The FDA has launched a safety review of the diabetes drug Actos in light of new data suggesting that the drug may increase risk of bladder cancer.
http://diabetes.webmd.com/news/20100920/diabetes-drug-actos-bladder-cancer-risk
While not considered a serious enough risk to prevent FDA approval, earlier animal and human studies linked Actos to bladder cancer.
As a condition of approval, the FDA insisted that Actos maker Takeda Pharmaceuticals look for bladder cancer in patients taking the drug.
Five years in to Takeda’s 10-year study, the overall data is reassuring. Patients taking Actos do not have an increased risk of bladder cancer. But when researchers looked only at patients who had taken Actos the longest, and who had accumulated the highest lifetime dose of the drug, they found what appears to be an increased risk of bladder cancer.
The risk emerged in patients who had taken Actos for at least 24 months.
The FDA stresses that the finding is not proof that Actos causes bladder cancer. Patients who are taking Actos are advised not to stop taking their medication unless advised to do so by their health care provider.
Concerned patients should discuss the new information with their doctors. Actos is widely considered to be safer than Avandia, the only other approved diabetes drug in its class. The FDA is currently considering whether Avandia should remain on the market.
An FDA expert advisory panel recently split over the issue.
September 11, 2011 at 5:17 pm
I began taking actos 30 mg for 15 weeks and 4 days. BSL was 132 in the beginning. began healthier diet and treadmill everyday. had gained 9-10 pounds-i was shocked.started samples in May because 259.99 a month. saw dr.on Aug.23- 3 month checkup -BSL 112.but cholestol was up. told him i was short of breath, complained of sharp pain under bra strap front to back,heart racing and shaky. flu- like symptoms.I did not have insurance until Sept. 1, so I waited to call dr. again. Bloodwork showed BSL 135 on Sept.6th. Very cold and shaking.a day after dr. visit could’nt eat or sleep.losing 2 pounds a day.had done a lot of moving of heavy furniture and compulsive about cleaning. had severe feet to butt pain had to stand to relieve.bulging muscles-vein. brain-can’t focus. cramping- like ovulation,but have been through menapause for years. word retrieval is mixed up. SEVERE HEADACHE that will not go away over right eye. 155# can’t even bend over without losing balance. Labor Day-2011- all muscles were weak and vision was dim.still weak- starting to use a cane for balance and I’m only 49 years old. I have lost 9 pounds in less than 2 weeks.Now went off all meds Sept.7th can’t drive now unless I stay under 30 miles-feet too weak- no relief yet. Muscles continue to twitch. it comes in waves.quit my job as a pre-school teacher Aug 5th. Very scary. Can’t focus to apply as a special ed. teacher. when will this get out of my system? told my brother about the side effects I found and that I was having a lot of them. he told me to calm down. I had not known of the effects until I researched Actos- not the other way around. I am off Synthroid .075 and Pravastatin 40 mg. not taking anything but Ibruphofen-when I can focus. I am documenting EVERYTHING!!