Here's the citation for the infantrix DTaP vaccine insert and also the citation for the law that requires there to be a likely causal relationship between the vaccine and the dangers listed within. Because people often argue that quote they have to say that. 🤔
**manufacturers insert for infantrix (DTaP) from the FDA at the end of page 12…
Here's the citation for the infantrix DTaP vaccine insert and also the citation for the law that requires there to be a likely causal relationship between the vaccine and the dangers listed within. Because people often argue that quote they have to say that. 🤔
**manufacturers insert for infantrix (DTaP) from the FDA at the end of page 12.**
"6.2 Postmarketing Experience
General Disorders and Administrative Site Conditions-
fatigue, injection site induration, injection site reaction, SUDDEN INFANT DEATH SYNDROME"
**FDA's requirements for including Adverse reactions as listed on the FDA website:**
“The ADVERSE REACTIONS section next should present those adverse reactions that occurred below the specified rate for inclusion in the common adverse reactions table or listing, but for which there is some basis to believe there is a CAUSAL RELATIONSHIP between the drug and the event (for purposes of this guidance, “less common” adverse reactions). …low-frequency adverse events generally will be listed when there is
reason to suspect that the drug may have caused the event. Typical reasons to suspect causality for an event include (1) timing of onset or termination with respect to drug use, (2) plausibility in light of the drug’s known pharmacology, (3) occurrence at a frequency above that expected in the treated population, and (4) occurrence of an event typical of drug-induced adverse reactions (e.g., liver
necrosis, agranulocytosis, Stevens-Johnson syndrome). For serious events that are typical of drug-induced adverse reactions, the occurrence of even a single event could be a basis for inclusion in the list. When none of these reasons exist, however, an event should be excluded from the list.”
Here's the citation for the infantrix DTaP vaccine insert and also the citation for the law that requires there to be a likely causal relationship between the vaccine and the dangers listed within. Because people often argue that quote they have to say that. 🤔
**manufacturers insert for infantrix (DTaP) from the FDA at the end of page 12.**
"6.2 Postmarketing Experience
General Disorders and Administrative Site Conditions-
fatigue, injection site induration, injection site reaction, SUDDEN INFANT DEATH SYNDROME"
https://www.fda.gov/media/75157/download
**FDA's requirements for including Adverse reactions as listed on the FDA website:**
“The ADVERSE REACTIONS section next should present those adverse reactions that occurred below the specified rate for inclusion in the common adverse reactions table or listing, but for which there is some basis to believe there is a CAUSAL RELATIONSHIP between the drug and the event (for purposes of this guidance, “less common” adverse reactions). …low-frequency adverse events generally will be listed when there is
reason to suspect that the drug may have caused the event. Typical reasons to suspect causality for an event include (1) timing of onset or termination with respect to drug use, (2) plausibility in light of the drug’s known pharmacology, (3) occurrence at a frequency above that expected in the treated population, and (4) occurrence of an event typical of drug-induced adverse reactions (e.g., liver
necrosis, agranulocytosis, Stevens-Johnson syndrome). For serious events that are typical of drug-induced adverse reactions, the occurrence of even a single event could be a basis for inclusion in the list. When none of these reasons exist, however, an event should be excluded from the list.”
https://www.fda.gov/media/72139/download