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U.S. Department of Health and Human Services

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FDA's MedWatch Safety Alerts: September 2011

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After products approved by the Food and Drug Administration (FDA) are on the market, the agency continues to monitor them for problems.

FDA encourages health care professionals and consumers to report problems with medical products, including

  • unexpected and undesirable side effects
  • quality problems, such as a drug with an unusual odor or color, or a device with defective parts
  • unclear or confusing instructions
  • failure to deliver the expected benefit.

Report problems to FDA's MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.

MedWatch reports can signal a safety problem and may lead to FDA action to protect the public from harm, serious illness, or death.

Here are some of the most recent safety alerts prompted by reports FDA has received through MedWatch.


Recall: Birth Control Pills by Qualitest Pharmaceuticals

Multiple lots of birth control pills have been recalled because of a packaging error that rotated some of the blisters on the pill pack 180 degrees, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible.

The recalled products include

  • Cyclafem 7/7/7
  • Cyclafem 1/35
  • Emoquette
  • Gildess FE 1.5/30
  • Gildess FE 1/20
  • Orsythia
  • Previfem
  • Tri-Previfem

See this website for the affected lot numbers. The lot number can be found on the bottom of the box or the individual blister card.

Risk: Women may not taking the correct daily regimen of pills, leaving them at risk for unintended pregnancy.


  • If you have been using one of the affected products, begin using a non-hormonal form of contraception immediately and talk with your health care professional or pharmacist.
  • Call Qualitest at 877-300-6153 between 8 a.m. and 5 p.m. CT Monday –  Friday for information or to arrange the return of any affected product.

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Birth Control Pills Containing Drospirenone: Risk of Blood Clots

FDA has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of birth control pills that contain the hormone drospirenone. FDA has completed a review of two 2011 studies that found a two to three times greater risk of venous thromboembolism events (VTE) for women who use birth control pills that contain drospirenone than for those using pills that contain the hormone levonorgestrel.

Names of drospirenone-containing products include

  • Ocella
  • Safyral
  • Syeda
  • Yasmin
  • Zarah
  • Beyaz
  • Gianvi
  • Loryna
  • Yaz
  • Drospirenone and ethinyl estradiol

Risk: VTEs include deep vein thrombosis and pulmonary embolism. Deep vein thrombosis is a rare condition in which a blood clot forms inside a vein, usually in the lower leg or thigh. If the clot breaks loose and travels to the lungs, it can block an artery, causing a life-threatening condition called a pulmonary embolism.

FDA actions
FDA is continuing its review of a study it funded that evaluated the risk of blood clots in users of several different hormonal birth control products. Preliminary results of this study suggest about a 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives.

Because of the conflicting nature of the findings from six published studies evaluating this risk, as well as the preliminary data from the FDA-funded study, the agency has scheduled an advisory committee meeting Dec. 8, 2011, to discuss the risks and benefits of birth control pills that contain drospirenone.


  • Call your health care professional immediately if you develop any symptoms of blood clots, including persistent leg pain, severe chest pain, or sudden shortness of breath.
  • If your birth control pill contains drospirenone, do not stop taking it without first talking to your health care professional.
  • If you smoke and are over 35 years of age, you should not take combination oral contraceptives (those that contain two types of hormones: estrogen and progestin) because they increase the risk of serious heart and blood vessel (cardiovascular) problems, including blood clots.

For more information

Questions and Answers - Safety review update on birth control pills containing drospirenone

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Reclast: Updated Warning on Kidney Problems

The drug label and medication guide for patients are being updated to reflect the risk of severe kidney problems in some people who take Reclast (zoledronic acid). Medication guides are paper handouts that come with many prescription medicines to warn about potential bad reactions, tell who shouldn’t take the drug, or give other safety information.

Reclast is used for several bone-related conditions, including to treat or prevent osteoporosis in women after menopause, and to increase bone mass in men with osteoporosis. It is given as a fluid injected into the vein in a single dose, once every one to two years. Osteoporosis is the gradual thinning of bone tissue and loss of bone density.

Risk: FDA has received reports of kidney failure requiring dialysis or resulting in death after the use of Reclast. Kidney failure is a rare but serious condition associated with the use of Reclast in patients with a history of, or risk factors for, kidney problems.


  • If you have kidney disease, discuss the necessity of Reclast treatment with your health care professional.
  • Make sure your health care professional knows about all the medications you are taking.
  • Ask your health care professional about checking your serum creatinine level (through a blood test) before and after each dose of Reclast to find out how well your kidneys are functioning.

For more information

FDA Drug Safety Communication on Reclast

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Saphris: Serious Allergic Reactions

Serious allergic reactions—some requiring hospitalization or emergency room visits—have been reported with the use of Saphris (asenapine maleate). The drug label has been revised to include information about reactions, such as:

  • severe, whole-body allergic reaction (anaphylaxis)
  • swelling beneath the skin (angioedema)
  • low blood pressure
  • rapid heart rate
  • swollen tongue
  • difficulty breathing, wheezing
  • rash

In several cases, these reactions occurred after taking the first dose.

Saphris is used to treat symptoms of schizophrenia and bipolar disorder.


Get medical attention immediately if you take Saphris and develop any signs or symptoms of a serious allergic reaction, such as:

  • difficulty breathing
  • swelling of the face, tongue or throat
  • feeling lightheaded
  • itching

For more information

FDA Drug Safety Communication on Saphris

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Recall: SynchroMed II Implantable Drug Infusion Pump

Two models of Medtronic’s SynchroMed II infusion pump have been recalled because of a battery problem.

Risk: The pump—contained in the SynchroMed II Infusion system—may not deliver the drug to the patient, causing underlying symptoms to return or drug withdrawal symptoms.

The recall includes the SynchroMed II Implantable Infusion Pump models 8637-20 and 8637-40, distributed between May 2004 and July 8, 2011.


  • To find out if your SynchroMed II infusion pump is recalled, enter the serial number at Medtronic’s Device Identification web page.
  • Medtronic encourages patients to carry their patient identification cards with them at all times and to contact their physicians immediately if their symptoms return or if they hear a device alarm.
  • If you have questions, talk to your physician or contact Medtronic Patient Services at 800-510-6735, Monday – Friday, 8 a.m. to 5 p.m. CDT.

For more information

Recall Notice: Medtronic Model 8637 SynchroMed II Implantable Infusion Pump

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Zofran: Risk of Abnormal Heart Rhythms

FDA is conducting an ongoing safety review and labeling changes for the anti-nausea drug Zofran (ondansetron, ondansetron hydrochloride, and their generics).

Ondansetron is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery.

Risk: Ondansetron may increase the risk of developing abnormal changes in the electrical activity of the heart. This particular irregularity is called QT interval prolongation and it can result in a potentially fatal abnormal heart rhythm.

Patients at particular risk include those with underlying heart conditions, those who are predisposed to low levels of potassium and magnesium in the blood, and those taking other medications that lead to QT interval prolongation.

FDA action: FDA is requiring GlaxoSmithKline to conduct a thorough QT study to determine the degree to which ondansetron may cause QT interval prolongation.


  • Do not stop taking ondansetron without talking to your health care professional.
  • While you are taking ondansetron, your health care professional may occasionally order an electrocardiogram (ECG, EKG) to monitor your heart rate and rhythm.
  • Get immediate care if you experience an irregular heartbeat, shortness of breath, dizziness, or fainting while taking ondansetron.

For more information

FDA Drug Safety Communication on Zofran


This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Oct. 6, 2011

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