I was taking Indocin, my miracle medicine for Osteo for 20 years. Last July 2010 told to discontinue due to kidney function was becoming a little abnormal. (0.6) Side Effect occurred on 2008-12-30

December 30, 2008 · Filed Under Uncategorized · Comment

Knee, back and hip pain on standing and walking long periods of time

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Unapproved Drugs – message from FDA

December 28, 2008 · Filed Under Side Effect Facts · Comment

FDA has serious concerns that drugs marketed without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling. The FDA drug approval process provides a review of product-specific information that is critical to ensuring the safety and efficacy of a finished drug product. For instance, the applicant must demonstrate that its manufacturing processes can reliably produce drug products of expected identity, strength, quality, and purity. Furthermore, FDA’s review of the applicant’s labeling insures that health care professionals and patients have the information necessary to understand a drug product’s risks and its safe and effective use.

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There are prescription and over-the-counter (OTC) drugs marketed illegally without FDA approval. The manufacturers of drug products have not received FDA approval and do not conform to a monograph for making OTC drugs. These manufacturers circumvent the FDA approval process. The lack of evidence demonstrating that these unapproved drugs are safe and effective is a significant public health concern.

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Suicidal Thoughts and Behavior: Antiepileptic Drugs

December 28, 2008 · Filed Under Side Effect Facts · Comment

On December 17, 2008 the Food and Drug Administration issued a public health advisory titled: Suicidal Thoughts and Behavior, Antiepileptic Drugs.

I am Yolanda Fultz-Morris from F-D-A’s Center for Drug Evaluation and Research.

FDA is issuing this advisory to inform you of the results of our completed review of clinical trials to see if patients who took antiepileptic drugs had more episodes of suicidal thoughts or behaviors than those who did not take one of these drugs. The review included clinical trials for eleven drugs that are a part of the antiepileptic drugs class used to treat epilepsy, psychiatric disorders and other conditions. In these trials, patients who took one of the antiepileptic drugs either alone or as part of a combination had almost twice the risk of having suicidal thoughts or behaviors compared to patients who did not take one of the drugs. This increase in the risk of suicidal thoughts or behavior represents the occurrence of about one additional patient experiencing suicidal thinking or behavior for every 530 patients treated with an antiepileptic drug. This increased risk was seen as early as one week after starting treatment and continued for the entire length of treatment time in the studies we reviewed.

In January of 2008, FDA issued an alert to healthcare professionals communicating the initial results of its analysis of the data. This analysis was also discussed at a public Advisory Committee meeting in July 2008. In keeping with our commitment to provide the public with drug safety information as it becomes available, we are issuing this public health advisory to inform you of the final results of our analysis and our decision to require that companies who make antiepileptic drugs change the labeling for these products to include Warnings and Information to Patients about the increased risk of suicidal thoughts and behaviors. The companies that manufacture antiepileptic drugs will also be required to develop special patient labeling called a Medication Guide to provide patients with information about the risk of suicidal thoughts and behaviors and the signs and symptoms to look for. After the Medication Guides for antiepileptic drugs become available, patients should receive one each time a prescription is filled.

Patients, caregivers, and healthcare providers should be aware of any signs of worsening depression, any suicidal thoughts or actions and any unusual changes in behavior. Some of the common warning signs for risk of suicidal behavior are:

Talking or thinking about wanting to hurt yourself or end your life
Becoming preoccupied with death and dying
Becoming depressed or having your depression get worse
Withdrawing from friends and family
Giving away prized possessions

Patients, family members and caregivers should pay close attention to any unusual day-to-day changes in mood, behavior and actions. These changes can happen quickly so it is important to be mindful of any sudden differences.

If you notice any of these signs or if any new and worrisome behaviors occur, contact a healthcare professional immediately. Do not stop taking these medicines without first talking with your healthcare professional. Stopping these medicines suddenly can cause serious problems.

Under the authorities provided in the Food and Drug Administration Amendments Act of 2007, FDA has required that all manufacturers of antiepileptic drugs make the changes to the labeling mentioned above and described in the updated Information for Healthcare Professionals at W-W-W dot F-D-A dot GOV slash C-D-E-R slash d-r-u-g slash i-n-f-o-s-h-e-e-t-s slash H-C-P slash a-n-t-i-e-l-e-p-t-i-c-s 2-0-0-8-1-2 dot htm (http://www.fda.gov/CDER/drug/InfoSheets/HCP/antiepileptics200812.htm)

The FDA asks health care professionals and caregivers to report possible cases of suicide, suicidal thoughts and behaviors in patients taking antiepileptic drugs; patients who experience any of the warning signs above and are taking any of these drugs should also report to the FDA through the MedWatch adverse event reporting program at 1-800-F-D-A-ten-88 or by the Internet at F-D-A dot GOV slash M-E-D-W-A-T-C-H

Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot GOV slash C-D-E-R.

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Animal Drug Safety Frequently Asked Questions

December 22, 2008 · Filed Under Uncategorized · Comment

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Purchasing Pet Drugs Online: Buyer Beware

December 22, 2008 · Filed Under Uncategorized · Comment

Consumers should be cautious when buying pet drugs online and should not let Internet pharmacies "evaluate" their pets

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FDA Warns Consumers About Tainted Weight Loss Pills

December 22, 2008 · Filed Under Side Effect Facts · Comment

Agency seeks recall of products that pose serious health risks

The U.S. Food and Drug Administration is alerting consumers nationwide not
to purchase or consume more than 25 different products marketed for weight
loss because they contain undeclared, active pharmaceutical ingredients that
may put consumers’ health at risk.

The tainted weight loss products are:

Fatloss Slimming	2 Day Diet	3x Slimming Power
Japan Lingzhi 24 Hours Diet	5x Imelda Perfect Slimming	3 Day Diet
7 Day Herbal Slim	8 Factor Diet	7 Diet Day/Night Formula
999 Fitness Essence	Extrim Plus	GMP
Imelda Perfect Slim	Lida DaiDaihua	Miaozi Slim Capsules
Perfect Slim	Perfect Slim 5x	Phyto Shape
ProSlim Plus	Royal Slimming Formula	Slim 3 in 1
Slim Express 360	Slimtech	Somotrim
Superslim	TripleSlim	Zhen de Shou
Venom Hyperdrive 3.0

An FDA analysis found that the undeclared active pharmaceutical ingredients
in some of these products include sibutramine (a controlled substance), rimonabant
(a drug not approved for marketing in the United States), phenytoin (an anti-seizure
medication), and phenolphthalein (a
solution used in chemical experiments and a suspected cancer causing agent).
Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended
levels, putting consumers’ health at risk.

These weight loss products, some of which are marketed as “dietary
supplements,” are promoted and sold on various Web sites and in some
retail stores. Some of the products claim to be “natural” or to
contain only “herbal” ingredients, but actually contain potentially
harmful ingredients not listed on the product labels or in promotional advertisements.
These products have not been approved by the FDA, are illegal and may be potentially
harmful to unsuspecting consumers.

The FDA advises consumers who have used any of these products to stop taking
them and consult their healthcare professional immediately. The FDA encourages
consumers to seek guidance from a healthcare professional before purchasing
weight loss products.

“These tainted weight loss products pose a great risk to public health
because they contain undeclared ingredients and, in some cases, contain prescription
drugs in amounts that greatly exceed their maximum recommended dosages,” said
Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA. “Consumers
have no way of knowing that these products contain powerful drugs that could
cause serious health consequences. Therefore FDA is taking this action to protect
the health of the American public.”

The FDA has inspected a number of companies associated with the sale of these
illegal products, and is currently seeking product recalls. Based on the FDA’s
inspections and the companies’ inadequate responses to recall requests,
the FDA may take additional enforcement steps, such as issuing warning letters
or initiating seizures, injunctions, or criminal charges.

The health risks posed by these products can be serious; for example, sibutramine,
which was found in many of the products, can cause high blood pressure, seizures,
tachycardia, palpitations, heart attack or stroke. This drug can also interact
with other medications that patients may be taking and increase their risk
of adverse drug events. The safety of sibutramine has also not been established
in pregnant and lactating women, or in children younger than 16 years of age.

Rimonabant, another ingredient found in these products, was evaluated, but
not approved by the FDA for marketing in the United States. The drug, which
is approved in Europe, has been associated with increased risk of depression
and suicidal thoughts and has been linked to five deaths and 720 adverse reactions
in Europe over the last two years.

Health care professionals and consumers should report serious adverse events
(side effects) or product quality problems to the FDA’s MedWatch Adverse
Event Reporting program either online, by regular mail, fax or phone.

Online: www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: (800) FDA-0178
Phone: (800) FDA-1088

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