Dangerous Drugs

The State of Wisconsin, through the Attorney General’s Office, announced settlements with two pharmaceutical companies over off-label marketing and kickback violations.

Off-label marketing involves marketing drugs for uses not approved by the Food and Drug Administration. The FDA prohibits drug manufacturers from marketing or promoting a drug for a use that the FDA has not approved.

Wisconsin will receive $74,026 as its share of a $41.5 million settlement with Kos Pharmaceuticals Inc. for allegedly engaging in kickback violations and off-label marketing of its cholesterol treatment drugs Advicor and Niaspan.

The state will also receive payment of $525,903 as its share of a $75.3 million settlement with Ortho-McNeil-Janssen Pharmaceutical Inc. stemming from allegations the company improperly marketed Topamax, which is used to control epileptic seizures. Ortho-McNeil allegedly marketed the drug to physicians for a variety of psychiatric conditions, including bipolar disorder and alcohol dependency.

This marketing strategy affects taxpayers because doctors prescribe drugs to patients covered by public insurance programs such as Medicare.

The Food and Drug Administration warned yesterday that some heartburn medications could increase the risk of hip, wrist and spine fractures in high doses or with long-term use.

The FDA’s decision came after it’s review of several studies that reported an increased risk of hip, wrist and spine fractures after using proton pump inhibitors in high dosages or with long-term use. Proton pump inhibitors are used to treat gastroesophageal reflux disease, stomach and small intestine ulcers and inflammation of the esophagus, along with frequent heartburn.

The medications include:

• Esomeprazole – sold as Nexium
• Dexlansoprazole – sold as Dexilant
• Lansoprazole – sold as Prevacid
• Omeprazole – sold as Prilosec or Zegerid
• Pantoprazole – sold as Protonix
• Rabeprazole – sold as Aciphex

Over the counter medications include:

• Omeprazole – sold as Prilosec OTC and Zegerid OTC
• Lansoprazole – sold as Prevacid 24 Hour

The FDA says that the product labeling will be altered, alerting consumers of the possible increased risk.

Pitman, Kyle & Sicula is a Wisconsin personal injury law firm handling dangerous drug cases through out the state. Our personal injury lawyers have successfully represented injured people in almost every county. We know Wisconsin.

The Food and Drug Administration will conduct a safety review of a group of drugs called bisphosphonates to see if there are any links to an increased risk of femur fractures.

Bisphosphonates are commonly prescribed to treat osteoporosis and are designed to build bone mass. Fosamax is classified as a biphosphonate and has been linked to femur fractures and Osteonecrosis of the Jaw (ONJ).

Pitman, Kyle & Sicula is a Wisconsin personal injury law firm handling Fosamax cases through out the state.  Our personal injury lawyers have successfully represented injured people in almost every county. We know Wisconsin.

An ABC investigation found growing evidence between long-term use of osteoporosis drugs such as Fosamax and spontaneous fractures of the thigh bone, or femur.

The investigation gave several examples of women who suffered femur fractures after prolonged use of bisphosphonates such as Fosamax. Doctors are concerned that the prolonged use of Fosamax can cause women to lose their ability to remodel and regenerate their skeleton, making their bones brittle.

Fosamax was approved in September 1995 to treat osteoporosis and help prevent hip and spine fractures. The drug is prescribed to women with signs of osteoporosis and those at high risk for developing the disease, such as post-menopausal women.

The ABC investigation reported numerous instances of women experiencing sudden fractures in the femur bone in the leg while walking, stepping over doorways, standing, or doing other low-impact activities that resulted in a fall from a standing height. Most of the women had been taking a bisphosphonate, such as Fosamax, for five years or longer to treat their osteoporosis.

Doctors have been treating women with broken femurs who simply were walking, walking down steps, or women performing low-intensity exercise. Most women reported severe leg pain in the days or months prior to the spontaneous femur fractures.

Fosamax has also been linked to a bone-related jaw diseased called osteonecrosis of the jaw (a.k.a. ONJ). Symptoms on ONJ include:

• Loose teeth
• Exposed bone
• Jaw / gum pain
• Jaw / gum swelling
• Jaw / gum infection
• Jaw numbness; loss of sensation
• Dramatic gum loss

The FDA is looking to reports of fractures and the possible connection to bisphosphonates, such as Fosamax.

A lawsuit filed against Bayer AG accuses the drugmaker of ignoring health risks of contraceptive Yaz and advertising the drug as safe in order to boost sales.

According to the lawsuit filed today in Ontario, users of Yaz and Yasmin are four times more likely to develop deep vein thrombosis and pulmonary embolism.

Yaz and Yasmin were Bayer’s top-selling drugs in 2008, earning approximately $1.8 billion.

In the U.S., approximately 350 Yaz lawsuits have been filed.

Pitman, Kyle & Sicula is a Wisconsin personal injury law firm handling Yaz cases through out the state.  Our personal injury lawyers have successfully represented injured people in almost every county. We know Wisconsin.

An annual report published by Bayer revealed that the drug-manufacturer is facing more than 1,100 lawsuits over the alleged dangerous side effects of its prescription birth control products Yaz, Yasmin and Ocella.

Yaz has been linked to serious, even life-threatening, side effects, including heart attacks, pulmonary embolisms, strokes, deep vein thrombosis, gallbladder disease, and death.

The FDA had warned Bayer about misleading advertising campaigns, resulting in Bayer’s $20 million corrective advertising campaign.

Yaz, Yasmin and Ocella are the only birth control pills in the U.S. to contain drospirenone, a diuretic.  Drospirenone raises the body’s level of potassium. Elevated levels of potassium can lead to blood clots and gallstones. Yaz is the leading brand of female birth control in the U.S.

Pitman, Kyle & Sicula is a Wisconsin personal injury law firm handling Yaz cases through out the state.  Our personal injury lawyers have successfully represented injured people in almost every county. We know Wisconsin.

The Senate Finance Committee released a report on Saturday that said drug-manufacturer GlaxoSmithKline was aware of the possible heart attack risks to Avandia users years prior to the public’s knowledge.

The report also asks why the FDA allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks from 1999-2007. The FDA ordered a black-box warning to be included on the label in 2007, saying the drug might increase the risk of heart attacks.

The committee’s report was based on researchers’ studies of Avandia, internal GlaxoSmithKline documents and FDA documents.

A New England Journal of Medicine analysis published in 2007 found a 43% higher risk of heart attack for those taking Avandia compared to people taking other diabetes drugs or no diabetes medications.

Glaxo has agreed to conduct a 6-year study between Avandia and a competitor’s diabetes medication to better understand Avandia’s safety. The FDA calls the study, which includes 16,000 participants, unethical and exploitative because patients will continue taking Avandia.

Avandia controls blood sugar by increasing the body’s sensitivity to insulin. Avandia was Glaxo’s third best-selling drug in 2006, making $2.2 billion, however, concerns about the drug’s safety caused revenues to fall to $1.2 billion.

Here’s a list composed by MSN.com of the ten medication mistakes experts say are most likely to kill or cause serious harm:

1. Confusing two medications with similar-sounding names
2. Taking two or more drugs that magnify each other’s potential side effects
3. Overdosing by combining more than one medication with similar properties
4. Getting the dosage wrong
5. Mixing alcohol with medications
6. Double-dosing by taking a brand-name drug and the generic version at the same time
7. Taking prescription drugs and over-the-counter or alternative medications without knowing how they interact
8. Not understanding interactions between medications and your diet
9. Failing to adjust medication dosages when a patient loses kidney or liver function
10. Taking a medication that’s not safe for your age

Johnson & Johnson expanded their recall Friday to include several other over-the-counter drugs sold in the U.S., the United Arab Emirates and Fiki.

The recall was prompted in response to complaints of a foul odor and “non-serious” gastrointestinal disorders including vomiting and diarrhea.

The recall has been expanded to include Tylenol caplets, Motrin IB, chewable extra strength Rolaids, Benadryl allergy tablets, Simply Sleep and St. Joseph aspirin.

For more information on the recall, please click here.

Inspectors from the U.S. Food and Drug Administration reported that a Johnson & Johnson unit failed to perform a formal investigation after receiving more than 70 complaints about its pain reliever Tylenol.

In 2008, consumers complained about a musty odor in Tylenol Arthritis Caplets, however Johnson & Johnson did not perform test to determine whether or not the product was chemically contaminated.