Tysabri PML Risk Increases With Use, FDA Says

Tysabri, a popular treatment for relapsing multiple sclerosis (MS), is more likely to cause a serious brain infection called progressive multifocal leukoencephalopathy, or PML, the longer it is used, according to the U.S. Food & Drug Administration (FDA). The agency announced Friday that the Tysabri label would be updated to include such a warning.

Tysabri is seen as one of the most effective MS treatments on the market, especially for those with severe cases who have few other options. Unfortunately, it also poses serious risks because of its association with PML. More Tysabri PML Risk Increases With Use, FDA Says

Mothers Use of Acetaminophen May Raise Child’s Asthma Risk

Another report has surfaced linking children exposed to acetaminophen and asthma. In the recent research, Science Daily said the exposure was seen prenatally; asthma symptoms were likely to be seen by the time the children reached age five.

Recently we wrote that acetaminophen, the active ingredient in Tylenol, was linked to increased asthma risks in adults and children. In that study, said Reuters Health previously, the analysis involved 19 studies and was detailed in the journal CHEST. More Mothers Use of Acetaminophen May Raise Child’s Asthma Risk

Some Herbal Remedies Risky for People on Heart Meds

Some popular herbal remedies can cause harm to some people taking cardiac medications. According to CNN, citing an emerging study, those on heart medications might want to reconsider taking herbal supplements such as ginseng, saw palmetto, and Echinacea, which can interact with cardiac drugs.

“These products are not by themselves dangerous,” said lead author, Dr. Arshad Jahangir, a cardiologist and professor of medicine at the Mayo Clinic, quoted CNN. “But when taken with medications for cardiovascular diseases, a relatively safe compound can become dangerous,” added Dr. Jahangir. More Some Herbal Remedies Risky for People on Heart Meds

Doctor Warned Over Dysport Endorsement

Justice News Flash just reported that the U.S. Food and Drug Administration (FDA) sent a warning letter to Dr. Leslie Baumann, a dermatologist and clinical researcher located in Miami Beach, Florida, for promoting a medication before it received agency approval.

The agency is strengthening its efforts to stop doctors from promoting unapproved
medications and cosmetic services, said Justice News Flash. This warning letter is just one such example. More Doctor Warned Over Dysport Endorsement

Hydroxycut Under investigation in Australia

Popular weight loss supplement, Hydroxycut, is making headlines, this time, in Australia. According to the Sydney Morning Herald the Therapeutic Goods Administration (TGA) has been asked to review Hydroxycut following an illness in that country. One death has been reported related to the supplement in the United States.

A 23-year-old man fell ill and was treated in a hospital in Sydney for an inflamed liver after taking the controversial dietary supplement, said the Sydney Morning Herald. According to the man’s physicians, he was the “first reported Australian case of acute hepatotoxicity associated with the weight-loss product Hydroxycut Hardcore,” quoted the Sydney Morning Herald. “… We advise medical practitioners and consumers in this country to be wary of the product and call on the TGA to re-examine its continued availability,” wrote doctors N. Nudrat Rashid, of the Royal Prince Alfred Hospital, and Jason Grant of Ryde Hospital, according to the paper. More Hydroxycut Under investigation in Australia

Childhood Vaccine Linked to Increase in Lung Infection

A serious lung infection called pneumococcal empyema has been on the rise in children since the PCV7 vaccination was introduced in 2000, according to researchers at the University of California, Davis, Children’s Hospital. The study appears in the January issue of Pediatrics.

The PCV7 vaccine prevents the development of pneumococcal disease. According to The New York Times, prior to its introduction, pneumococcal disease caused more than 700 cases of meningitis in children, 13,000 blood infections, about 5 million ear infections and 200 deaths in the U.S. each year. Use of the PCV7 vaccine has been credited with reducing the number of children hospitalized for pneumonia because of pneumococcus by 50 percent and bacterial pneumonias have decreased overall. More Childhood Vaccine Linked to Increase in Lung Infection

FDA Says Videx Has Liver Risks

The U.S. Food and Drug Administration (FDA) just issued a safety announcement alerting healthcare professionals and patients about a rare, but serious liver complication known as non-cirrhotic portal hypertension occurring in some patients using Videx or Videx EC (didanosine). Didanosine is an antiretroviral medication used to treat the Human Immunodeficiency Virus (HIV) infection. Videx was the first approved didanosine medication; Videx EC is a delayed-release version of Videx. Bristol-Myers Squibb markets both.

Didanosine is a prescription medication in the nucleoside analogues class of medications used with other drugs to treat patients infected with HIV, the virus that causes AIDS, and works by reducing the growth of HIV. Didanosine helps the body maintain its supply of immune cells called CD4 cells, which are critical for fighting HIV and other infections. More FDA Says Videx Has Liver Risks

Novartis Settles Trileptal Marketing Allegations

Novartis AG, a Swiss pharmaceutical giant, announced that its offices in the United States have reached a plea agreement with federal investigators, reported the Wall Street Journal. Allegations include criminal charges concerning how Novartis marketed its epilepsy drug Trileptal, added the Journal. Novartis will pay a $185 million fine, according to the agreement.

Both civil and criminal investigations have been conducted over how Novartis promoted Trileptal and its marketing of the drug for uses not approved by the U.S. Food and Drug Administration (FDA), said the Journal. Such off-label marketing is illegal. “Payments made to health-care providers in connection with this medicine,” were also reviewed, Novartis said, quoted the Journal. Novartis previously revealed an investigation was underway, said the Journal, which noted that the probe is being conducted by the U.S. Attorney’s Office for the Eastern District of Pennsylvania. More Novartis Settles Trileptal Marketing Allegations

Paxil, Other SSRIs Linked to Nursing Difficulties

We have long been writing about the link between adverse health effects and SSRIs during pregnancy. As a matter-of-fact, we wrote very recently that, according to Reuters Health, expectant mothers taking certain antidepressant or anti anxiety medications could experience increased risks for premature births and other birth complications, citing a new study published in the American Journal of Obstetrics & Gynecology. Now, CBC News writes that mothers who have recently given birth and who are taking selective serotonin reuptake inhibitors (SSRIs)—a popular class of antidepressants—may experience breast-feeding difficulties.

SSRIs such as Prozac and Paxil seem to be connected to delays in full milk secretion and lactation onset, said CBS News, referring to a study published in the February issue of the Journal of Clinical Endocrinology & Metabolism. Apparently, the production and regulation of the hormone serotonin is very closely linked to how the breasts secrete milk and initiating that process at the appropriate time, noted Nelson Horseman of the University of Cincinnati and a co-author of the study, said CBC News. More Paxil, Other SSRIs Linked to Nursing Difficulties

Lawsuit Alleges Botox Overdose Caused Little Girl’s Death

A Botox overdose is being blamed for the death of a 7-year-old girl in California. The girl died in November 2007 of respiratory failure and pneumonia, after receiving Botox injections to treat cerebral palsy. Her mother has since filed a lawsuit against Allergan, the maker of Botox.

Last April, the U.S. Food & Drug Administration (FDA) mandated a black box label for Botox and similar products that warned of the risk of adverse events when the effects of a botulinum toxin injection spreads beyond the site where it was injected. The label revision followed an FDA safety review prompted by reports of adverse reactions that resembled botulism infections in patients receiving the injections. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. More Lawsuit Alleges Botox Overdose Caused Little Girl’s Death

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