Actos bladder cancer risks persist in generic form

Actos bladder cancer risks are the same for Actos, the brand name of the Type 2 diabetes drug made by Japanese pharmaceutical company Takeda, and for pioglitazone, the drug’s generic name.  But will people still consider the bladder cancer risks of Actos once the popular diabetes medication becomes available as a generic drug?

CNBC reports that as of August 2012, Takeda’s patent for Actos will expire, meaning that other companies are free to sell Actos in its generic form as pioglitazone. Two studies have reported on the increased risk of bladder cancer associated with long term Actos usage.

Though Actos has been marketed as a safe alternative to Avandia (rosiglitazone), there are risks involved with both, in their brand name and generic forms. Drs. Kasia Lipska and Joseph Ross cautioned against Takeda’s claim that “Actos lower[s] blood sugar without increasing your risk of having a heart attack or stroke.”

In a commentary written for JAMA, the doctors noted that “just because pioglitazone might be safer than rosiglitazone does not mean it is the safest and most effective treatment choice. For many patients currently taking rosiglitazone, simply switching to another thiazolidinedione (TZD) such as pioglitazone is not necessarily the best option.”

The doctors’ statement is especially true for patients with a family history or personal history of bladder cancer.

 

Actos bladder cancer risks cited as cause of new EMA warnings

After a month of evaluation, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) decided, given Actos’ bladder cancer risks for vulnerable patients, the regulating agency will require “new contra-indications and warnings for pioglitazone (Actos) to reduce small increased risk of bladder cancer.”

In the press release concerning their decision, dated July 21, 2011, the EMA went on to say that “Prescribers are advised not to use these medicines in patients with current or a history of bladder cancer or in patients with uninvestigated macroscopic hematuria [blood in urine].”

Though a history of bladder cancer is an obvious risk factor, there were others that the CHMP wanted doctors to stay aware of when treating Type 2 diabates patients and considering prescribing Actos. Age was a factor, as well as a family history of bladder cancer.

In all cases, the CHMP stated that “prescribers should review the treatment of patients on pioglitazone after three to six months (and regularly afterwards) to ensure that only patients who are deriving sufficient benefit continue to take it.”

The studies the EMA was looking at when making their decision found an association between a higher incidence of bladder cancer and long term usage (over one year) and higher accumulated dosage. However, the EMA made sure to mention that a “possible [Actos bladder cancer] risk after short term treatment cannot be excluded.

JAMA Affirms Risk of Bladder Cancer for Actos Users

On July 13th, 2011, The Journal of the American Medical Association (JAMA) published an article that affirmed the risk of bladder cancer associated with the diabetes drug Actos. This comes nearly a month after the FDA released an official warning about the drug’s risks of bladder cancer when the drug is used for more than a year.

Currently, the FDA advises that health care professionals avoid using Actos (generic: pioglitazone) for patients who are suffering from bladder cancer, or patients who have a history of bladder cancer.

The JAMA article details the ongoing research being conducted on Actos. For instance, a French epidemiological study on Actos revealed that it contains an increased risk in bladder cancer. This study sparked a nationwide ban of the drug in France and Germany. The US is now conducting a “comprehensive review of the results from the French study,” reports JAMA.

With JAMA now taking notice of the reports on Actos’s risk of bladder cancer, perhaps the United States and other countries will take a closer look, as well.

Anyone seriously injured by Actos should immediately seek legal counsel.

Prescribing antipsychotics for Parkinson’s disease: proven risks, unproven benefits

Despite the black box warning of increased risk of death for patients with dementia, doctors are still prescribing antipsychotics for Parkinson’s patients.  A study in the Archives of Neurology found that despite the known risks, doctors continue to prescribe antipsychotics for patients suffering from Parkinson’s disease and dementia, due to a perceived lack of alternatives.

In 2008, the rate of antipsychotic prescriptions for Parkinson’s had not gone down from 2002, despite the FDA black box warning issued in 2005. Researcher Dr. Daniel Weintraub of the University of Pennsylvania told WebMD: “My sense is that the black box warnings don’t factor into decision making.”

The study estimates that 60% of Parkinson’s patients will experience some form of psychosis during their illness. Researchers also found that half of all patients with Parkinson’s and psychosis were treated with antipsychotic medications.

Not only do most antipsychotics lead to an increased risk of death for those with dementia, some common antipsychotics (such as Risperdal and Zyprexa) can worsen Parkinson’s symptoms. According to the study, nearly 30% of patients with Parkinson’s and psychosis take Risperdal or Zyprexa, despite the fact that neither has been shown to effectively relieve Parkinson’s symptoms.

The most popular antipsychotic, Seroquel, was not shown to be any more effective for Parkinson’s and dementia patients than the others. “[Seroquel] is the No. 1 choice without clear evidence that it’s effective,” Dr. Weintraub noted.

Parkinson’s patients who have experienced extreme side effects from their antipsychotics have legal options, and the families of those who have died from extreme reactions to antipsychotics have legal options as well. To learn more, visit www.weitzlux.com.

 

FDA warns weight loss pills contain sibutramine, which can cause heart attacks

On July 8, 2011, the Food and Drug Administration issued a statement warning consumers not to use or buy “Slim Forte Slimming Capsules,” “Slim Forte Slimming Coffee,” and “Botanical Slimming Soft Gel,” all weight loss drugs containing distributed by InterCharm, Inc. An FDA lab analysis confirmed that all three of the products contain sibutramine.

Sibutramine was taken off the American market in October 2010 for safety reasons. The FDA says: “These products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmia, or stroke. These products may also interact in life threatening ways with other medications a consumer may be taking.”

The National Institute of Health (NIH) says sibutramine is in a class of medications called appetite suppressants that work by acting on appetite control centers in the brain to decrease appetite. Used in combination with a low calorie diet and increased exercise, these appetite suppressants (or “weight loss pills”) are meant to help overweight people lose weight and maintain their weight loss. Pills can be dangerous, and the FDA stresses that you should not trust any weight loss pill that they have not approved.

If you have been taking the sibutramine supplements “Slim Forte Slimming Capsules,” “Slim Forte Slimming Coffee,” or “Botanical Slimming Soft Gel,” the FDA says you “should stop using these products immediately and throw them away,” and contact a health care professional if you have experienced any side effects. If you have legal questions about your sibutramine side effects and health problems, visit www.weitzlux.com for a free consultation.