Elmiron, also known as pentosan polysulfate sodium, is a medication prescribed to treat a bladder condition. Even though it has been around for several decades, new information links it to an eye condition, which can lead to vision loss.
An initial report in 2018 linked Elmiron to retinal damage. After this report was released, three ophthalmologists reviewed patients who had been given this prescription. They discovered that about one-third of those who took Elmiron had indications of damage to the eye. It could also cause macular degeneration and other eye conditions.
What Does Elmiron Do?
Elmiron is prescribed by doctors to treat interstitial cystitis. It is a condition which leads to chronic pain in the pelvic area and in the bladder. Patients diagnosed with the condition are mostly women, but more than one million people are estimated to have it. Elmiron is prescribed to treat the pain and is the only pill approved by the FDA for this condition.
A medical doctor reported that six of his patients had unusual changes in the retina. They had been taking the medication for over 15 years, which led the doctor to believe that long-term use of Elmiron could cause damage to the eye, specifically the retina. No other information in the patients’ medical histories indicated other causes for the change in vision.
Three ophthalmologists at Kaiser Permanents reviewed all 4.3 million patients in the database. They discovered 140 patients who had long-term use of Elmiron with more than 5,000 pills taken in the last 15 years. A total of 91 patients were willing to come in for an eye exam.
Of the 91, 22 showed definite signs of toxicity to the drug. The more of the drug taken, the more patients who had eye problems. It appears that the longer the person took the medication, the more likely they were to experience a severe eye condition. Doctors recommend that patients who take this drug get screened for damage once a year. If tests indicate damage, the person should talk to their doctor about stopping the prescription.
If the eye damage is found early, damage may be stopped as long as the person stops taking the medication. If the damage is in the late stages, it could lead to loss of vision which is permanent.
What is Interstitial Cystitis?
Interstitial cystitis is a chronic illness which causes pain and pressure in the bladder. It can be severe or just uncomfortable. Many times, the person can be misdiagnosed with a urinary tract infection. A person with this condition will feel the need to go to the bathroom more often while having lower output. In fact, they may feel the need to urinate up to 60 times in a day. There is no cure for interstitial cystitis.
Anyone diagnosed with this condition should be aware of the risks of taking Elmiron and remain under a doctor’s care. If they notice any changes with their sight, they should alert their doctor.
FDA Failed in Monitoring of Program to Curb Opioid Prescriptions
The US Food and Drug Administration (FDA) requested that drug manufacturers of long-acting opioid prescriptions pay for safety training in 2011. However, records show that the agency failed to follow up on whether the program was successful.
The goal of the program was to determine if the training for physicians who prescribed opioids was effective and to monitor other measures being taken to reduce addiction of opioid prescriptions as well as overdoses and fatalities.
A Flawed Program
According to critics, the program had a flawed design from the beginning, but it was never evaluated accurately either. Congress granted authority to the FDA back in 2007 to require training of physicians on drugs that were likely to cause addiction. The bill went into effect as a response to the oversight of the agency to monitor dangerous drugs.
Documents showed that the FDA couldn’t determine if the program was effective because the design of the studies was poor. Around 60 drugs can be included in the risk-management program. This not only includes opioids but other medications, such as isotretinoin, which is a drug to treat acne and often branded as Accutane.
Critics of the program say that the FDA allowed the pharmaceutical companies to monitor their own training. It also fails to monitor the quality of the training being given. According to a report from the Department of Health and Human Services, only about 14 percent of the programs for safety that had been reviewed by the FDA were able to meet the requirements.
The Dangers of Prescription Drugs
When it came to opioids, the requirement was that 60 percent of prescribers must take the classes, but only less than 30 percent followed through during 2012 to 2016. Even though the number of prescriptions given out was dropping, it couldn’t be determined if it was because of the training. Another issue with the program is that it didn’t provide accurate data on the correlation between the training and the reduction in overdoses and deaths. National data on overdoses had no distinction to show which doctors had taken the training and which ones hadn’t. Because of this, it was impossible to determine if the program was effective in this area.
This same problem has occurred in other programs. For instance, one program was designed to monitor the prescribing of fentanyl drugs that are to be given only to patients with cancer. While these drugs were meant only for those specific patients, many doctors prescribed the medication for other conditions.
The FDA made it a requirement for safety programs to be in place when prescribing all opioid prescriptions and not just the long-acting kinds. This change happened in 2017, but it implies that the long-acting opioids are safe for chronic pain, which goes against most research.
Prescription painkillers have been responsible for many deaths related to overdose. Doctors were prescribing these drugs at a high rate that reached its peak in 2012 at 81.3 prescriptions per 100 patients. While the rate has declined, overdosing is still a major problem in the US, especially in certain regions.
House Approves Bill Which Could Reduce Prescription Drug Prices
The House recently approved a bill that is aimed at lowering the cost of prescription medications by allowing the government to negotiate with manufacturers of the drugs.
Bill H.R. 3
The bill is titled H.R. 3 and would have a direct impact on Medicare programs. The provisions include benefits for vision, dental and hearing, and it also caps the costs Medicare beneficiaries pay out of pocket to $2000.
This bill was proposed and supported by Democrats, but the Republicans have also been working on legislation to cut prescription costs. Pharmaceutical companies oppose both this bill and the Senate bill.
One of the features of the bill includes allowing the Department of Health and Human Services to negotiate pricing for as many as 250 of the most common drugs. Manufacturers would have to provide the same prices to insurers as what was agreed upon during negotiations.
Drug manufacturers would be required to pay rebates to Medicare if prices went up faster than inflation. The Senate bill, which is sponsored and supported by Republicans, doesn’t contain the same provisions, but it does require the companies to pay rebates for raising prices above the rate of inflation.
Other Options for Legislation
Even though the Republicans didn’t agree with the Democrats’ bill, they did come up with a similar measure, which had the support of eight Democrats at the vote. It would not only cap the expenses paid out of pocket, but it would require insurance providers to provide information about medication prices to patients before they were prescribed the drugs.
The argument against the legislation to allow government to negotiate prices is that it would reduce the amount of money for research and development with pharmaceutical companies, which could limit the number of new medicines available for life-threatening illnesses. It has been estimated that the enactment of the bill would reduce the number of new drugs available by 40 for the next 20 years.
H.R. 3 allocates over $10 billion for the National Institutes of Health, which would be used for research to provide breakthrough cures. Taxpayers could save as much as $5 billion during the next ten years if it is enacted.
The rising costs of prescription medications has placed a hardship on many Americans. Some even have difficulty affording food and other necessities because of the expensive drugs they need. The situation has put pressure on lawmakers to find a solution.
Prescription manufacturers do not support the measures that limit their ability to raise prices. However, politicians recognize the need to make drugs more affordable for the average American. With another election year coming up, they are working on their campaign promises to ensure support from their constituents for the next election.
While it’s not expected for the bill to become law in its present state, there is hope that the overall goal will be met even with the changes that would be made. Some day in the future, Americans may be able to afford the drugs they need to manage their medical conditions or cure them.
FDA Tests Diabetes Drug for Carcinogen Levels
The US Food and Drug Administration is testing for the presence of certain cancer-causing chemicals in the diabetes medication metformin. This medication is a prescription drug that is given to patients with type 2 diabetes to control high blood sugar.
Continued Risks with NDMA in Drugs
Several drugs have been discovered to contain known carcinogens at levels not acceptable to the FDA in the past year. Now, metformin is under scrutiny due to the possibility that it may also contain a carcinogenic substance. The concern with these chemicals is that continued exposure could raise the risk for developing cancer in the future.
Other countries have found some metformin drugs to have low levels of N-nitrosodimethylamine or NDMA. After testing those medications, it has been determined that the level of NDMA is in the acceptable range, which is what is naturally found in food and water. However, some countries are recalling metformin medications. The US is not on that list at this time.
The FDA has a current investigation into the medication to determine if NDMA is found and whether it is above the acceptable limit of 96 nanograms per day. The agency is working with manufacturers to test the samples of the drug. If levels above 96 nanograms are found, the FDA will recommend recalls.
Experts recommend that patients continue taking the medication. If a recall is issued, the FDA will provide information to health care personnel and patients. It can be dangerous to stop taking this medication without the advice of their physician. There are no alternative medications to treat the high blood sugar in the same way.
What Does Metformin Do?
This medication works in several ways to control blood sugar in diabetics. It reduces the amount of sugar the liver makes as well as how much is absorbed throughout the body from the person’s diet. It also causes the insulin receptors in the body to be more accurate in how much insulin the system manufactures.
One of the benefits of this medication is that it doesn’t increase the amount of insulin being made in the body, which means the patient has a lower risk of hypoglycemia or low blood sugar. Other medications carry a higher risk for this condition.
The doctor may prescribe metformin in tablet form, a liquid or one of two long-acting medications. Brand names for metformin include Glucophage XR, Glumetza, Fortamet and Riomet. The medication was originally manufactured by Bristol-Myers Squibb, but several manufacturers make the generic version.
Taking a medication like metformin can control sugar levels and prevent many health issues that are related to high blood sugar. This includes diabetic neuropathy, heart disease and diabetic retinopathy. Regular use of the medication may prevent complications which arise from diabetes.
Manufacturers of metformin are working with the FDA to determine if metformin is safe for use. Anyone who is concerned about the risk of carcinogenic chemicals in this medication or other medicines should discuss the issue with their health care provider. The doctor can recommend other options or put their minds at ease.
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