In addition, a new Contraindication warning was added against use of Adcetris with the cancer drug bleomycin due to increased risk of pulmonary (lung) toxicity.

The signs and symptoms of PML may develop over the course of several weeks or months. They may include changes in mood or usual behavior, confusion, thinking problems, loss of memory, changes in vision, speech, or walking, and decreased strength or weakness on one side of the body.

BACKGROUND: Adcetris (brentuximab vedotin) is used to treat Hodgkin lymphoma and a rare lymphoma known as systemic anaplastic large cell lymphoma. At the time of Adcetris’ approval in August 2011, one case of PML was described in the Warnings and Precautions section of the label.

RECOMMENDATION: Patients who develop any signs and symptoms of PML should notify their healthcare professional immediately. Healthcare professionals should hold Adcetris dosing if PML is suspected and discontinue Adcetris if a diagnosis of PML is confirmed. See the Data Summary in the Drug Safety Communication for additional information.

The best-selling statin is atorvastatin, marketed as Lipitor and Torvast. A number of statins are on the market: atorvastatin (Lipitor and Torvast), fluvastatin (Lescol), lovastatin (Mevacor, Altocor, Altoprev), pitavastatin (Livalo, Pitava), pravastatin (Pravachol, Selektine, Lipostat), rosuvastatin (Crestor) and simvastatin (Zocor, Lipex)

A study published Monday adds to the evidence, finding a modest risk among older women who used a variety of statins. It’s a puzzling link, and specialists say people who most need statins because of a high risk for a heart attack should stick with the drugs.

Statins are one of the most widely prescribed drugs, and among the most touted with good reason. They can dramatically lower so-called “bad” LDL cholesterol. Studies make clear that they save lives when used by people who already have heart disease.

What is debated is how much the drugs help people who do not yet have cardiovascular disease but whose chances are higher because of other factors such as smoking or high blood pressure — or diabetes. In fact, long-term diabetes is so heart-risky that the American Diabetes Association urges fairly aggressive statin use by many diabetics. For everyone else, Nissen says the general rule is statins help people who have at least a 10 percent chance of a heart attack in the next 10 years, something a doctor can calculate.
All drugs have side effects that are important to consider while deciding whether they are a good bet for an individual. Statins have long been known to cause muscle pain that on rare occasions becomes a serious breakdown of muscle that can lead to kidney failure, even death.

But whether statins can make blood sugar rise enough that someone crosses the threshold to diabetes has been confusing.
After all, some of the same risks for heart disease — such as being overweight and sedentary — also increase the odds of developing Type 2 diabetes. And Ma says too many statin users wrongly assume the pills will let them eat whatever they want.

Ma’s team examined a huge U.S. government study that tracked the health of postmenopausal women for many years. They culled the records of more than 153,000 women who did not have diabetes when they enrolled in the Women’s Health Initiative in the 1990s. Just 7 percent were taking statins at the time.
Fast forward to 2005: Nearly 10 percent of the statin users had developed diabetes, compared with 6.4 percent of the older women who hadn’t used the drugs at the study’s start, Ma concluded. The findings were reported online Monday by the journal Archives of Internal Medicine.

This is what scientists call an observational study, which can hint at a risk but can’t prove it.
But it comes after a number of smaller but more precise studies — where patients were randomly assigned to take a statin or some other treatment — that also have found a link. The first to prompt doctor head-scratching was in 2008, a study of the drug Crestor. Last June, a report in the Journal of the American Medical Association analyzed five additional randomized trials and concluded the increased risk was small but real for people taking higher doses of any statin.

That report calculated that one fewer patient would experience a heart attack or other cardiovascular problem for every 155 patients treated for a year — and there would be one additional case of diabetes for every 498 patients treated.

At the National Institutes of Health, diabetes specialist Dr. Judith Fradkin says statins’ benefits outweigh the potential side effect, and that newly developed diabetes won’t harm right away.
“The danger here is alarming people and having them go off a medication that’s of proven benefit,” she says.

But Dr. Beatrice Golomb of the University of California, San Diego, welcomed the new study as a needed note of caution for women, saying there’s less certainty about the drugs’ overall effects in them. Stay tuned: Her own research aims to narrow down which statin users are more likely to experience a blood-sugar jump.

Source: Associated Press

Recent medical studies confirm that Actos can cause bladder cancer and other injuries. Actos (pioglitazone) is a Type 2 diabetes drug often prescribed as an alternative to Avandia. At one time it was believed that Actos was safer.

Actos lawsuits against Takeda Pharmaceuticals whoe manufactures the Actos drug, allege that patients who took Actos developed bladder cancer. Patients who have bladder cancer are urged stop using Actos, while the medication should be used with caution in patients who have a prior history of bladder cancer, the FDA warns.

Injuries caused by Actos

Bladder Cancer
Heart Attack
Congestive Heart Failure
Heart Disease
Rhabdomyolysis
Kidney Damage
Liver Damage
Bone Fracture

Actos Side Effects

Actos, or pioglitazone hydrochloride, is a commonly prescribed anti-diabetic medication used in combination with dietary constraints to control adult onset diabetes (diabetes II). The drug, a single-molecule chemical cousin of Avantia, is popular with medical professionals, for it succeeds at regulating blood glucose and reducing insulin resistance far more effectively than other medications. In a nation suffering an epidemic increase in diabetes II cases, a reliable and effective support to help control the central symptoms of the illness is welcome.

Nonetheless, Actos is not without side effects. The drug has both common, low-impact side effects and more serious ones – so serious that studies have led France and Germany to remove the drug from the market entirely, forbidding doctors to prescribe the medication.

Among the milder and less sinister side effects are headache, respiratory and sinus infections, sore throat, muscle pain, tooth problems and water retention. These are common to many drugs, and are seldom debilitating, though on a patient by patient basis, it is possible to find a degree of variation in response among patients. Most experience few, if any side effects.

Updated list of drugs with active ingredient of Actos.

The  data was obtained from ATHENA and PALLAS clinical trials.  New information and recommendations are being provided by FDA for the use of Multaq to manage the potential serious cardiovascular risks with dronedarone.

The Multaq drug label has been revised with the following changes and recommendations:

1. Healthcare professionals should not prescribe Multaq to patients with AF who cannot or will not be converted into normal sinus rhythm (permanent AF), because Multaq doubles the rate of cardiovascular death, stroke, and heart failure in such patients.
2. Healthcare professionals should monitor heart (cardiac) rhythm by electrocardiogram (ECG) at least once every 3 months. If the patient is in AF, Multaq should be stopped or, if clinically indicated, the patient should be cardioverted.
3. Multaq is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of non-permanent AF (known as paroxysmal or persistent AF)
4. Patients prescribed Multaq should receive appropriate antithrombotic therapy.

For more safety information please visit fda.gov.

Here is an updated list of drugs with active ingredient of Actos.

Common Symptops:

• Dark urine
• Frequent urination
• Painful urination
• Urinary tract infection

Drugs effected

Generic name: Pioglitazone
Actos
ACTOplus met
ACTOplus met XR
duetact

NDC numbers found on Actos packaging:

00247-1924-30
00247-1925-30
00247-1926-30
12280-0060-30
13411-0101-03
13411-0102-03
13411-0103-03
21695-0147-15
21695-0148-15
49999-0450-30
49999-0451-30
54569-4880-00
54569-4881-00
54569-4882-00
54868-4343-00
54868-4354-00
54868-4354-01
54868-4391-00
55289-0540-30
55289-0862-15
55289-0862-30
55887-0062-30
55887-0063-30
55887-0100-30
58864-0670-14
58864-0670-30
58864-0745-15
58864-0745-30
58864-0862-30
64764-0151-04
64764-0151-05
64764-0151-06
64764-0301-14
64764-0301-15
64764-0301-16
64764-0451-24
64764-0451-25
64764-0451-26
68115-0671-30
68115-0841-30

NDC numbers found on ACTOPlus met packaging:

35356-0130-60
54868-5500-00
54868-5500-01
54868-5553-00
54868-5553-01
64764-0155-18
64764-0155-60
64764-0158-18
64764-0158-60

NDC numbers found on ACTOPlus met XR packaging:

64764-0310-30
64764-0510-30

NDC numbers found on duetact packaging:

64764-0302-30
64764-0304-30

If you have been diagnosed with bladder cancer after taking any of these drugs, you may be entitled to monetary compensation!

To Submit a FREE case evaluation please use the link below.

Studies have shown that several commonly prescribed SSRIs – including Zoloft, Depakote, and Paxil – may be putting infants at risk for developing heart defects at the very beginning of their lives. The heart defects that have been tied to those drugs are as follows:

• Zoloft – transposition of the great arteries, tetralogy of fallot, hypoplastic left and right heart syndrome, atrial septal defect
• Paxil – atrial and ventricular septal defects (holes in the heart), tetralogy of fallot, double outlet right ventrical, transposition of the great arteries

Many of these conditions require surgery and put infants at risk for further health complications. Women should use caution when taking SSRIs or other medications during pregnancy to protect their children from heart defects and other health problems.

While SSRIs cause a number of side effects in people who take them, mothers who take SSRIs while pregnant may be putting their babies at risk for additional side effects, some very serious. These SSRI medications have been linked to the following birth defects:

• Zoloft – club foot, lung defects, asthma/breathing problems, craniosynostosis, omphalocele, limb reduction
• Paxil – persistent pulmonary hypertension of the newborn (PPHN), cardiomyopathy, craniosynostosis, spina bifida, club foot

As with any medication, women who take SSRIs should talk to their doctors if they are pregnant or plan to become pregnant while on the medication.

Taking frequent, high does of the drug Diflucan (generic name fluconazole) while pregnant has been shown to increase health risks in newborn babies. The risk appears especially great when mothers take Diflucan during the first trimester of pregnancy.

Diflucan is normally prescribed to patients suffering from yeast infections in various parts of the body, including the vagina, throat, mouth, and esophagus. It is occasionally used for the prevention of yeast infections in certain patients or for the treatment of some cases of meningitis.

Prolonged use of Diflucan in high doses received a higher level of warning than the single, low doses that are often used to treat vaginal yeast infections.

Women who are pregnant should talk to their doctors about whether the risks of taking Diflucan outweigh the possible benefits. Women who become pregnant while taking Diflucan should contact their doctors to minimize risk to their babies’ health.

Along with nausea, common side effects of taking the drug include dizziness, diarrhea, loss of appetite or weight, excessive tiredness, and insomnia. In severe cases, the drug has been shown to cause confusion, inability to concentrate, seizures, and an increase in depression, sometimes involving suicidal thoughts.

The use of Zoloft while pregnant has been shown to pose special risks to the babies of mothers who took it. Taking Zoloft during pregnancy, especially during the third trimester, has been shown to increase the possibility of having a baby with certain birth defects.

Studies have linked a variety of birth defects to the use of Zoloft, particularly birth defects of the heart. The defects these studies have focused on include atrial and ventricular septal defects, transposition of the great arteries, hypoplastic left and right heart syndrome, and tetralogy of fallot. These birth defects often require surgery, sometimes while the baby is still an infant.

Zoloft is an antidepressant medication and is more specifically classified as a selective serotonin reuptake inhibitor (SSRI). It is used to treat obsessive-compulsive disorders, depression, panic attacks, and other disorders related to anxiety and stress.