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FDA

Groups Urge FDA Not to Recall Abbott Laboratories’ Synthroid – (06-21-01)

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Groups Urge FDA Not to Recall Abbott Laboratories’ Synthroid

It’s always interesting to follow a heated debate over what many times appears to be an ineffectual therapy. I have seen many patients whose lab values came back to normal using synthetic hormone replacement, and yet clinically they still had all the signs and symptoms of hypothyroidism. The pharmaceuticals get rich and the patient doesn’t get any better. Thyroid glandulars, nutrients helping the conversion of thyroid hormone to its active form, and removing all sources of xenoestrogens can be a much more powerful approach to managing thyroid problems.

(article) In response to reports that the US Food and Drug Administration (FDA) might force Abbott Laboratories’ to recall Synthroid (levothyroxine), three professional and patient advocacy groups urged the agency on Monday to defer any action for the sakes of the millions of Americans on the thyroid drug. The American Thyroid Association, The Endocrine Society and Thyroid Cancer Survivor Association expressed concern that the removal will lead to the unnecessary discontinuation of these patients’ prescribed treatment. About two thirds of the 13 million Americans with hypothyroidism, thyroid cancer and other thyroid conditions are on this third most commonly prescribed drug in the US, the organizations noted. Therefore, “Even the threat of an interruption could cause alarm, inconvenience, and cost for patients who are doing well on their current thyroid medication,” said Dr. Paul Ladenson, secretary of the American Thyroid Association. Despite this appeal, the future of Synthroid remains uncertain. In April, the FDA told Abbott Laboratories that its thyroid medicine Synthroid has a “history of problems” and cannot be “generally recognized as safe and effective.” The FDA’s concerns were expressed in a letter, rejecting an Abbott petition to have the compound approved without the filing of a new drug application (NDA) detailing the drugs safety and effectiveness. Abbott, who acquired Synthroid’s maker earlier this year, is now expected to submit an application to the agency by the FDA’s August deadline. However, the FDA’s statements still raise the possibility that the popular 40-year-old drug could be removed from the market. The agency previously has refused to rule out asking for the drug’s withdrawal, saying it believes there are two other drugs in Synthroid’s class that could fill the void. Earlier this year, King Pharmaceuticals and Watson Pharmaceuticals secured FDA approval for similar products. But Abbott maintains that it is confident the drug will be allowed to stay on the market. The safety and efficacy of Synthroid has been extensively studied and validated, the company said in a prepared statement. The results of these studies have also been published in prominent peer-reviewed journals such as the New England Journal of Medicine, the drugmaker noted.

FDA Warns Against Use of Product That Phyne Will Not Recall – (02-12-01)

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FDA Warns Against Use of Product That Phyne Will Not Recall

This article seems strange. The FDA has ordered a recall, but the recall of one of the items, inject-able adrenal cortex extract, is not going to be done by Phyne Pharmaceuticals. Kind of makes you wonder who’s in charge… Ironically, the recall was due to substandard manufacturing processes. Instead of using this potentially unsafe extract, I would consider using glandulars long before I would consider using an inject-able extract. Glandulars are purified portions of organs from healthy tissue (usually bovine) . If you want to support a gland in the body, instead of figuring out all the potential micronutrients necessary for optimal functioning, glandulars are the best answer.

(article) The US Food and Drug Administration (FDA) issued on Monday a strong recommendation against the use of injectable adrenal cortex extract (ACE) manufactured by AMRAM Inc. and marketed by Phyne Pharmaceuticals. A recall of ACE and about 38 other injectables marketed by Phyne was enacted by AMRAM in December due to concerns of substandard manufacturing conditions found by FDA officials on a visit to AMRAM’s facilities. However, the FDA believes that Phyne delayed taking action to remove the recalled products from the market, and the agency last week issued a warning to healthcare organizations and medical product distributors that AMRAM and Phyne’s products may be unsafe. Phyne has now informed the FDA that it will not include ACE in the recall effort, according to the agency’s statement on Monday. “FDA shares the same safety concern about ACE as it does with the products which Phyne Pharmaceuticals is recalling because all of the products were manufactured by AMRAM Inc. under the same conditions violating good manufacturing standards for pharmaceuticals,” the agency said. Phyne was not immediately available for comment. In interviews with Reuters Health last week, company representatives argued that it was the FDA that had held up the recall and that the products at issue are not actually defective.

FDA OKs Limited Heart Disease Claim for B vitamins – (12-14-00)

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FDA OKs Limited Heart Disease Claim for B vitamins

No known side effects at reasonable levels. Cheap. Helps with liver detoxification. Helps with nervous function. On and on. Any physician who plans on waiting for the FDA to determine the necessity and safety of B vitamins in lowering rates of heart disease via homocysteine would do well to remember that it took near to four DECADES to make the recommendation for folic acid and neural tube defects.

(article) The US Food and Drug Administration (FDA) said late on Tuesday that foods and dietary supplements containing vitamins B6, B12 and folic acid will be permitted to carry a claim that the vitamins may reduce the risk of heart disease. However, the claim must note that the scientific evidence is not conclusive, the agency said. The FDA said that an acceptable claim would run along the lines of: “Studies in the general population have generally found that these vitamins lower homocysteine, an amino acid found in the blood. It is not known whether elevated levels of homocysteine may cause vascular disease or whether high homocysteine levels are caused by other factors.” Earlier this month, the FDA said that it would allow a limited claim for the association between omega-3 fatty acids and heart disease. The agency said scientific evidence that these compounds could reduce the risk of coronary heart disease (CHD) was not conclusive. vitamin B6 (pyridoxine) is found in fortified foods such as cereals and grains. vitamin B12 (cobalamin) is found in meat, fish and poultry, as well as fortified milk and breakfast cereals. Folate, or folic acid, is found in many fruits and vegetables and in fortified foods.

FDA Says Evidence of Omega-3 Health Benefits Unclear – (11-29-00)

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FDA Says Evidence of Omega-3 Health Benefits Unclear

They were probably saying the same thing about folic acid and neural tube defects in the late fifties when the evidence started to show a benefit in the reduction of defects w/ folic acid supplementation. I’m not sure where the FDA looked (possibly under their own rock??), but I could easily come up with a few hundred articles on Omega-3 fatty acids and numerous diseases such as Crohn’s, Rheumatoid arthritis, osteoporosis and heart disease.

(article) The scientific evidence that omega-3 fatty acids protect against heart disease is not definitive, the US Food and Drug Administration said on Thursday. The agency ruled that food manufacturers can use only a limited claim about the relationship between the oils, found in fish and other foods, and cardiac illness. The approved claim reads, “The scientific evidence about whether omega-3 fatty acids may reduce the risk of coronary heart disease (CHD) is suggestive, but not conclusive. Studies in the general population have looked at diets containing fish and it is not known whether diets or omega-3 fatty acids in fish may have a possible effect on a reduced risk of CHD. It is not known what effect omega-3 fatty acids may or may not have on risk of CHD in the general population.”

Glaxo Unsure of Which Patients Suitable for Lotronex – (11-29-00)

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Glaxo Unsure of Which Patients Suitable for Lotronex

Sorry I didn’t get this news out to you sooner….Lotronex was just pulled off the market by the FDA. Remember, functional medicine practitioners have been treating IBS very successfully for many years now using various natural methods.

(article) Many patients with irritable bowel syndrome (IBS) alternate between the two main forms of the disease, Glaxo Wellcome said on Thursday as the US Food and Drug Administration (FDA) continued to investigate 70 reports of adverse events and five deaths in women taking the company’s IBS drug Lotronex. As of October 20, the FDA had received 49 reports of ischemic colitis, a condition in which blood flow to the colon is reduced, and 21 reports of severe constipation in women taking Lotronex (alosetron) for IBS. Five of these 70 women died, FDA spokesman Jason Brodsky said. A Glaxo spokesman denied a causal link had been established between the adverse events and the drug, which has been taken by some 300,000 women in the US since its launch in March, but which has not yet been approved in Europe. The spokesman told Reuters Health that some women had been misdiagnosed and prescribed Lotronex when they had the constipation-predominant form of IBS rather than diarrhea-predominant form for which the drug is indicated. According to the spokesman, a correct diagnosis is not straightforward because many patients — possibly as many as a third of all IBS patients — alternate between the two types.

Court Rules That FDA Can Regulate Pharmanex’s Cholestin – (08-28-00)

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Court Rules That FDA Can Regulate Pharmanex’s Cholestin

This battle has been waging for awhile. A natural product derived from red Chinese yeast rice has been shown to lower cholesterol levels. Keep a close eye on this one–it could have major implications on the supplement market if the FDA and the pharmaceuticals win.

NEW YORK, Jul 25 (Reuters Health) – Pharmanex’s cholesterol-fighting formula Cholestin is subject to US Food and Drug Administration (FDA) regulation as a drug product, the 10th US Circuit Court of Appeals ruled on Friday. However, the FDA asserts that Cholestin is a drug because it contains a substance chemically identical to lovastatin, the active ingredient in Merck’s Mevacor, which is an approved prescription therapy for lowering cholesterol. As a drug, Cholestin cannot legally be marketed without an approved New Drug Application, the agency maintains. Pharmanex has argued that mevinolin, the ingredient that the agency equates with lovastatin, is actually a significantly different substance. Mevinolin is naturally occurring, while lovastatin is synthetically isolated, purified and crystallized, according to the company.

Alosetron: case study in regulatory capture, or victory for patients’ rights? – (09-19-02)

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Alosetron: case study in regulatory capture, or victory for patients’ rights?

This article brings to light the scary concept that the FDA is funded strongly by the pharmaceutical companies they are supposed to regulate. Does anyone get a little nervous about this association besides me?

bmj.com Moynihan 325 (7364): 592

Read entire article here

Glaxo Stops Study of Asthma Drug – (02-03-03)

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Glaxo Stops Study of Asthma Drug

A few important things here. First, this drug was already approved–meaning it was already on the market and this was just a larger follow up study. This study was stopped because it may be associated with an increased risk of life-threatening asthma episodes or asthma-related deaths. HUH?? An asthma drug study is stopped because of side effects of worsening asthma?? Does the word “guinea pig” ring a bell here?

Read entire article here

Jan. 24, 2003 — The U.S. Food and Drug Administration (FDA) yesterday announced that an interim analysis of a large safety study of the approved asthma drug salmeterol xinafoate (Serevent Inhalation Aerosol) suggests that the drug may be associated with an increased risk of life-threatening asthma episodes or asthma-related deaths, particularly in some patients. At the same time, the drug’s manufacturer, GlaxoSmithKline, notified investigators that it is stopping this study, mostly due to difficulties in enrollment and the likelihood the study would not give a clear result, even if fully enrolled.The interim analysis did not show a statistically significant result for the primary endpoint — a combination of respiratory-related deaths or intubations (or ventilatory failure). There was a trend, however, toward increases in asthma deaths and serious asthma episodes when all patients in the study were considered, though again this did not reach statistical significance. A further analysis of the data from the study suggested that the risk might be greater in African-American patients, who made up 17% of the study population. Further analyses showed that patients not taking inhaled corticosteroids at study entry appeared to have greater risk for serious outcomes than those who were taking inhaled corticosteroids.”We don’t know why there was this pattern, and would like to do further studies,” Laura Bradbard, a spokesperson for the FDA, told Medscape. “Is it a socioeconomic reason? Is there a problem getting to the doctor often enough? Is the doctor following the guidelines? Or is there a physiological reason why African-Americans have more asthma? It does seem that population suffers from more asthma, and it tends to be more severe. Is it because it’s not being treated, or because it’s being treated too late? There are too many questions. That’s why we need more studies.”The halted study was designed to further investigate the safety of Serevent, particularly whether it might rarely cause serious asthma-related adverse events. It was begun in 1996, after the FDA received postmarketing reports of several asthma deaths associated with the use of salmeterol and after publication of studies raising concern about the regular use of short-acting and long-acting beta agonists, including salmeterol. Because asthma patients can sometimes suffer sudden, serious life-threatening episodes of bronchospasm as a consequence of their disease, the deaths and serious adverse events reported for salmeterol could neither be clearly attributed to use of this product, nor could it be excluded as a cause. This study was undertaken to try to help provide better information on the safety of this product. The Glaxo Data Safety Monitoring Board overseeing this trial conducted the interim data analyses that led to today’s action. Approximately 26,000 subjects, representing more than 4.3 million patient-days of exposure to the drug, had participated in the study. The study was intended to enroll 60,000 patients.The FDA approved Serevent Inhalation Aerosol in 1994 to treat asthma, and later this approval was extended to use for treatment of chronic obstructive pulmonary disease (COPD). The FDA plans to meet with Glaxo soon to obtain more details about the data from the interim analyses of the study and to determine what steps are warranted to address this information, according to a talk paper posted on the FDA’s Web site. The FDA is particularly interested in further evaluating the question of whether certain patients may be at a greater risk for rare, but potentially serious adverse events due to Serevent use and use of other related drugs.Despite the study stoppage, the FDA emphasizes in the talk paper that based on available data, the benefits of salmeterol for the asthma population continue to outweigh the risks and that the serious adverse events reported in the trial were rare. Patients are strongly advised that they should not stop taking salmeterol, or any other medication, for asthma or COPD, without first talking to their physicians, because abruptly stopping drugs for the treatment of asthma and COPD can result in serious exacerbations of these diseases that could be life-threatening.