Toxic Injury

August 24, 2009

FDA: Safety Review of Weight Loss Drugs Orlistat, Xenical and Alli

The U.S. Food and Drug Administration announced today that it is reviewing adverse event reports of liver injury in patients taking the weight loss drug orlistat, marketed as the prescription drug Xenical and the over-the-counter medication Alli.

Between 1999 and 2008, the FDA received 32 reports of serious liver injury in patients taking orlistat. Of those cases, 27 reported hospitalization and six resulted in liver failure. Thirty of the adverse events occurred outside the United States. The most commonly reported adverse events included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.

The FDA is reviewing additional data submitted by orlistat manufacturers on suspected cases of liver injury, and the issue has been discussed at the FDA’s Center for Drug Evaluation and Research Drug Safety Oversight Board.

“The issues here are complex, but FDA has benefited from the input of the Board, including comments from representatives from three FDA Centers and several other Agencies in the Department of Health and Human Services,” said Steven Osborne, M.D., executive director of the Board.

August 23, 2009

Yaz Birth Control Dangers and Lawsuits

by Dr. Shezad Malik

The Yaz birth control pill has been on the market since 2006. Yaz is taken orally once daily to prevent pregnancy.

Yaz differs from other birth control methods because it contains a progestin hormone called drospirenone, which can increase potassium levels in the bloodstream. Yasmin, a birth control drug very similar to Yaz, has been on the market since 2001. It contains the same hormone as Yaz and is associated with the same health issues.

August 23, 2009

Yaz, Yasmin and Pulmonary Embolism, Stroke, Heart Attack

by Dr. Shezad Malik

Yaz and Yasmin manufacturers are now involved in multiple Federal and State lawsuits.

In October of 2008, a warning letter was sent by the Food and Drug Administration to Bayer HealthCare Pharmaceuticals, Inc., in response to claims the company had made for Yaz, a very popular and heavily promoted birth control pill.

The warning letter stated that Yaz has additional risks compared to other birth control pills because it contains drospirenone, a progestin hormone that can increase potassium levels.

Among the serious and debilitating injuries reported from the birth control pills are heart attacks, blood clots, strokes, pulmonary embolisms, deep vein thrombosis, gall bladder disease, and other serious injuries. Some deaths have even occurred.

August 22, 2009

Popcorn Workers Lung – Bronchiolitis Obliterans

by Dr. Shezad Malik

Bronchiolitis Obliterans also known as Popcorn Workers Lung, is an obstructive lung disease in which the bronchioles of the lungs are blocked by the growth of fibrous tissue.

The moniker Popcorn Workers Lung has been given to Bronchiolitis Obliterans because workers in factories that make microwavable popcorn that uses diacetyl for the buttery flavoring are known to contract the disease. The disease is irreversible, and can become so severe that a lung transplant may be necessary. Popcorn Workers Lung is a rare disorder that is known to be caused by repeated exposure to toxic gases, namely diacetyl.

August 22, 2009

Yaz Lawsuit

by Dr. Shezad Malik

Yaz and Yasmin are popular and widely-used oral contraceptives targeting women with the promises of worry free contraception. But there is potentially life threatening Yasmin side effects and Yaz side effects.Yaz was recently targeted by the Food and Drug Administration (FDA) as a prescription drug that is more dangerous and less effective than advertised by Bayer Healthcare Pharmaceuticals.

In mid-August 2009, the results of two new studies of oral contraceptives, including Yaz and Yasmin, were released in the British Medical Journal Online. The studies showed that Yaz, Yasmin and the generic form of Yaz, Ocella, caused a six-fold increase in the risk of blood clots, which cause injuries such as Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

August 22, 2009

FDA Cracks Down on Ibuprofen Pain Relief Gels

by Dr. Shezad Malik

The Food and Drug Administration has issued warnings to eight companies for illegally marketing pain relief ointments containing ibuprofen.

Regulators said in a statement Thursday the companies do not have federal permission to market their products, which mix the popular pain relief drug with other ingredients. While ibuprofen is available in a variety of tablets like Advil, the FDA has not approved any ointments containing the drug.

“These companies have an obligation to demonstrate to the FDA that their products are safe and effective, and they have failed to do so,” said Deborah Autor, director of FDA’s office of compliance.

August 22, 2009

Yaz and Yasmin: Birth Control Pill Has Caused Patient Deaths, Heart Attack, and Stroke

by Dr. Shezad Malik

Yasmin is an oral contraceptive pill made by Bayer HealthCare Pharmaceuticals, Inc. that has been linked to heart attack, stroke, and blood clots in users. Women taking the drug to prevent pregnancy or to treat emotional and physical symptoms of PMDD (Premenstrual Dysphoric Disorder) and moderate acne have suffered severe injuries and even died as a result.

The drug has been linked to 50 or more deaths in the United States between 2004 and 2008 in addition to many other injuries. Bayer has been named in numerous lawsuits filed on behalf of women who were injured or died as a result of taking Yasmin.

Yasmin was approved by the Food and Drug Administration in 2006. A lower-dose version of the same drug, called Yaz, was approved in 2001. Yasmin is essentially the same drug as Yaz and uses a different kind of hormone than other birth-control pills, a drug called DRSP (drospirenone). DRSP has been shown to increase potassium in the body, which raises the possibility of severe health complications for women with kidney (renal) disease and cardiovascular conditions.

August 21, 2009

Avandia Risk of Heart Failure and Lawsuits

by Dr. Shezad Malik

If you believe you may have been harmed by the use of Avandia, it is important to note that your time to file a lawsuit against the maker of the drug could be running out. The statute of limitations in many states is coming up soon, and there still may be people who do not realize that the injury they have suffered could be related to their Avandia use.

New research shows that diabetics treated with the popular drug Avandia have higher risk of heart failure and death than those taking Actos, leading Canadian scientists to conclude that “continued use of [Avandia] may not be justified.”

The findings, published in today’s edition of the British Medical Journal, are the latest blow to the controversial blockbuster drug, manufactured by GlaxoSmithKline Inc.

Researchers stressed that the findings are relative and that Actos, a product of Takeda Pharmaceuticals North America Inc., also poses heart risks, albeit lesser ones.

August 21, 2009

Wastewater From MI Food Plants Getting Into Home Water Wells

by Dr. Shezad Malik

When Kari and Ron Craton moved a few years ago to a more rural area of southwestern Michigan, they were seeking a more rustic life. What they got was more rust.

Government officials say food-processing plants that turn raw crops into products have contaminated the water-supply wells of the Cratons and other property owners in agricultural areas of Michigan and could do the same in other states. Residents claim increased amounts of metals in water drawn from their wells have killed their pets, ruined their plumbing and made their houses impossible to sell or rent.

August 21, 2009

Gadolinium Nephrogenic Systemic Fibrosis (MRI Dye) and Lawsuits

by Dr. Shezad Malik

A dye used in MRI (magnetic resonance imaging) and MRA (magnetic resonance angiography) scans has been linked to a rare and potentially fatal skin disease in some users.

The problem stems from the metal gadolinium found in the dyes injected into some patients before MRI scans and all patients before MRA scans.

The disease is known as nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy (NSF/NFD), and appears to only occur in patients with kidney disease who undergo an MRI or MRA where a gadolinium-based dye is used.