Pfizer is recalling about a million packets of birth control pills in the United States because they may not contain enough contraceptive to prevent pregnancy.

The birth control pills posed no health threat to women, Pfizer said, but it urged consumers affected by the recall to “begin using a non-hormonal form of contraception immediately.”

According to Pfizer the pills were manufactured by Pfizer and marketed by Akrimax Pharmaceuticals and shipped to warehouses, clinics and retail pharmacies nationwide.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Lot numbers of affected packs of Lo/Ovral®-28 (norgestrel and ethinyl estradiol)Tablets and Norgestrel and Ethinyl Estradiol Tablets (generic) follow on the table below:

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.

The Johnson & Johnson trans-vaginal mesh patch may cause numerous injuries.  Ethicon, a subsidiary of Johnson & Johnson, manufactures surgical mesh products under the following names that have also been linked to serious risks:

• Ethicon TVT
• Gynecare TVT
• Gynemesh PS

Johnson & Johnson and Ethicon have both been named in more than hundreds of lawsuits filed by victims claiming the trans-vaginal mesh implants were defective and led to harmful side effects and injuries.

Transvaginal Mesh Use

Implanted and stretched across the vaginal wall, the patch helps support internal organs that were once supported by the vaginal wall until a significant stretching, such as during childbirth, may have damaged the tissue.

FDA Warning

A July 2011 FDA alert warned that serious complications associated with the surgical mesh patches are not rare. The Agency announced that the surgical mesh treatment of pelvic organ prolapse may be no more effective than the traditional non-mesh repair, in addition to posing greater risks for the patient.

The most common serious injury reported from defective Transvaginal Mesh patches is the perforation or puncture of the bladder, intestines and bowels, as well as blood vessels in and around the vaginal wall.

The Food and Drug Administration (FDA) has received over thousands of reports of significant complications associated with transvaginal mesh patches.

SSRI Drugs in dangor: Celexa (citalopram); Lexapro (escitalopram); Prozac, Sarafem, Symbyax (fluoxetine); Luvox, Luvox CR (fluvoxamine); Paxil, Paxil CR, Pexeva (paroxetine); Zoloft (sertraline); Viibryd (vilazodone)

AUDIENCE: Psychiatry, OB/GYN, Family Practice

ISSUE: FDA notified healthcare professionals and the public on the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by women during pregnancy and the potential risk of a rare heart and lung condition known as P ersistent Pulmonary Hypertension of the Newborn (PPHN). The initial Public Health Advisory in July 2006 on this potential risk was based on a single published study. Since then, there have been conflicting findings from new studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN.

FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN. FDA will update the SSRI drug labels to reflect the new data and the conflicting results.

BACKGROUND: SSRIs are marketed under various brand and generic drug names, and are used to treat depression and other psychiatric disorders. There are no adequate and well-controlled studies of SSRIs in pregnant women.

PPHN occurs when a newborn baby does not adapt to breathing outside the womb. Newborns with PPHN may require intensive care support including a mechanical ventilator to increase their oxygen level. If severe, PPHN can result in multiple organ damage, including brain damage, and even death.

RECOMMENDATION: FDA advises health care professionals not to alter their current clinical practice of treating depression during pregnancy. See the Data Summary in the FDA Drug Safety Communication for additional information.

The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.

Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.

Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.

Physicians should:

• Obtain specialized training for each mesh placement technique, and be aware of its risks.
• Be vigilant for potential adverse events from the mesh, especially erosion and infection.
• Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
• Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
• Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).
• Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.

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.