Saturday, April 7, 2012

Actos® Side Effects other than Heart Disease and Bladder Cancer

Osteoporosis and Bone Fractures
While many people are now aware of the association between the Type 2 diabetes drug, Actos, and both bladder cancer and heart disease, there are several other quite serious side effects also associated with the drug. For instance, there is strong evidence to suggest that Actos, like its sister-drug, Avandai, may cause osteoporosis and bone fractures among those taking it, most especially in female patients. In one particular randomized trial which studied patients with Type 2 diabetes who were currently taking Actos, an increased occurrence of bone fractures was observed in the female patients and in a follow-up study at nearly three years, almost 5.1% of the females taking Actos had suffered a bone fracture.

Most of the bone fractures were seen in arms and legs, and there was no apparent escalation of fracture occurences among male patients. Because this drug study lasted less than five years, it is strongly believed that a much greater frequency of fractures and osteoporosis would be seen in women taking Actos for longer periods of time. Since men typically have much stronger bones than women, fractures and osteoporosis would probably not have been seen in men who were studied for only a few years. Since broken hipbones happen to be a primary killer of the elderly, seniors should not take Avandia or Actos as their benefits do not appear to outweigh the serious side effects.

Macular Edema
A study presented at the yearly meeting of the American Diabetes Association this past June found that those taking Actos have a three to six times increased risk of developing macular edema. Macular edema causes an eye disease in which the retina swells and thickens and can lead to permanent blindness. Diabetic eye disease is now the most common cause of blindness in those younger than age 65, and although the best way to avoid this particular side-effect of diabetes is by keeping your blood sugar under control, Actos appears to increase the risk of macular edema even though it does control the blood sugar.

Weight Gain
Weight gain also appears to be a side effect of Actos, however it must be noted that there is significant difference between a slow weight gain as the result of the drug and a rapid weight gain which could signal congestive heart failure. Rapid weight gain is any more than five pounds in a week, and should be a reason to consult your physicians immediately. On average, those taking Actos gained from two to six pounds over a period of four months to six months, while those patients not taking Actos lost about three pounds during the same time period.

In patients who were taking both Actos and insulin or other oral diabetes medications, the weight gain increased to between nine and ten pounds on average. Patients taking higher dosages of Actos gained larger amounts of weight than those taking lower doses, however those whose weight gain was related to fluid retention likely suffered more serious cardiovascular problems. Actos has been shown to worsen congestive heart failure or in some cases cause it. A primary initial symptom of congestive heart failure is an unexplained, quick weight gain, so it is important for those taking Actos to monitor their weight regularly.

Liver Disease
Patients who have shown signs of prior liver disease should not take Actos or any other drug in the thiazolidinedione class. These drugs have been definitively associated with significant elevations in liver enzymes, jaundice, liver failure and death due to liver failure. These liver problems have been seen both in long-term and short-term patient use of Actos. Any patients taking Actos should be aware of the potential liver problems, and should report any unexplained nausea, vomiting, fatigue, dark urine or abdominal pain to their physician immediately. If jaundice develops the medication should be immediately discontinued. Those taking Actos who show even a moderate increase in liver enzymes should continue the drug only with their physician’s approval, and with great caution. If Actos use has led to a seriously impaired liver, a liver transplant may be necessary. Conversely, while Actos has been shown to potentially cause liver enzymes to increase to serious levels, there is medical evidence which shows Actos may actually provide beneficial effects in treating fatty liver disease. Several studies have shown that Actos can reduce the liver fats by half in less than half a year.

Other Serious Side Effects
Actos has also been known to cause allergic reactions, blurry vision, easy bruising or bleeding, flu-like symptoms, muscle pain and serious tooth pain and problems. Actos is contraindicated in those who are scheduled for an upcoming surgery or have any type of known allergy to foods, dyes or preservatives. Women who are pregnant or thinking of becoming pregnant, or those who are breastfeeding should not take Actos as it is considered a Pregnancy Category C drug meaning it is not considered safe to take when pregnancy is a possibility. Actos can also pass into breast milk, so should definitely not be taken by women who are currently breastfeeding. Actos can also potentially interact with other prescription drugs as well as non-prescription medications, vitamins and herbal supplements, so it is important that your doctor be aware of everything you take regularly. While bladder cancer and cardiovascular problems are the most serious of the known side effects of Actos, the side effects listed above can also have potentially serious consequences.

Author: Sullo & Sullo Attorneys

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