A clinical trial of Zetia, a popularly prescribed cholesterol-lowering drug, “failed to show that the drug has any medical benefits.” In fact, fatty plaques grew almost twice as fast in patients who took Zetia along with Zocor in a combo product called Vytorin. However, “patients who are taking Vytorin or Zetia should talk to their doctors if they are concerned and not discontinue taking the medicines on their own.” [New York Times]
Two former sales reps for the pharmaceutical company Amgen are suing “for lost wages and other compensation after refusing to participate in improper promotion of the company’s blockbuster psoriasis drug Enbrel.” They claim that Amgen encouraged them to “illegally access patient records to induce insurance carriers to pay for the pricey drug,” according to their attorney. Amgen promptly responded that the suits were without merit, and then handed out blister packets of popular drugs, branded desk calendars, and free t-shirts, so everything’s cool.
It’s okay for drug companies to spend oodles on advertising because they spend even more making sure their drugs are safe and effective, right? Not so much, according to a study in PLOS Medicine.
Bayer is recalling certain diabetes test strips because they tend to over-report blood glucose level readings by 5 to 17 percent. Affected lots begin with WK7 and then either a D, E, F or G. All other lot numbers are fine and can be used. More information.
The FDA said today that a small number of preventable cases of accidental death have occurred since their first Duragesic warning in 2005, prompting them to ask Johnson & Johnson and the makers of a generic version to add new warnings. “Despite a July 2005 warning, the Food and Drug Administration ‘has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or patients have incorrectly used it,’ the agency said.”
This week, an FDA advisory panel will review a recommendation to put a warning on flu drugs Tamiflu and Relenza that says there have been “psychiatric events observed in some patients.” The companies who make the drugs have both responded that they’ve found no causal link between their drugs and “psychiatric events.”
A new study from the University of California at San Diego School of Medicine suggests that simvastatin, also known as the cholesterol-lowering drug Zocor, may interfere with sleep patterns: “people who took the statin drug Zocor or simvastatin found they had significantly worse sleep quality compared with people who took Pravachol or pravastatin, another cholesterol-lowering drug.” Simvastatin is fat soluble, which means it can more easily penetrate cell membranes and mess with brain chemistry.
The Reuters headline is so perfect, we can’t improve upon it. Hide your old pills in poop, folks, before you discard them, especially ones that are frequently abused like the painkillers oxycodone, morphine, and fentanyl, and the stimulant methylphenidate.
The health blog at the New York Times points out that there are all sorts of behavioral changes you can adopt to fight insomnia that have been proven to work—they just sound so ordinary and common that people either don’t think they’re effective or assume pills will work better.
The Chinese government has discovered a fake diabetes medicine on a fake research institute website, which then links to a fake version of the official government health and drug watchdog agency’s site. If you’re paying attention to urls, it’s hard to not notice that something’s wrong—but we’re sure there’s more than enough people who don’t notice that little detail.
Pfizer is in panic mode about its rapid decline in Lipitor sales—in the last 18 months, it has dropped from 40% of the market for cholesterol-lowering drugs to 30%, and likely to drop further—so it’s launched a big media-blitz to convince people not to switch to simvastatin, the generic version of its name-brand competitor, Zocor. Zocor was more expensive than Lipitor, so Pfizer had nothing to worry about for years—but then Zocor lost its patent protection last year, and now doctors are switching patients from Lipitor over to Zocor’s generic twin to save money.
Stop doing that or you’ll go deaf! That’s the new warning (sort of) the FDA will require on popular anti-impotence drugs, spurred after a published report of a man who suffered sudden hearing loss after taking Viagra. The FDA took a look at side effect data and found 29 cases since 1996 where men suffered from similar hearing loss after taking one of the three drugs. “In two thirds of the cases, the hearing loss was ongoing, the agency said.” A drug to treat pulmonary hypertension, Revatio, will also receive the warning because it contains the same ingredient as Viagra.
Too many patients don’t remember the names of the medications they’re on, posing problems for doctors who are trying to treat them, warn researchers at Northwestern University’s Feinberg School of Medicine in Chicago. About 40% of the patients surveyed “could not accurately recall what drugs they were taking,” and among those with “low health literacy,” the rate jumped to 60%.
Zyprexa, Lilly’s best-selling drug to treat schizophrenia, has been shown to cause “cause weight gain, high blood sugar, high cholesterol and other metabolic problems,” but until now, the company has refused to add any warnings about these side effects to the label. Now, sparked in part by lower sales, Lilly has announced that Zyprexa will warn consumers that it can cause high blood sugar. The American Diabetes Association claims that Zyprexa causes diabetes, but this isn’t addressed on the new warning labels.
Next Month, the FDA will hold a public meeting to discuss whether or not they should allow certain drugs to be sold “behind-the-counter”—that is, after consultation with a pharmacist, but without the need for a prescription. If they move ahead with the plan, a new BTC category will be created, although what drugs will fall under it have not been determined.
The FDA’s own parent department, the Department of Health and Human Services, just issued a report that says the FDA “does very little to ensure the safety of the millions of people who participate in clinical trials,” according to the New York Times. The FDA has 200 inspectors, some of whom are part-time, to monitor 350,000 testing sites—and even when they reported “serious problems,” their findings were downgraded 68% of the time by higher-ups in Washington.
Starting today at 10 a.m., the powerful Chairman of the House Energy and Commerce Committee, John Dingell (D-MI), will hold a hearing on H.R. 3610, The Food and Drug Import Safety Act of 2007, or, as we have dubbed the bill, The Poison-Free Food Act. The bill would dramatically alter the FDA’s handling of imported foods, empowering the agency to:
- Issue mandatory recalls;
- Limit food imports to ports clustered near FDA inspection labs;
- Require a country of origin labels for food, drugs and medical devices;
- Subject exporters to a strict certification program administered by the Department of Health and Human Services.
The Committee will hear from two panels: The first will see FDA Commissioners and regulators defending their agency, while the second will host a panoply of foodies, including the Coalition for a Stronger FDA, the Center for Science in the Public Interest, the Grocery Manufacturers Association, and Big Pharma.
A new antifungal drug, voriconazole, causes patients to “develop a range of neurological side effects, including auditory and visual hallucinations,” within 24 hours to 2 weeks of beginning treatment. The drug is marketed as Vfend, and is administered intraveneously to treat serious fungal infections. The National Institute of Health has been testing the toxicity of the drug and reported the neurological side effects at a recent conference.