerPreventionAndTreatment/fda-radiation-safety-standards-popular-rays/story?id=9795804

http://www.kaiserhealthnews.org/Daily-Reports/2010/February/10/FDA-and-medical-radiation.aspx