For Consumers

FDA's MedWatch Safety Alerts for Consumers: March - April 2015

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Human and Veterinary Drugs Recalled from Prescription Center Pharmacy, Fayetteville, NC

Patients are urged not to use products made and distributed by Prescription Center Pharmacy, 915 Hay St., Fayetteville, North Carolina.

Concerned about the company’s ability to ensure the sterility, stability, and potency of human and veterinary products, North Carolina officials closed the facility and ordered a recall of the products compounded or repackaged there between September 10, 2014, and March 10, 2015.

Risk: FDA is not aware of any adverse events associated with these products.

Recommendation

  • Report to FDA any adverse effects associated with products from Prescription Center Pharmacy

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Topical Pain Medication Dangerous to Pets

Pets may become ill or die if exposed to topical medications containing flurbiprofen, used to treat muscle, joint, and other pain in humans.

Cats in two households became ill or died after their owners used topical medications containing flurbiprofen on themselves to treat muscle, joint, or other pain. It is unclear how these animals became exposed to the drug.

Risk: Exposure—even very small amounts—can be dangerous to animals.

Recommendations

  • Prevent pets from any kind of exposure, no matter how unlikely, to medicines containing flurbiprofen.
  • Store all medications safely out of reach of pets.
  • Safely discard or clean any cloth or applicator that may retain medication and avoid leaving residues of the medication on clothing, carpeting or furniture.
  • Ask a physician if you should cover the treated area or take other steps to keep pets from being exposed to medications.
  • If your pet is exposed to medications containing flurbiprofen, bathe or clean your pet as thoroughly as possible and consult a veterinarian.
  • If your pet vomits, won’t eat, seems unusually tired or otherwise sick, consult a veterinarian. Make sure to tell the vet about your pet’s exposure.

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Incorrect Facts on Some Mucinex Labels

Some labels of over-the-counter Mucinex medications include incorrect facts, misleading consumers about the safety and side effects of the products.

RB (Reckitt Benckiser) recalled lots of the following Mucinex® FAST-MAX®:

  • Night Time Cold & Flu
  • Cold & Sinus
  • Severe Congestion & Cough
  • Cold, Flu & Sore Throat

Risk: Consumers who take the mislabeled Mucinex—particularly people with liver problems—could become sick, requiring medical care.

Recommendations

Contact your physician or health care provider if you think the medicine made you sick.

Properly dispose of unused medicine:

  1. Mix the unused medicine with kitty litter, used coffee grounds, or other uneatable substance.
  2. Put the mixture in a closed container, such as a sealed plastic bag.
  3. Throw the container in household trash.

If you have questions about the recalled Musinex, call 1-888-943-4215, between 8:00a.m. and 8:00 p.m., Eastern Standard Time, to speak with a company representative.

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Problems with Mammograms Performed at Richard D. Adelman, M.D., Family Practice

FDA is alerting patients about possible quality problems with mammograms performed any time after August 24, 2012, at Richard D. Adelman, M.D., Family Medicine practice in Raleigh, North Carolina.

The American College of Radiology (ACR) revoked the facility's accreditation on November 5, 2014. On November 18, 2015, the FDA required the facility to stop performing mammography and to notify patients who received mammograms at its facility any time after August 24, 2012 about these problems.

Patients have the right to request their original mammogram and copies of their medical reports from the practice.

Risk: The ACR identified problems with the quality of mammograms performed at the facility between August 25, 2012, and August 25, 2014. This does not necessarily mean that mammogram results were inaccurate, but patients should have their mammograms reviewed at a Mammography Quality Standard Act (MQSA)-certified facility to determine if they need a repeat mammogram or additional medical follow-up.

Recommendation

For patients who had a mammogram at Richard D. Adelman M.D., Family Medicine practice any time after August 24, 2012, and who have not had a mammogram at an MQSA-certified facility since then, consider requesting your mammogram and copies of your medical reports from the practice and having your mammogram reviewed at a MQSA-certified facility to determine whether a repeat mammogram or additional medical follow-up is needed.

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Possible Side Effects of Anti-smoking Medicine Chantix (varenicline)

FDA is warning that the anti-smoking prescription drug Chantix (varenicline) can change the way people react to alcohol.

Risk: Interactions between alcohol and Chantix reportedly resulted in some patients becoming more intoxicated, showing unusual or aggressive behavior, or experiencing memory loss. In addition, there have been rare accounts reported of patients having seizures after being treated with Chantix.

Recommendations

  • Until you know how Chantix affects your ability to tolerate alcohol, you should decrease the amount of alcohol you drink while taking the medicine.
  • If you have a seizure while taking Chantix, immediately seek medical attention and stop taking the medicine.

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Beware of Homeopathic Asthma Products

FDA is warning consumers not to rely on asthma products labeled as homeopathic that are sold over the counter. FDA has not evaluated these products for safety and effectiveness.

Many of these products are promoted as "natural," "safe," and "effective," and purport to treat a range of asthma symptoms. In general, consumers can identify such products by looking for the word "HOMEOPATHIC" on a product's label and looking for whether the product's active ingredient(s) are listed in terms of dilution, such as "LM1," "6X," or "30C."

Risk: Asthma is a serious, chronic lung condition. If it is not appropriately treated and managed, patients may have wheezing, shortness of breath, and coughing, and could be at risk for life-threatening asthma attacks that may require emergency care or hospitalization.

Recommendations

  • Speak to your health care provider if you think you or your child may have asthma.
  • If you or your child has asthma, make sure you have appropriate treatments on hand in the event of an asthma attack or a worsening of asthma symptoms, and consult with a health care provider when needed.

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FDA Concludes Review of a Study About a Drug to Treat Schizophrenia

After reviewing a study by Eli Lilly and Company, FDA could not exclude the possibility that two people died from an unexplained rapid distribution into their bloodstream of Zyprexa Relprevv (olanzapine pamoate), a drug for the treatment of schizophrenia.

However, the study suggested that the sudden surge of the drug in the two patients could have occurred after their deaths.

Recommendations

  • Do not deviate from the prescribed use of Zyprexa Relprevv injection.
  • Do not stop receiving treatment without first talking to your health care provider.

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May 13, 2015

     

Page Last Updated: 05/13/2015
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