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FAQs

Why did the FDA pull Quinine products from the market?

The FDA has gathered dangerous statistics revealing fatalities caused by quinine. From 1969 through September 11, 2006, FDA received 665 reports of adverse events with serious outcomes associated with quinine use, including, 93 deaths. The FDA discovered that many of the adverse events associated with quinine were not caused by the drug itself, but were dose-related. Also many of the adverse events were attributed to age-related issues more commonly seen in the elderly.

Why does the same company manufacture three drugs for the same purpose?

Prilosec was the first drug manufactured by AstraZeneca pharmaceuticals in 1989. Due to lenient drug patent laws generic forms of Prilosec were created by alternative drug companies and sold for less. So AstraZeneca created a more specific version of Prilosec called Nexium and there specific version of the drug is now under patent with the more recently strict drug laws. Prilosec was then approved by the FDA to be distributed as an over the counter medicine.

Why is is the FDA recalling Permax?

The FDA is responding to two recent New England Journal of Medicine studies which confirm previous findings tying pergolide to increased chance of regurgitation (backflow of blood) of the mitral, tricuspid, and aortic valves of the heart. Valve regurgitation is a condition in which valves don’t close tightly, allowing blood to flow backward across the valve. Symptoms include shortness of breath, fatigue and heart palpitations.

Why is Metabolife Still Being Sold?

Although evidence has shown Metabolife to be potentially dangerous, and even fatal, it is still being sold because the FDA has little control over herbal supplements. The FDA has proposed limiting doses to no more than 24 milligrams ephedra per day (8 milligrams per dose), though, and advises against using ephedra supplements for more than 7 days at a time. However, this proposal is in limbo due to the Dietary Supplement Health and Education Act (DESHA).

Why was Duract approved in the first place?

While there are many pain relievers, there is still a need for good medicines, and Duract was very effective in relieving pain. The safety profile of Duract was acceptable in testing before approval. No cases of serious liver injury were reported in pre-marketing clinical trials. There were some cases of liver enzyme elevations in patients treated for 30 days or longer, but these elevations resolved with discontinuation of therapy and patients did not experience any problems.

Why was Trasylol approved in 1993?

Clinical studies showed that patients who received Trasylol had less need for blood transfusions and less bleeding than patients who received a placebo. These clinical studies did not detect an increase in the risk for serious side effects.

Why was Tysabri approved by the FDA in the first place?

A study called the AFFIRM Monotherapy Trial showed a 66% reduction in the rate of MS relapses when Tysabri was used as a stand-alone treatment. The Sentinel Add-on Study showed a 54% reduction in the rate of relapses when Tysabri was used in conjunction with Avonex (interferon beta-1a). Additionally, MRIs showed that Tysabri prevented brain lesions from developing or enlarging.

Why were Digitek pills defective?

There is no clear answer to this question. Regardless of the specifics, the pills at issue were extremely dangerous given their double density and intensity, and it was seen as more prudent to simply take the steps taken to prevent further injuries.

Will I feel a Achilles tendon rupture before it happens?

There are cases where an Achilles tendon rupture will have no warning by way of symptoms, but many ruptures are preceded by extreme soreness and swelling in the area, along with an inability to move the foot normally. If you notice any of these problems, seek medical help immediately.

Will I feel anything before my Achilles tendon ruptures?

There is no set list of symptoms prior to the rupture of an Achilles tendon, as some patients report no pain or any other indications that there was a problem before the injury occurs. However, others have reported symptoms that include pain, swelling, stiffness and general irritation prior to the rupture of their Achilles tendon. If you have taken Levaquin and are experiencing any of these symptoms, seek immediate medical attention to find out how you can avoid an exacerbation of the injuries.