BACKGROUND: Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills.

The revised drug labels will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products. The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

RECOMMENDATION: Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.

Healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk for developing a blood clot before prescribing these drugs.

Pictures of the counterfeit version of Avastin are shown below:

Avastin is an injectable medicine used to treat cancer and is administered to patients in clinics, hospitals, and doctors’ offices. Roche is the company that manufactures Avastin approved for marketing outside of the United States. Roche conducted laboratory tests that confirmed the counterfeit version of Avastin. Packages or vials may be counterfeit if they:

• are labeled with Roche as the manufacturer
• display batch numbers that start with B6010, B6011 or B86017

Medical practices that have obtained products from Volunteer Distribution and QSP should stop using them and contact the FDA. These products should be retained and securely stored. To report suspect counterfeit products and other suspect products obtained from Volunteer Distribution or QSP/Montana Health Care Solutions:

• Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989,
• Visit OCI’s Web site (www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm), or
• Email – DrugSupplyChainIntegrity@fda.hhs.gov

Healthcare professionals and patients are encouraged to report adverse events related to the use of suspect injectable cancer medications to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the FDA Counterfeit Statement, letters to medical practices, and the company Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm291968.htm

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  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.

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.

Oral diabetes medication Actos (pioglitazone) is made by Takeda Pharmaceutical Company and co-marketed in the United States by Eli Lilly Pharmaceuticals. Actos is used to control type-2 diabetes in patients whose condition is not adequately controlled by diet and exercise alone. Actos belongs to a class of drugs called Thiazolidinedione drugs, which work to lower blood glucose levels and increase the body’s sensitivity to insulin.

Pioglitazone may be prescribed alone (as Actos) or in combination with other active ingredients such as metformin (sold as Actoplus Met) or glimepiride (sold as Duetact). A patient’s drug regiment may also include insulin or other medications in addition to those containing pioglitazone.

Bladder Cancer Lawsuits filed

In August 2011, the first lawsuits were filed against Actos manufacturer Takeda Pharmaceuticals blaming the diabetes drug for instances of bladder cancer. Victims are suing for financial compensation for the cost of hospital bills and loss of income, as well as physical and emotional suffering. Legal experts predict that these are the first of many Actos lawsuits that will be filed.

Heart Risks Also a Concern

Actos has been favored for its once-a-day dose and its success with controlling blood sugar. Once competing drug Avandia was linked to serious risk of heart attack in 2006, Actos’ popularity quickly increased and sales had climbed from $2.9 billion to $4.3 billion by 2010. Sales are likely to take a hit with the revelation of the research linking long-term Actos use to bladder cancer.

If you are taking Actos and are concerned about the risk of bladder cancer posed by this medication, it is important to speak with your healthcare provider. Remember, it is crucial to speak with a qualified physician before changing your treatment regiment or stopping Actos. Patients who choose to continue use of Actos should be made aware of the possible side effect risks and the symptoms of these complications.

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.