What's New | Current Newsletter | Newsletter Archive | Newsletter Sign Up

Current Newsletter

FDA Warnings And Recalls

Many drug products will develop recalls or FDA warnings as ongoing research provides more information about them. As more and more people use new medications, unbefore seen adverse effects can arise.  Often patients are unaware of potentially harmful drug interactions or side effects of the various medications they are taking.

At South Florida Institute of Sports Medicine, we were recently made aware of new FDA drug warnings. We would like to share a few of these with you for your knowledge and benefit. A full list of FDA recalls, warnings and safety alerts can be found at www.fda.gov/opacom/7alerts.html

Important Note: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. If you have any specific concerns about a medication you are taking, contact your physician directly.

Drug Warnings

Activella, an estrogen/progesterone hormone replacement therapy (HRT)        
used to reduce menopause symptoms and prevent bone loss (osteoporosis)

  • In the Women’s Health Initiative Study, an increased risk of stroke and blood clot was observed in women receiving estrogen compared to placebo.
  • Should not be used in women with suspected or known pregnancy.

Arixtra, a "blood thinner" used to help prevent blood clots following hip fracture, hip replacement surgery, knee replacement surgery, or abdominal surgery.

  • Prophylactic use of Arixtra is contraindicated in patients with body weight less than 50 kg (110 lbs.)
  • Cannot be used with spinal anesthesia.

Alora, an estradiol patch used to reduce menopause symptoms and prevent bone loss (osteoporosis).

  • Should not be used in individuals with liver dysfunction or disease.
  • Should not be used in individuals with known or suspected pregnancy.
  • Should not be used in individuals with known hypersensitivity to its ingredients.

Keppra, used in combination with other medications to treat seizures disorders (epilepsy).

  • In pediatric patients, Keppra is associated with sleepiness, fatigue and behavioral abnormalities.

Lodine, an NSAID used to relieve pain, swelling, and joint stiffness.

  • Gastro-intestinal toxicity such as bleeding, ulceration, and perforation of the stomach or intestine can occur with chronic use.
  • Lodine is not recommended for people with advanced kidney disease.

Mevacor, a “statin” used to lower cholesterol.

  • Mevacor should be avoided when other drugs such as danazol, itraconazole,  ketoconazole, erythromyacin, clarithromyacin, telithromyacin, or large quantities of grapefruit juice are also used.

Raptiva, used to treat adults with severe plaque psoriasis.

  • Serious infections ( necrotizing fasciitis, tuberculous pneumonia), immune-mediated thrombocytopenia, and immune-mediated hemolytic anemia, and worsening psoriasis have been reported.

Requip, used to treat Parkinson’s disease.

  • Falling asleep during normal daily activities, hypotension, and hallucination have been reported.

Topamax, used to treat migraine headaches.

  • Headache, dizziness, anorexia, fatigue and metabolic acidosis have been reported.