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FDA's MedWatch Safety Alerts: October 2011

Posted Dec 01 2011 1:59pm

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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.

  • Online
  • Regular Mail: Use postage-paid, pre-addressed FDA form 3500
  • Fax: 800-FDA-0178
  • Phone: 800-332-1088

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: Nostrilla Nasal Decongestant

One lot (#11G075) of Nostrilla Nasal Decongestant nasal spray has been recalled by Insight Pharmaceuticals LLC because it may contain the bacteria Burkholderia cepacia.

The decongestant comes in a one-half ounce plastic bottle with an expiration date of 05/2014 stamped on the side. It was distributed nationwide to retail outlets and pharmacies.

Risk: These bacteria may cause serious infection in individuals who have a compromised immune system or a chronic lung condition, such as cystic fibrosis.

Recommendations

  • Do not use Nostrilla Nasal Decongestant nasal spray, lot #11G075; return all bottles to the place where you bought them for a refund.
  • If you have any questions, call Insight Pharmaceuticals at 877-546-9059 Monday through Friday from 9 a.m. to 5 p.m. EST.
  • Contact your health care professional if you have experienced any problems that you think may be related to using this product.

Update on Drug Interaction: Psychiatric Medications Used With Zyvox or Methylene Blue

FDA has updated its information on the potential drug interaction when taking either Zyvox (linezolid) or methylene blue with psychiatric drugs that work through the serotonin system of the brain (serotonergic psychiatric drugs).

FDA stated in July that it had received reports of serotonin syndrome when linezolid or methylene blue was taken with serotonergic psychiatric drugs.

Serotonin syndrome is a potentially life-threatening drug reaction that causes the body to have too much serotonin—a neurotransmitter that helps relay signals from one area of the brain to another. Symptoms may include

  • mental changes (confusion, hyperactivity, memory problems)
  • muscle twitching
  • excessive sweating
  • shivering or shaking
  • diarrhea
  • trouble with coordination
  • fever

Linezolid is used to treat infections, such as pneumonia. Methylene blue is used as a dye in diagnostic procedures and also to treat a number of medical conditions.

The updated information includes:

  • Not all serotonergic psychiatric drugs have an equal ability to cause serotonin syndrome with linezolid or methylene blue. Drugs reported to have reacted that way with linezolid include the anti-depressants Paxil and Prozac. Serotonin syndrome was also reported when methylene blue was taken with a group of anti-depressant drugs that includes Cymbalta and Celexa.
  • Most cases of serotonin syndrome reported when a serotonergic psychiatric medication and methylene blue were used together occurred in people undergoing parathyroid surgery, which involved giving methylene blue into a vein (intravenously). It is not known whether there is a risk when methylene blue is given by mouth or by injection into the tissue of the skin.

Recommendations

  • You may need to temporarily stop taking your serotonergic psychiatric medication if you need to take linezolid or methylene blue.
  • Do not stop taking your serotonergic psychiatric medicine without first talking to a health care professional.
  • Make sure your health care professional knows about all the medications you are taking.
  • Contact your health care professional immediately if you are taking a serotonergic psychiatric medication and develop any of the symptoms of serotonin syndrome listed above.

For More Information

FDA Drug Safety Communication: Updated information about the drug interaction between linezolid (Zyvox) and serotonergic psychiatric medications

FDA Drug Safety Communication: Updated information about the drug interaction between methylene blue (methylthioninium chloride) and serotonergic psychiatric medications

Recall: CooperVision Avaira Soft Contact Lenses

Certain lots of Avaira Toric and Avaira Sphere contact lenses made by CooperVision Inc. have been recalled because of a silicone oil residue on them.

Risk: Symptoms of people wearing these lenses include blurry vision, eye pain and eye injuries requiring medical treatment.

Recommendations

  • If you wear Avaira Toric or Avaira Sphere contact lenses and experience any symptoms, stop wearing the lenses immediately and contact your eye care professional for advice.
  • If you wear either of these contact lenses and do not have symptoms
    • go to the CooperVision recall website and enter the lot number of your lens package to determine whether your lenses have been recalled, or
    • contact CooperVision on its toll-free hotline at 1-855-526-6737.
  • If your lenses have been recalled, immediately remove them and return them to the place where you bought them.

For More Information

CooperVision AVAIRA Toric Soft Contact Lenses Recall

Expanded Recall Involves Limited Number of Lots of Avaira Sphere Lenses

Sprycel and Risk of Pulmonary Arterial Hypertension

The leukemia drug Sprycel (dasatinib) may increase the risk of a rare but serious condition in which there is abnormally high blood pressure in the arteries of the lungs (pulmonary arterial hypertension, or PAH).

Risk: Having PAH requires the heart to work harder to pump blood into the lungs. Over time, the overworked heart may become weak and lose its ability to pump enough blood through the lungs. Symptoms of PAH may include shortness of breath, tiredness, and swelling of the body (such as the ankles and legs).

In cases reported to FDA, people developed PAH after starting Sprycel, including some who had been taking it for more than one year.

Information about this risk has been added to the Sprycel drug label.

Recommendation: If you take Sprycel and develop symptoms of PAH, contact your health care professional immediately.

For More Information

FDA Drug Safety Communication: Sprycel (dasatinib) and risk of pulmonary arterial hypertension

Recall: Uprizing 2.0

Lab test results show that Uprizing 2.0, sold as a testosterone booster, contains the synthetic steroid superdrol, which makes the product an unapproved new drug.

Uprizing 2.0, a product of Superior Metabolic Technologies Inc. (SMT), comes in a black plastic bottle with a black, red and silver label and contains 90 capsules. The SMT logo is on the top of the bottle. Uprizing 2.0 was distributed through retail health food stores in Alabama, Arizona, California, Georgia, Mississippi, New Jersey, South Carolina and Texas.

Risk: Sudden, severe liver injury is known to be a possible harmful effect of using products that contain synthetic anabolic steroids. These steroids may cause other serious, long-term health consequences, including

  • shrinkage of the testes
  • male infertility
  • masculinization of women
  • breast enlargement in males
  • short height in children
  • harmful effects on blood cholesterol levels
  • increased risk of heart attack, stroke and death

Recommendations

  • Stop using Uprizing 2.0 and return it to the place of purchase for a full refund.
  • If you have questions, contact Superior Metabolic Technologies at 1-888-445-3230 Monday through Friday from 10 a.m. to 6 p.m. EST.

Drug Safety Labeling Changes

In September, FDA required safety labeling changes to be made to more than 35 drug products, including Latisse ophthalmic solution, Nicorette gum, Cymbalta capsules, and Detrol tablets. Changes were made to the prescribing information and, in some cases, to the patient package inserts and medication guides (paper handouts for patients that come with many prescription medicines) to warn about potential harmful reactions, tell who shouldn’t take the drug, or give other safety information.

For More Information

Monthly Safety Labeling Changes

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

Dec. 1, 2011

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