Injuries from Medical Drugs

Pharmaceutical and Dietary Supplement Litigation: Drug Safety Poses Health Risk for Consumers

Every day, Americans put their health and well–being in the hands of the pharmaceutical industry and the medical profession. Sometimes, however, a drug manufacturer knows that a drug could endanger consumers, but fails to warn physicians or the public of the serious health risks associated with its use. Although the federal Food and Drug Administration (FDA) oversees the drug manufacturing process, the agency’s approval of a specific drug does not always guarantee that it is safe. In fact, the FDA may pull a harmful drug off the market after it has already caused significant damage to patients.

Oral-Cleft Birth Defects Linked to Topamax®

The FDA has reclassified Topamax (topiramate) to a Preganancy Category D antiepileptic drug based on a study by the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The study’s findings showed an increased risk of oral cleft birth defects—cleft lip and cleft palate—in infants born to mothers who had taken Topamax. See Topamax Linked to Birth Defect for more information.

CHANTIX® (varenicline)

CHANTIX® (varenicline) helps patients quit smoking by blocking the uptake of nicotine within the brain. The FDA has received numerous reports of serious side effects including visual disturbances, transient forms of blindness, movement disorders, seizures, loss of consciousness, suicidal thoughts, suicidal behavior, psychosis, hostility, aggression, paranoia and depression. Read more about CHANTIX® side effects.

Fentanyl Transdermal Pain Patch Recall

PiCar recalled two lots of 50 microgram/hour (mcg/hr) fentanyl pain patches on December 31, 2008. The defective patches leak fentanyl gel into the outer foil packaging, possibly leading to an accidental overdose.

Other Prescription Drugs; Over–the–Counter Drugs

These are some other prescription drugs and over–the–counter medications that may have caused health problems:

  • Celebrex® May Increase Heart Attack Risk

    The arthritis drug Celebrex®(celecoxib) may increase the risk of heart attacks and strokes (see Celebrex® Gets Black Box Warning). Taking the drug is particularly dangerous for patients who have already undergone heart bypass surgery. Celebrex® is closely related to Vioxx® and Bextra®, which were withdrawn from the market for safety reasons.

  • Cytotec® (misoprostol)

    Cytotec® decreases the chances of getting stomach ulcers caused by taking certain arthritis or pain medicines. Although the FDA has only approved Cytotec® to treat ulcers, Cytotec® has often been used to induce labor or to decrease blood loss after delivery of a baby. A woman who uses Cytotec® during labor or after delivery may tear her uterus or womb, resulting in severe bleeding, miscarriage or death.

  • Femara® (letrozole)

    The FDA approved Femara® for the treatment of breast cancer in women who have gone through menopause. However, some doctors have used the drug “off-label” as a fertility treatment. If a woman uses Femara® and becomes pregnant, she may deliver a baby who has birth defects.

  • FOSAMAX® and Jaw Damage

    FOSAMAX® (alendronate sodium) is mainly used to prevent and reverse bone loss, called osteoporosis. However, the drug may cause severe decay of the jaw bone or jaw osteonecrosis. This disorder causes loose teeth and jaw pain. At present, there is no cure for jaw osteonecrosis. For more details, please see FOSAMAX®: A Bone–Building Drug that Can Damage the Jaw.

  • Remicade® (infleximab)

    Remicade® treats the symptoms of rheumatoid arthritis and Crohn’s disease, which is a disorder that causes inflammation and fistulas (tunnel–like structures) in the intestine. Remicade® is also approved to treat a type of spinal arthritis called ankylosing spondylitis.

  • Tequin®

    The antibiotic Tequin® has caused severe blood glucose changes in some patients, leading to hospitalizations and deaths. One Canadian study found that Tequin® users were almost 17 times more likely to have a high blood sugar (hyperglycemic) episode than were patients taking other antibiotics such as erythromycin. They had four times the odds of having a low blood sugar (hypoglycemic) episode.

    Tequin® is prescribed for bronchitis, pneumonia, gonorrhea, and lung, skin, kidney and urinary tract infections. Its manufacturer, Bristol–Myers had $150 million in sales for the drug in 2005. However, the company stopped manufacturing Tequin® in May, 2006, citing business reasons. See Antibiotic Tequin® To Be Taken Off the Market.

Individuals who have taken an unsafe drug or been exposed to a contaminated vaccine, may be at risk for serious health problems and should be medically monitored. If you have questions about your legal rights concerning medical drugs and vaccines, please feel free to contact us at Brayton Purcell. There is no charge for our initial consultation.

back to top