PRESCRIPTION DRUG SUMMARIES
Accutane (isotretinoin) is indicated for severe nodular acne. However, Accutane administration is associated with severe side effects. If taken while pregnant, Accutane can cause serious birth defects, premature birth, or miscarriage. The use of Accutane has also been associated with depression, thoughts of suicide, and other mental disturbances that may continue even after the drug is discontinued.
Arava (leflunomide) is indicated for the treatment of active rheumatoid arthritis. Arava treatment has been associated with serious hepatic injury, including fatalities.
Aredia (pamidronate disodium) is indicated for the treatment of hypercalcemia of malignancy, Paget’s disease, osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma. The administration of Aredia has been associated with the occurrence of osteonecrosis of the jaw in cancer patients receiving intravenous bisphosphonates, such as Aredia.
Avandia (rosiglitazone) is used in the treatment of diabetes. Currently, reports of new onset and worsening diabetic macular edema for patients treated with rosiglitazone. Patients have also reported concurrent peripheral edema. Serious side effects also include life threatening occurrences such as cardiac events, including cardiac failure, and hepatic risks.
Avastin (bevacizumab) is used in combination with intravenous 5-fluoracil-based chemotherapy, and is indicated for first-line treatment of patients with metastatic carcinoma of the colon or rectum. Arterial thromboembolic events, including cerebral infarction, transient ischemic attacks (TIAs), myocardial infarction(MI), and angina, occurred at a higher incidence in patients receiving Avastin in combination with chemotherapy as compared to those receiving chemotherapy alone. Some of these events were fatal.
Avonex (interferon beta-1a) is approved for the treatment of multiple sclerosis. Severe hepatic injury, including hepatic failure, has been reported in patients taking Avonex. Asymptomatic elevation of hepatic transaminases has also been reported. The risk associated with other hepatotoxic drugs and alcohol should be considered in patients receiving Avonex.
Baycol (cerivastatin) is a cholesterol lowering medication falling under a class of drugs known as statins. Baycol, like all statins, can cause rhabdomyolysis, a severe muscle adverse reaction. However, Baycol is ten times more likely to cause rhabdomyolysis than the other statins. On August 8, 2001, as a result of 31 deaths in the United States, Bayer A.G. Pharmaceuticals voluntarily withdrew Baycol from the United States market.
Betaseron (interferon beta-1b) is approved for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Betaseron administration has been linked to serious hepatic injury including autoimmune hepatitis and severe liver damage leading to hepatic failure and transplant.
Bextra (valdecoxib) is a non-steroidal anti-inflammatory drug (NSAID) known as COX-2 selective agent. Bextra is indicated for the treatment of osteoarthritis, rheumatoid arthritis, and dysmenorrhea. It has been associated with an increased risk of serious cardiovascular events, including heart attack and stroke, especially when used for long periods of time or in a high risk situation such as following heart surgery. Bextra is contraindicated in patients undergoing coronary artery bypass graft (CABG) surgery.
Bextra has also been associated with risk of life-threatening skin reactions including Steven-Johnson Syndrome and toxic epidermal necrolysis.
Celebrex (celecoxib) is a non-steroidal anti-inflammatory drug (NSAID) known as COX-2 selective agent. It has been associated with an increased risk
of serious cardiovascular events, including heart attack and stroke, especially when used for long periods of time or in a high risk situation such as following heart surgery.
Cialis (tadalafil) is used for the treatment of erectile dysfunction. The FDA has received reports of sudden vision loss, attributed to NAION (non arteritic ischemic optic neuropathy), a condition in which blood flow is blocked to the optic nerve.
Clozaril (clozapine) is an atypical antipsychotic medication. The use of Clozaril requires the monitoring of white blood cells in all Clozaril users. Use of Clozaril has been associated with an increased risk of hyperglycemia in diabetic patients taking Clozaril. The use of Clozaril is also associated with a pharmacokinetic interaction with citalpram.
Cordarone (amiodarone) is a drug used to treat heart irregularities. Cordarone has serious side effects including lung problems, blindness, liver damage, and nerve damage.The FDA requires a Medication Guide to be provided with each prescription due to the serious and significant public health concern posed with this drug.
Crestor (rosuvastatin calcium), like other statin drugs, is used to treat high cholesterol. The FDA has reported the risk of rhabdomyolysis or serious muscle damage in patients using Crestor.
Cylert (pemoline) was a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). In May of 2005, Abbott Pharmaceuticals took Cylert off the market due to FDA’s conclusion that the overall risk of liver toxicity outweighed the benefits of this drug.
Depo- Provera is a contraceptive injection that is given every three months to prevent pregnancy. It has recently received a black box warning from the FDA indicating that prolonged use of the drug may result in significant loss of bone density. The loss is greater the longer the drug is administered and may not be completely reversible after discontinuation of the drug.
Duragesic (fentanyl transdermal patch) is a potent narcotic drug used for pain management. Death has been associated with the use of this powerful pain medication.
Effexor (venlafaxine HCl) is drug known as a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of depression. Neonates exposed to Effexor, late in the third trimester have developed complications requiring prolonged hospitalization, respirator support, and tube feeding. Patients with major depressive disorder should also be monitored when taking anti-depressants such as Effexor for worsening of depression symptoms and the emergence of suicidal ideation and behavior.
Ephedra, an ephedrine alkaloid, is an adrenaline-like stimulant that can have potentially dangerous effects on the heart. Recent studies confirm that ephedrine alkaloids raise blood pressure, and otherwise stress the circulatory systems, which may lead to heart attacks and strokes.
Flomax (tamsulosin HCl) is prescribed for the treatment of the signs and symptoms of benign prostatic hyerplasia (BPH). A surgical condition known as Intraoperative Floppy Iris Syndrome (IFIS) has been observed during phacoemulsification cataract surgery with alpha-1 blocker including Flomax.
Fortovase (rifampin) is an antiviral used for HIV infection. Incidences of drug-induced hepatitis with marked transaminase elevations have been observed in healthy volunteers receiving rifampin 600 mg once daily in combination with ritonavir 100mg/ saquinavir 1000mg twice daily. Fortovase should not be administered with the combination of ritonavir and saquinavir as a part of antiretroviral therapy (ART) for HIV infection.
Gabitril (tiagabine) is used for epilepsy and other off label uses including various psychiatric illnesses. The FDA has received reports of the occurrence of seizures in patients prescribed Gabitril for conditions other than epilepsy.
Humira (adalimumab) is indicated for the treatment of rheumatoid arthritis. Humira has been reported to be linked to serious infections with the combined use of Humira and anakinra, hypersensitivity reactions, including anaphylaxis, and hematologic events, including pancytopenia and aplastic anemia.
Hydroxycarbamide (Hydrea) is a chemotherapy drug that is given as a treatment for some types of cancer. The administration of Hydrea or Droxia has serious side effects associated with its use in patients with myeloproliferative disorders and with a history
of, or currently receiving, interferon therapy. These include cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene.
Invirase (rifampin) is an antiviral used for HIV infection. Incidences of drug-induced hepatitis with marked transaminase elevations have been observed in healthy volunteers receiving rifampin 600 mg once daily in combination with ritonavir 100mg/ saquinavir 1000mg twice daily. Invirase should not be administered with the combination of ritonavir and saquinavir as a part of antiretroviral therapy (ART) for HIV infection
Ketek (telithromycin) is an antibiotic. Cases have been reported to FDA MedWatch and a recent article in Annals of Internal Medicine reported patients suffering from serious liver toxicity following the administration of Ketek.
Kugel Mesh Patch
This patch is used to repair ventral hernias caused by thinning or stretching of scar tissue that forms after surgery. The “memory recoil ring” responsible for opening the patch can break after it has been inserted. This can lead to bowel perforations and/or chronic intestinal fistulae.
Levitra (vardenafil) is used for treatment of erectile dysfunction. The FDA has received reports of sudden vision loss, attributed to NAION (non arteritic ischemic optic neuropathy), a condition in which blood flow is blocked to the optic nerve.
Macugen (pegaptanib sodium injection) is indicated for the treatment of neovascular (wet) age-related macular degeneration and is administered once every six weeks by intra-vitreous injection. The administration of Macugen has been associated with anaphylaxis/anaphylactoid reactions, including angioedema.
Meridia is indicated for weight loss treatment and was approved by the FDA in 1998. However, Meridia is associated with dangerous and potentially life-threatening side effects including cardiovascular complications including Primary Pulmonary Hypertension, stroke, increase in heart rate, and increase in blood pressure.
Methylin (Methylphenidate HCL) is used in the treatment of Attention Deficit Hyperactivity Disorder and Narcolepsy. In 2005, Alliant Pharmaceuticals voluntarily recalled all lots of the product due to the fact that some tablets may contain too little or too much active ingredient.
Mifeprex (mifepristone, RU-486) is used for medical abortions. The FDA released a public health advisory reporting the risks of sepsis or blood infections after administration of Mifeprex. Other serious side effects include serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death.
Neurontin (Gabapentin) is indicated for the treatment of partial seizures associated with epilepsy. Neurontin has also been prescribed for off-use labels such as treatment for chronic pain, bipolar disorder and migraines. Warner-Lambert Corp., acquired by Pfizer in 2000, used illegal marketing techniques to promote Neurontin for off-label uses. Neurontin is associated with severe and sometimes life-threatening side effects including suicide and suicidal thoughts.
Novantrone (mitoxantrone) is indicated for the treatment of multiple sclerosis (MS). Administration of Novantrone has been associated with cardiotoxicity and also with cases of secondary acute myelogenous leukemia (AML) in patients with MS.
Ontak (denileukin diftitox) is indicated for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma. Loss of visual acuity, usually with loss of color vision, has been linked to Ontak administration
Orlaam is a synthetic opioid agonist solution indicated for the management of opiate dependence usually a second line therapy. Roxane Laboratories, Inc. has discontinued the sale and use of Orlaam following reports of severe cardiac-related events, including Torsades de Pointes and cardiac arrest.
Oxycontin (oxycodone hydrochloride controlled release) is a powerful narcotic medication used for the management of moderate to severe pain. Oxycontin is an effective medication if used properly. However, it is often misused, diverted, and has high abuse potential. The illegal market for Oxycontin is rapidly growing. Reports of the misuse and abuse of Oxycontin have been associated with serious consequences including death.
Palladone (hydromorphone hydrochloride) is a once-a-day pain management drug containing a potent narcotic. The FDA requested Purdue Pharma L.P., to remove Palladone
from the market after reports of serious and potentially fatal adverse reactions which could occur when Palladone is taken with alcohol.
Paxil (paroxetine) is currently indicated for the treatment of depression and several other psychiatric disorders. Paxil is a member of a class of drugs known as Selective Serotonin Reuptake Inhibitors (SSRI). The class of SSRI is linked to severe consequences such as suicide and suicidal thoughts. Studies have also indicated that the drug increases the risk for birth defects, particularly heart defects, when women take Paxil in
the first three months of pregnancy.
Permax (pergolide mesylate) is indicated as adjunctive treatment to levodopa/carbidopa in the management of the signs and symptoms of Parkinson’s disease. Patients may fall asleep while performing daily activities, including operation of motor vehicles, after being treated with Permax.
Prempro / Premelle / Premarin
Prempro, Premelle, and Premarin are all hormone replacement therapy (HRT) medications used for the treatment of moderate to severe menopausal symptoms. However, HRT medication use has been associated with severe consequences including ductal and lobular breast cancer, ovarian cancer, non-hodgkin’s lymphoma and gall bladder cancer. HRT administration has also been associated with adverse cardiac events including increased rates of blood clots, cardiovascular disease, and stoke.
Promethazine is used to treat nausea and vomiting. It may also be used for sedation, allergy symptoms and motion sickness. The use of promethazine has been linked to breathing problems, some causing deaths when the drug was used in children less than two years of age.
Prozac (fluoxetine) is indicated for the treatment of depression, obsessive compulsive disorder, bulimia nervosa, and panic disorder. Prozac is a member of a class of drugs known as Selective Sertonin Reuptake Inhibitors (SSRI). Prozac administration has been associated with severe consequences including suicide, suicidal thoughts and violence directed to the patient or to others.
Phenylpropanolamine (PPA) was a widely used active ingredient in many over-the-counter (OTC) nasal decongestants and OTC diet medications. In November of 2000, the FDA removed PPA from the market. Reports of hemorrhagic stroke in women were associated with the use of PPA. Men also were likely at risk.
Remicade (infliximab) is indicated for the treatment of rheumatoid arthritis, Crohn’s disease and ankylosing spondylitis. Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported. Remicade has also been associated with fatalities in patients with existing heart conditions.
Rezulin (troglitazone) was indicated for type 2 diabetes in helping the body lower blood sugar levels. On March 21, 2000, the FDA asked Parke-Davis/Warner Lambert to remove the drug from the market. Rezulin administration was associated with severe liver toxicity.
Risperdal (risperidone) is indicated for the treatment of schizophrenia. Administration of Risperdal has been identified to increase the risk of hyperglycemia in diabetic patients. Cerebrovascular adverse events such as stroke and transient ischemic attack, including fatalities, have been reported in elderly patients with dementia-related psychosis.
Serevent (salmeterol) inhaler is indicated for the long-term treatment of asthma, and chronic obstructive pulmonary disease. After 1996, the FDA received reports of several asthma deaths associated with Serevent.
Serzone (nefazodone HCl) is anti-depressant medication. The FDA and
Bristol-Myers Squibb have encouraged health professionals to perform a
risk-benefit analysis when prescribing Serzone instead of alternatives for depression. Treatment with Serzone has been linked to hepatic failure. Caution has also been issued to health care providers to closely observe patients treated with Serzone for clinical worsening of the symptoms of depression and for the emergence of suicidality.
Stadol (butorphanol titrate) is indicated for management of pain and is a powerful opioid medication. Stadol is available in two forms: a nasal spray and an injectable. Stadol was marketed as a non-controlled substance. However after reports of addiction and death associated with Stadol use, the FDA changed the medication to a controlled substance. Yet given the severe addictions and death associated with the use of Stadol, Bristol-Myers Squibb is questioned for heavily marketing the drug as non-addictive in trying to obtain governmental approval.
Sustiva (efavirenz) is indicated in the treatment of HIV-1 infection. Pregnancy should be avoided in women receiving Sustiva. Sustiva has been associated with neural tube defects found in infants born to women with first trimester exposure to Sustiva.
Tequin (gatifloxacin) is an antibiotic indicated for the treatment of patients with pneumonia, bronchitis, uncomplicated gonorrhea, and various other infections. The use of Tequin has been associated with serious cases of hypoglycemia and hyperglycemia. Some cases have been life-threatening.
Tracleer (bosentan) is a drug used to treat patients who have been diagnosed with Primary Pulmonary Hypertension (PPH). Tracleer use has been associated with cases of hepatotoxicity.
Trasylol (aprotinin injection) is used to prevent blood loss during surgery. Trasylol has been linked in two scientific publications to higher risks of serious side effects including kidney problems, heart attacks, and strokes in patients undergoing artery bypass graft surgery.
Trileptal (oxcarbazepine) is indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and children ages 4-16 with epilepsy. The administration of Trileptal has been linked to serious dermatological reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
Viagra is indicated for the treatment of erectile dysfunction. The FDA has received reports of sudden vision loss, attributed to NAION (non arteritic ischemic optic neuropathy), a condition in which blood flow is blocked to the optic nerve. Viagra is also contraindicated in men currently using nitrates.
Vioxx (rofecoxib) is a non-steroidal anti-inflammatory drug (NSAID) known as COX-2 selective agent. Merck & Co., Inc., voluntarily withdrew Vioxx
from the market due to the serious and significant side effects. Vioxx was indicated for the treatment of osteoarthritis, rheumatoid arthritis, acute pain in adults, and dysmenorrhea. It has been associated with an increased risk
of serious cardiovascular events, including heart attack and stroke, especially when used for long periods of time or in a high risk situation such as following heart surgery.
Viramune (nevirapine) is used in HIV triple combination therapy. Viramune treatment is not recommended in women with CD4+ cell counts greater than 250 cells/mm3 unless the benefits outweigh the risk. Women with higher CD4 cell counts are observed to be at a higher risk of serious liver toxicity including fatal hepatotoxicity, including fulminant and cholestatic hepatitis, hepatic necrosis, and hepatic failure. These severe events are usually associated with a rash.
Wellbutrin (bupropion HCl) is indicated for the treatment of depression. Patients with major depressive disorder should also be monitored when taking anti-depressants such as Wellbutrin for worsening of depression symptoms and the emergence of suicidal ideation and suicidal behavior especially at the beginning of drug therapy and at the time of dose changes.
Zevalin (ibritumomab tiuxetan) is a radiolabeled monoclonal antibody used for B-cell lymphomas including Non-Hodgkin lymphoma. Zevalin use has been associated with severe cutaneous or mucocutaneous reactions. Some reactions
have had fatal outcomes.
Zometa (zoledronic acid) is prescribed in the treatment of hypercalcemia of malignancy, the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors. The administration of Zometa has been associated with the occurrence of osteonecrosis of the jaw in cancer patients receiving intravenous bisphosphonates, such as Zometa. Zometa administration should also be reduced in patients with reduced renal function because it can also cause further renal deterioration.
Zyprexa (olanzapine) is indicated for the treatment of schizophrenia and bipolar disorder. Administration of Zyprexa has been identified to increase the risk of hyperglycemia in diabetic patients. Zyprexa can also cause diabetes and diabetes-related complications, including coma and death. In the United States, Zyprexa is currently linked to 288 cases of diabetes, including 23 deaths. It may also increase the risk of cardiac events and infections in elderly dementia patients.
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