The Food and Drug Administration announced on Tuesday the changes to the safety information on the labels of statins such as Pfizer Inc’s Lipitor, AstraZeneca’s Crestor and Merck & Co’s Zocor that are taken by tens of millions of people. Statins have been shown to significantly reduce the risk of heart attack and heart disease, and the FDA said the new information should not scare people into stopping taking the drugs.

“The value of statins in preventing heart disease has been clearly established,” Amy Egan, deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products, said in a statement. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.”

Lipitor, which became available late last year in generic form as atorvastatin, is the world’s all-time biggest selling prescription medicine with cumulative sales in excess of $130 billion. As a class, statins have helped enrich the world’s largest drugmakers, but most of the major brands are now prescribed as far cheaper generic medicines.

Last year, more than 20 million Americans were taking some form of statin, according to IMS Health.

“These are nuances, tiny little tweaks to the label, and the bigger picture doesn’t change,” said Steven Nissen, chief of cardiology at Cleveland Clinic. “There are few drugs that have saved as many lives as statins and we don’t want to throw the baby out with the bathwater here.

“If you have heart disease, you probably should be on a statin. If you’re at high risk, a statin may be warranted. But we don’t think these drugs should be put in the water supply,” Nissen said. Asked what prompted the label changes, FDA spokeswoman Erica Jefferson said they were based on the agency’s review of medical literature, clinical trial data and reports of adverse events.

“I wouldn’t point to any one thing,” she said. “We’ve been looking at all the information for some time. It’s part of our ongoing surveillance.” The FDA said it was aware of studies in which some patients taking statins may have a small increased risk of higher blood sugar levels and of being diagnosed with type 2 diabetes. The statin labels will also now reflect reports of certain cognitive effects such as memory loss and confusion experienced by some patients taking the drugs, the agency said. It said those reports generally have not been serious and the symptoms were reversed by stopping use of the statin.

“We have known for three or four years that statins slightly increase blood sugar,” Nissen said. “The fact that the blood sugar went up a little bit did not diminish the effectiveness of the statins in reducing (heart) risk for patients.” The elevated diabetes risk cropped up in a 2008 Crestor study of nearly 18,000 patients. A separate study published in the Lancet medical journal in 2010 found that statins can raise the risk of diabetes by 9 percent.

The memory loss issue was more anecdotal from adverse event reporting and not from formal studies, the FDA said, adding that there was no proof that the problem was caused by statins but that it wanted people to be aware of the possibility. One safety warning long associated with the class of medicines will be reversed, the FDA said. Patients taking statins will no longer need periodic monitoring of liver enzymes, since cases of serious liver injury are rare and unpredictable in individual patients.

Other statins, most of which are available as generics, include Livalo, Mevacor, Pravachol, Altoprev and Lescol. There are also combination medicines that include statins, such as Merck’s Vytorin and Abbott Laboratories’ Simcor. Jon LeCroy, an analyst who follows the pharmaceutical industry for MKM Partners, said he did not believe the label changes would have a lasting impact on statin use.

“The overwhelming evidence on statins is they save lives, so I can’t imagine this would reduce anyone prescribing them,” LeCroy said. “There are some buzzwords that tend to scare the lay public. This is not a cancer warning,” he said.

The FDA also specifically said that Merck’s Mevacor, the world’s first approved statin, known generically as lovastatin, should never be taken with certain drugs used to treat HIV and certain bacterial and fungal infections due to increased risk of a serious muscle disease. “I don’t think we should change our practice based on this report,” said Dr. Kenneth Ong, acting chief of cardiology at the Brooklyn Hospital Center in New York. “But the report is a sobering reminder there’s no such thing as a free lunch,” Ong said. “Every drug has its problems and its side effects, despite the benefits.”

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Keen to find whether a non-invasive alternative could be used, researchers tested frequency magnetic resonance imaging (fMRI) and computed tomography (CT) scanners in 182 adult deaths where the corpse was afterwards given an autopsy. Autopsy was not needed in a third of cases that had been imaged by fMRI and in half of the cases imaged by CT, according to the study.

However, the scanners were not perfect. They failed to spot, or misattributed, more than two dozen cases of heart disease as well as several dozen cases of embolism, pneumonia and intra-abdominal lesions. Screening by scanners could identify some of the major causes of death and thus make some autopsies unnecessary, the paper suggests.

It could also identify suspect lesions that would enable pathologists to carry out only a minimal dissection to pinpoint the cause of death. “When radiologists are confident that the cause of death on imaging is definite, the discrepancy rate between the radiological and autopsy diagnoses is lower and might be acceptable from a medico-legal point of view,” says the study, headed by Ian Roberts, a professor of pathology at the John Radcliffe Hospital in Oxford.

But several practical hurdles must be overcome before any screening becomes routine. Scanners — diagnostic tools that get cross-sectional or 3-D images of internal organs — are very expensive and require specialist training to operate them and interpret their results.

“Autopsy is regarded as the gold standard for diagnosis,” said James Underwood of the University of Sheffield in a commentary. “Post-mortem imaging cannot yet be regarded as a universal substitute for autopsy; it is one of several methods available for determining the cause of death.”

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Most of the cases have been reported in Lahore, the provincial capital, where about 2,950 people tested positive.”So far, eight people have died of dengue. We are trying our best to control this epidemic,” Jehanzeb Khan, secretary of the provincial health department, told Reuters.

Health experts say the illness is spreading across the Punjab because of poor hygiene conditions, and heavy monsoon rain provides ideal conditions for dengue-carrying mosquitoes to thrive in stagnant waters. The first case of dengue was reported in Pakistan in 1994.

Those who died included Ataullah Siddiqui, head of the provincial department of minerals and natural resources. Khan said the government had launched a fumigation drive to kill mosquitoes.

Sri Lanka is sending a team of experts to Pakistan to help fight the disease, the Sri Lankan High Commission said in a statement. Pakistan’s weak civilian government, struggling to deal with floods that have killed 266 people, has been criticized by the media for dragging its feet on the dengue issue. “The response to dengue has been adhoc, ex post, and therefore reactionary at best,” The News daily said in its editorial.

The disease is a threat to nearly half of the world’s population. Of the estimated 220 million people infected each year, two million — mostly children in Latin America and Asia — develop a severe form called dengue hemorrhagic fever. There is currently no cure or vaccine for dengue fever.

“Improving nutritional status, preventing obesity, and stressing the importance of weight loss might improve asthma control and exacerbation risk in children and decrease the incidence of asthma in adults,” researchers write in the Journal of Allergy and Clinical Immunology. Both asthma and obesity rates have soared among kids in recent decades, reaching nearly 10 percent and 17 percent today, respectively.

While some studies have hinted at a link between the two conditions, conclusions on whether heavier kids also have more severe asthma than others have been mixed.

Dr. Kenneth B. Quinto from the University of California, San Diego, and colleagues looked back at more than 32,000 kids who’d been diagnosed with asthma and were enrolled in a Kaiser Permanente health plan. Nearly half of the children were overweight or obese.

The researchers found that the heavier kids were more likely to have more than a handful of yearly prescriptions for rescue inhalers, which contain short-acting drugs such as albuterol that open up the airways when an asthma attack is coming on.

On average, normal-weight children used 2.8 rescue inhalers a year, whereas obese kids used 3.1.

The heavy youngsters also used more inhaled steroids, such as Pulmicort or Flovent, which are a mainstay treatment to keep airway inflammation under control on a daily basis in asthmatics.

And the results held up after Quinto and his colleagues accounted for alternative explanations of the differences, such as sex, race, diabetes and parents’ education levels.

The team speculates that the extra pounds might be weighing on the lungs, making obese kids feel like they need more medication. Scientists have also found that overweight people don’t respond as well as others to steroids, which might help explain the new findings.

Still, in an observational study like theirs, the researchers warn it’s never possible to be certain what causes what. So whether bigger waistlines should be blamed for the extra flare-ups remains an open question.

Meanwhile, the team writes, “The best time for prevention of obesity and nonsurgical weight reduction likely occurs in childhood.”

Instead, the review comes at the request of the government’s Vaccine Injury Compensation Program, which as the name implies, pays damages to people who are injured by vaccines. Federal law requires this type of independent review as officials update side effects on that list to be sure they agree with the latest science.

“Vaccines are important tools in preventing serious infectious disease across the lifespan, from infancy through adulthood. All health care interventions, however, carry the possibility of risk and vaccines are no exception,” said pediatrician and bioethicist Dr. Ellen Wright Clayton of Vanderbilt University, who chaired the institute panel.

Still, the report stresses that vaccines generally are safe, and it may help doctors address worries from a small but vocal anti-vaccine movement. Some vaccine-preventable diseases, including measles, are on the rise.

“I am hopeful that it will allay some people’s concerns,” Clayton said. The review echoed numerous other scientific reports that dismiss an autism link.
But it found convincing evidence of 14 side effects:

—Fever-triggered seizures, which seldom cause long-term consequences, from the measles-mumps-rubella, or MMR, vaccine.

—MMR also can cause a rare form of brain inflammation in some people with immune problems.

—The varicella vaccine against chickenpox sometimes triggers that viral infection, resulting in widespread chickenpox or a painful relative called shingles. It also occasionally can lead to pneumonia, hepatitis or meningitis.

—Six vaccines — MMR and the chickenpox, hepatitis B, meningococcal and tetanus-containing vaccines — can cause severe allergic reactions known as anaphylaxis.

—Vaccines in general sometimes trigger fainting or a type of shoulder inflammation.

There’s suggestive evidence but not proof of a few other side effects, including anaphylaxis from the human papillomavirus, or HPV, vaccine and short-term joint pain in some women and children from the MMR vaccine. On the other hand, the report cleared flu shots of blame for two long-suspected side effects: Bell’s palsy and worsening of asthma.

That doesn’t mean there aren’t other side effects — the review couldn’t find enough evidence to decide about more than 100 other possibilities. Some vaccines are just too new to link to something really rare. Another example: Flu shots have long come with a caution about rare, paralyzing Guillain-Barre syndrome, but Clayton said research hasn’t settled if that’s a coincidence since the disorder is more common during the winter. The Health Resources and Services Administration, which runs the vaccine compensation program, is reviewing the report but said it’s too early to predict if it will prompt changes to the injury list.