Tag Archives: fda

US diet pill ban over heart attack and stroke risk?

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The US watchdog, the Food and Drug Administration, has yet to decide whether diet pill, Meridia, should stay on the market after a report revealed that it may cause heart attack and strokes in some individuals.

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Meridia, also known as sibutramine, was first approved in the US in 1997, but a large study released last November shows that people who took the drug had an 11% risk of cardiovascular events, while those who took a placebo had a 10% risk.

The study, called the SCOUT trial, prompted regulators to order the drug off the market in Europe. And demands for it be banned in the US are now being made.

 

Meridia: Risks vs. Benefits

Meridia has been shown to reduce weight in many patients – on average 4% more body weight below what they might lose with a placebo, an amount considered a modest benefit. About one-fifth of patients lose more. But the drug also causes increases in heart rate and blood pressure, both of which pose a danger to patients with cardiovascular disease.

Patients with known cardiovascular disease are not meant to be prescribed teh drug. But experts said they were troubled that many patients with undiagnosed disease could be at greater risk if they use the drug to lose weight.

The FDA’s own monitoring linked 14 deaths to the use of Meridia.The patients who died were in their 40s 71% were women.

Conflicting Viewpoints

The Public Citizen Health Research Group,in the US, which first petitioned FDA to ban Meridia in 2002, says the drug poses a “deadly tradeoff” between modest weight loss and the danger of heart attack and stroke.

Others say Meridia can be made safe by closely monitoring things like patients’ pulses and blood pressure readings.

Abbott, which manufactures Meridia, had pledged step up warnings and educational efforts for doctors and patients if the drug is allowed to stay on the market.

Meridia’s popularity has plummeted in recent years, particularly since the release of the Scout trial’s data in November. Only an estimated 280,000 prescriptions were filled last year in the US.

The FDA now has to decide if the clear benefits of even modest weight loss to most patients is worth a rise in cardiovascular risk in some of them. The FDA will also likely consider what vital signs doctors should monitor, and how often they should monitor them, to minimize the drug’s risks.

 

Trypan Blue withdrawal in US

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Custom-Rx Compounding Pharmacy Issues Nationwide Recall of Trypan Blue 0.06% Ophthalmic Solution
Contact:
Verne Betlach
612-866-2211
Richfield, MN — August 26, 2005 — Custom RX Compounding Pharmacy of Richfield, Minnesota, is initiating a nationwide recall of Trypan Blue 0.06% Ophthalmic Solution because it may be contaminated with Pseudomonas aeruginosa, a bacteria that, if applied to the eyes, might lead to serious injury, including possible blindness. Use of Trypan Blue which is being recalled should stop immediately.

Trypan Blue was distributed to hospitals and clinics in MD, MN, IL, NE, ND, MI, DC, and PA. This product is intended for ophthalmic use (in the eyes) during cataract surgery. FDA requires that all ophthalmic products be sterile.

The solution is dark blue in appearance and is packaged in one cc sterile tuberculin syringes. Custom Rx Pharmacy is asking that all unexpired syringes be collected and returned to the pharmacy. The recall includes, but may not be limited to the following lot numbers: 05042005:86@17, 05252005:36@13, 06282005:91@27, 08012005:63@24, and 08182005:43@17.

The pharmacy has voluntarily recalled the products based on 2 reports of loss of vision possibly associated with use of the product as reported by CDC and a positive bacterial culture obtained at an outside hospital. Custom RX has verified the processes and technicians involved in the preparation of this medication. The pharmacy has been apprising the Food & Drug Administration (FDA) of the recall efforts and is working them on its investigation into the cause of the contamination.

The pharmacy immediately began notifying customers and/or distributors and working with the Centers for Disease Control (CDC) has called each individual hospital and clinic to arrange for the return, destruction and reimbursement of all recalled product.

For more information on the recall, please contact Verne Betlach with Custom RX Pharmacy at 612-866-2211 , 612-810-1363 (mobile) for information.

Injectable fillers and implants

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All of these treatments are best used for deeper lines such as deep mouth to nose and around the lips. Aimed at individuals who would prefer to avoid surgery, such as a facelift.

Autologous fat

Fat is taken from the stomach, thights or bottom and after being processed is can be injected into lips, hands, nose to mouth lines, cheeks or acne scars. The results last up to two years.

Arteplast (Artecol)

A combination of collagen and polymermethyl-methacrylate used on superficial facial lines such as the forehead.

Collagen

A connective substance found naturally in the skin and which helps it maintain elasticity. As you get older it diminishes giving way to to lines, particularly around the mouth and eyes. In these procedures the collagen is created from bovine sources, steralised and suspended in saline. It is injected, using a fine needle, into the required areas that need plumping out. The effect lasts for several months and treatments can be repeated time and time again. Anyone considering this would need to have an allergy
test beforehand. About $400 to $500 for each area.

Polymethylmethacrylate

One of the new permanent injectable skin fillers that is awaiting FDA approval is polymethylmethacrylate, made from a mixture of micronized plastic spheres and bovine collagen. When polymethylmethacrylate is injected into the skin, the collagen works by holding the synthetic spheres in place until it dissipates after injection — leaving the spheres behind to prop up the wrinkles. These spheres stimulate the body’s own production of collagen, which then forms around the spheres.

One side effect of polymethylmethacrylate include permanent or long-term lumps and temporary swelling and redness, especially when used in the lips.

Hydroxyapatite with a Methylcellulose Vehicle

For patients looking for longer-lasting results than collagen but not the permanent results of polymethylmethacrylate, a new filler known as hydroxyapatite with a methylcellulose vehicle — which is currently FDA approved for other purposes — is being studied as an injectable skin filler. The synthetic compounds used in this filler contain beads of calcium hydroxyapatite, which is a substance used to replace missing bones.

Hydroxyapatite with a methylcellulose vehicle provides a temporary correction of wrinkles that lasts about one year, but the exact duration of this filler has not been demonstrated yet. If not injected properly, the calcium beads could clump together and result in lumpiness in the treated area.

Poly-L Lactic Acid

Poly-L lactic acid is not really considered a skin filler, but a “dermal stimulator” because it stimulates the skin cells to make collagen — providing a slow correction over time. Patients are treated every month for four to five months until the correct results are achieved, results typically last one to two years.

Research studies of poly-L lactic acid for FDA approval of wrinkles are just beginning and it could be a new option for patients looking for a safe, long-lasting fix for wrinkles.

Before considering any skin filler treatment, it is recommended that patients ask the following questions:

1. Are the results permanent or temporary?
2. What are the potential side effects?
3. Is the filler approved by the FDA for this use?
4. How long has the physician used the filler? How many patients has
the physician treated? Are before and after photos available?

Isolagen

Cells are taken from behind the patient’s ear, where there is less sun damage, and cultured in a laboratory and then injected back six to eight weeks later into the face. Isolagen was launched in the UK in 2003 and although the results are not immediate it appears that top up injections are not needed as the results last.It has also proved successful in treating acne, scars and burns. It may also be used to help receding gums. It has yet to get the go-ahead of the FDA in the US. www.isolagen.com

Hyaluronic Acid Fillers

Recently approved by the FDA as a skin filler, hyaluronic acid is a naturally-occurring component of the skin that functions by holding together collagen and elastin, providing a framework for the skin. When injected into the skin in gel form, hyaluronic acid binds to water and provides volume to easily fill in larger folds of skin around the mouth and cheeks. Patients notice an immediate plumping of the skin in the treated areas.

One of the main advantages of hyaluronic acid gel is that it does not pose an allergy risk for patients and there is no risk of transmitting animal diseases by injection. Since a skin check for allergies is not required with hyaluronic acid gel, patients can be treated on their first visit to the dermatologist. The results of hyaluronic acid last approximately four to six months and require less volume to fill wrinkles and hard-to-treat skin folds compared to collagen. The main brands are Restylane and Perlane which is a stronger version.

These are used to fill out lines as a result of ageing where the skin has lost its elasticity. The target areas include eyes lines, mouth lines, smile lines and frowns between the eyebrows. Treatment takes 10-20 minutes and results last for up to nine months before a top up treatment is necessary. There may be some redness and swelling after treatment but this normally goes in a couple of days.

Newfill

Newfill is a way of resculpting the face without surgery, using an injection which consists of a saline gel with a product called Newfill, a naturally occuring polylactic acid which stimulates the body to produce its own collagen. Initially the gel fills the wrinkles and hollows, but soon disperses in the body and the patient’s own collagen is given a kick-start.

Patients usually have two sessions, at least 15 days apart, and the final result can be seen 20 days later. Results from most fillers, such as Restylane, last only three or four months, But the improvement from Newfill typically lasts for a year or longer.Th amazing thing is that Newfill has been used in surgery for the last20 years, and as a polylactic acid is found naturally in the body, and as a a result allergic reactions are rare.Unlike collagen it is not derived from animals.It can be used to treat lines on the neck as well as to rejuvenate hands, knees and ankles.

Permanent/Semi Permanent Fillers

Silicone

Banned in the US because of the risks of infection and scarring but it is still used in the UK, although increasingly less so. The liquid is injected straight into wrinkles, is permanent but there is a greater risk of hard lumps.

Gortex

This is a man-made breathable membrane, is used as a permenant wrinkle-filler and comes in several differnt forms such as, sheets, strips and tubes. Since it is porous the skingrows into it. Used to correct wide scars and deep wrinkles.

Alloderm

Made in the US from a natural deep-layer skin collected from corpses, purified and freeze-dried. Prior to use it is reconstituted using saline and implanted in sheets or strips,acting as a frame for the patient’s skin. Overtime it may be partially reabsorbed but there is little risk of rejection. A similar treatment using pig tissue is also being developed.

There is always a risk of rejection with foreign materials. The injected collagen eventually breaks down and fades away. Top-up treatments will be needed every few months, dependingon the individual. Some people develop an allergy – a test is made prior to the treatment, and a furtherone percent may show a reaction is excessive redness and swelling after treatment.
Three months and silicon and Gortex are permenant. Alloderm is semi-permanent. Recovery is immediate with perhaps some redness and swelling which will go down after a few days.Discomfort is minimal as the procedures are carried out with local anaesthetic.A hospital stay nnecesssary as it can be done in a lunch hour and is available at various clinics.
The Collagen Information Service Freefone is run by Collagen (UK) 0800 888 000.