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U.S. Department of Health and Human Services

For Consumers

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FDA's MedWatch Safety Alerts: June 2010

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After the Food and Drug Administration (FDA) approves a product and it is on the market, the agency continues to monitor that product for unexpected and undesirable side effects (adverse events).

Health care professionals and consumers may report side effects, product quality problems, product use errors, or therapeutic failure with the use of medical products 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: 1-800-FDA-0178
  • Phone: 1-800-332-1088

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

Here are some of the most recent safety alerts prompted by reports FDA has received from health care professionals and patients.

 

Magic Power Coffee Potentially Dangerous

Magic Power Coffee, an instant coffee product sold online as a dietary supplement for sexual enhancement, contains a chemical similar to the active ingredient in the prescription drug Viagra. Viagra is used to treat erectile dysfunction.

The chemical in Magic Power Coffee may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure.

Recommendations

  • Stop using Magic Power Coffee immediately.
  • If you have experienced any bad side effects from Magic Power Coffee or any sexual enhancement product, talk to a health care professional.

For More Information

Magic Power Coffee: Potentially Dangerous—Not Magical

Hidden Risks of Erectile Dysfunction "Treatments" Sold Online

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Beware Fraudulent Tamiflu Sold on Internet

A fraudulent product promoted on the Internet as “generic Tamiflu” can be life-threatening to people allergic to penicillin.

FDA has not approved a generic version of Tamiflu, which is used to treat the flu.

FDA tests revealed that the phony product does not contain Tamiflu’s active ingredient, oseltamivir. Instead, the fraudulent product contains cloxacillin, an ingredient in the same class of antibiotics as penicillin.

People who are allergic to penicillin and use the fraudulent Tamiflu are at risk of experiencing difficulty breathing, tightness in the chest, swelling of the throat or tongue, hives, dizziness, loss of consciousness, and a rapid or weak pulse.

Recommendations

  • Do not use drugs misrepresented as “generic Tamiflu.” If you suspect a website is selling this product, contact FDA's Office of Criminal Investigations by visiting www.fda.gov/OCI or calling 800-551-3989. If you suspect a website is selling any fraudulent medical product, you may report it on FDA’s website, Reporting Unlawful Sales of Medical Products on the Internet.
  • If you buy medications on the Internet, buy only from legitimate Internet pharmacies, which are licensed by the appropriate state board of pharmacy and follow laws and regulations. Legitimate Internet pharmacies display a VIPPS (Verified Internet Pharmacy Practice Sites) seal. See a list of these pharmacies at www.vipps.info.

For More Information

FDA Sounds Alarm on Phony Tamiflu

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Overdose Risk With Vitamin D Supplements for Infants

Some liquid vitamin D supplement products for infants are sold with droppers that can hold a greater amount of vitamin D than an infant should receive. This could allow caregivers to accidentally give harmful amounts of the supplement to the infant.

Excess vitamin D can cause infants to have nausea and vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, and fatigue, as well as more serious consequences like kidney damage.

Recommendations

  • Ensure that your infant does not receive more than 400 international units (IUs) of vitamin D a day. This is the dose the American Academy of Pediatrics recommends for breast-fed and partially breast-fed infants.
  • Keep the vitamin D supplement product with its original package so that you can follow the instructions.
  • Use a product with a dropper that will give no more than 400 IU per dose.
  • If you cannot clearly determine the dose of vitamin D delivered by the dropper, talk to a health care professional before giving the supplement to your infant.
  • If your infant is being fully or partially fed with infant formula, check with your pediatrician or other health care professional before giving the child vitamin D supplements.

For More Information

Infant Overdose Risk With Liquid Vitamin D

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New Safe Use Requirements for Some Inhaled Asthma Drugs

New recommendations are now included in the drug labels for inhaled medications called Long-Acting Beta-Agonists (LABAs), a class of drugs used to treat asthma and chronic obstructive pulmonary disease (COPD). The new recommendations apply to LABAs only when they are used to treat asthma—not COPD.

In February 2010, FDA announced it was requiring LABA manufacturers to revise their drug labels to help promote the safe use of LABAs used to treat asthma. This requirement was based on FDA’s analysis of studies that showed an increased risk of severe worsening of asthma symptoms, leading to hospitalizations as well as death in some people who used LABAs to treat their asthma.

Recommendations

  • Be aware that LABAs do not relieve asthma symptoms that appear suddenly. You should always have a rescue inhaler, such as an albuterol inhaler, to treat asthma symptoms that begin suddenly.
  • If you need a LABA plus a long-term asthma control medication that is not available as a combination product, work with your health care professional to ensure that each medication is taken correctly.
  • Read the medication guide that comes with each prescription for a LABA and ask your health care professional any questions you may have about using LABAs.

For More Information

Long-Acting Beta Agonist (LABA) Information

FDA Urges Safe Use of Certain Inhaled Asthma Medicines

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Recall: Additional Over-the-Counter Drugs From McNeil

Additional lots of Benadryl and Tylenol products have been added to the Jan. 15, 2010, recall of certain over-the-counter products from McNeil Consumer Healthcare. The medicines may not meet required quality standards.

The recently recalled products are

  • Benadryl Allergy Ultratab Tablets, 100 count, lot numbers AJA008, ADA194, ABA022, and ABA264
  • Extra Strength Tylenol Rapid Release Gels, 50 count, lot number ASA202

Recommendations

  • Stop using these products.
  • For a full list of McNeil's recalled products and how to get a refund or replacement coupon, see the company’s website at www.mcneilproductrecall.com or contact McNeil at 1-888-222-6036.
  • Discuss any questions you may have about these products with your pharmacist or other health care professional.

For More Information

Recall of Liquid Products for Children: What Consumers Need to Know

 

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

Posted July 2, 2010

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