FDA's MedWatch Safety Alerts: July 2012
- MS Drug Carries Seizure Risk
- Recall: iFlora Kids Dietary Supplement
- Recall: X-ROCK 3 DAy Pill for Men, Z-ROCK Supplements
- Safety Labeling Changes
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.
- 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 and ongoing safety reviews prompted by reports FDA has received through MedWatch.
MS Drug Carries Seizure Risk
FDA is updating health care professionals and the public about the risk of seizures in multiple sclerosis (MS) patients who are starting to take the medication Ampyra (dalfampridine). FDA recently evaluated the risk based on adverse event (negative outcome) reports. The agency found that most of the seizures happened within days to weeks after starting the recommended dose and occurred in patients who had no history of seizures. Ampyra is FDA-approved to improve walking in patients with MS.
Risk: Seizures are a known side effect of Ampyra, and seizure risk increases with higher blood levels of the drug. Ampyra is eliminated from the body through the kidneys, so patients with kidney problems may be at greater risk.
- Tell your health care professional if you have kidney problems. He or she should order blood tests periodically to evaluate your kidney function. Do not take Ampyra if you have ever had a seizure.
- Take Ampyra tablets whole and do not divide, crush, chew or dissolve them.
- Do not take double or extra doses of Ampyra if you miss a dose. Side effects, including seizures, are more frequent at higher doses.
For More Information
Recall: iFlora Kids Dietary Supplement
Sedona Labs has recalled certain lots of iFlora Kids Multi-Probiotic distributed between March 16, 2011 and May 3, 2012 because of an ingredient that may have been contaminated with Salmonella.
Risk: Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy people infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.
In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections, endocarditis (an inflammation of the heart’s inner lining), and arthritis.
Product lots affected by this recall include: 1074711, 1479611, 1640811, 1734411, 1595811 and 2089411.
- Stop using the product immediately.
- Return the product to the place of purchase for a full refund, and call the company with questions at 1-888-816-8804, Monday-Friday, from 7:00 AM-3:00 PM PST.
For More Information
Recall: X-ROCK 3 Day Pill For Men, Z-ROCK Supplements
CRM Laboratories is recalling all X-ROCK 3 Day Pill For Men and Z-ROCK dietary supplements sold between October 2011 and April 2012. FDA tested these products and found that they contained sildenafil—the active ingredient in an FDA-approved drug used to treat erectile dysfunction—and hydroxythiohomosildenafil, which is similar to sildenafil and is expected to have the same side effects. The presence of these ingredients make these products unapproved new drugs.
Risk: These undeclared active ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates. Additionally, hydroxythiohomosildenafil, like sildenafil, may cause side effects, such as headaches and flushing.
All codes of X-Rock 3 Day Pill for Men and Z-Rock All Natural Male Supplement, within expiration, are included in this recall. The products are blue capsules individually packaged on a cardboard blister card; some older packaging includes a blister double pack (2 capsules per blister card) and white plastic bottles (6, 12, 24 count). The products were sold nationwide through the Internet and at retail locations.
- Stop using these products immediately and contact your physician if you have experienced any problems that may be related to taking them. Return any unused products, for a refund of the full purchase price, to the retail location from which you bought it, or to the Company directly. Call 305-587-9830 Monday through Friday 9am-5pm EST to receive instructions for returning the products.
For More Information
Safety Labeling Changes
In June 2012, FDA required safety labeling changes to be made to 35 drug products. These include the antibiotic Zithromax (azithromycin), which may cause changes in the electrical activity of the heart—specifically, prolongation of the QT interval, a measure of the heart’s electrical activity—and can lead to a potentially fatal abnormal heart rhythm called Torsades de Pointes.
In addition, the following birth control pills may interact with lamotrigine (Lamictal), an antiepileptic drug, reducing seizure control—talk with your health care provider about adjusting dosage:
- Modicon (norethindrone/ethinyl estradiol) Tablets
- Ortho-Cept (desogestrel and ethinyl estradiol) Tablets
- Ortho-Cyclen (norgestimate/ethinyl estradiol) Tablets
- Ortho Tri-Cyclen (norgestimate/ethinyl estradiol) Tablets
- Ortho Tri-Cyclen Lo (norgestimate/ethinyl estradiol) Tablet
- Ortho-Novum (norethindrone/ethinyl estradiol) 1/35 Tablets
- Ortho-Novum (norethindrone/ethinyl estradiol) 7/7/7 Tablets
For More Information
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
August 13, 2012