Three weight-loss drugs are seeking FDA approval. Qnexa cut body weight 13 to 15 percent but carries a small increased risk of heart palpitations and memory problems, and had the highest trial drop-out rate; Arena's lorcaserin had fewer side effects but only met the 5 percent minimum.
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Drug
Prescription drugs, vaccines and their risks and benefits.
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Drug
Is Pfizer the BP of Drug Companies?
A catalogue of Pfizer's troubles in a single June week: pulling the leukemia drug Mylotarg, suspending pediatric Geodon and tanezumab trials, a House inquiry into Rapamune marketing, a pain researcher imprisoned for fraud, and the Supreme Court letting Nigerian Trovan suits proceed.
Drug
FDA Issues Requirements for Baxter Healthcare Infusion Pump Recall
The FDA required Baxter Healthcare to carry out its April 2010 recall of all Colleague Volumetric Infusion Pumps, as many as 200,000 in use, and to give customers a refund, replacement pump or lease termination, plus a transition guide listing cleared alternatives.
Drug
Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury
FDA is adding severe liver injury to the boxed warning for leflunomide, used for rheumatoid arthritis, after reviewing 49 cases of severe liver injury, including 14 fatal liver failures, between August 2002 and May 2009. Patients with liver disease or elevated ALT should not take it.
Drug
Marijuana Imposter: "People who use it are idiots"
Synthetic cannabinoid blends sold as Spice, K2 and roughly 100 other names are legal in more than 40 states with no age limits. Clemson chemist John Huffman, whose lab created the compounds, says they have never been tested in humans; reported effects include hallucinations and memory loss.
Drug
Tylenol Recall 2010
Johnson & Johnson's McNeil unit recalled 21 lots of Benadryl, Tylenol and Motrin, about 500,000 bottles, after consumers reported a moldy, musty odor traced to 2,4,6-tribromoanisole in packaging materials. Early reports said the smell sickened at least 70 people; J&J calls the side effect remote.
Drug
Tylenol recall 2010 lot numbers
Johnson & Johnson's McNeil unit recalled 21 lots of Benadryl, Tylenol and Motrin on July 8, about 500,000 bottles per Reuters, after reports of a moldy, musty odor traced to trace 2,4,6-tribromoanisole in packaging. The full list of lot numbers follows.
Drug
FDA may not ban Avandia
FDA advisers meet July 13 and 14 to decide whether Avandia stays on the market. Agency reviewers disagree over the RECORD trial, with one calling it inadequately designed and saying the drug raises heart attack risk; cardiologist Steven Nissen will argue for withdrawal.
Drug
Could Diabetes drug Avandia escape this time?
Two FDA advisory committees met July 13 and 14 to weigh whether Avandia stays on the market. A Harvard meta-analysis of 42 studies covering 28,361 patients found death rates 15 percent higher and heart failure 13 percent higher than with Actos.
Drug
Why is Drug Company with 50 Years of Proven Safety Violations Using Taxpayer Money to Make Next Gen Flu Vaccine?
Mercola questions the government's decision to commission Baxter for a new flu vaccine, citing the May 2010 Hylenex recall over flake-like particles, a Class I recall of Baxter's Colleague infusion pumps, and a $144 million jury verdict over a hepatitis C infection.
Drug
Cancer Drug Kills Four Times More than No Treatment at All
Pfizer withdrew the leukemia drug Mylotarg at the FDA's request after a trial showed a 5.7 percent early death rate versus 1.4 percent without it, and no benefit. The company also suspended trials of tanezumab, an experimental osteoarthritis pain drug, after patients worsened.
Drug
Prostate cancer screening not reliable
Richard Ablin, who developed the PSA test, says it should not screen men without known risk factors: it cannot tell aggressive cancer from benign, and he calls the roughly $3 billion it costs the US each year a public health disaster.
Drug
Testosterone therapy raises heart risk
Researchers halted a six-month trial of testosterone gel in 209 elderly men with poor mobility after 23 in the treatment group suffered heart, breathing and skin problems, against five on placebo. Strength and mobility improved, but the risks ended the study early.
Drug
Blood test may predict timing of menopause
Researchers built a model that predicts when menopause will arrive from a single blood test for anti-Mullerian hormone, using samples from 266 women aged 20 to 49. Average error was under four months and the maximum three to four years; larger studies are needed to confirm it.
Drug
National HIV Testing Day --- June 27, 2010
CDC estimates that in 2006 about 21 percent of Americans living with HIV, some 232,700 people, did not know it. The share of adults aged 18-64 ever tested rose from 40.4 percent in 2006 to 44.6 percent in January-September 2009, suggesting more people are learning their status earlier.
Drug
Tetanus: Make Sure You and Your Child Are Fully Immunized
Tetanus bacteria live in soil, dust and manure and enter through cuts and puncture wounds, producing a toxin that causes painful muscle contractions and can lock the jaw. The disease does not spread person to person. The Tdap booster is recommended for all 11- to 18-year-olds.
Drug
Having Surgery? What You Should Know Before You Go
Most surgery patients avoid infection, but CDC counts surgical site infections as the second most reported healthcare-associated infection, at 17% of infections among U.S. hospital patients. Patients can cut the odds: disclose other conditions, quit smoking, and never shave near the surgical site.
Drug
Pfizer withdraws leukemia drug
At the FDA's request, Pfizer is pulling the leukemia drug Mylotarg after a trial found acute myeloid leukemia patients taking it were more likely to die, 5.7 percent versus 1.4 percent in a couple of months, with no benefit added to chemotherapy.
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