Recall and Defect News

A:

Accutane  (isotretinion)

Uses:   Accutane is prescribed for acne, a serious skin condition often occurring in adolescents. There is no generic version of Accutane available for acne-sufferers.
Side Effects: According to FDA reports, Accutane may cause depression, psychosis, suicide attempts and suicide. Discontinuing Accutane therapy may not be sufficient to stop these effects. Feelings of depression may be episodic, but include loneliness, sadness, loss of energy, irritability and change in sleep pattern. In addition, Accutane has been linked to stomach problems (Crohn’s disease, IBS, ulcerative colitis, bowel disease), pancreatitis, vision damage and birth defects.
Manufacturer: Hoffman-La Roche
Status: On the Market

Arava   (lenflunomide)

Uses:   Arava is an anti-inflammatory drug used for the treatment of rheumatoid arthritis. Patients with rheumatoid arthritis (RA) take Arava to reduce the pain and swelling that occurs in joints, most notably in the hands or feet.
Side Effects: According to the Public Citizen, there have been 12 reported deaths, 56 hospitalizations and 130 cases of severe liver toxicity associated with Arava between September 1998 and September 2001. Two of the twelve Arava-related deaths reported were people in their 20's. In addition, Arava has been linked to twelve cases of the autoimmune disease Stevens-Johnson Syndrome with symptoms of an extreme allergic reaction.
Manufacturer: Aventis
Status: On the Market

B:

Baycol  (cerivastatin sodium)

Uses:   Baycol was a prescription drug used to lower cholesterol in patients who could not control their cholesterol levels through diet and exercise alone. Baycol was sometimes prescribed to be taken with other cholesterol-lowering medications for a stronger effect.
Side Effects: The Bayer Corporation voluntarily took Baycol off the market on August 8, 2003. According to FDA reports, at least 31 deaths have been associated with Baycol use. In some patients Baycol causes a muscle cell condition called rhabdomyolysis in which muscle cells breakdown, rupture and release muscle cell proteins and pigments into the bloodstream that cause kidney damage and in some cases, even kidney failure and death.
Manufacturer: Bayer Corporation
Status: Withdrawn from the Market  (August 2001)

Breast Implants

Uses:   The silicone gel-filled breast implants were removed from the market for general use in 1992. In their place arrived the saline breast implants. These saline-filled implants do use a silicone envelope, whose long-term safety has not been demonstrated, thus making the implants not entirely without risk.
Side Effects: Increased risk for fibromyalgia has been linked to leakage of the silicone from the breast implants. Capsular contracture - scar tissue that forms around the breast implant which causes the breasts to harden, Calcium deposits - in tissue around the breast implant, Granulomas - small lumps in tissues caused by inflammation, Rupture - of the breast implants, Leak of silicone gel - may escape from the breast implant and reach distant parts of the body, causing autoimmune-like disorders, Interference with mammography, Changes in nipple and breast sensation, Interference with breast feeding.
Manufacturer: multiple
Status: Silicone removed from the market (1992), others remain on the market

C:

Contraceptive Devices

Uses:   Over the last two decades, women have experienced serious side effects while using various brands of contraceptive devices for menstrual problems, birth control and cancer prevention.
Side Effects:
Norplant is a hormonal contraceptive for women that prevents pregnancy for five years after a single application. Wyeth, the maker of Norplant, settled claims with more than 35,000 women who said the Norplant contraceptive device caused side effects such as headaches, irregular menstrual bleeding, nausea and depression. Other Norplant side effects include severe headaches, nervousness, change in appetite, extreme weight gain, hair loss, dizziness, acne, breast tenderness, swelling of the ovaries and ovarian cysts, and problems with Norplant insertion and removal.
Depo Provera is a shot given every three months that prevents pregnancy through suppressing ovulation and making the cervix uninhabitable for sperm. Women taking Depo Provera have experienced side effects including nausea, depression, extreme weight gain, osteoporosis, loss of sex drive, short term sterility, headaches, hair loss, acne, weakness, and nervousness. Some research indicates that Depo Provera is linked with increased risk of breast and uterine cancer as well.
The Pill, known by a variety of brand names, is taken by over 10 million women in the United States. The birth control pill, the most popular form of contraceptive device, has some safety issues of its own.  For example, some research suggests possible links between birth control pill use and breast cancer, strokes, heart attack and blood clots. Other side effects of the pill include breast tenderness, depression and weight gain. 
Status: On the Market

Crestor   (Rosuvastatin)

Uses:   Approved on August 14, 2003 for the treatment of high-cholesterol. Crestor reduces cholesterol levels by blocking the liver from producing bad cholesterol (LDL). Crestor became the sixth cholesterol lowering "statin" drug on the U.S. market, following drugs like Lipitor, Pravachol and Zocor.
Side Effects: Only three months after its approval, three patients in the United States who were taking approved doses of rosuvastatin developed kidney failure or muscle damage. As in the case with Baycol, a cholesterol-lowering medicine withdrawn from the market by Bayer due to its serious side effects in August 2002, the muscle damage, known as rhabdomyolysis deteriorates the kidneys. In studies before Crestor's approval, seven people were struck by cases of rhabdomyolysis. Since the original Public Citizen petition was filed with the FDA in early March, the organization said, eleven additional cases of muscle damage, ten of them in the United States, and three additional cases of kidney problems, have been reported.
Manufacturer: Astra-Zeneca
Status: On the Market

D-L:

Ephedra   (Ma Huang)

Uses:   Originating from the Ephedra plant, ephedrine has been advertised as a time-tested Chinese herb (ma huang) that will relieve asthma and allergy symptoms, as well as enhance athletic performance and weight loss. More recently, the ma huang/ephedrine herb has been identified as a dangerous ingredient in many well-known household medications.
Side Effects: Ephedrine, the active ingredient found in popular diet pills, over-the-counter allergy medications, herbal energy boosters, sport drinks and herbal asthma remedies, has been linked with serious side effects and injuries including, stroke, heart attack and death. To date, the FDA has reported over 100 deaths and over 1000 serious side effects linked to Ephedra. Ephedrine has been frequently linked to episodes of anxiety, fever, vomiting, sleeplessness, migraines, memory loss, muscle injury, and high blood pressure. More serious ephedra side effects include seizures, paranoid psychosis, convulsions, comas, heart arrhythmias, heart attacks, intracranial bleeding, kidney disease, strokes and death.
Manufacturer: multiple products
Status: Withdrawn from the Market  (April 2004)

Fen Phen  (Fenfluramine and Phentermine)

We are no longer taking new Fen Phen cases.

Guidant Ancure Stent Grafts  (EndoVascular “Ancure” stent)

Uses:   The EndoVascular stent graft device, known as the "Ancure graft," is used to strengthen the aorta, the main blood vessel stemming from the heart, as it passes through the abdomen. For example, the device is used to treat an abdominal aortic aneurysm, a potentially life-threatening condition.
Side Effects: According to one report, during the implant procedure, the equipment used to insert the Ancure graft could become lodged. In other circumstances, the equipment would break apart into pieces before being removed. On June 16, 2003, the company announced it would stop making its abdominal aortic graft. It has been reported that the graft procedure resulted in complications that have been linked to 12 unreported deaths (28 total) and more than 57 unreported emergency operations to date. According to federal reports, 2600 of the total 7500 Ancure devices sold in the first 19 months experienced problems and complications during the operation.
Manufacturer: Guidant Corporation
Status: Withdrawn from the Market  (June 2003)

M - N:

Meridia  (sibutramine)

Uses:   Meridia, the popular weight-loss drug approved by the FDA in 1997, has come under considerable scrutiny in recent days due to its deadly side effects. Generically known as sibutramine, Meridia was the first diet drug approved following the FDA’s ban on Fen-Phen, and Redux.
Side Effects: Meridia has been associated with 29 deaths and 397 serious adverse events since 1998. These Meridia side effects include heart arrhythmias, heart attacks, high blood pressure, dilated cardiomyopathy, seizures, stroke and death. These complications were discovered by the Public Citizen in documents submitted by Abbott Laboratories to the FDA. On March 7, 2002, Italy suspended the marketing of Meridia due to the adverse effects, including 2 deaths and 50 adverse events.
Manufacturer: Abbott Laboratories
Status: On the Market

Neurontin  (gabapentin)

Uses:  The FDA approved Neurontin in 1993 as an anti-seizure medication for epileptics. Also, it is approved as a treatment for a condition related to shingles.
Side Effects: Neurontin is believed to be linked to suicidal behavior and suicidal ideation. Evidence of suicides supplied to the FDA by the manufacturer are less than the number the FDA itself has gathered. It is believed that approximately 80% of all Neurontin prescriptions were filled for unapproved medical conditions. The 11 illegally promoted unapproved uses for Neurontin are: Bipolar Disorder, Pain Syndromes, Peripheral and Diabetic Neuropathy, Treatment of Epilepsy alone (as monotherapy), Reflex Sympathetic Dystrophy (RSD), Essential Tremor Periodic Limb Movement, Attention Deficit Disorder (ADD), Restless Leg Syndrome (RLS), Trigeminal Neuralgia, Post-Hepatic Neuralgia, Migraine, Drug & Alcohol Withdrawal Seizure. When a patient takes a prescription for an unapproved use, the person runs the risk of having serious side effects because the medication was not tested in clinical trials for that use.
Manufacturer: Parke-Davis (subsidiary of Pfizer)
Status: On the Market

O:

OxyContin  (oxycodone)

Uses:  OxyContin was approved by the FDA in 1996 as a 12-hour time-release pain medication for the treatment of moderate to severe pain experienced chronically in patients with terminal cancer, paralysis, and musculoskeletal conditions.
Side Effects: If the tablets are broken, chewed, or crushed, the patient could absorb a potentially fatal dose of the oxycodone as it is rapidly released in the bloodstream.  As a popular black market drug, OxyContin tends to be consumed improperly by addicts.  OxyContin has been linked to more than 120 overdose deaths nationwide, and the death rate is expected to increase as its popularity on the black market grows.
Manufacturer: Purdue Pharma
Status: On the Market

P:

Permax  (pergolide mesylate)

Uses:  Permax is a drug to treat Parkinson’s disease. Parkinson's disease is a progressive neurological disorder resulting from the degeneration of neurons in a region of the brain that controls movement. The degeneration creates a shortage of the brain-signaling chemical known as dopamine, causing the involuntary movements that characterize the disease.
Side Effects: Researchers from the Mayo Clinic reported that three patients who used Permax developed severe heart valve disease, much like the deterioration and regurgitation resulting from the diet drug Fen Phen. Two of these Permax patients needed heart valve replacement and the third suffered other serious damage to the valves. The patients had symptoms such as fluid retention in the legs, breathing difficulties and heart murmurs that can be indicative of heart valve problems. The heart valves keep blood from flowing backwards in the organ, and are essential to the normal flow of blood.
Manufacturer: Eli Lilly
Status: On the Market

PPA  (phenylpropanolamine)

We are no longer taking PPA cases.

Propulsid  (cisapride)

Uses:  Propulsid is a prescription drug designed for the treatment of severe gastroesophageal reflux disease (GERD), a disorder more commonly known as acute nighttime heartburn. Propulsid was prescribed in both tablet and liquid form for use in cases of adult heartburn and pediatric colic.
Side Effects: Propulsid has been linked to 386 reports of heart rhythm abnormalities, including 125 deaths. All of the deaths involved ventricular arrhythmias, non-specified arrhythmias, cardiac arrest or sudden death. Symptoms include heart palpitations, rapid heartbeat, chest pain and fatigue. A simple EKG can be used to diagnose a potential problem associated with these conditions (frequently undetected prior to a serious heart attack).
Manufacturer: Janssen Pharmaceutical Inc., a division of Johnson & Johnson
Status: Withdrawn from the Market (July 2000)

R:

Remicade  (infliximab)

Uses:  In August of 1998, Remicade was approved for the treatment of Crohn’s disease. In November of 1999, the FDA approved Remicade to treat rheumatoid arthritis. Remicade controls the pain associated with rheumatoid arthritis, the chronic inflammation in the lining of the joints and the pain from Crohn's disease, an intestinal disease.
Side Effects: The results of the Remicade study suggest that taking the drug nearly quadruples the risk of developing tuberculosis. Since the study, the FDA has issued a series of warnings of the risk of tuberculosis. The revised labeling indicates that patients should be tested and treated for latent (inactive) TB prior to infliximab therapy, so that the immune-suppressing medication will not increase the tuberculosis risk.
Manufacturer: Centocor unit of Johnson & Johnson
Status: On the Market

Rezulin  (troglitazone)

Uses:  Rezulin was a prescription drug that helped diabetics utilize insulin in the bloodstream. For those diabetics with adult-onset (Type 2) diabetes who had built a resistance to insulin, Rezulin was designed to reduce the amount of sugar produced by the liver and control the body's blood sugar levels.
Side Effects: The symptoms of Rezulin-induced liver damage include jaundice (yellow skin or eyes), dark urine, nausea, vomiting, abdominal pain, fatigue, and loss of appetite. These may be early signs of liver damage. Blood tests to monitor your liver function should be administered to determine if you have suffered any liver damage.
Manufacturer: Warner Lambert
Status: Withdrawn from the Market (May 2000)

S:

Serzone  (nefazodone hydrochloride)

Uses:   Serzone is an antidepressant for oral administration in patients battling depression often with symptoms of anxiety. In 2001, the FDA issued a revised black box warning on Serzone, a drug taken for depression that boasts less sexual side effects than other antidepressants.
Side Effects: Serzone was taken off the market in all European countries because it has been linked to serious side effects including 26 deaths from liver damage. Serzone should not normally be prescribed to individuals with liver disease or with liver inflammation. Look for the following symptoms: Jaundice (yellowing of the skin or eyes), discolored or dark urine, loss of appetite, nausea, and abdominal pain.
Manufacturer: Bristol Myers Squibb
Status: Withdrawn from the Market (June 2004)

Sulzer Hip Implants 

Uses:  The Inter-Op shells were implanted in patients beginning in August 1997 until the December 8, 2000 recall.
Side Effects: The recall stemmed from a production error in which the Inter-Op shells had retained a slight oil residue that was supposed to be completely removed prior to surgery. When the oily residue was not removed, it could cause the shells to loosen or fail.
Manufacturer: Sulzer Orthopedics
Status: Withdrawn from the Market (December 2000)

T:

Tamoxifen  (Nolvadex)

Uses:  Tamoxifen first came into widespread use in the late 1970s for women who had metastatic breast cancer, where the disease had spread to other parts of the body. Decades since, Tamoxifen's use has been expanded to women after their initial treatment of surgery, chemotherapy or radiation to prevent recurrences of the cancer.
Side Effects: These include increased risk of uterine (endometrial) cancer and blood clots (deep vein thrombosis) in the legs. More mild Tamoxifen side effects include hot flashes similar to those experienced during menopause. In addition, women taking Tamoxifen may be at slightly increased risk of developing cataracts. Other common side effects of tamoxifen include vaginal dryness, irregular periods, and weight gain.
Manufacturer: Zeneca Pharmaceuticals
Status: On the Market

V-Z:

Vioxx and Celebrex  (rofecoxib)

Uses:  The FDA approved Vioxx in 1999 for the treatment of osteoarthritis and the management of acute pain in adults. An article published in August 2001 in the Journal of the American Medical Association raised concerns over the negative side effects on cardiovascualar health related to Vioxx and another cox-2 inhibitor Celebrex.
Side Effects: Vioxx, a Cox-2 inhibitor used most often for patients with osteoarthritis, has been linked by researchers to serious side effects including an increase in the risk of blood clots; severe intestinal damage, including ulcerations and bleeding; heart attacks and strokes. In addition, meningitis was a side effect involved in seven cases of patients taking Vioxx.
Manufacturer: Merck & Co. (Vioxx)
Status: On the Market

Zyprexa  (olanzapine)

Uses:  Zyprexa is known as an atypical antipsychotic medication. The FDA approved Zyprexa in 1996 for short-term treatment of bipolar disorder and schizophrenia.
Side Effects: Some patients developed diabetes or pancreatitis after taking Zyprexa. In addition, some people have suffered hyperglycemia, diabetes-induced heart attacks, and ketoacidosis after taking Zyprexa. The researchers at Duke and JAMA found metabolic abnormalities, including mild blood sugar problems, and more seriously, diabetic ketoacidosis in patients prescribed Zyprexa (olanzapine). Diabetic ketoacidosis (DKA) is a serious health condition in which a person experiences a sharp rise in blood glucose level combined with an acute lack of insulin. There have been over 380 reports of side effects and adverse reactions, mainly diabetes, made to the FDA by patients taking Zyprexa.
Manufacturer: Eli Lilly
Status: On the Market