Drug Safety

My husband has high cholesterol. His doctor put him on Lipitor. After the dosage was increased, I noticed he wasn't as enthusiastic about our previously very active sex life. He said he wasn't feeling aroused and his usual morning erections weren't occurring. He asked his doctor if the Lipitor might be responsible, and the doc said to stop it for a month and see what happened. Our sex life is back to normal. He takes niacin, eats oatmeal and exercises, but is unwilling to have his cholesterol checked.

SACRAMENTO - Two of the nation's largest biotech companies - Amgen Inc. of Thousand Oaks and Genentech Inc. of South San Francisco - are fighting in Sacramento to keep a tight grip on some of their most lucrative drugs. At stake is a potential market worth tens of billions of dollars for pricey biological medicines they make from human blood, serums, bacterial cultures, viruses and other microorganisms. They are used to treat cancers, immune disorders and many other complex diseases.

The Food and Drug Administration took a highly unusual step this week: It acknowledged that a widely used generic drug -- a copycat of the antidepressant Wellbutrin XL -- was not the equivalent of the original drug produced by GlaxoSmithKline since 2003. The move prompted the world's largest manufacturer of generic drugs, Israel-based Teva Pharmaceuticals, to stop shipping its generic extended-release bupropion -- marketed as Budeprion 300 mg XL-- and to remove it from U.S. shelves.

I Ioften use sleeping pills containing zolpidem (Ambien is the predominant brand-name version) to help reset my biological clock when I travel across time zones, or if I just have trouble getting to sleep. And I'm not alone. Doctors wrote about 40 million prescriptions for it in 2012. Although this drug has been around and used extensively for two decades, it was not until January that the U.S. Food and Drug Administration got around to recommending that women should receive a lower dose of zolpidem than men - 5 milligrams instead of the standard 10. The reason is that as long as eight hours after taking it, women may have unacceptably high blood levels of zolpidem that can impair driving and other activities that require alertness (three to five times more frequently than men)

SACRAMENTO - Two of the nation's largest biotech companies - Amgen Inc. of Thousand Oaks and Genentech Inc. of South San Francisco - are fighting in Sacramento to keep a tight grip on some of their most lucrative drugs. At stake is a potential market worth tens of billions of dollars for pricey biological medicines they make from human blood, serums, bacterial cultures, viruses and other microorganisms. They are used to treat cancers, immune disorders and many other complex diseases.

The Senate's passage of a drug-safety bill (May 10) expanding the authority of the Food and Drug Administration will benefit the public. Before passage, an unsuccessful effort for a provision allowing consumers to buy drugs from foreign sources produced contentious debate. Why? Such a provision would undermine the original intent of the bill: drug safety. When will politicians in Washington understand that foreign sources are not regulated by the FDA? Inspections of drug purchases made abroad have revealed dangerous bogus copies that place our prescription-drug supply chain in jeopardy.

Your Feb. 19 editorial, "In the Dark About Drugs," was too tepid. As an internist with many senior patients, I find it troubling that the Food and Drug Administration has agreed to allow the sale of certain Cox-2 inhibitors that have been shown to almost double the likelihood of a heart attack or a stroke in high-risk individuals. Placebo effects are very powerful. I realize that it is part of our retail culture to believe that, if a pill costs $3, it must relieve pain better than an over-the-counter pill that costs 30 cents.

"Clinton Sells Out on Drug Safety" (by Henry Miller, Commentary, June 25) provides a wildly false and inflammatory picture of a recent package of "Mutual Recognition Agreements" negotiated between the European Union and the United States. This package of agreements does represent a new way of doing business that is good for manufacturers, strengthens cooperation between U.S. and EU regulatory agencies and is fundamentally good for consumers on both sides of the Atlantic. Under this series of agreements, the U.S. will continue to exercise and enforce the highest standards of health and safety in the world.

The Food and Drug Administration on Monday endorsed an idea that experts said could greatly improve the nation's drug safety system: using information from the forthcoming Medicare prescription benefit to spot problems with new medications. The "FDA strongly supports the use of data from Medicare ... to identify safety risks for recently approved medications and to learn more about the real-world outcomes of medication use," Dr.

The Food and Drug Administration needs an independent office that would monitor the safety of drugs it approves and warn the public of emerging risks, a senior Senate Republican said Thursday. Senate Finance Committee Chairman Charles E. Grassley (R-Iowa) said he was drafting legislation to create such an office and give it authority to restrict the use of medications that develop safety problems.

Almost a quarter of prescription medications approved for patients in Canada over a 16-year period went on to be pulled from the market or to require a strongly worded safety warning to patients, a new study says. In a " Research Letter " published online in the Archives of Internal Medicine, University of Toronto researcher Dr. Joel Lexchin looked at the 434 drug approvals that moved through Health Canada's drug-safety arm from the start of 1995 to the end of 2010. Canada's drug safety agency operates much like the U.S. Food and Drug Administration, so the study may reflect the state of drug safety in the United States as well.

The Food and Drug Administration took a highly unusual step this week: It acknowledged that a widely used generic drug -- a copycat of the antidepressant Wellbutrin XL -- was not the equivalent of the original drug produced by GlaxoSmithKline since 2003. The move prompted the world's largest manufacturer of generic drugs, Israel-based Teva Pharmaceuticals, to stop shipping its generic extended-release bupropion -- marketed as Budeprion 300 mg XL-- and to remove it from U.S. shelves.

The congressional legislators who oversee the Food and Drug Administration and control the nation's coffers have shown again that they neither understand drug development nor the regulatory problems that plague it. In February, Sen. Barbara A. Mikulski(D-Md.) unveiled a bipartisan bill intended to spur innovation in research and drug development for chronic, costly health conditions such as Alzheimer's disease, cancer, diabetes and heart disease. According to the press release, the bill will invest "in public-private partnerships to ensure scientists and researchers are able to develop new safe and effective drugs," shrink product development timelines, increase the number of drugs in the development pipeline and expedite the FDA review process.

A new proposal to toughen the Food and Drug Administration's power to regulate dietary supplements has the makers of vitamins, minerals and botanical extracts up in arms. But an editorial in the New England Journal of Medicine says the drug-safety agency's proposed new powers do not go nearly far enough. To expand its current $28-billion-a-year market, the dietary supplements industry is widely devising and selling formulations that use "novel" products -- minerals, plants, or amino acids that appear newly promising, which have not circulated widely in the United States before, or which are offered in "mega-doses" much higher than have been customarily used in supplements.

Abbott Laboratories said Friday that it would withdraw the diet drug Meridia at the request of the U.S. Food and Drug Administration, less than a month after it failed to win over one of the federal agency's safety advisory panels. The FDA confirmed the Chicago drug giant's decision, saying Abbott withdrew the drug because of "clinical trial data indicating an increased risk of heart attack and stroke. " The withdrawal of Meridia, also known by its scientific name sibutramine, leaves just one U.S.-approved diet drug on the market: the prescription Xenical.

Expanding access to low-cost prescription drugs from overseas might look like a sure winner in the effort to make healthcare more affordable. President Obama supports the idea, as do many Democrats and several Republicans. But the seemingly popular proposal brought the Senate healthcare debate to a standstill Thursday, as Democrats divided over whether they should bow to the drug industry's fierce opposition. Majority Leader Harry Reid (D-Nev.) temporarily halted consideration of the healthcare bill after three days of inconclusive debate on an amendment by Sens.

The heightened anger and fear felt by average Chinese over the safety of food ingredients, medicine and other consumer products were vividly on display here Tuesday after the execution of the former head of China's food and drug safety agency. Within hours of an announcement that Zheng Xiaoyu, 62, had been put to death for taking bribes from pharmaceutical companies, China's Internet lighted up. "Good job!" said an anonymous posting on Sina.com, a major Chinese Web portal.

The Food and Drug Administration pledged Tuesday to make major changes in the nation's drug safety system, responding to a blue-ribbon panel that last fall found the agency's priorities skewed toward approving new medications without adequate follow-up to identify rare but risky side effects. FDA Commissioner Andrew C.

My husband has high cholesterol. His doctor put him on Lipitor. After the dosage was increased, I noticed he wasn't as enthusiastic about our previously very active sex life. He said he wasn't feeling aroused and his usual morning erections weren't occurring. He asked his doctor if the Lipitor might be responsible, and the doc said to stop it for a month and see what happened. Our sex life is back to normal. He takes niacin, eats oatmeal and exercises, but is unwilling to have his cholesterol checked.

If the U.S. Supreme Court were in the business of compensating victims of medical error because of the poignancy of their plight, Diana Levine wouldn't be in suspense about whether the justices would rule in her favor. Levine, a guitarist and pianist from Vermont, developed gangrene after an anti-nausea drug was injected -- and hit an artery instead of a vein. Her arm had to be amputated, and Levine wants the court to uphold a verdict ordering the manufacturer of the drug to pay her $6.