Articles filed under 'PRESCRIPTION DRUGS'
Whenever a new drug or medical device comes on the market, the process leading up to FDA approval has been costly and time-consuming. Biotech companies spend many years working in their laboratories to develop new drugs to ready them for testing. Companies that can’t afford their own study staffs are increasingly turning to contract research organizations (CROs) to do the testing. Launched by entrepreneurs, an army of CROs is taking on the daunting task of testing for pharmaceutical companies without the time and resources to perform their own.
In a few cases, these contract firms which have emerged over the past twenty years have not been up to the rigorous task of controlled clinical trials. Mistakes can lead to a product’s delay in being approved, or test subjects may develop unanticipated side effects. Some bioethicists are urging more regulatory attention for CROs. The FDA is looking at more stringent regulations of firms conducting clinical trials with human subjects, to hold them fully accountable.
Stages in the Drug Approval Process:
Preclinical trials – Testing of a new drug is usually tried first on animals.
Phase I studies – If laboratory testing of animals shows no harm to them, federal regulators often allow tests on 20 to 80 people, primarily checking for any ill effects.
Phase II studies – These studies usually involve groups of up to 300 people in order to provide an initial assessment of the drug’s effectiveness.
Phase III studies – Hundreds to several thousand people are involved in an attempt to determine whether a drug is safe and effective. If it holds up well and shows no unacceptable side effects, the medication has a good chance of approval and subsequent sale.
Source: Oakland Tribune; April 25, 2008; business section
May 1st, 2008
According to the Center for Health Statistics, deaths from Methadone nationwide are increasing at a faster rate than other deaths related to drug use. The number of Methadone deaths nationwide rose from 786 in 1999 to 4,462, a nearly six-fold increase. As a comparison, fatal cocaine overdoes rose 63 percent.
Most cocaine users realize they are dealing with a drug with potentially lethal consequences. In contrast, Methadone is not widely perceived as being especially hazardous. Substance abusers are often given Methadone as a heroin substitute, but generally under tight controls. In addition, chronic pain clinics are increasingly prescribing Methadone for pain relief. Because methadone is slow-acting and patients seek immediate relief, they may take a pill or more than the prescribed dose. Methadone does not give a high and is sometimes dangerously combined with other drugs or alcohol.
Some chronic pain patients obtain multiple prescriptions for Methadone from different medical providers. These prescriptions are difficult to track. Other persons get their prescriptions illegally from friends or buy them from individuals. Those who take Methadone without appropriate medical supervision may be unaware of its potential risks. The drug oxycodone, or OxyContin, belongs to the same class of drugs as Methadone. In states such as Vermont, OxyContin is the leading cause of 80 drug-related deaths last year.
For someone with a low tolerance for certain drugs, even low doses of Methadone or OxyContin can be dangerous. While the Northeast is seeing Methadone as the street drug of choice, methamphetamines are the predominant street drugs in other parts of the U.S. Deaths from Methadone are beginning to drop in New England and the Eastern Seaboard where educational campaigns are emphasizing the potential hazards of its use.
Source: San Francisco Chronicle; April 18, 2008; Holly Ramer, A.P.
April 20th, 2008
This month the FDA approved the first birth-control pill designed to stop women’s menstrual periods indefinitely. Lybrel, expected to be on the market by July, is approved for continuous use to prevent pregnancies.
Lybrel can have troubling side effects for some women, especially in its first year of use. About half the women enrolled in the study of the new low-dose hormone pill did not continue in the study. Many dropped out due to irregular and unscheduled bleeding and spotting that can replace scheduled monthly periods.
In one test of Lybrel, 59% of women who stayed on the pill for a year had no spotting or breakthrough bleeding in the last month of the study. Because many women dropped out, only about one-third of women who originally entered the study experienced this result.
Women with especially difficult periods due to headaches, breast tenderness, cramps and nausea may be willing to put up with initial unscheduled bleeding and spotting that may last for a year. Some do not experience these side effects. In those who have no periods while on Lybrel, it may be difficult to know if they become pregnant.
With a lower-dose pill, its effectiveness can be reduced, although it is still able to prevent pregnancy approximately 96% of the time. Lower-dose pills have been developed to reduce the risk of serious side effects such as blood clots and stroke.
For many women, menstruation is a natural part of their experience. They may not want to treat a normal function as though it were a medical condition. Others may rejoice to be able to skip their menstrual periods indefinitely.
Another method of eliminating monthly periods is by receiving the hormonal contraceptive Depo-Provra by injection.
Other pills already on the market (Seasonale and Seasonique) can reduce the number of periods a woman has to three or four a year. Some nontraditional pills such as Yaz and Loestrin 24 are able to shorten monthly periods to three days or less.
Source: CNN.com
May 28th, 2007
While some women embrace the concept of eliminating their periods entirely, others are reluctant to take the new pill Lybrel that would in essence eliminate monthly menstrual bleeding entirely. Newer birth control pills already on the market (such as Seasonale) can enable women to have periods just once every three or every four months. Lybrel is expected to be FDA approved in May 2007.
Doctors generally express no concern about extra risks with the complete elimination of the menses. About two-thirds of women surveyed showed interest in taking Lybrel, as they believe they are “too busy” to bother with monthly bleeding. At this point, however, there have been no long-term studies. It is yet unknown whether adverse unintended consequences might occur after having no periods for 30 or 40 years of a woman’s life.
Some women express concerns that menstrual cycles may involve complex interactions with the brain, bones and skin. Others are emotionally attached to their symbol of fertility when monthly bleeding does occur, or they may feel relief to have evidence that they are not pregnant.
Women on any type of birth control pill are not having real periods, as the hormones they are taking stop the monthly release of an egg and the buildup of the uterine lining. For that reason, the new pill is not offering a drastically different option, just more convenience for women.
Women who have difficult, painful periods that cause them to miss work and keep a low profile for several days may welcome the addition of Lybrel to choices they can make for contraception.
Source: New York Times
May 4th, 2007
The FDA warned in mid-March that all prescription sleeping pills have the potential to cause bizarre behaviors, such as “sleep-driving.” In extremely rare instances, patients have been known to get up in the night and drive, with no later memory of the event.
About one out of 1,000 persons on these medications has experienced unusual behaviors such as sleep driving, preparing and eating food, making phone calls, or even having sex while asleep. More common than middle-of-the-night excursions is driving while still feeling dangerously drowsy, for example, during an early morning commute.
Although extremely rare, another reported risk is a life-threatening allergic reaction and severe facial swelling. This side effect can occur with first use or anytime thereafter when the pills are taken. Seek immediate emergency treatment for such an occurrence.
Later this year, pharmaceutical companies that manufacture 13 prescription sleep medications will include new, extensive warnings in a special “medication guide” brochure. Some insomnia drugs may be riskier than others. The FDA has recommended clinical trials to compare their complications and frequencies with which they occur.
Ambien and a second drug Phenergan were implicated in sleep-driving headlines last year when Rep. Patrick Kennedy crashed into a barrier outside the U.S. Capitol building. Kennedy stated that he did not recall being behind the wheel.
To lower the risk of sleep-driving and other risky behaviors, patients are advised never to take any prescription insomnia drug with alcohol or another sedating drug. Also, never exceed the recommended dosage.
The thirteen drugs for insomnia, so-called “sedative-hypnotics,” which will carry the new warnings are: Ambien, Butisol sodium; Carbrital; Dalmane; Doral; Halcion; Lunesta; Placidyl; Prosom; Restoril; Rozerem; Seconal; and Sonata.
Source: CNN.com
March 17th, 2007
If you’ve ever experienced chronic pain (lasting more than six months), you were probably depressed. Pain and depression can form a vicious cycle, with one fueling the other. When your quality of life takes a big nosedive, you generally get depressed. If a significant disability is also involved, your chances of depression are even greater.
Most physicians who treat patients with chronic pain also treat the depression that usually accompanies it. Your internist may wish to give you a prescription or refer you to a psychiatrist. Sometimes you may be referred to a licensed “behavioral medicine” specialist. So-called “cognitive therapy” classes may be especially useful in helping you find new ways of thinking and thus reduce your pain levels.
Talk therapy usually takes a back seat to prescription antidepressants these days. In fact, sometimes talking about your pain can actually make it worse because you focus on it more. Antidepressant medications are often a primary treatment for depression, especially when chronic pain syndromes or nerve-related disorders are involved.
The earlier your depression is treated, the better the outcome can be. Early diagnosis and appropriate medications can reduce distress and even prevent suicide, in many cases. Those receiving treatment for depression that takes place while experiencing chronic pain often have an improvement in their overall medical condition.
Antidepressants work by altering certain chemical levels in the brain. It may take a while to find a particular antidepressant with minimal side-effects that works well for you. Every person experiences pain and reacts to medications differently. Among the antidepressants which are commonly prescribed today are the following:
• Celexa
• Prozac
• Zoloft
• Elavil
• Norpramin
• Effexor
• Serzone
• Wellbutrin
• Cymbalta
• Paxil
• Remeron
If you are depressed about a serious, life-changing event or due to severe, unremitting pain and disability, you should consult a physician about treating your depression.
Source: WebMD
March 11th, 2007
The FDA recently approved a new amphetamine-based drug for hyperactivity disorder that will be harder to abuse than older stimulants, according to pharmaceutical company Shire. Vyvanse remains inactive until swallowed, after which it gradually releases its active ingredient d-amphetamine. It is activated after coming into contact with enzymes in the digestive tract.
Vyvase is expected to stop the potential for abuse by individuals who snort or inject crushed pills. The newly developed drug will be listed as a Schedule II drug, a category including cocaine, methadone, methamphetamines, and other ADHD medicines such as Adderall and Ritalin. Vyvanse will carry a “black-box” warning because of safety concerns related to amphetamine abuse, as well as the risk of sudden death in patients with heart defects.
The FDA approval of Vyvanse took place in the same week when the agency required manufacturers of other ADHD drugs to warn patients and parents of potential mental and heart problems associated with these medications in a small percentage of users.
FDA statistics indicate that ADHD affects about 3 to 7% of schoolchildren and 4% of adults. The principal symptoms are hyperactive behavior, difficulty paying attention, and problems with impulse control. Medications approved to treat ADHD have major benefits for many patients but for some, they can also pose serious risks.
New warning instructions required for ADHD medications will be included for Adderall, Concerta, Daytrana, Dexedrine, Focalin, Metadate, Methylin, Ritalin, and Strattera. It is hoped these new cautionary guidelines will not keep people who need these drugs from taking them.
Sources: Yahoo News; Medical News Today
February 27th, 2007
Pharmaceutical companies who make Ritalin, Adderall, Strattera and other ADHD drugs have been advised to give patients and parents additional warnings about the potential for serious psychiatric and heart problems. Patients would be given a 2-page medication guide with each new prescription.
Drug companies are expected to comply with the new requirement within 30 days. The announcement covers 15 drugs, including those offered in extended-release, patch and chewable versions.
Serious side effects for ADHD drugs are rare. However, the new warnings advise calling a physician immediately in case of chest pain, shortness of breath, fainting or hallucinations. A sudden change in behavior should also be noted and promptly reported.
Of the 3.3 million children taking ADHD medications, more than 2,500 went to emergency rooms in 2004. About a fourth of them had serious heart or blood pressure problems, according the Centers for Disease Control. Of the 25 deaths thought to be linked to the drugs, 19 involved children. In the 54 patients who experienced serious heart problems, some had prior heart conditions.
Proposed guidelines are to state that these amphetamine-based drugs have been linked to stroke and heart attacks in adults and sudden death in patients with heart problems or defects. A few children and teens reported hearing voices, growing suspicious or becoming manic while on ADHD medication. About 1 child in 1000 may experience hallucinations.
It is vital that patients give doctors a full history of cardiovascular or mental problems. In addition, they should make it known if they take antidepressants, seizure medications or blood thinners. The FDA emphasizes that persons with heart disease, blood pressure problems, hyperthyroidism or glaucoma should not take ADHD medications.
The FDA emphasizes that new requirement for expanded warnings is precautionary and should not discourage patients from taking these drugs, which are safe in appropriate patients.
Source: San Francisco Chronicle; Feb. 22, 2007 (article from Baltimore Sun)
CNN.com
February 24th, 2007
The U.S. government has stocked a supply of Tamiflu and other antiviral medications, some 21 million doses, to be used in case of a flu pandemic such as the 1918 Spanish Flu. It is believed these drugs would be effective for treatment or prevention of wide-scale “avian” or bird flu if it arrives on our shores. Countries such as Great Britain have done a commendable job in obtaining enough Tamiflu and other antivirals to treat its population.
As governments around the world prepare for the potential emergence of a deadly flu pandemic, they are looking at several strategies. A different class of antivirals known as ion channel inhibitors (amantadine and rimantadine) used in combination with neuraminidase inhibitors such as Tamiflu, could play an important role. An article published in the British Medical Journal indicated that taking only amantadine or rimantadine would be more likely than Tamiflu to produce unacceptable side effects and to be associated with a rapid emergence of resistance. British researchers emphasized the benefits of a combination therapy – ion channel inhibitors and neuraminidase inhibitors.
The World Health Organization also endorsed combined use of the two types of antivirals, especially in planning for some future flu pandemic. In laboratory tests, the combined antivirals even prevented emergence of resistant strains of the highly pathogenic avian influenza H5N1 virus. These chemically stable, antiviral drugs have a long shelf life and could be stored for long periods.
The U.S., the U.K., and Greece are already stockpiling ion channel inhibitors in addition to neruraminidase inhibitors such as Tamiflu. Research scientists and governments are cooperating to confront the potential emergence of a virus that could be spread by migrating birds and people on international flights. If the H5N1 virus eventually changes into a form easily transmitted from one person to another, the resulting flu pandemic would rapidly sweep around the globe.
Sources: Science Daily;
February 17th, 2007
Xenical is a prescription weight loss drug primarily intended for adults who are obese, with a body mass index of 30 or higher. It can also be used effectively in those who are considered overweight (BMI of 27-29). Persons with other risk factors such as high blood pressure, high cholesterol, heart disease or diabetes can also benefit from taking Xenical (orlistat) for weight loss.
Xenical must be taken in conjunction with a regular exercise program and a nutritionally balanced diet containing no more than 30% calories from fat. Taking a daily multivitamin supplement is also important, as Xenical reduces the absorption of vitamins from food.
This weight-loss drug works differently from other diet drugs, as it does not suppress your appetite. Instead, Xenical blocks the absorption of a portion of your dietary fat intake to produce weight loss. As a result, Xenical produces gastrointestinal side effects that usually occur in the first weeks of treatment. Side effects usually taper off after the first few months. You may experience side effects such as gas with oily discharge, underwear stains, and an increased number of bowel movements. These side effects can be minimized by staying within the 30% dietary fat guidelines.
If side effects become distressing, discuss the symptoms with your prescribing doctor or pharmacist. You should not take Xenical if you are pregnant, nursing, have food absorption problems or reduced bile flow. Children should not be given Xenical for weight loss.
Several clinical studies have shown that after 52 weeks, persons on a reduced fat diet who took Xenical as prescribed lost an average of twice as much weight as those (in the control group) on the diet alone. That is, 13 pounds, compared to about 6 pounds. Within the first three months, those on Xenical had lost 3% of their body weight. There is clear scientific evidence to demonstrate that obese or significantly overweight persons who lose as little as 5% to 10% of their body weight can improve their health.
The clear health benefits of the effects of weight loss with Xenical on other weight-related health problems such as high cholesterol, type 2 diabetes and high blood pressure have been assessed in seven studies of 1 to 2 years. These studies involved multicenters, double-blind, and placebo-controlled clinical trials. More than 4,100 patients took part.
Clearly, there is now a weight loss drug that effectively takes weight off and helps improve general health if your excessive pounds put you at risk. The question is, will the side effects be tolerable to you? Will you be motivated to do the following:
- Set realistic, achievable weight-loss goals with your doctor?
- Take Xenical three times daily with meals?
- Record your food intake each day, and eat a reduced-calorie diet with 30% or less calories from fat?
- Take one multi-vitamin daily — 2 hours before or after taking Xenical or at bedtime?
- Maintain a realistic exercise program?
An over-the-counter version of Xenical, a reduced-strength version, is now being sold under the name “alli.” This drug is approximately half-strength of the prescription version. Alli is also intended for use along with diet and exercise programs. Taking the drug without the other components is unlikely to produce the desired results.
The FDA recently approved the sale of alli without prescription. The agency cautioned that people who had organ transplants should not take orlistat (Xenical) or alli because of possible drug interaction side effects. Those taking blood-thinning medications or being treated for diabetes or thyroid disease should also consult a doctor before using alli, according to the agency.
Sources: xenical.com; cnn.com
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February 12th, 2007
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