Bayer AG has been hit with 78 lawsuits over the drug Trasylol. In November, Bayer suspended Trasylol sales after a Canadian study linked it to a higher risk of death.

Trayslol was approved in 1993, and was used to prevent bleeding during open heart surgeries. Since its approval, about a third of all heart surgery patients in the US have been treated with Trasylol. Trayslol was the subject of several Food & Drug Administration (FDA) safety reviews before it was finally pulled from the market last year. (more…)

At a meeting of the U.S. Food and Drug Administration’s (FDA) Ophthalmic Devices Panel Friday where post-LASIK quality-of-life issues were discussed, it was recommended the FDA ensure clearer warnings outlining the risks of LASIK, according to the Associated Press.  LASIK—laser-assisted in situ keratomileusis—surgery involves using a laser to cut a small flap in the eye’s cornea to allow for reshaping of the corneal tissue with another laser to correct nearsightedness, farsightedness and, sometimes, astigmatism.  Lasik was approved a decade ago and an estimated six million Americans have undergone Lasik surgery.  The surgery permanently reshapes the cornea, there are no guarantees of 20/20 vision, and the long-term safety of Lasik remains unknown.

The FDA has received 140 letters of complaints.  “The FDA has called this a quality-of-life issue, because patients are complaining that their vision isn’t sharp, they have poor night vision, some have glare or halos, some complain that their eyes are dry,” said Dr. Robert Cykiert, associate professor of ophthalmology at New York University Langone Medical Center.  FDA advisers recommended the agency clarify warnings regarding LASIK, including:  Photographs to clearly show what people with side effects see, such as glares and light bursts; information indicating how often patients suffer side effects, such as dry eye; and clear information outlining the conditions under which someone should be disqualified from LASIK, such as large pupils or severe nearsightedness. (more…)

A congressional hearing into tainted heparin that begins tomorrow will feature testimony from the Chief Executive Officer of Baxter International.  Baxter International supplied about 50 percent of the heparin used in the US, and recalled most of its heparin products in February following reports of adverse deaths and reactions linked to the blood thinner.  At least 81 deaths among US patients have been linked to heparin contaminated with a counterfeit ingredient, although not all of the deaths have been blamed on Baxter heparin.

In March, the Food & Drug Administration (FDA) confirmed that it had found a counterfeit ingredient, oversulfated chondroitin sulfate, in samples of the active ingredient used in Baxter heparin. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. Since then, companies in several other countries have issued heparin recalls, and a cluster of heparin reactions has been reported in Germany. In the US, some other manufacturers have issued precautionary recalls. (more…)

The new Xience heart stent out-performed the more popular Taxus heart stent in a one-year trial; however, experts disagree on whether stent science is moving too fast and doctors are concerned over the recent discovery that blood clots can form at the site of drug-coated stents long after implantation.

Stents are tiny wire-mesh tubes used to prop open arteries after doctors clear them of blockages. Some stents have a drug coating meant to keep vessels from re-clogging following balloon angioplasty procedures.  Bare-metal stents tend to re-clog more often than drug-coated stents, so physicians are quick use drug-coated stents, even in those patients with complex heart disease, not the patients in whom the devices were tested. (more…)

A new study of Texas school district and industrial mercury-release data, which was conducted by researchers at The University of Texas Health Science Center at San Antonio, reveals that there is a statistically significant link between the pounds of industrial release of mercury and an increase in autism rates. The study examined mercury-release data from 39 coal-fired power plants and 56 industrial facilities in Texas and autism rates from 1,040 Texas school districts.

The study confirmed—for the first time in scientific literature—that there is a statistically significant link between autism risk and distance from the mercury source.  “This is not a definitive study, but just one more that furthers the association between environmental mercury and autism,” said lead author Raymond F. Palmer, Ph.D., associate professor of family and community medicine at the UT Health Science Center San Antonio.  The article appears in the journal Health & Place. (more…)

Democrats in Congress said yesterday that new user fees and other proposals would help give the U.S. Food and Drug Administration (FDA) much needed resources to improve food safety.  Critics disagreed saying that these measures could do more harm than good.  The FDA is responsible for the vast majority—80 percent—of the U.S. food supply, mostly fruits, vegetables, and processed foods.

The FDA has faced intense criticism from lawmakers and consumer groups and has long been accused of being too passive in handling changes in the food supply, especially in the areas of recent increases in imports and growing consumer demand for fresh produce.    The move to increase food and drug protection, which was included in draft legislation introduced in the House of Representatives last week, follows a number of incidents including problems with U.S.-grown spinach, U.S.-made peanut butter, problems linked to contaminated ingredients made in China that were later used in pet food; and the recent tragedies over the blood thinner heparin.  “The agency is starved for resources and cannot meet its basic responsibility,” Representatie John Dingell, chairman of the House Energy and Commerce Committee, said at a hearing on the bill.  The measure, he said, “will focus on efforts to seek real legislative conclusions to what is, in fact, a public health crisis.” (more…)

U.S. pet food makers and makers of all other animal feed will no longer be permitted to use certain materials from cattle in an effort to reduce the increasing risks for spreading mad cow disease.  The U.S. Food and Drug Administration (FDA), which oversees animal feed, just finalized a new rule this Wednesday that states that excluding high-risk materials from cattle which are 30 months of age or older from all animal feed will prevent any accidental cross-contamination between ruminant feed and non-ruminant feed or feed ingredients.  Ruminant feed is that feed which is intended for animals such as cattle.  This measure finalizes a proposed rule that was open for public comment in October 2005; the measure will be going into effect next year on April 23, 2009.

Contamination can occur in any of a variety of stages in the meat process from manufacture to transport.  Contamination can also occur through the accidental misfeeding of non-ruminant feed to ruminant animals.  Following a mad cow disease outbreak in Britain several years back, both Canada and the United States banned the inclusion of protein from cows and other ruminant animals, such as goats and sheep, in cattle feed in 1997. (more…)

In collaboration with the Consumer Product Safety Commission (CPSC), Avon has issued two voluntary recalls.  In both cases, the defective products were distributed by Avon Products Inc., of New York, New York and sold in Puerto Rico and the U.S. Virgin Islands

In the first incident, Avon is recalling approximately 17,000 Infant Santa Outfits due to a choking hazard.  The Infant Santa Outfits were manufactured in China and imported by MacSwed, Inc., of New York, New York.  Although no injuries or incidents have been reported, to date, the pom poms on the 2006 and 2007 Infant Santa Outfit and the snaps on the 2007 Infant Santa Outfit can detach, posing a choking hazard to young children. (more…)

Christopher Padilla, the under secretary of commerce for international trade, told a group of businessmen that the United States was concerned that Chinese regulators did not have the authority to monitor both pharmaceuticals and bulk chemicals and that China did not have the ability or will to regulate its economy properly, allowing the export of a chemical that tainted the blood-thinning agent heparin which is linked to the deaths of dozens and the illnesses of hundreds.  The Chinese manufacturer of heparin did not register with that country’s State Food & Drug  Administration (SFDA) as a maker of active pharmaceutical products.

“This is a loophole that must be closed,” Padilla said, adding that the Chinese SFDA does not have the authority to simultaneously regulate pharmaceutical makers of active pharmaceutical ingredients and makers of bulk chemicals which may be used in pharmaceuticals but not considered of medicinal use.  “The rapid growth of China’s economy has clearly outstripped the ability and the will of the government to effectively police that economy,” Padilla said.  Padilla, who is leading a group of healthcare executives to China, also said effective monitoring was a part of larger healthcare reforms that mainland authorities were handling. (more…)

Federal regulators who investigated Merck & Co.’s vaccine plant in Philadelphia, Pennsylvania cited a variety of potentially serious problems.  According to the report, contaminated packaging of children’s vaccines, unwanted fibers on vaccine vial stoppers, failure to follow good management practices, and contamination of bulk vaccine lots were among the problems cited by U.S. Food and Drug Administration (FDA) inspectors.  Based on an unpublished FDA report the Philadelphia Inquirer obtained the information through a Freedom of Information Act request, the article said inspectors found 49 areas of concern.

In December, Merck recalled over 1.2 million doses of defective vaccines—11 lots of PedvaxHIB vaccine and two lots of Comvax vaccine—when quality control checks revealed production equipment might not have been properly sterilized.  Merck also quarantined a nearly one-year supply of other potentially suspect doses.  Vaccines involved protect against Hib—or Haemophilus influenzae type b—disease and other conditions; Comvax also prevents against hepatitis B.  The vaccines were distributed beginning April 2007 and all but one lot was distributed in the United States.  Merck supplies about half the 14 million doses of Hib vaccine used in the U.S. annually.  FDA inspectors visited the Montgomery County plant on 30 separate occasions from November through January. (more…)