Serevent, Advair, Symbicort and Foradil – asthma medications known as long-acting beta agonists (LABAs) – are being subjected to new safety restrictions, the U.S. Food & Drug Administration (FDA) announced yesterday.

LABAs prevent the release of substances in the body that cause inflammation of airways in the lungs. Advair and Symbicort use a LABA with an inhaled steroid; Serevent and Foradil (marketed in the U.S. by Schering-Plough Corp.) only contain LABAs. These drugs are approved to treat both people with asthma or with chronic obstructive pulmonary disease (COPD). The new recommendations announced by the FDA only apply to the use of LABAs in the treatment of asthma. More New Restrictions on Serevent, Advair, Symbicort and Foradil

Zometa, a bisphosphonate drug made by Novartis Pharmaceutical, has been associated with a serious side effect called osteonecrosis of the jaw (ONJ) or dead jaw syndrome. Well over 500 lawsuits filed in federal courts by alleged victims of this Zometa side effect have been consolidated in two multidistrict litigations in Tennessee federal court and New Jersey state court. The first of those cases are scheduled to go to trial in March.

Bisphosphonates, sold under the brand names Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa, are commonly used in tablet form to prevent and treat osteoporosis in post-menopausal women. Stronger forms of bisphosphonate drugs are used in the management of advanced cancers that have metastasized to the bone, where the disease often causes bone pain and possibly even fractures. Several cancers can involve or metastasize to the bone, including lung cancer, breast cancer, prostate cancer, multiple myeloma, and others. When bisphosphonates are given in cancer chemotherapy, the drugs are given intravenously in higher doses and usually for longer periods of time. More First Zometa Dead Jaw Syndrome Trials Scheduled to Start in March

The U.S. Food and Drug Administration (FDA) just issued a warning to consumers about the potential for serious side effects resulting from mistakenly using Maalox Total Relief instead of other Maalox products. Both products are intended for the relief of different symptoms and contain different active ingredients.

Maalox Total Relief is an upset stomach reliever and anti-diarrheal medication; traditional Maalox liquid products—Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength—are antacids. Both Maalox Total Relief and Maalox are made by Novartis Consumer Health Inc. (NCH) and are available without a prescription as over-the-counter liquid medications.
More Maalox Mix-Ups Causing Adverse Reactions, FDA Warns

In addition to the wide array of dangerous and, in many cases, life-threatening diseases, linked to hormone replacement therapy (HRT), an emerging study has revealed a link with estrogen-only HRT and asthma, said Reuters.

According to the scientists, the risk increase is seen after menopause and the study involved nearly 58,000 women over a 12-year period, said Reuters, noting that the researchers in France and Mexico compared the women on HRT to those who were never on hormone therapy. Compared to those women who never received HRT, the women who did use HRT experienced a 21 percent increase for asthma; the risk was even more pronounced in women on estrogen-only therapy, at an increased rate of 54 percent, said Reuters. More Estrogen Risks May Boost Asthma Risk

A massive $25.16 million judgment has been awarded by a New Jersey jury to an Alabama man who filed suit against Hoffman-La Roche Inc., the pharmaceutical company that manufactures Accutane. Andrew McCarrell, 38, blamed the drug for his inflammatory bowel disorder, said the Associated Press (AP).

Accutane, which is used to treat severe acne—nodular and/or inflammatory—that cannot be cleared up by other treatments, including antibiotics, has been the subject of controversy for years. It first garnered attention in the late 1980s for causing severe birth defects. It has also been known to cause psychiatric problems, and has been linked to hundreds of cases of suicide in the U.S. More Accutane Victim Awarded Millions

“Total Body Formula” and “Total Body Mega Formula” dietary supplements were associated with a 2008 outbreak of selenium poisoning. According to a case report published in Archives of Internal Medicine, the batch of Total Body supplements responsible for the selenium poisoning contained up to 200 times the amount of selenium stated on the label.

Selenium is an antioxidant that can be beneficial in small amounts, and the recommended daily intake is set at 55 micrograms. According to The Institute of Medicine of the National Academy of Sciences, adults should not consume more than 400 micrograms of selenium daily to avoid selenium toxicity. Symptoms of selenium poisoning include nausea; vomiting; nail discoloration, brittleness, and loss; hair loss; fatigue; irritability; and foul breath odor. More “Total Body” Supplements Linked to Selenium Poisoning

Thiazolidinediones, a class of diabetes drugs which include Avandia and Actos, may put women at a higher risk of bone fractures, according to a new study. The study, which was conducted by the Center for Health Services Research at Henry Ford Hospital and published in the February issue of the Journal of Clinical Endocrinology & Metabolism, is one of the one of the largest to examine the longitudinal relationship between drugs like Actos and Avandia and fractures.

To determine the relationship between thiazolidinedione use and fracture risk in patients with type 2 diabetes, researchers conducted a retrospective study from Jan. 2, 2000 to May 31, 2007 of 19,070 Henry Ford patients. Among the study group, 9,620 were women and 9,450 were men. During the study period, 4,511 patients had at least one prescription fill for a thiazolidinedione. The researchers used electronically maintained medical claims data to identify non-traumatic bone fractures. More Avandia, Actos Up Fracture Risk for Women, Study Finds

Accutane has been associated with severe, and possibly fatal, skin reactions, including erythema multiforme [EM], Stevens-Johnson syndrome [SJS] and toxic epidermal necrolysis [TEN], according to a public health alert issued by Health Canada. The agency said the Canadian Product Monograph for Accutane will be updated to reflect this new safety information.

Accutane, which is used to treat severe acne (nodular and/or inflammatory) that cannot be cleared up by other treatments, including antibiotics, has been the subject of controversy for years. It first garnered attention in the late eighties for causing severe birth defects. It has also been known to cause psychiatric problems, and has been linked to hundreds of cases of suicide in the U.S. Accutane has also been associated with inflammatory bowel disease, problems of the liver, kidneys, central nervous system, and pancreas, as well as the cardiovascular, musculoskeletal and auto-immune systems. More Serious Skin Reactions Reported in Accutane Patients

A new study of Hydroxycut has found a strong connection between the dietary supplements and liver damage. Hydroxycut supplements were recalled last year, after the U.S. Food & Drug Administration (FDA) received 23 reports of liver damage in users of the products.

The new Hydroxycut study, published in the American Journal of Gastroenterology, involved the analysis of 17 cases of liver damage among Hydroxycut users that had not yet appeared in the medical literature. Nine of the cases had been reported to the FDA, while eight were seen by the authors of the study. Researchers from University of Southern California, Los Angeles investigated the patients’ medical histories and ruled out other causes of liver damage, like viral hepatitis or liver inflammation caused by an abnormal immune system reaction. More Hydroxycut Study Finds Association with Liver Damage

Toxic metals are being found in a wide array of herbal medicines and potentially lethal doses, the Australian reports. According to the Australian, calling herbal and natural products “low-risk,” is far from accurate.
It seems that less expensive herbs with reduced efficacy are routinely swapped for items listed on product labels; in some cases, medicines are, said the Australian, “secretly adulterated with conventional prescription or over-the-counter drugs” to increase efficacy.
Australian expert, Professor Roger Byard, a forensic pathologist at the University of Adelaide, said his review linking hazards to herbal medications was shocking, said the Australian. A prior review of 251 herbal products sold in the United States discovered arsenic in 36 products, mercury in 35, and lead in 24m said the Australian, citing Byard.

We have long written about the dangers from lead poisoning and have also long stressed that, once poisoned by lead, no organ system is immune, particularly the developing brain because negative influences can have long-lasting effects and can continue well into puberty and beyond. Most recently, we wrote that a study revealed that childhood exposure to lead can lead to permanent brain damage. In children and fetuses, lead exposure can cause brain and nervous system damage, behavioral and learning problems, slowed growth, hearing problems, headaches, mental and physical retardation, and behavioral and other health problems. Lead is known to cause cancer and reproductive harm and, in adults, can damage the nervous system. Experts agree that there is no safe level of lead. More Herbal Medications Hold Dangers, Pathologist Warn