New Drugs and Devices 1998

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Aggrastat (Tirofiban)

This injectable drug is the first of a new class of drugs called glycoprotein inhibitors which block the ability of platelets to aggregate thus preventing or reducing clotting. When combined with intravenous heparin and aspirin for the treatment of acute coronary syndrome and unstable angina, it reduces the risk of death and the probability of a heart attack by 32%.

Arava (Leflunomide)

This new drug is indicated for the treatment of active rheumatoid arthritis (RA). It is significant in ARAVA is specifically designed to treat that debilitating disease and is not indicated for any other inflammatory disease at this time. In addition to relieving pain, it appears to slow progression of the irreversible joint damage characteristic of RA. The major side effects include: diarrhea, rash and transient alopecia.

Celebrex (Celecoxib)

1998 was a banner year for drugs to treat arthritis with Celebrex as an oral agent representing the first drug of another class of antiinflammatory drugs. Celebrex acts by interfering with the formation of COX-2, one of the many mediators of the inflammatory process. Because its mechanism is different from the standard antiinflammatory drugs such as ibuprofen and naproxan, it may have a much lower incidence of gastrointestinal bleeding. However, the FDA is reserving judgement on that important issue until more extensive use has occurred.

Ciloxan (Ciprofloxin)

Ophthalmic - this is a new dosage form of the popular anti-infective, Cipro. As expected, it has a spectrum of activity different from many of the older ophthalmic antibacterials and may be particularly useful when resistance to the commonly prescribed neomycin-polymyxin B preparations is anticipated.

Detrol (Tolterodine)

Tolteridine is indicated in the tratement of overactive bladder which leads to involuntary urination and urinary frequency (more than 8 times/24 hours). Compared to placebo, patients taking this drug reduced their periods of incontinence by 50% and mean number of urinations/day by 15-20%.

Enbrel (Etanercept)

This new injectable drug for rheumatoid arthritis represents a significant contribution to the medications avaialble for treating this disease. Enbrel binds to tumor necrosis factor, an important mediator of the inflammatory process. Thus, it significantly reduces pain and inflammation. There is a 2-3 fold reduction in the number of tender and swollen joints, pain and overall patient and physician assessment of disease severity.

Evista (Reloxafine)

Reloxafine is a estrogen analogue which is approved for use in the prevention of postmenopausal osteoporosis. It reduces the resorption of bone and decreases overall bone turnover. The advantage of this drug over the regularly prescribed estrogen preparation is the absence of estrogen side effects such as: menstrual-like spotting and breast tenderness. It does not appear to increase the risk for breast cancer or cancer of the uterus.

Herceptin (Trastuzumab)

This drug which is given intravenously, is a significant advance in the treatment of metastatic breast cancer which expresses HER2 protein. In 25-30% of women with metastatic breast cancer this protein is overexpressed. When Herceptin was added to standard chemotherapy regimen in those women HER2+, a complete or partial response rate was observed in 48% of women compared with 32% on chemotherapy alone. The median time to disease progression was 7.6 months in the Herceptin group compared with 4.6 months in the chemotherapy alone group.

Integrilin (Epifibatide)

This injectable agent is approved for use in patients with acute coronary syndrome (unstable angina and non Q-wave myocardial infarction. As with Aggrastat, it inhibits platelet aggregation however by a different mechanism, by preventing the binding of fibrinogen to platelet. That is a necessary step to clot formation. The incidence the angina progressing to either death or myocardial infarction was significantly reduced from 7.6% to 5.9%.

Meridia (Sibutramine)

This is a controlled drug (Schedule 4) recently released for the treatment of obesity. Mean weight loss ranged between 7-14 lbs. Side effects consist of:an increase in blood pressure of 1-3 mm mercury, headache, muscle pain, constipation, dry mouth and innsomnia. There have been no reports of primary pulmonary hypertension associated with Sibutramine use.

Preven

This is a combination of levonorgestrel, a progestin, and ethinyl estradiol (an estrogen) which has recently been approved as a "morning after" drug. It contains 1. A pregnancy test kit as it should not be used if a woman is pregnant and 2. two doses of the combination taken 12 hrs apart. To be successful, the tablets must be taken within 72 hours after sex. Because of the brief time the drugs are taken, side effects are minimal.

Proleukin (Aldesleukin)

This interleukin analogue was recently approved for use in the treatment of metastatic renal cell carcinoma and metastatic melanoma. In renal cell carcinoma studies, Proleukin produced a 15% objective response rate (7% complete and 8% partial). When used to treat metastatic melanoma there was a response rate of 16% (6% complete, 10% partial). In both cases a few patients did not have any disease progression for over 1 year. The most common side effects are: chills and fever, hypotension and tachycardia, diarrhea and vomiting, and shortness of breath.

Propecia (Finasteride)

This testosterone antagonist is indicated for use in the treatment of male pattern baldness. It is a lower dose of the drug Proscar which is used to treat prostatic hypertrophy. After 3 months of therapy, approximately 50% of patients show an increase in hair as determined by before and after photographs. The 1 mg tablets are given once daily. It has a low incidence of side effects (1-2%) of patients which consist primarily of decreased libido and ejaculate volume.

Provigil (Modafinil)

This is a schedule 4 controlled drug which is indicated for narcolepsy (the uncontrollable urge to sleep at inappropriate times). It is chemically different from the amphetamines. Although a central nervous system stimulant, the side effects are much less than the amphetamines and those taking this drug feel less "wired". With a success rate of from 20-50% it is not a "cure-all" for this condition but does represent a significant advance.

Rebetron (Ribavirin and Interferon Alfa-2b)

This combination was approved for the treatment of chronic hepititis C infections. Although the interferon had been approved for the treatment of hepatitis C earlier, relapses were common. The combination resulted in a 10-fold increase in the number of patients showing reduction of viral particles in the blood to non-detectable levels (HCV-RNA (qPCR-negative). After 6 months of combined therapy, 40-50% of patients on the double therapy had non-detectable viral levels compared with 4-6% given interferon alone.

Refludan (Lepirudin [rDNA])

Refludan is first agent to be approved for the treatment of heparin-induced thrombocytopenia type II. It allows for patients who need to be anticoagulated with heparin to continue to receive it despite the presence of the heparin-induced thrombocytopenia.

Remicade (Infliximab)

This important new drug for intravenous infusion is indicated for the treatment of Crohn's disease, a debilitating inflammation of the intestine. This drug blocks the activity of tumor necrosis factor, one of the products associated with the inflammatory process. When tested on patients who failed to respond to conventional therapy, 82% of patients achieved a clinical response while 48% went into clinical remission.

Renagel (Sevelamer)

RenaGel is a orally administered drug which binds phosphate. It is indicated in end stage renal disease where phosphorus retention and hyperphosphatemia can occur. It has an advantage over aluminum hydroxide in that it does not cause aluminum toxicity. Taken with meals, the side effects are primarily gastrointestinal as would be expected including diarrhea, and dyspepsia (upset stomach).

Rifapentine (Priftin)

This drug is an analogue of its predecessors, rifampicin and rifabutin. Its primary advantage lies in that it only has to be given two times a week. When combined with INH, pyrizinamide, and ethambutol the rate of conversion is similar to that of rifampin, 87% vs. 81%. After the intensive phase, both the rifapentine and INH can be given twice weekly. A drug interaction exists with indinavir (Crixivan) with rifapentine increasing indinavir blood levels by 70%. The most significant side effect is liver damage which occurs in <1% of patients.

Rotashield (Rotavirus Vaccine, Oral, Tetravalent)

This is the first vaccine for the prevention of rotavirus infections. Rotavirus is responsible for a highly contagious disease in children characterized by severe vomiting, diarrhea, and cramps. The subsequent dehydration results in the death of approximately 1 million children worldwide each year. The vaccine is administered orally at 2,4,6 month of age.

Sustiva (Efavirenz)

This is a very important addition to the drugs available to treat infections due to the HIV virus. It is a non-nucleoside reverse transcriptase inhibitor and importantly, can be used in place of protease inhibitors in the standard triple therapy regimens. Side effects which are self-limiting include: lightheadness, anxiety, and the inability to concentrate. Because of the ongoing problem of adherance to the complicated dosing regiments now in effect for the treatment of HIV positivity and AIDS, Sustiva, given once daily and is also less expensive than the protease inhibitors, will assist in lessening the adherance problem.

Synagis (Palivizumab)

This recently released drug is an injectable monoclonal antibody approved for use as a agent for preventing respiratory syncytial virus (RSV) in babies. This virus is particularly dangerous in children with bronchopulmonary dysplasia (infant respiratory distress syndrome). In one clinical trial the rate of hospitalization in children who received Synagis prophylaxis was 4.8% compared with 10.6% in the placebo group.

Thalomid (Thalidomide)

This drug which was responsible for a number of congenitial abnormalities when used as a sedative in the 1960¦s has been approved for the treatment of erythema nodosum leprosum, a complication of Hansen's disease. In order to prevent off-label uses, there are substantial restrictions on the prescribing of thalidomide including a mandatory registration of both pharmacies and physicians in an program to assure patient education to the dangers of this drug.

Viagra (Sildenfil)

This much awaited drug is an oral (by mouth) agent indicated for male impotence. It has a success rate of 80% when taken 1 hour prior to anticipated intercourse which is an improvement over the injection and uretheral insert (Muse) which are effective 60% of the time. The major side effects are: headache and facial flushing. This drug has no effect on libido.

Xeloda (Capecitabine)

This drug represents a major advance in the treatment of metastatic cancer of the breast which either has not responded or has become resistant to conventional chemotherapy. In 25% of patients it produces a reduction in tumor size of >50%. Unlike many of the other chemotherapy agents, Xeloda produces minimal hair loss and bone marrow depression. The most frequently reported side effects are: diarrhea, nausea, sores in the mouth and pain and swelling of the hands and feet. Side effects are greater in women > 80 years old. Note: This drug is very expensive at a cost averaging $25/day.

Ziagen (Abacavir)

Is used to treat human immunodeficiency virus (HIV). Its mechanism of action is similar to Retrovir which is a nucleoside reverse transcriptase inhibitor (NRTI). It can be given twice daily with no food or water recommendations. Drug-drug interactions are minimal. It is most effective in antiretroviral-naive persons who are HIV positive. Those previously treated with drugs for HIV (particularly Retrovir) have a minimal response with some notable exceptions. Common side effects include: headache, nausea, vomiting, and malaise. The most significant side effect seen in 3-5% of patients is a hypersensitivity (allergic) reaction characterized by: fever, rash, and fatigue. Should this occur the drug must be stopped immediately and not restarted under any circumstances as deaths have occurred if Ziagen is continued or restarted. The cost/month is approximately 10% higher than Retrovir.