The U.S. Food & Drug Administration (FDA) is asking the makers of Tysabri to update its safety information after two patients in Europe developed a serious brain infection called progressive multifocal leukoencephalopathy (PML) while undergoing monotherapy with the drug. Tysabri had already been linked to PML when it was used with other drugs, but it was thought that treatment with Tysabri alone – monotherapy – lessened the risk of developing the disorder.

According to the FDA, one of the European patients had been treated with Tysabri for 14 months, while the other received it for 17 months. Both were receiving Tysabri alone, but one of the patients had a history of prior immunosuppressant therapy with azathioprine and beta-interferons, the FDA said.  The drug’s makers, Elan and Biogen Idec, reported the two new PML cases. (more…)

Postmarketing reports of a type of temporary amnesia have prompted labeling changes for Viagra and Cialis. The new information on  Transient Global Amnesia (TGA) for Viagra and Cialis does not amount to a safety warning, but will be added to the “Postmarketing” section of the drugs’ labels. Such label changes usually mean that multiple users have reported health problems after taking a drug, but the reports don’t necessarily mean that the drug caused the problem, according to the Food & Drug Administration (FDA).  A third Erectile Dysfunction (ED) drug, Levitra, had information about the temporary form of memory loss added to its label in June.

Despite a lack of direct evidence linking the ED drugs to TGA, this isn’t the first time they have been implicated in the condition. A 2005 article in the International Journal of Impotence Research described the case of a 46-year-old man who was brought to the emergency room because he had couldn’t remember any events since waking up in the morning or the night before, taking Cialis. His memory gradually improved, and tests for cardiovascular and brain problems – potential causes of TGA – came back normal. According to the authors of that article, there had been 35 reports of amnesia in Viagra users between 1998 and 2001. (more…)

The Food & Drug Administration (FDA) has scheduled a meeting this October to consider new rules for over-the-counter children’s cold medicines. Some patient advocates are hoping that the FDA will finally take these dangerous drugs off of the market. In March 2007, a group of pediatricians filed a petition asking the FDA to restrict the use of the products. The group cited a lack of evidence that the drugs work and growing evidence that they can cause a host of side effects, including hallucinations, seizures, trouble breathing, heart problems and other complications, including deaths.

According to The Washington Post, the FDA will hold a special hearing Oct. 2 to consider a number of issues. Chief among them are the types of studies that should be done to evaluate the safety and effectiveness of children’s cold medicines. Also on the agenda is the question of whether the drugs should remain available without a prescription. Dosage and ingredient combinations will also be discussed. (more…)

More bad news for Vytorin, as the Food & Drug Administration (FDA) announced today that it is reviewing the controversial drug for a possible link to cancer. The FDA decided to conduct the review following the release last month of the SEAS study, which investigated the effects of Vytorin in patients with partial blockages of the aortic valve of the heart, known as aortic stenosis.

Not only did SEAS find that Vytorin did little to help patients with aortic stenosis avoid other heart problems, but patients in the trial taking the Merck and Schering-Plough drug had higher rates of cancer. In SEAS, 102 patients taking Vytorin developed cancer, compared with 67 taking the placebo. Of those, 39 people taking Vytorin died from their cancer, compared with 23 taking placebo. Researchers conducting the study said those numbers were “statistically significant”, meaning the odds were less than 5 percent that they were the result of chance. (more…)

Liko AB has undertaken a corrective action for some models of its Liko Universal SlingBar because of a defect that poses a fall risk to patients. According to the Liko AB safety notice issued on June 2, when mounted on Viking or LikoLight mobile lifts, a component securing the Universal SlingBar to the lift may experience unanticipated fatigue. In extreme cases this can result in the sling bar becoming detached from the mobile lift. If this were to happen when a patient was being lifted, the patient would risk falling. To date, Liko says it has had no report of personal injuries.

To correct the problem, Liko has launched a field correction program to replace all affected products with a new sling bar design. The company says all sling bars now being delivered from Liko AB are the new design. (more…)

More questions about the cervical cancer vaccines Gardasil and Ceravix have been raised by two articles in the the New England Journal of Medicine (NEJM). Gardasil, Merck & Co.’s vaccine, was approved by the U.S. Food & Drug Administration (FDA) in June 2006. Ceravix, made by GlaxoSmithKline, has not been approved by the FDA yet, but is widely used in Europe.

The makers of both vaccines claim they prevent the strains of Human Papillomavirus  (HPV) most responsible for causing cervical cancer. But in Western countries, like the U.S. and Great Britain, regular screening via Pap tests has already greatly reduced incidences of cervical cancer and deaths. But even after vaccination, regular Pap tests are necessary because the shots don’t protect against all HPV strains known to cause the cancer. Both Gardasil and Ceravix are given as a series of three injections, and can cost as much as $1,000 to complete, and unlike most vaccines, they don’t save health systems money. (more…)

Alarmed that the U.S. Supreme Court might hand drug makers a powerful lawsuit shield when it hears an important case this fall, editors at the New England Journal of Medicine (NEJM) have written an Amicus Brief arguing against such a ruling. On the other side, drug make Wyeth is trying to convince the High Court that Food and Drug Administration (FDA) approval of a drug preempts the filing of defective drug product liability lawsuits in state courts.

Forty-seven state attorneys general have joined the NEJM in supporting Levine’s lawsuit. So have two former FDA commissioners – David Kessler, who served in the Clinton Administration, and Donald Kennedy who served in the Administration of George H.W. Bush. (more…)

Japan is investigating two new report of iPod Nano fires, and Apple says defective lithium ion batteries are to blame. The Japanese ministry had also received a similar report of another iPod Nano fire last March. In all of the fires, the iPods began to overheat while they were being recharged.

IPod Nanos use lithium-ion batteries. Lithium batteries have been a known fire risk. On August 24, 2006, the U.S. Consumer Product Safety Commission and Apple issued a recall of rechargeable, lithium-ion batteries made by Sony for certain iBook G4 and PowerBook G4 notebook computers. The recall was based on nine reports of batteries overheating, two of which involved minor burns. (more…)

Critics of Merck & Co.’s Gardasil marketing campaign say it ignores important questions over the vaccine’s safety and effectiveness. In the past two years, Merck has saturated the airwaves with catchy commercials, paid doctors as much as $4500 a pop to promote Gardasil via talks and lectures, and lobbied women’s group, medical societies and politicians to make Gardasil a mandatory vaccine for girls in many states. Those efforts have made Gardasil one of Merck’s fastest growing drugs, but many are beginning to wonder what the cost might be to public health.

For starters, many believe the vaccine was not subject to enough pre-market scrutiny. According to The New York Times, the Food & Drug Administration (FDA) expedited Gardasil’s approval application, and gave it the ok in just six months. It was recommended by the Centers for Disease Control (CDC) just weeks later. (more…)

A new report says that Merck & Co. was more interested in marketing than science when it when it conducted a Vioxx study known as Advantage. According to internal Merck documents obtain in the course of Vioxx injury lawsuits, Advantage was called a “seeding trial”, the purpose which was to boost the confidence of 600 participating doctors in the new drug and get them to promote it to colleagues.

This is not the first time Vioxx trials run by Merck have raised serious ethical questions. In April, it was learned that Merck concealed mortality risks in two key Vioxx studies, and hired “ghostwriters” to author research that was supposedly conducted by independent scientists. According to articles that appeared in the April issue of the “Journal of the American Medical Association”, an analysis of court documents uncovered in the course of Vioxx injury lawsuits found that Merck employees worked alone or with publishing companies to write study manuscripts and later recruited academic medical experts to put their names as first authors on the studies. In many cases, Merck’s involvement in producing the data wasn’t disclosed. (more…)